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For an update on what medical science is doing to fight the global HIV/AIDS pandemic, read a Parade article by NIH Director Francis S. Collins and NIAID Director Anthony S. Fauci, AIDS in 2010: How We're Living with HIV .

Over the past several decades, researchers have learned a lot about the human immunodeficiency virus (HIV) and the disease it causes, acquired immunodeficiency syndrome (AIDS). But still more research is needed to help the millions of people whose health continues to be threatened by the global HIV/AIDS pandemic.

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A Review of Recent HIV Prevention Interventions and Future Considerations for Nursing Science

Author Contributions

As our knowledge of HIV evolved over the decades, so have the approaches taken to prevent its transmission. Public health scholars and practitioners have engaged in four key strategies for HIV prevention: behavioral-, technological-, biomedical-, and structural/community-level interventions. We reviewed recent literature in these areas to provide an overview of current advances in HIV prevention science in the United States. Building on classical approaches, current HIV prevention models leverage intimate partners, families, social media, emerging technologies, medication therapy, and policy modifications to effect change. Although much progress has been made, additional work is needed to achieve the national goal of ending the HIV epidemic by 2030. Nurses are in a prime position to advance HIV prevention science in partnership with transdisciplinary experts from other fields (e.g., psychology, informatics, and social work). Future considerations for nursing science include leveraging transdisciplinary collaborations and consider social and structural challenges for individual-level interventions.

Approximately 1.2 million people in the United States are currently living with HIV, and an estimated 14% are infected, yet unaware of their status ( Office of Infectious Disease and HIV/AIDS Policy, 2020 ). HIV and AIDS continue to have a disproportionate impact on certain populations, including youth—gay, bisexual, and other men who have sex with men (MSM)—racial and ethnic minorities, people who inject drugs, and residents of highly affected geographic regions such as the Southeastern United States ( Aral et al., 2020 ; Hill et al., 2018 ; Lanier & Sutton, 2013 ). Ending the HIV epidemic requires increasing engagement along the HIV prevention and care continua ( Kay et al., 2016 ; McNairy & El-Sadr, 2014 ). Early and repeat HIV testing are recommended strategies for early entry into HIV care and improved HIV-related outcomes ( DiNenno et al., 2017 ). Late and infrequent HIV testing may result in receiving an initial HIV diagnosis late in the disease trajectory, and individuals unaware they are living with HIV may be more likely to transmit HIV to others. It is essential for people living with HIV (PLWH) to receive a timely diagnosis so that they can begin combination antiretroviral therapy with the goal of achieving an undetectable viral load, a key HIV prevention strategy ( Cohen et al., 2016 ). To improve linkage and retention along the prevention and care continua, researchers have developed HIV prevention interventions in four key areas: behavioral-, technological-, biomedical-, and structural/community-level interventions.

Behavioral interventions are approaches that promote protective or risk-reduction behavior in individuals and social groups via informational, motivational, skill-building, and community-normative strategies ( Coates et al., 2008 ). HIV-specific examples include, but are not limited to, interventions promoting abstinence, condom use, sex communication, condom negotiation, HIV testing, reduction in number of sexual partners, stigma reduction, and use of clean needles among people who inject drugs. Behavioral interventions target various HIV risk behavior mediators and moderators, including symptoms of mental illness and emotion regulation ( Brawner et al., 2019 ), attitudes, beliefs, subjective norms, intentions ( Fishbein & Ajzen, 1975 ), and self-efficacy ( Bandura, 2001 ). The effectiveness of behavior-change interventions in reducing risk for HIV during the early stages of the HIV pandemic demonstrated the importance and utility of this approach ( Bekker et al., 2012 ). Classic approaches to behavioral interventions established in the early 1990s and 2000s paved the way for future research to build on, replicate, adapt, tailor, and disseminate a multitude of programs to meet the needs of various populations, such as women ( Jemmott et al., 2007 ; Wingood et al., 2004 ), MSM ( Crosby et al., 2009 ), and adolescents ( DiClemente et al., 2009 ; Jemmott et al, 1992 , 1998 , 1999 , 2010 ; Villarruel et al., 2007 ). To extend the reach of behavioral interventions, in recent years, researchers have begun leveraging technologies to promote protective and risk reduction behaviors.

The rapid expansion of the internet, mobile, and social computing technologies (e.g., text messaging, e-mail, chat, mobile phones, social media, video games, and geospatial networking applications) has provided new strategies for engaging populations who may be harder to reach through traditional venue-based HIV prevention interventions. Electronic health (eHealth) and mobile health (mHealth) have become especially popular for the delivery of technology-enabled HIV prevention interventions among populations reporting high technology ownership and use ( Barry et al., 2018 ; Conserve et al., 2016 ; Duarte et al., 2019 ; Henny et al., 2018; Hightow-Weidman & Bauermeister, 2020 ; Jongbloed et al., 2015 ; Maloney et al., 2020 ; Nadarzynski et al., 2017 ). In recent years, gamification, serious games, and virtual reality have been used in HIV prevention interventions to deliver highly engaged content and bolster interactions/behaviors in and outside of planned interventions ( Enah et al., 2013 ; Hightow-Weidman et al., 2017 , 2018 ; Liran et al., 2019 ; Muessig et al., 2015 , 2018 ). The potential role that technologies can play in increasing the scale of HIV prevention interventions, including those that aim to increase the adoption of biomedical HIV prevention methods, add to the appeal of these strategies ( Hightow-Weidman et al., 2020 ; Horvath et al., 2020 ; Maloney et al., 2020 ; Marcus et al., 2019 ; Muessig et al., 2015 ; Ramos et al., 2019 ; Threats & Bond 2021 ).

Efficacious biomedical advancements in HIV prevention, such as treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP), remain underutilized because of structural barriers and social determinants of health ( Cahill et al., 2017 ; Jaiswal et al., 2018 ; Kuhns et al., 2019 ). TasP, postexposure prophylaxis (PEP), PrEP, and pharmacologic therapy for substance abuse treatment have proven to be effective for reducing the transmission of HIV and minimizing the risk of new HIV infection ( Coffin et al., 2015 ; El-Bassel & Strathdee, 2015 ; Hosek, Green, et al., 2013 ; Page et al., 2015 ; Springer et al., 2018 ). Although biomedical prevention methods such as PEP and TasP are highly effective, we explicitly focus on PrEP because of its status as the premiere user-controlled HIV prevention medication regimen and its ability to be taken without disclosure to sexual partner(s).

In addition to behavioral, technological, and biomedical strategies that help to mitigate risk at the individual-, structural-, and community-levels, additional intervention strategies are needed to address broader social and structural factors that contribute to inequitable geobehavioral vulnerability to HIV ( Brawner, 2014 ). Such HIV prevention interventions target contextual factors (e.g., social, political–economic, policy–legal, and cultural factors) that influence transmission of and infection with HIV ( Blankenship et al., 2015 ), with an effect that diffuses out to members of key populations. Where individual-level interventions are designed to change individual beliefs, norms, and behaviors, community-level interventions aim to change the social environment (e.g., community-level norms and collective self-efficacy) and behaviors of entire populations ( Underwood et al., 2014 ). Structural- and community-level interventions are crucial to a comprehensive HIV prevention plan because they are designed to target macrolevel contextual factors (e.g., concentrated disadvantage in neighborhoods, syringe exchange policies, community-level stigma, and limited PrEP accessibility) that shape individual risk or hamper adoption of risk reduction strategies and therapeutics ( Allen et al., 2016 ; Colarossi et al., 2016 ; Gamble et al., 2017 ; Hoth et al., 2019 ; Kerr et al., 2015 ). Researchers in this space have successfully partnered with churches to decrease stigma and increase HIV testing ( Berkley-Patton et al., 2016 ; Payne-Foster et al., 2018 ), expand access to screening and prevention resources and change provider behavior ( Bagchi, 2020 ; Bernstein et al., 2017 ; Wood et al., 2018 ), and increase HIV testing in correctional facilities ( Belenko et al., 2017 ).

In this review of the literature, we explore the evolution of HIV prevention science over the past 5 years, presenting an overview of recent advances in the United States. We focused on four intervention categories—behavioral-, technological-, biomedical- (PrEP), and structural-/community-level—given the advancement of HIV prevention approaches over time. The findings highlight areas where nurses and others can advance the science of strategies to reach the national goal of ending the HIV epidemic by 2030 ( Fauci et al., 2019 ).

In our review of recent randomized controlled trials testing the efficacy of condom use and/or abstinence interventions, most targeted vulnerable populations included MSM ( Arnold et al., 2019 ; Crosby et al., 2018 ; Rhodes et al., 2017 ), adolescents ( Donenberg et al., 2018 ; Houck et al., 2016 ; Peskin et al., 2019 ), and adolescent/caregiver dyads ( Hadley et al., 2016 ; Jemmott et al., 2019 , 2020 ). Other interventions targeted incarcerated women ( Fogel et al., 2015 ) and illicit drug users ( Tobin et al., 2017 ). Many interventions were delivered in a health care or school setting, where multiple 60- to 120-min group sessions were presented. However, some interventions used a variation of frequencies and durations, such as a single 60-min one-to-one session ( Crosby et al., 2018 ) or multiple 4-hour group sessions ( Rhodes et al., 2017 ). One intervention allowed participants to attend one or two independent learning sessions, totaling 3 hours ( Hadley et al., 2016 ). About half of the reviewed studies tested the efficacy of new interventions, whereas the other half adapted previously established behavioral interventions. Crosby et al. (2018) , Fogel et al. (2015) , and Hadley et al. (2016) each adapted a different sexual health intervention. Conversely, Donenberg et al. (2018) adapted an intervention from a combination of three evidence-based programs. Instead of adapting an intervention, Peskin et al. (2019) replicated an evidence-based intervention. All interventions, except one ( Rhodes et al., 2017 ), were delivered in English.

Although several behavioral interventions led to significant increases in condom use and/or abstinence, compared with control conditions, others found no indication of intervention efficacy. For instance, Hadley et al. (2016) reported no significant group by time differences for condom use at the 3-month follow-up. These findings may be the result of delayed effects, as seen in the Fogel et al. (2015) intervention where significant group differences in condom use occurred at the 6-month follow-up, but not at the 3-month follow-up. Conversely, neither Arnold et al. (2019) nor Donenberg et al. (2018) found significant group by time differences in condom use at or beyond the 6-month follow-up, and Peskin et al. (2019) did not find differences in sexual initiation at the 24-month follow-up. These findings show that longer follow-up periods do not always have better results compared with short (i.e., 3 months) follow-up periods.

Among efficacious behavioral interventions, there was a single-session skill-building condom buffet activity ( Crosby et al., 2018 ) and multisession programs focusing on the costs and benefits of behavior change ( Fogel et al., 2015 ), emotion regulation ( Houck et al., 2016 ), cultural values ( Rhodes et al., 2017 ), environmental stressors ( Tobin et al., 2017 ), mother–son communication ( Jemmott et al., 2019 ), and scripture- and nonscripture-based abstinence ( Jemmott et al., 2020 ). Each was rooted in theoretical foundations, including those of the Theory of Planned Behavior, Social Cognitive Theory, cognitive behavioral techniques, and the AIDS Risk Reduction Model ( Azjen, 1991 ; Bandura, 1991 ; Catania et al., 1990 ). The Jemmott et al. (2019) intervention was unique in that intervention outcomes were assessed for both mothers and their sons, although the intervention was only implemented among the mothers. All other studies reported the findings of interventions that were implemented among the same participants for which outcomes were assessed.

We unexpectedly identified a nearly equal number of efficacious and nonefficacious behavioral interventions. Many studies reported increases in constructs leading to behavior change, such as self-efficacy, intentions, and attitudes, but did not find changes in actual condom use or abstinence behaviors ( Arnold et al., 2019 ; Donenberg et al., 2018 ; Hadley et al., 2016 ; Peskin et al., 2019 ). Interventions that were effective in increasing condom use and/or abstinence varied in characteristics, showing that single-session and multisession, short- and long-duration, newly created and adapted interventions can be efficacious.

Of the four interventions adapted from existing evidence-based programs, two were efficacious ( Crosby et al., 2018 ; Fogel et al., 2015 ). These interventions adapted the Focus on the Future ( Crosby et al., 2009 ) and Sexual Awareness for Everyone ( Shain et al., 1999 ) interventions. Adaptation has been long supported as an effective way to bring evidence-based interventions to new target populations and is often preferred over the creation of new interventions ( McKleroy et al., 2006 ; Solomon et al., 2006 ). However, with only half of the adapted interventions showing increased condom use among participants, it is critical that interventionists pay close attention to fidelity, proper use of theoretical foundations, and inclusion of core components during intervention adaptation and replication to maintain efficacy of the original intervention.

In accordance with previous research, the identified studies indicate the need to move away from interventions addressing a single behavior to those focusing on a combination of behavioral, biomedical, and structural approaches ( Belgrave & Abrams, 2016 ; Kurth et al., 2011 ) and those using popular technologically advanced delivery methods.

Technological Interventions

Most of the technological intervention literature we reviewed reported on studies that were at lower levels of the hierarchy of evidence ( Melnyk & Fineout-Overholt, 2011 ). Specifically, there was an imbalance in studies favoring more formative qualitative work or pilot studies compared with fewer studies reporting on randomized control trials or meta-analysis. Many studies reporting on randomized control trials also did not report on HIV-related outcomes but focused on content, protocols, or feasibility aspects of the randomized control trials. As a result, most studies reviewed were cross-sectional descriptive studies or qualitative descriptive studies using data collection strategies such as focus groups, interviews expert panels, surveys, and mixed methods ( Rodríguez Vargas et al., 2019 ; Velloza et al., 2019 ). Many of these formative studies ( Bauermeister et al., 2019 ; Cordova et al., 2018 ; Do et al., 2018 ; Enah et al., 2019 ; Erguera et al., 2019 ; Maloney et al., 2020 ; Sullivan et al., 2017 ) focused on the appeal, usability, acceptability, and feasibility of using mHealth and eHealth HIV prevention intervention across the continuum from primary prevention to disease management.

Reviewed studies show that technological interventions in HIV prevention have been studied in various target populations. These target populations include youth and young adults ( Cordova et al., 2018 ; Do et al., 2018 ; Erguera et al., 2019 ), MSM ( Alarcón Gutiérrez et al., 2018 ; Fan et al., 2020 ; Holloway et al., 2017 ), incarcerated women ( Kuo et al., 2019 ), couples ( Mitchell, 2015 ; Velloza et al., 2019 ), adults in drug recovery ( Liang et al., 2018 ), and PLWH ( Bauermeister et al., 2018 ; Schnall et al., 2019 ). These interventions vary in the technological innovations used, duration, language, format of delivery, and target outcomes.

The technology-enabled intervention studies reviewed used varying strategies to target different areas along the continuum of HIV prevention and care. In HIV testing, the focus was on synching home test results with phone counseling support ( Wray et al., 2017 ) and ordering, scheduling, and reminders associated with testing kits (e.g., Sullivan et al., 2017 ). Some studies focused on education using interactive web-based games and social media platforms ( Bauermeister et al., 2019 ; Bond & Ramos, 2019 ; Cordova et al., 2018 ; Gabarron & Wynn, 2016 ), behavioral change interventions ( Danielsonetal.,2014 ),or linkage to care and care support ( Bauermeister et al., 2018 ) targeting people who are living without HIV. Other studies focused on similar points along the care and prevention continuum targeting PLWH ( Maloney et al., 2020 ). Studies reviewed also focused on a wide range of interventions such as provision of information, self-assessments, adherence reminders, delivery of prevention information, referrals, and service from providers ( Boni et al., 2018 ; De Boni et al., 2018 ; Maloney et al., 2020 ). A number of studies included text messaging for health education, reminders, and assessments ( Dietrich et al., 2018 ; Njuguna et al., 2016 ; Ware et al., 2016 ), whereas others focused on primary behavioral preventions such as drug use ( Cordova et al., 2018 ) and engagement in care and disease management for PLWH ( Fan et al., 2020 ; Jongbloed et al., 2015 ). Reviewed studies targeting both persons living with and without HIV also used various technological-based approaches, such as interactive web-based content ( Bauermeister et al., 2019 ), smartphone geolocators near gay venues reinforcing safer sex practices ( Besoain et al., 2015 ), immersive adventure games ( Enah et al., 2019 ), and use of eye tracking technologies to monitor use ( Cho et al., 2018 , 2019 ).

Eight studies reviewed were narrative, scoping, and systematic reviews of the use and efficacy of technology-based interventions ( Bailey et al., 2015 ; Duarte et al., 2019 ; Gabarron & Wynn, 2016 ; Henny et al., 2018; Jongbloed et al., 2015 ; Maloney et al., 2020 ; Nadarzynski et al., 2017 ; Niakan et al., 2017 ). Scoping reviews of earlier digital STI prevention interventions revealed moderate effects on sexual health knowledge, small effect of behavior change, and no significant changes in biological outcomes ( Bailey et al., 2015 ; Gabarron & Wynn, 2016 ). These reviews examined studies that incorporated interventions using various designs, content, formats, target populations, and quality of content. Taken together, these reviews suggest that more research is needed to identify or develop components that can promote changes in biological outcomes. The most recent systematic review ( Maloney et al., 2020 ) found a wealth of published literature on technology-based interventions. However, findings from this systematic review suggest that most of the studies focus on educational and behavior change interventions, whereas relatively few focused on linkage to and retention in HIV prevention and care and adherence to HIV medicines, especially PrEP.

The drug combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), widely known by its brand name Truvada, used as oral PrEP in preventing HIV infections for MSM in the United States, is a well-documented, effective prevention strategy ( Grant et al., 2010 ; Mayer et al., 2020 ). However, many communities impacted by HIV are underrepresented in research trials in the United States, including transgender populations, cisgender women, and people who inject drugs. Most of the research in these groups has occurred internationally and has not had as strong an impact on HIV incidence as that of the MSM ( Baeten et al., 2012 ; Kibengo et al., 2013 ; MacLachlan & Cowie, 2015 ; Marrazzo et al., 2015 ; Martin et al., 2017 ; Mutua et al., 2012 ; Peterson et al., 2007 ; Thigpen et al., 2012 ; Van Damme et al., 2012 ).

Despite Black MSM bearing a disproportionate burden of HIV infection in comparison to MSM of other ethnicities, they are underrepresented in PrEP studies ( Hess et al., 2017 ). Most PrEP clinical trials, open-label studies, and observational studies included less than 10% Black MSM. ( Grant et al., 2010 ; Mayer et al., 2020 ). The few studies that included higher proportions of Black MSM had small numbers, including three community studies by Chan (49%, n = 109), Project PrEPare-ATN 082 (53%, n = 31), Project PrEPare-ATN 110 (47%, n = 93), and Project PrEPare-ATN 113 (29%, n = 23; Hosek et al., 2017 ; Hosek, Siberry, et al., 2013 ). Moreover, there are study gaps in sex, and the number of studies on high-risk cisgender women and transgender women is significantly smaller compared with MSM ( Kamitani et al., 2019 )

In 2019, the U.S. Food and Drug Administration (FDA) approved tenofovir alafenamide/emtricitabine (TAF/FTC), widely known as Descovy, as the first alternative medication for PrEP for MSM and transfeminine communities (FDA, 2019). TAF/FTC was shown to be noninferior to TDF/FTC. The side-effect profiles differ in that TDF/FTC has increases in renal and bone toxicities and TAF/FTC has increases in weight and lipids ( Mayer et al., 2020 ). TAF/FTC was not studied in other communities and did not gain an FDA indication for cisgender women and transmasculine communities. Some studies have found a potential link between the use of estradiol for gender-affirming care and lower tenofovir levels in the blood ( Hiransuthikul et al., 2019 ; Shieh et al., 2019 ; Yager & Anderson, 2020 ).There have been smaller studies to verify this interaction, but reported controlling for confounding variables was difficult. Further research is needed to understand whether there is effect on the efficacy of TDF and how this may impact nondaily dosing strategies.

Currently, daily oral PrEP is the only antiretroviral medication recommended for the prevention of HIV through sexual contact and drug injection use among people without HIV by the U.S. Centers for Disease Control and Prevention (CDC; U.S. Centers for Disease Control and Prevention & U.S. Public Health Service, 2018 ). In 2015, Molina et al. (2015) published a placebo-controlled trial of an “On-Demand” or 2-1-1 dosing strategy for MSM and transfeminine communities where 2 TDF/FTC pills would be taken 2 to 24 hr before sex, followed by 1 pill every 24 hr while sex continues, and ending 2 doses after the last sex act. This study found high efficacy and acceptability with an 86% reduction in HIV incidence relative to placebo on an intention to treat basis; no one acquired HIV while using 2-1-1 dosing of this nondaily dosing strategy. Furthermore, additional prospective open-label studies also showed no HIV acquisition among study participants ( Hojilla et al., 2020 ; Siguier et al., 2019 ). Despite the lack of endorsement by the CDC, many local Departments of Public Health support PrEP 2-1-1 as a way to make PrEP more attainable for the MSM community ( Los Angeles County Department of Public Health, 2019 ; New York City Department of Health and Mental Hygiene, 2019 ; San Francisco Department of Public Health, 2019 ).

Although effective, researchers and primary care providers note the need to simplify current PrEP delivery models. The CDC recommends a follow-up visit every 3 months while on PrEP, which can often be challenging for individuals to attend visits and pay laboratory costs ( U.S. Centers for Disease Control and Prevention & U.S. Public Health Service, 2018 ). A new model of care that leverages mHealth (e.g., mobile and social computing technologies) to increase initiation, retention, and adherence to PrEP, such as electronic PrEP (ePrEP), has been introduced and found to be acceptable and effective among PrEP users ( Siegler et al., 2020 ). PrEPmate is one such multicomponent mHealth intervention that uses short-message service (SMS) and youth-tailored interactive online content to enhance PrEP adherence among at-risk young MSM ( Liu et al., 2019 ). Currently, it is the only PrEP study identified as an Evidence-Based Intervention by the CDC Prevention Research Synthesis project ( CDC, 2020 ). Siegler et al. implemented the PrEP at Home Study among 50 young Black MSM in a rural area. In the study, 42% of participants received PrEP via the ePrEP system, whereas 93% preferred to use ePrEP over standard provider visit and 67% were more likely to remain on PrEP if ePrEP were available ( Siegler et al., 2019 ).

Future biomedical HIV prevention modalities such as long-acting injectable agents have the potential to prevent HIV acquisition without relying on adherence to a daily or 2-1-1 oral dosing regimen. In MSM and transfeminine communities, an injectable form of cabotegravir given intramuscularly every 2 months had an estimated 66% lower incidence of HIV, compared with daily TDF/FTC ( Landovitz, 2020 ). Additional cabotegravir studies in cisgender women are being conducted under HPTN 084 to evaluate safety and efficacy (the LIFE Study; HIV Prevention Trials Network, 2020 ). The dapivirine (DAP) vaginal ring, for use by cis-women as a flexible silicone ring that continuously releases the antiretroviral HIV drug DAP in the vagina as a long-acting option for HIV prevention is another biomedical HIV prevention modality being studied ( Psomas et al., 2017 ). A phase 2a trial of a 25-mg DAP vaginal ring has been shown to be safe and acceptable among U.S. adolescents ages 15–17 ( Psomas et al., 2017 ). The DAP vaginal ring has been approved by the European Medicines Agency for women older than 25 years, and further studies are ongoing for women ages 15–25 years in the United States ( National Institutes of Health, 2020 ).

Although there are clear benefits to the aforementioned intervention strategies, structural- and community-level interventions are distinctly different, given their focus on macrolevel factors that influence risk versus individual beliefs and behaviors. This is imperative because in many highly affected demographics (e.g., Black women and young racial and ethnic minority MSM), broader social and structural factors drive HIV risk more than individual behavior ( Bauermeister et al., 2017 ; Brawner, 2014 ). With this wider focus, changes are seen in factors such as social diffusion of safer sex messages and comfort with being gay ( Eke et al., 2019 ), better viral suppression and continuity in care ( El-Sadr et al., 2017 ; Towe et al., 2019 ; Wohl et al., 2017 ), and increased HIV testing in populations that may not have otherwise been tested ( Belenko et al., 2017 ; Berkley-Patton et al., 2019 ; Frye et al., 2019 ).

Addressing structural barriers can reduce viral load, prevent HIV infection, and increase HIV testing. In homeless populations, researchers used a rapid rehousing intervention to place participants in stable housing faster (3 months earlier than usual service clients), doubling the likelihood of achieving or maintaining viral suppression ( Towe et al., 2019 ), and worked through primary care providers in Veterans Affairs to increase PrEP access ( Gregg et al., 2020 ). Community-level interventions that used financial incentives reduced viral load and decreased self-reported stimulant use among sexual minority men who use methamphetamine ( Carrico et al., 2016 ) and increased viral suppression and continuity in care in HIV-positive patients ( El-Sadr et al., 2017 ). The latter intervention, however, did not demonstrate an effect on increasing linkage to care.

Health care access remains a concern, and novel strategies can be used to get services to those in need. Pharmacies have also been promising locations for HIV prevention work. Persons who inject drugs were more likely to report always using a sterile syringe than not when they were connected to pharmacies that received in-depth harm reduction training and provided additional services (i.e., HIV prevention/medical/social service referrals and syringe disposal containers; Lewis et al., 2015 ). Providing a PEP informational video and direct pharmacy access to PEP also increased PEP knowledge and willingness; however, this did not translate to more PEP requests ( Lewis et al., 2020 ).

In correctional facilities, researchers have used strategies such as referral to care within 5 days after release, medication text reminders, and local change teams with external coaching to maintain viral suppression post-release and increase HIV testing among inmates ( Belenko et al., 2017 ; Wohl et al., 2017 ). High fidelity to the required institutional changes needed to improve HIV services was also noted ( Pankow et al., 2017 ). With the detrimental effects of mass incarceration, including disparate HIV outcomes while incarcerated and post-release, correctional settings are prime targets for future structural intervention work.

Success is tied to meeting people where they are—engaging them through existing programs, organizations, and institutions they are already connected to. Congregation-level interventions have demonstrated success in doubling HIV testing rates and reducing HIV stigma ( Berkley-Patton et al., 2019 ; Derose et al., 2016 ; Payne-Foster et al., 2018 ); however, effects on HIV stigma varied across studies. The studies demonstrating an effect on HIV stigma only achieved this at the individual—not congregation—level ( Payne-Foster et al., 2018 ), and in Latino—but not African American—churches ( Derose et al., 2016 ). Key to these interventions was the inclusion of multilevel activities (e.g., ministry group activities, HIV testing events during services, and pastors delivered sermons on HIV-related topics) and flexibility to accommodate church schedules and levels of comfort with covering different topics. Churches were not the only setting where addressing HIV stigma beyond the individual-level was a challenge. In a community-level intervention on HIV stigma, homophobia, and HIV testing, researchers used workshops, space-based events, and bus shelter ads in a high HIV prevalence area but did not have an effect on HIV stigma or homophobia ( Frye et al., 2019 ). They did, however, increase HIV testing by 350%.

Individuals within key systems and communities can also be pivotal to share HIV-related information and increase access to services. Integration of lay health advisors (“Navegantes”) into existing social networks (i.e., recreational soccer teams) among Hispanic/Latino men led to twice the likelihood of reporting consistent condom use in the past 30 days and HIV testing at the 18-month follow-up ( Rhodes, Leichliter, et al., 2016 ). A year after the intervention ended, 2 years after their training, 84% of the Navegantes (16 of 19) continued to conduct 9 of the 10 primary health promotion activities (e.g., talking about sexual health, describing where to get condoms, and showing segments of the intervention DVD; Sun et al., 2015 ). Furthermore, using a popular opinion leader model targeting alcohol-using social networks, researchers demonstrated a decline in composite sexual risk (e.g., having sex while high or with a partner who is high and exchanging sex for drugs or money) and an increase in HIV knowledge ( Theall et al., 2015 ). An intervention developed for college students and those in the surrounding area integrated HIV testing and education, mental health, and substance abuse services and referrals and noted a preliminary effect on social norms and sexual health messages on campus ( Ali et al., 2017 ).

Culturally situated marketing and other media approaches reach a broader audience to effect change. Successful social marketing campaigns to promote HIV testing should be performed in a way that enhances well-being (rather than fear-based messages), does not represent the target community in stigmatizing ways, and acknowledges barriers to HIV testing (e.g., stigma; Colarossi et al., 2016 ). One study evaluated a city-level, culturally-tailored media intervention combined with an individual risk reduction curriculum in comparison to no city-level media and a general health curriculum ( Kerr et al., 2015 ). Study findings suggested that all media-exposed participants had greater HIV-related knowledge at 6 months, and those who received the media intervention and risk reduction content had lower stigma scores at 3 and 12 months. A community-level intervention designed to decrease HIV risk among young MSM via persuasive media communication and peer-led networking outreach reduced anal sex risk among participants who reported binge drinking and/or marijuana use; the effect was not sustained for those who used other drugs ( Lauby et al., 2017 ). Another community mobilization intervention (e.g., publicity, groups, and outreach) addressed psychosocial factors at individual, interpersonal, social, and structural levels and documented an increase in HIV testing and a reduction in condom-less sex (although not sustained at 6 months; Shelley et al., 2017 ).

Interventions targeting providers and care delivery increase risk screening, HIV testing, timely linkage to care, and PrEP access for eligible individuals. Similar to the ways lay health workers are activated internationally, Health Promotion Advocates were employed in pediatric emergency departments to survey patients (e.g., health risks, stresses, and needs; Bernstein et al., 2017 ). Positive screens triggered critical resources (e.g., brief conversation on risks and needs and treatment as indicated), and, as a result, the intervention extended emergency services beyond the scope of the presenting complaint, engaging more than 800 youth in critical services such as mental health treatment and HIV testing. By pairing intensive medical case management with formalized relationships with local health departments and resources and addressing structural barriers (e.g., ability to access HIV prevention, testing, and medical care), researchers were able to decrease the average number of days to link to care and maintain the decline over a 6-year period ( Miller et al., 2019 ). Ninety percent of those linked to care had an initial medical visit in 42 or fewer days postdiagnosis. The integration of PrEP referrals into STI partner services led to 54% of PrEP eligible men accepting a PrEP referral and a 2.5-fold increase in PrEP use after partner services among MSM ( Katz et al., 2019 ).

Another group had health professional students (e.g., medicine and pharmacy) provide education about PrEP to public health providers, contributing to an increase in PrEP prescriptions, including for PrEP-eligible at-risk groups who previously were not given prescriptions ( Bunting et al., 2020 ). An underway pilot targets training primary care providers to better understand historical influences of structural factors, assess structural vulnerability among patients, create a more integrated system of care (e.g., opioid use and HIV risk) and empathy and nonjudgement in patient interactions ( Bagchi, 2020 ). There is strong precedent for this, given that significant effects were noted in creating affirming environments for sexual and sex minority youth, including improvements in providers’ and staff’s knowledge and attitudes, clinical practices, individual practices, and perceived environmental friendliness/safety ( Jadwin-Cakmak et al., 2020 ).

Policy changes can hinder or advance HIV prevention efforts, and modeling is an effective strategy to project outcomes and identify targeted prevention strategies. In an examination of Washington, DC’s buffer zone policy—prohibition of syringe exchange program operations within 1,000 feet of schools—researchers found that adherence to this 1,000 Foot Rule reduced syringe exchange program operational space by more than 50% a year ( Allen et al., 2016 ). These restrictions on the amount of legal syringe exchange program operational space have a significant impact on service delivery among injection drug users, which in turn affects HIV transmission through syringe sharing ( Allen et al., 2016 ). Analysis of a natural policy intervention indicated that removing a ban that prohibited the use of federal funds for syringe exchange programs potentially averted 120 HIV cases ( Ruiz et al., 2016 ).

In examining which prevention approach would achieve the greatest impact on HIV transmission, in light of available resources, study findings suggested that targeted testing by venue is more cost effective than routine emergency department testing ($31,507 vs. $59,435, respectively; Holtgrave et al., 2016 ). Modeling of interventions in 6 cities indicated that HIV incidence could be reduced by up to 50% by 2030, with cost savings of $95,416 per quality-adjusted life-year, by implementing combinations of evidence-based interventions (e.g., medication for opioid use disorder, HIV testing, ART initiation, and retention; Nosyk et al., 2020 ). Of note, nurse-initiated rapid testing was included in the optimal combination that produced that greatest health benefit while remaining cost effective across all cities. An ongoing microenterprise RCT will determine the effects of multiple strategies (e.g., weekly text on job openings, educational sessions on HIV prevention, and $11,000 start-up grant) on sexual risk behaviors, employment, and HIV preventive behaviors among economically vulnerable African American young adults ( Mayo-Wilson et al., 2019 ); a paucity of reviewed studies focus in this area. A comparable holistic health demonstration project, which engaged young Black MSM, successfully achieved viral suppression, connected participants to employment opportunities, and addressed housing discrimination ( Brewer et al., 2019 ).

Discussion and Future Considerations for Nursing Science

This review of current HIV prevention interventions provides a substantial contribution to the literature by synthesizing literature on four key areas of HIV prevention science. Nursing focuses on holistic care, assessing, diagnosing, and treating all areas that influence individual and population health. As we consider where and how to develop these programs, research indicates that more people may receive HIV prevention interventions in community-based clinics than in primary care or acute care settings ( Levy et al., 2016 ). Future nursing research should aim to address the needs of underserved populations who may benefit from robust HIV prevention strategies as outlined in this discussion section.

As we continue to generate knowledge about the multidimensional nature of HIV risk, especially for marginalized and vulnerable populations, there are increasing opportunities to learn from and use previous research to design multilevel and combination intervention strategies to better overcome barriers to HIV prevention ( Brawner, 2014 ; Frew et al., 2016 ). As suggested by the identified behavioral intervention studies, classic and current prevention programs have used useful strategies, but there remains room for improvement. These studies advance the science of HIV prevention, which helps fill gaps in the current literature and offer valuable insights that can contribute toward advancing the plan of Ending the HIV Epidemic ( U.S. Department of Health and Human Services, 2019 ; Treston, 2019 ).

As behavioral interventions continue to be created, replicated, and adapted, researchers should focus on implementing and testing these interventions in real-life settings. Implementation science strategies include planning, education, finance, restructuring, quality management, and policy strategies ( Powell et al., 2012 ). These strategies include various aspects of collecting data from stakeholders and community members, assessing setting readiness, determining realistic dosing, and assessing intervention acceptability and feasibility among target populations. The translation of science from research settings to real-life settings is imperative in the sustainability of efficacious behavioral interventions.

Technological

Although there is a plethora of technological-based HIV interventions with many in the pipeline, gaps persist in the current literature. There is a lack of precise knowledge regarding the content components of these interventions that are associated with improving clinical outcomes ( Dillingham et al., 2018 ; Ramos, 2017 ). There is also limited knowledge of optimal delivery approaches for these types of digital HIV interventions ( Côté et al., 2015 ; Schnall et al., 2015 ). In addition, there is a dearth of studies evaluating the efficacy, effectiveness, and cost effectiveness of using emerging technologies in HIV prevention interventions, such as gaming, gamification, social media, and virtual interventions ( Garett et al., 2016 ; Kemp & Velloza, 2018 ; LeGrand et al., 2018 ). Furthermore, there is a lack of resource-sharing platforms that would allow for new research to build on impactful elements of technology-based HIV prevention interventions without recreation of these components. Making these components available in an open platform would substantially reduce time and costs of developing new technological interventions and prevent wasteful use of resources on elements that do lead to desired outcomes.

In all, because technology continues to evolve and potential users of these interventions gain more access and complex skills in the use of other applications in everyday life, the demand for more user-centric HIV prevention interventions will likely continue to grow. Current interventions will need to be updated to maintain relevance, and new interventions will need to be designed to be adaptable to continuing technological advances. Policymakers have a role to play in allowing for governmental sharable databases of impactful interventions so that limited resources can be used to design predictably effective components of technological interventions leading to better health outcomes.

The nurse plays a vital role in HIV prevention and PrEP care ( O’Byrne et al., 2014 ). The University of California, San Francisco School of Nursing, recently developed and validated a set of entry-level nurse practioner competencies to provide culturally appropriate comprehensive HIV care ( Portillo et al., 2016 ). Similar programs should be implemented to train nurses and further the delivery of nursing-led biomedical HIV interventions. Magnet is a nurse-led clinic in San Francisco that has successfully leveraged expanded scopes of practice to allow for nurses to practice to the full extent of their licensure and allow for the rapid expansion of PrEP services to the community ( Holjilla et al., 2018 ). Such a unique and successful community-based PrEP delivery intervention led to the development and implementation of pharmacist-led PrEP clinics ( Havens et al., 2019 ; Lopez et al., 2020 ; Tung et al., 2018 ). More community-based, nursing-led biomedical HIV interventions are needed. Furthermore, future research should explore the efficacy of biomedical HIV prevention among transmasculine and cis-women populations, especially those of color who are underrepresented in existing research efforts ( Bond & Gunn, 2016 ; Chandler et al., 2020 ; Deutsch et al., 2015 ; Golub et al., 2019 ; Rowniak et al., 2017 ; Willie et al., 2017 ). Community-based nursing-led HIV interventions may be opportune for reaching these populations.

Structural and Community

Most HIV prevention structural- and community-level interventions still focus on developing countries, with less attention in the United States ( Adimora & Auerbach, 2010 ). However, with several communities facing limited resources, large percentages of individuals living below the federal poverty level and high HIV incidence and prevalence rates, it is time to expand these international success stories to domestic work (e.g., microfinance, credit programs, and comprehensive sexual health education). There is also a paucity of these interventions targeted to women and youth. Relative to the other reviewed strategies, very few nurses are engaged in structural-/community-level interventions. If successful, the in-progress microenterprise RCT by Mayo-Wilson et al. (2019) has the potential to serve as a blueprint for integrating multiple structural approaches that have demonstrated effectiveness abroad into U.S. contexts. The work by Werb et al. (2016) can also transform approaches to structural approaches to prevent injection drug initiation—given nursing’s focus on prevention, initiation of, and/or partnership in such work could be pivotal.

An approach to consider moving forward is applying the multiphase optimization strategy (MOST) to HIV prevention strategies ( Collins et al., 2016 ). MOST uses randomized experimentation to assess the individual performance of each intervention component. This rigorous process, based on a priori optimization criteria (e.g., cost and time), identifies whether aspects of an intervention component (e.g., presence, absence, and setting) have an impact on the performance of other components. Ultimately, this knowledge is used to engineer an intervention that is effective, efficient, and readily scalable. Multilevel interventions that target more than one level can lead to the most sustainable behavior change and can be delivered in venues known to be associated with HIV risk (e.g., bars and nightclubs; Pitpitan & Kalichman, 2016 ). An ongoing study on neighborhood contexts (e.g., poverty, HIV prevalence, and access to care) and network characteristics (e.g., size and frequency of communication) among Black MSM in the deep south will generate rich data to inform interventions for this key demographic ( Duncan et al., 2019 ). There also remains a need for explicit research with transgender populations—versus only including them in other samples—to fill gaps and meet unique needs ( Mayer et al., 2016 ).

Nursing Advancements

Nurse scientists around the globe are contributing to the development of interventions along the care continuum. Jemmott et al. have created numerous behavioral interventions over the past 30 years, which have been adapted for use in new settings and with different populations ( Advancing Health Equity: ETR, 2019 ). Behavioral interventions have been implemented using technology. Nursing exemplars in technology include the development of an immersive adventure game for African American adolescents ( Enah et al., 2019 ; Enahet al., 2015). In a series of studies in the primary prevention end of the prevention and care continuum, Enah et al. studied relevant content and design elements, evaluated an existing web-based game for relevance, developed and qualitatively studied acceptability of an individually tailored adventure game, and evaluated the potential efficacy of the game among African American adolescents ( Enah et al., 2019 ; Enah, Piper & Moneyham, 2015 ). At the care end of the continuum, Schnall et al. adapted an existing intervention for MSM ( Schnall et al., 2016 ), addressing co-morbidities for PLWH using multimodal techniques ( Schnall et al., 2019 ).

Flores developed a novel sex communication video series to support parent–child communication for gay, bisexual, and queer male adolescents ( Flores et al., 2020 ). Nurses have also collaborated on telehealth interventions to identify barriers to HIV care access and adherence and address mental health, substance use, and other issues among youth and young adults living with HIV ( Wootton et al., 2019 ). Other researchers piloted HIV/STI prevention content curated from online resources (e.g., YouTube and public and private websites) and found that youth who received links to publicly accessible online prevention content had a significant improvement in HIV self-efficacy and a significant reduction in unprotected vaginal or anal sex ( Whiteley et al., 2018 ). Nurses can partner with public health experts, computer scientists, and others to leverage these resources for population health improvement because new technologies continue to emerge ( Rhodes, McCoy, et al., 2016 ; Stevens et al., 2017 ; Stevens et al., 2020 ). Nurses, including members of the Association of Nurses in AIDS Care, have also been instrumental in the All of Us Research Program, a National Institutes of Health initiative aiming to enroll one million people across the United States to increase accessibility to data on individual variability in factors including genetics, lifestyle, and socioeconomic determinants of health to speed up medical breakthroughs ( National Institutes of Health, 2020 ).

As experts in community-engaged HIV research, partnerships that are committed to engaging key communities will lead to the development of interventions—across levels—to help achieve national goals of ending the HIV epidemic by 2030 ( Fauci et al., 2019 ). Health departments, academia, and community partners can also collaborate on policy modeling to improve resource allocation and better address HIV prevention priority setting ( Holtgrave et al., 2016 ). Investigators have also called for legal reform to address state-level structural stigma (index including density of same-sex couples and state laws protecting sexual minorities) experienced by MSM, given linkages between decreased state-level stigma and reduced condomless anal intercourse and increased PEP and/or PrEP use ( Oldenburg et al., 2015 ). Geographic information systems mapping can also be used to identify areas of greatest need and allocate necessary resources ( Brawner et al., 2017 ; Brawner, Reason, Goodman, Schensul, & Guthrie, 2015 ; Eberhart et al., 2015 ).

Recommendations to Further Advance HIV Prevention Intervention Science

Based on the literature reviewed and gaps identified, we offer three recommendations to further advance HIV prevention intervention science. First, nurses should leverage transdisciplinary partnerships to lead the development and testing of comprehensive interventions. For example, nurses could develop and test a nurse-delivered intervention model that engages pharmacists for PrEP access, psychologists and social workers for mental health treatment, librarians and health communication scholars for improving health literacy, and health informaticists to program the content for virtual delivery. Second, nurse researchers are at the cutting edge of knowledge generation in multiple fields, including HIV science (as evidenced by this review), and should be highly sought after for research collaboration accordingly. Although nursing is one of the most trusted professions, nurses are often overlooked when researchers in other disciplines search for collaborators with advanced methodological skill sets, content-specific expertise, or additional perceived benefits to their research teams. Finally, regardless of the intervention type (e.g., behavioral and biomedical), future intervention work must account for social and structural challenges experienced by the intended intervention recipients (e.g., racism, homelessness, and concentrated poverty in neighborhoods). This could include activities such as adding social service linkages to research protocols (e.g., providing participants with information on stable housing programs) or implementing structural interventions to improve neighborhood conditions (e.g., hiring community members to green vacant lots).

Nurses have made tremendous strides in behavioral interventions; however, representation in biomedical-, technological-, and structural-/community-level interventions is limited. We believe this hinders possible advancements in HIV prevention science, given the uniqueness a nursing lens contributes to research endeavors. We encourage nurses to expand the scope of their intervention work, and for individuals working in fields of HIV prevention where nurses are underrepresented, to seek out nursing collaborators. Together, these transdisciplinary teams can curb the epidemic and achieve an AIDS-free generation.

Key Considerations

• Nurses should leverage transdisciplinary partnerships to lead the development and testing of comprehensive interventions.
• Future intervention work must account for social and structural challenges experienced by the intended intervention recipients.
• Nurse researchers should be used for their advanced methodological skill sets and expertise in HIV prevention science.

Disclosures

The authors report no real or perceived vested interests related to this article that could be construed as a conflict of interest.

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HIV Treatment Research and Key Takeaways: Dr. Dieffenbach’s Final Update from CROI 2024

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On Wednesday as the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) was winding down, HIV.gov spoke with NIH’s Dr. Carl Dieffenbach about highlights of long-acting HIV treatment research discussed at the conference. Dr. Dieffenbach is the Director of the Division of AIDS at NIH’s National Institute of Allergy and Infectious Diseases . He spoke with Brian Minalga, MSW, Deputy Director of the NIH-supported  Office of HIV/AIDS Network Coordination Exit Disclaimer . Watch our conversation with Dr. Dieffenbach below:

Research Suggests Possible Expanded Options for Long-Acting HIV Treatment

Dr. Dieffenbach highlighted findings from several clinical trials and a plenary session presented at CROI about current and future options for long-acting antiretroviral treatment (ART) for HIV.

First, he discussed a NIAID-supported randomized clinical trial that found that long-acting ART with cabotegravir and rilpivirine was superior in suppressing HIV replication compared to daily oral ART in adults who had been unable to maintain viral suppression through an oral daily regimen. The LATITUDE study Exit Disclaimer enrolled participants in 31 sites in the United States. Last month, the trial’s Data and Safety Monitoring Board conducted a planned review of interim data and recommended halting randomization and offering all eligible study participants long-acting ART based on its observed superior viral suppression of HIV. At CROI, study leaders reported that the interim analysis of data from 294 participants showed that the chance of experiencing unsuppressed HIV was 7% among people taking long-acting ART compared to 25% among those taking daily oral ART . The likelihood of discontinuing the assigned regimen due to adverse events or experiencing unsuppressed HIV was 10% among people taking long-acting ART compared to 26% among those taking daily ART. These findings were statistically significant. Dr. Dieffenbach observed that these results may support expanding the use of long-acting ART among a broader population. Read the study abstract Exit Disclaimer . Read more in this NIAID news release .

Another ongoing clinical trial reported initial findings on the safety of the same long-acting injectable treatment regimen for adolescents with HIV with a suppressed viral load. The NIH-supported MOCHA study Exit Disclaimer enrolled participants aged 12 to 17 who were virally suppressed in Botswana, South Africa, Thailand, Uganda, and the United States. In what he characterized as very encouraging results, Dr. Aditya Gaur of St. Jude Children's Research Hospital, one of the trial’s co-chairs, reported that after the first six months all participants remained virally suppressed, and the level of the ART in their systems was comparable to what has been shown as efficacious in adult studies of the same drug . He also reported that, while about one-third of the participants reported an injection-site reaction, there were no surprising or unanticipated adverse events. These data support the use of cabotegravir and rilpivirine in virally suppressed adolescents, according to Dr. Gaur and colleagues. Dr. Dieffenbach noted that NIH will continue to support safety and dosing studies to determine the proper doses for adolescents and that these studies could eventually expand access to this long-acting HIV treatment to more people. Read the abstract Exit Disclaimer . Read NIAID’s news release about the study .

In addition, Dr. Dieffenbach mentioned an industry-sponsored Phase 2 trial that presented 24-week results of an oral once-weekly investigational combination of two drugs ( islatravir and lenacapavir ). Researchers reported that the investigational combination maintained a high level of viral suppression among study participants and was well tolerated. The study will continue to gather data and suggests that a weekly oral HIV treatment regimen could someday be possible . Read the abstract Exit Disclaimer .

Finally, Dr. Dieffenbach discussed Wednesday’s plenary session by Dr. Charles Flexner of The Johns Hopkins University School of Medicine, which was titled “The End of Oral? How Long-Acting Formulations Are Changing the Management of Infectious Diseases.” In his big picture, future-focused presentation exploring long-acting drug delivery, Dr. Flexner observed that there is a need for HIV products with less frequent dosing, greater convenience, and greater likelihood of viral suppression, as well as for the prevention and treatment of other diseases, including tuberculosis, malaria, and viral hepatitis. He discussed recent advances in formulation science that are going to help make available better replacements for daily oral drugs for HIV and many other infectious diseases . Dr. Dieffenbach underscored Dr. Flexner’s point that these novel products must be developed with access and equity in mind so that people who need them, especially in resource-limited settings, can use them.

Key Takeaways

Reflecting on key takeaways from the entire conference, both Dr. Dieffenbach and Brian pointed to the importance of partnership between the HIV community and scientists in all aspects of HIV research , a theme also discussed in HIV.gov’s conversation with Dr. LaRon Nelson from the conference. In terms of research highlights, Dr. Dieffenbach pointed to the results reported from the IMPAACT P1115 study in which several children who started HIV treatment within hours of birth later surpassed a year of HIV remission after a treatment pause. ( See HIV.gov’s interview with Dr. Deborah Persaud about this study .) He also noted that the additional data accumulating on the effectiveness of Doxy-PEP is encouraging and will hopefully soon be reflected in clinical guidelines that help to reduce the incidence of syphilis, chlamydia, and gonorrhea in men who have sex with men and transgender women.

Catch Up on More HIV Research Updates

HIV.gov has shared other interviews from CROI 2024 with federal HIV leaders, participating researchers, and community members. You can find all of them on HIV.gov’s social media channels and recapped here on the blog this week and next week.

More than 3,600 HIV and infectious disease researchers from 73 countries gathered in Denver and virtually from March 3-6 this year for CROI, an annual scientific meeting on the latest research that can help accelerate global progress in the response to HIV and other infectious diseases, including STIs and viral hepatitis. Over 1,000 summaries of original research were presented. Visit the conference website Exit Disclaimer for more information. Session webcasts and more information will be published there for public access in 30 days.

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• Review Article
• Published: 01 December 2021

Research priorities for an HIV cure: International AIDS Society Global Scientific Strategy 2021

• Steven G. Deeks 1 ,
• Nancie Archin 2 ,
• Paula Cannon   ORCID: orcid.org/0000-0003-0059-354X 3 ,
• Simon Collins 4 ,
• R. Brad Jones 5 ,
• Marein A. W. P. de Jong 6 ,
• Olivier Lambotte 7 ,
• Rosanne Lamplough 8 ,
• Thumbi Ndung’u 9 , 10 , 11 ,
• Jeremy Sugarman   ORCID: orcid.org/0000-0001-7022-8332 12 ,
• Caroline T. Tiemessen   ORCID: orcid.org/0000-0002-0991-1690 13 ,
• Linos Vandekerckhove   ORCID: orcid.org/0000-0002-8600-1631 14 ,
• Sharon R. Lewin   ORCID: orcid.org/0000-0002-0330-8241 15 , 16 , 17 &

The International AIDS Society (IAS) Global Scientific Strategy working group

Nature Medicine volume  27 ,  pages 2085–2098 ( 2021 ) Cite this article

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• Translational research

Despite the success of antiretroviral therapy (ART) for people living with HIV, lifelong treatment is required and there is no cure. HIV can integrate in the host genome and persist for the life span of the infected cell. These latently infected cells are not recognized as foreign because they are largely transcriptionally silent, but contain replication-competent virus that drives resurgence of the infection once ART is stopped. With a combination of immune activators, neutralizing antibodies, and therapeutic vaccines, some nonhuman primate models have been cured, providing optimism for these approaches now being evaluated in human clinical trials. In vivo delivery of gene-editing tools to either target the virus, boost immunity or protect cells from infection, also holds promise for future HIV cure strategies. In this Review, we discuss advances related to HIV cure in the last 5 years, highlight remaining knowledge gaps and identify priority areas for research for the next 5 years.

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Modern antiretroviral regimens can effectively block HIV replication in people with HIV for decades, but these therapies are not curative and must be taken for life. However, there is evidence that a cure can be achieved; initially, this came from a single case study (Timothy Brown, a man living with HIV who became widely known as the ‘Berlin patient’) following bone-marrow transplantation from a donor who was naturally resistant to HIV 1 . On the basis of this inspiring development and the recognition that not everyone can access and/or adhere indefinitely to antiretroviral therapy (ART), a global consensus emerged approximately 10 years ago that a curative intervention was a high priority for people with HIV and would be necessary to bring an end to the HIV pandemic. Since then, there has been a second case report of a cure following bone-marrow transplantation 2 as well as evidence of persistence of only defective forms of the virus in certain patients 3 and enhanced immune control of the virus by others after only a short time on ART 4 —further supporting the notion that a cure for HIV can be achieved.

An HIV cure includes both remission and eradication. Here, we define the term remission as durable control of virus in the absence of any ongoing ART. Eradication is the complete removal of intact and rebound-competent virus. The minimal and optimal criteria for an acceptable target product profile for an HIV cure, including the duration and level of virus control off ART, has recently been developed and published by the International AIDS Society (IAS), following wide consultation with multiple stakeholders 5 .

In 2011 and 2016, the IAS convened expert working groups to outline a strategy for developing an effective and scalable cure 6 , 7 . Since then, significant progress has been made, and the overall agenda has evolved. Here, we assembled a group of experts from academia, industry, and the community (Box 1 ) to evaluate recent progress and to outline cure-related research priorities for the next 5 years. The key recommendations for each component of the strategy are summarized in Box 2 .

Box 1 The Global Cure Strategy—forming a consensus

The Global Cure Strategy was created using a full online process during the COVID-19 pandemic from November 2020 to August 2021. The co-chairs of the initiative identified the major topics which were divided into eight subthemes, each with its own working group, which included a chair, three scientific experts, at least one community member, an IAS Research-for-Cure fellow, and an industry representative. Working groups met at least twice virtually to generate a summary of key advances and recommendations for the next five years. The steering committee consisted of the chairs of each working group, the co-chairs of the cure strategy and a community expert, selected for diversity in geographic background, gender, age, and expertise. We engaged people living with HIV at all levels as well as a wide range of scientific and nonscientific stakeholders.

The Global Cure Strategy was further refined through a broad, online stakeholder consultation, including an online survey, a review by key stakeholders in the field, and interviews with select experts and opinion leaders (more than 25 respondents). The survey received 162 responses, primarily from people working in academia, nongovernmental organizations, and hospitals or research institutions; 11% of respondents were from organizations of people living with HIV, and 4% were from industry. The majority of respondents were working in Africa, followed by Western and Central Europe, North America, and Central and South America. The summary and detailed responses can be found here: https://www.surveymonkey.com/results/SM-7YYFTZ599/.

Box 2 Key research goals to be addressed in the next 5 years

Understanding hiv reservoirs.

Define and characterize the sources of the replication- and rebound-competent viruses during ART

Define the phenotype of cells harboring intact HIV genomes

Define the clinical significance of defective yet inducible proviruses

Define the mechanisms of clonal proliferation

Determine if infected cells that persist on ART are resistant to cell death

Define the impact of sex and other factors on the reservoir and virus-specific therapies

HIV reservoir measurement

Develop and validate a high-throughput assay to quantify the rebound-competent reservoir

Develop assays that quantify integration sites

Develop assays that account for key qualitative differences in viral transcripts

Develop methods to quantify HIV protein expression in cells and tissues

Develop imaging modalities that quantify the size, distribution, and activity of the reservoir in tissues

Define the link between the cellular reservoirs, residual plasma viremia, and the rebounding virus

Develop assays for point-of-care and eventually at-home viral-load monitoring

Mechanisms of virus control

Identify the mechanisms that contribute to SIV/HIV control

Define the role of HIV-specific antibodies, B cells, and the innate immune response in virus elimination or control

Define the viral dynamics and biomarkers associated with post-treatment control

Optimize human organoid models, as well as mouse and nonhuman primate models, for cure- and remission-related studies

Targeting the provirus

Develop improved strategies to reverse latency

Develop strategies to permanently silence the provirus

Determine the impact of targeting the provirus at the time of initiation of ART

Define the role of viral subtype on the effectiveness of interventions that target the provirus

Targeting the immune system

Develop ‘reduce and control’ approaches

Develop immune modulators

Conduct clinical trials to determine whether combination immunotherapies will result in safe and durable HIV remission

Cell and gene therapy

Define the level of antigen expression needed to enable recognition of infected cells by immunotherapies

Develop gene-editing strategies that target the provirus

Develop strategies for sustained production in vivo of antiviral antibodies

Leverage advances in other biomedical fields to develop safer and more scalable approaches

Pediatric remission and cure

Characterize the establishment, persistence, and potential for preventing or reversing HIV latency in infants and children on ART

Develop assays to monitor and identify biomarkers to predict the efficacy of HIV-1 cure therapeutics

Test HIV immunotherapies and other strategies in infants and children

Social, behavioral, and ethical aspects of cure

Expand community/stakeholder engagement and capacity building

Develop HIV cure research with equity, representation, and scalability considerations

Establish standards for the safe conduct of clinical research

Integrate social, behavioral, and ethics research as part of HIV cure trials

Build capacity for basic discovery research and clinical trials in high-burden, resource-limited settings

A shared definition of the HIV reservoir is crucial for researchers, clinicians, and people living with HIV. Here, we use the term ‘HIV reservoir’ in the context of eradication or remission, as a representative term for all cells infected with replication-competent HIV in both the blood and different anatomical sites in individuals on ART—in other words, all potential sources of viral rebound in the context of a treatment interruption. Although the source of virus rebound is still not entirely understood, we now know that virus can persist in multiple forms, in multiple cells and in multiple sites.

Characterization of the complete HIV reservoir

HIV DNA can be detected in CD4 +  T cells in blood and lymphoid tissue in nearly all people with HIV on ART. These viral genomes are mainly defective. Only a small proportion (less than 5%) appear to be intact and potentially replication-competent 8 . But the HIV reservoir goes beyond circulating CD4 +  T cells; it also includes tissue-resident CD4 +  T cells and cells of the monocyte/macrophage lineage, further complicating efforts to characterize and quantify it. In vitro, HIV preferentially integrates into transcriptionally active genes 9 ; however, in people with HIV on ART, many proviruses (defined as virus that is integrated into the host genome), including intact ones, have been identified in genomic regions that are silent (known as ‘gene deserts’), which limits or precludes their reactivation 3 .

Our initial conception of the HIV reservoir as a static viral archive has given way to a more dynamic view in which, over time on ART, certain within-host HIV variants are gradually eliminated while others persist through various mechanisms, including clonal expansion of infected cells 10 , 11 , 12 , 13 , 14 , 15 . Sporadic infection of new cells during ART has been reported 16 , although there has been no convincing demonstration that viral sequences evolve during effective ART 17 , suggesting that the degree of virus spread is minimal. The sources of viral rebound following cessation of ART are incompletely defined. Multiple factors can contribute to viral replication following ART, including anatomical and microanatomical locations, the infected cell type, cellular phenotype, the nature of the provirus, the antigen specificity of the infected cell, the potential for transcriptional activity given the specific integration site, and/or distribution of antiretroviral drugs within tissues (Fig. 1 ).

The HIV reservoir can be defined across a number of dimensions, including: (1) anatomical and microanatomical locations, (2) cell type (for example, CD4 + T cell or macrophage), (3) cell functional profile (activated or resting; resistance to killing), (4) pool of proviruses with a particular functional profile (for example, interferon-alpha resistant) or (5) triggering event (for example, response to stimulation with a particular antigen), and (6) integration-site features of the rebounding virus.

We recommend prioritizing efforts to understand integration sites of the virus during long-term ART and to understand the inducibility of a provirus on the basis of its chromosomal context. In addition, large prospective studies incorporating analytical treatment interruptions (ATIs) are still needed to probe clinically relevant sources of viral rebound and to identify a biomarker that predicts this. A favorable cure intervention could either prolong the time to the point when virus is detectable (that is, rebound) in plasma or reduce the viral ‘set point’ (that is, post-treatment control).

One of the most daunting obstacles to designing more effective methods to target persistent HIV infection is the lack of biomarkers to unambiguously identify the cells that harbor the rebound-competent reservoir. Recent work has demonstrated that the viral reservoir is preferentially enriched in cells that express programmed death-1 (PD-1) and other immune checkpoint markers, activation markers such as HLA-DR, and chemokine receptors such as CCR6 and CXCR3, but there is no phenotypic marker specific for the reservoir 18 , 19 , 20 , 21 . Specific biomarkers of the reservoir are needed, particularly to assess the impact of cure interventions. Furthermore, understanding how HIV persists in specific tissue sites and relevant local cell populations, such as those in the brain, gastrointestinal tract liver, or genital tract, will be important, given that the mechanism for persistence in each site may be distinct, and therefore different approaches may be required to eliminate each of these reservoirs.

There is growing evidence that some defective proviruses can produce transcripts and proteins (including novel viral RNAs and chimeric viral proteins) that in turn can elicit immune responses and perhaps contribute to chronic inflammation 22 , 23 , 24 , 25 . This may be of high relevance to end organ complications, such as HIV-associated neurological disease 26 . If the production of RNA and proteins from these defective proviruses proves to have clinical relevance, then their removal may be necessary to ensure long-term health.

A major mechanism of HIV persistence is the proliferation of cells that were infected prior to ART, resulting in large clonal populations of infected cells that arise as a result of the site of HIV integration 27 , 28 , response to antigen 29 , 30 , or homeostatic drivers 31 . Characterization of these presumably physiological expansions might lead to the development of therapies aimed at interrupting proliferation of infected cells. It will be important to determine to what degree these expanded clones are transcriptionally active, whether they are an important of post-ART viral rebound, and whether they have some innate survival advantage that prevents the cells from being effectively cleared by the host.

Recent studies have provided some evidence for preferential survival of infected cells with proliferative advantages or with deeper viral latency. Prosurvival and immune-resistance profiles may be particularly important in infected cells that persist despite expression of viral RNA or proteins 32 , 33 , 34 . Opportunities likely exist for collaboration and cross-fertilization of concepts with the cancer field, where the clonal dynamics of tumors have been extensively studied in relation to prosurvival and immune-resistance advantages, such as the work being done on lung cancer through prospective genetic studies in TRACRx ( https://clinicaltrials.gov/ct2/show/NCT01888601 ).

Biological sex can influence HIV pathogenesis, the immune response to HIV infection, and response to antiviral therapy 35 . Furthermore, in some but not all studies, women’s reservoirs have been shown to be less transcriptionally active and less inducible than those of men 36 , 37 , 38 , 39 , 40 . Sex, therefore, is a critical variable that should be considered as new therapies to target the reservoir are developed.

Quantification of the HIV reservoir

Significant progress toward a cure for HIV depends on having sensitive, specific, and quantitative measures of persistent virus that can be applied to various anatomical compartments 41 . Achieving this has been challenging, however, owing to the many sources and heterogeneous properties of persistent, replication-competent HIV. The reservoir can be quantified using assays that measure viral nucleic acid (total and integrated DNA, intact and defective DNA, or different forms of RNA), virus protein (p24), or viral inducibility (by measuring HIV RNA or virus replication following activation in vitro). Each approach has advantages and limitations, and assay outcomes may not always be interchangeable, comparable, or even correlated 8 .

Several groups have developed droplet digital PCR-based assays that discriminate genetically intact proviruses from a large background of defective proviruses, which are slightly less accurate but more high throughput than full genome sequencing 42 , 43 . The application of these assays to large clinical cohorts has demonstrated that there is a modest decrease in the frequency of cells with intact provirus over years on ART 44 , 45 , 46 . These assays have largely been optimized for subtype B virus, the major HIV subtype found in the United States and Europe. Yet there are over ten subtypes worldwide, some of which have evolved different mechanisms for immune evasion and persistence 47 . Pan-subtype-specific assays will need to be developed, and challenges related to cost and scalability remain. Research in this field should ideally culminate in harmonization across laboratories and crossvalidation of results. Future work will need to expand from quantification of virus in blood to quantification in tissue, particularly the more accessible tissues such as lymph nodes and gut mucosa.

Understanding the proviral landscape (defined as the degree of intactness, its transcriptional activity, and its location) is crucial, as these characteristics almost certainly influence the degree to which a provirus will rebound 48 . Over the last decade, several assays have been developed to analyze the exact location at which the virus integrates and whether the integrated virus is intact or defective. The ability to analyze single cells for integration site, viral sequence, and transcription is a major advance 48 ; however, these assays are expensive and low throughput. Technological advances are required to apply this more broadly to clinical samples, including assessment of interventions that target the reservoir.

Cell-associated viral RNA (CA-RNA) provides a measure of the total transcriptional activity of proviruses within a given sample. Several assays have recently been developed that quantify different RNA species, including total, elongated, unspliced, polyadenylated, and multi-spliced RNA, and these stand to give higher-resolution insights into the impact of therapeutic intervention 49 . An important unmet need is to develop approaches to distinguish transcripts arising from defective versus intact proviruses. Another shortcoming hampering broad use of RNA assays is the fact that they are subtype-sensitive. Overall, our ability to study the biology of transcriptionally active proviruses and the role of transcriptional activity as a potential biomarker needs to be further explored.

Since HIV protein expression is also required for recognition by HIV-specific T cells and other immune-based therapies, measuring and characterizing viral proteins in cells and tissues is an important step to understanding HIV persistence and might prove to be a critical determinant for the efficacy of therapies that target the HIV-infected cells directly (for example, chimeric antigen receptor (CAR) T cells or broadly neutralizing antibodies). Quantification of the p24 protein with ultrasensitive enzyme-linked immunosorbent assays can determine the efficacy of therapies that target the reservoir directly. Ultrasensitive p24 assays have emerged as useful tools 25 , but drawbacks include low levels of sensitivity compared with nucleic acid detection, overestimation of the replication-competent reservoir, and the requirement for specialized instrumentation 25 , 50 . Detection of viral envelope protein (the target of many therapeutic interventions for an HIV cure) also remains a challenge. Future strategies should leverage advances in single-cell techniques and new approaches to imaging tissue using super-resolution or expansion microscopy, together with multi-omics approaches.

Substantial progress in other fields of medicine has been made in using advanced imaging techniques to quantify rare diseased cells in tissues. On the basis of some preliminary success in nonhuman primate models 51 , efforts to use radiolabeled HIV-specific tracers and sensitive imaging modalities (for example, positron emission tomography, PET) have been initiated 52 . Similar efforts aimed at characterizing sites of inflammation or expression of specific surface markers that are associated with HIV persistence should also be a priority.

Several studies have attempted to identify sources of rebound virus by probing phylogenetic linkages with the proviral sequences present in various anatomical and cellular compartments. Success has been limited, however, in part owing to the challenging nature of obtaining full-length sequences from the limited number of infected cells in blood or tissue, as well as from plasma with low level viremia 53 . Strategies that can enhance enrichment of infected cells and/or depth of viral sequencing together with high-throughput low-cost single-cell analyses are likely to advance the field. As the RNA in circulating virions is a well-accepted surrogate marker for untreated HIV disease, this measurement could be an effective tool to characterize the rebound-competent population of HIV-infected cells.

Currently, any impact of a therapeutic intervention on the viral reservoir can only be determined with an ATI. A tool for very early detection of viral rebound post-ART using a nonvirological marker—such as measures of the innate immune response 54 —could be very valuable. In addition, better ways to monitor viral load that do not require frequent healthcare appointments will be needed 5 . This should include the development of home-based tests that may not necessarily require high sensitivity as long as testing is performed frequently 55 . Finally, emerging evidence suggests that virus replication during an ATI may be associated with some long-term adverse events 56 , so careful follow up of participants in ATI studies will be necessary.

Mechanisms and models of virus control

Natural control in people living with hiv.

Individuals who naturally control HIV in the absence of any therapy and can maintain a viral load of <50 copies/ml (known as ‘elite’ controllers) have been the focus of intense investigation for years. Research in this area is increasingly focused on those controllers who exhibit remarkably stringent control (‘exceptional’ controllers) 57 , 58 , some of whom might be considered true cures 48 , 59 , and those who became controllers after ART interruption (post-treatment controllers) 60 , 61 . In exceptional controllers, the frequency of infected cells is extremely low, often below the limit of detection of most standard assays for HIV DNA 57 , 59 , there is no intact virus 48 and the site of HIV integration may be distinct 48 ; an agreed definition for an exceptional controller is needed.

Virus-specific CD8 +  T cells targeting particularly vulnerable or conserved epitopes are generally recognized as the key mediator of elite control; such cells are rare in post-treatment controllers and have not yet been characterized in exceptional controllers 4 , 62 . Further characterization of the various controller phenotypes (elite, exceptional, post-treatment) should remain a priority; the identification of unique and potentially informative phenotypes should also be pursued, including individuals on ART who have very small reservoirs 62 . Functional multi-omics studies and emerging single-cell technologies should help to determine the mechanisms involved in exceptional, elite, and post-treatment control. Better animal models of exceptional and post-treatment control would greatly enhance the field, giving access to tissue and the opportunity for longitudinal assessment of virus control 63 .

Virus elimination and control will likely require a coordinated immune response involving more than just T cells. Recent data suggest that autologous antibodies targeting archived viruses as well as interferon sensitivity might influence which virus populations emerge post-ART 54 , 64 , 65 . Studies in simian immunodeficiency virus (SIV)-infected nonhuman primates that naturally control infection have provided indirect evidence that natural killer (NK) cells might be able to effectively control virus in tissues 66 . Better insights into the role of antibodies, natural killer cells, and innate immunity in post-treatment and/or post-intervention control are needed.

The interplay between the virus and immune system during acute infection or immediately after the interruption of ART is largely unknown, at least in humans. During acute infection, those destined to become controllers typically have an initial period of poorly controlled viremia 61 , 67 . For post-treatment controllers, virus control is often achieved more rapidly after cessation of ART than after primary infection 61 , 68 . We need to understand the viral dynamics associated with eventual post-ART control/remission, as this will inform how a treatment interruption should be conducted. It is likely that biomarkers other than the plasma HIV RNA level might allow for the development of safer and more cost-effective strategies for interrupting ART.

Animal models of control

The role of humanized mouse models in cure research is still evolving. Recent studies showing similar effects of latency-reversing strategies in mice and the less scalable nonhuman primate model are encouraging 69 , 70 . Given that access to nonhuman primates for cure studies will likely remain a barrier, ongoing optimization, standardization, and validation of mouse models should be prioritized.

An important discrepancy in translating cure-related findings from SIV-infected nonhuman primates to people with HIV lies in the duration of ART. Although effective ART regimens with integrase inhibitors have been optimized in nonhuman primates, high costs, and treatment-related toxicities necessitate relatively shorter study durations (less than 1–2 years of ART). One possible solution would be for primate research centers to maintain colonies of SIV-infected nonhuman primates receiving very-long-term ART to be directly assigned for studies.

There is ongoing debate about the most appropriate virus to be used in cure-related studies in nonhuman primates. Investigations utilizing broadly neutralizing antibodies or select vaccines directed against the HIV-1 envelope necessitate infection with a virus that expresses HIV envelope proteins (simian-human immunodeficiency virus, SHIV). However, SHIV infections with some strains are characterized by post-treatment control in the absence of any intervention 71 , while others can induce significant disease progression 72 . Therefore, the specific strain used can limit the generalizability of the model. Although SIV infection of nonhuman primates can cause more significant disease progression than HIV infection of people, early ART for SIV infection can limit rapid disease progression and is therefore a useful model for cure studies 73 . Developing immunotherapies that target the SIV envelope in addition to SHIV should also be pursued.

A major recent advance has been the development of genetically barcoded SIV mac239 strains 74 . Because the barcode ‘tags’ are easily quantified and also passed on to progeny virus, this model allows for tracking of clonal dynamics, providing more precise insights into how interventions affect seeding of the reservoir, viral reactivation during ART, or viral recrudescence after ART interruption.

Therapeutic interventions

Since the discovery that HIV can establish a latent infection with minimal HIV transcription, a range of approaches has emerged that specifically target latently infected cells. These include pharmacological modulation of epigenetic or signaling pathways involved in HIV transcription to reactivate latent HIV such that the cells can be targeted and eliminated (‘shock and kill’) or to permanently silence HIV transcription (‘block and lock’) 75 , 76 , 77 . Recent reports have demonstrated that HIV latency is heterogeneous and that latency reactivation is stochastic, implying that a combination of agents targeting various pathways controlling HIV transcription may be necessary to achieve either robust silencing or latency reversal 49 , 78 , 79 , 80 .

A clear limitation of the ‘shock and kill’ approach comes from the discovery that only a fraction of proviruses is intact and among these, only some are inducible by a potent stimulus such as T cell stimulation, let alone by far less potent latency-reversing agents (LRAs) 8 , 81 , 82 , 83 . Furthermore, cells containing reactivated latent HIV may also be relatively resistant to killing by cytotoxic T cells 84 . Complicating the situation even more, CD8 +  T cells appear to suppress HIV transcription and can blunt the effect of LRAs 70 .

Although LRAs tested in humans can induce HIV RNA expression and virion production in vivo, they have failed to reduce the size of the reservoir, even when combined with immunotherapeutic strategies designed to enhance clearance of infected cells 85 , 86 , 87 , 88 , 89 , 90 . This could be due to poor antigen induction by LRAs or insufficient clearance of these targets by immunotherapies (Fig. 2 ). Furthermore, many of the tested LRAs have off-target effects. Newer approaches for delivery of LRAs to reduce toxicity, enhance potency, and improve targeting, potentially leveraging advances in nanomedicine, should be explored. Greater potency could potentially be achieved using LRAs in combination, however, care is needed in these clinical trials, given that unexpected toxicities can emerge—as was recently demonstrated in the evaluation of high-dose disulfiram and vorinostat 91 . Finally, LRAs will likely need to be partnered with therapies that enhance the clearance of cells expressing viral proteins, such as immune-enhancing strategies or proapoptotic drugs 92 .

Reversing latency is an important component of revealing HIV-infected cells, allowing for conversion of a latently infected to a productively infected cell. a , Currently available LRAs reverse latency in only a subset of infected cells, and, when used alone, do not sufficiently eliminate these. b , Enhancing the efficacy of an LRA can be achieved with increased potency, targeted delivery or through using combinations of LRAs. c , Ultimately, depletion of the reservoir will require combining an LRA with other interventions, such as immunotherapy or a proapoptotic drug.

Permanently silencing the HIV promoter by suppressing factors that promote HIV transcription has also emerged as a strategy to target the provirus. The concept is to therapeutically drive HIV into a permanently silenced epigenetic state that resists reactivation (‘deep latency’). The Tat inhibitor didehydro-cortistatin A (dCA) blocks HIV reactivation from human CD4 +  T cells in vitro through epigenetic repression; treatment with dCA in ART-suppressed humanized mouse latency models induces a measurable delay in virus rebound 76 , 93 . Gene therapy can also play an important part in permanent silencing of the provirus using short interfering RNA or other modalities 94 . Thus far, these approaches have yet to be successfully translated into human trials.

Further exploration of the therapeutic potential of permanently silencing the reservoir (‘block and lock’), presumably as part of a combinatorial cure approach, is a high research priority. Some pathways that might be targeted include mTOR, HSF1, and others 95 , 96 , 97 . Efforts to screen for drugs that suppress HIV transcription are encouraged, 96 , 98 , 99 with the goal to rapidly move into preclinical and clinical studies 100 , 101 .

With a recent report indicating that the HIV reservoir is stabilized at the start of ART initiation, efforts should be devised to inhibit this stabilizing effect and/or to enhance reservoir turnover during ART, where such interventions are ideally delivered at ART initiation 102 , 103 , 104 .

Most methods to target the provirus have been developed using subtype B. Thus, while conserved mechanisms govern latency across the different virus subtypes, differences at the level of the promoter may impact responsiveness to various stimuli. Therapies targeting the provirus should be evaluated across multiple HIV subtypes including recombinants.

There is a robust and growing toolbox of immune therapies that might be advanced to proof-of-concept testing. Arguably, the most impactful innovation to date is the isolation and development of broadly neutralizing antibodies for clinical use, but advances have also been made in the development of therapeutic vaccines, vaccine adjuvants, and other immunotherapies. When used in combination in nonhuman primates, these immune therapies have resulted in sustained post-ART control 71 , 105 . When used alone, most of these approaches have had limited effectiveness in people, although some promising results are emerging 88 , 106 , 107 . Combination clinical trials have recently started and are ongoing. Although the combination of either vorinostat or romidepsin (HDAC inhibitors that can increase viral transcription through epigenetic modification) together with different HIV vaccines showed no or minimal reduction in the HIV reservoir 107 , 108 , 109 , results from other studies including a combination of Toll-like receptor agonists, LRAs and broadly neutralizing antibodies are eagerly awaited ( NCT03837756 ; NCT04319367 ; NCT03041012 ).

As it may be challenging to reactivate and eliminate all latently infected cells, or to induce deep irreversible latency in all cells, it seems unlikely that these approaches will be curative by themselves. By reducing the reservoir, however, they might make strategies aimed at controlling the virus long term post-ART more effective. This overall approach of 'reduce and control’ is supported by observations in elite and post-treatment controllers, and theoretical modeling 110 . Multiple approaches that might result in control of a small reservoir are being developed. Assessment of therapeutic vaccines including live vector vaccines such as adenovirus 26, modified vaccine Ankara, and also a cytomegalovirus in nonhuman primate models have been particularly promising, with a subset of animals achieving eradication of virus 71 , 111 . Such studies have not yet been performed in people. Research to develop and test novel immunogen and vaccine designs with broad, potent and durable immunity should be prioritized. Given the recognition that autologous neutralizing antibodies might contribute to reservoir control 64 , novel vaccine approaches aimed at the induction of broadly neutralizing antibodies—including germline targeting 112 —should also be prioritized.

Immune stimulators, immunomodulators, and novel immunotherapies (such as cytokine formulations, Toll-like receptor agonists, immune checkpoint inhibitors or agonists, and novel vaccine adjuvants), used alone or more likely in combination with other approaches, hold promise but have undergone relatively limited testing in HIV-cure studies in people so far 106 , 113 , 114 , 115 .

With the exception of a few anecdotal cases 116 , immunotherapy in people with HIV has yet to recapitulate the promising advances made in nonhuman primates. Combination of various therapies will almost certainly be needed (Fig. 3 ). Conducting such studies is feasible 108 , 117 ; it is expected that initial clinical research will be intensive in nature and designed to identify strategies that might then be tested in well-powered, controlled clinical trials. Defining the mechanisms and potential biomarkers associated with remissions/cures in the preclinical and clinical setting should remain a priority. Determining which combinations to study, and how to define the optimal doses and strategies, poses a significant challenge from a methodological and regulatory perspective. As immunotherapies for HIV move into the clinic, careful attention will have to be paid to immune-related adverse events, including cytokine-release syndrome and autoimmunity.

Strategies that will enhance immune-mediated clearance of latently infected cells include early initiation of ART and the administration of combined interventions at the time of suppressive ART (colored arrows) or during the treatment interruption phase, which will allow for increased antigen presentation. Given that there is no biomarker that can predict viral rebound, analytical treatment interruptions are used to determine whether the intervention has had a clinically meaningful impact. The overarching goal is to either delay viral rebound by at least months or years or reduce the set point of virus replication (that is, the stable level of viral load that the body settles at), preferably to a level of <200 copies/ml. The dashed colored lines represent different potential favorable outcomes from a cure intervention. bNAbs, broadly neutralizing antibodies; LRA, latency reversing agent; TLR, Toll-like receptor.

Cell and gene therapy clinical trials for people with HIV, although safe so far, have been small in scale and with no clear demonstrations of efficacy. The interest in gene therapy for an HIV cure was inspired by the elimination of intact virus in Timothy Brown (also known as the Berlin patient) and Adam Casteljo (also known as the London patient), who both received stem-cell transplants from a CCR5-negative donor 1 , 2 to treat their underlying malignancies. CCR5 is a co-receptor that is needed by most strains of HIV to enter a cell; a reduction in the size of the reservoir has also been reported following stem-cell transplantation to people with HIV from donors who are CCR5-positive 118 , 119 , but the HIV reservoir can’t be completely eliminated, irrespective of the CCR5 status of the donor. In the case of CCR5-negative stem-cell transplantation, the absence of CCR5 in the donor cells is thought to protect the newly transplanted cells from infection, at least with CCR5-dependent HIV strains. Interestingly, in both cases of cure following stem-cell transplantation of CCR5-negative cells, defective virus has been detected, but not intact or replication-competent virus 120 , 121 . These reports have prompted researchers to evaluate CCR5-targeted gene editing as a potentially safer path to cure in people living with HIV on ART, given the high mortality rate and significant morbidity associated with stem-cell transplantation. Timothy Brown unfortunately died in early 2020 owing to recurrence of his leukemia, but remained HIV-free until his death.

Ex vivo gene editing of CCR5 using zinc finger nucleases and re-infusion of CCR5-modified T cells has not yet prevented viral rebound following ATI 122 , 123 , possibly because insufficient cell numbers were engineered and/or engrafted with first-generation editing tools and cell culture protocols and/or because CCR5 disruption alone cannot shift the balance in favor of post-treatment control in the presence of persistently infected cells. More recently, gene therapies have shifted to creating effectors, including chimeric antigen receptor (CAR) T cells, which can recognize and eliminate HIV-infected cells (Fig. 4 ). Other approaches include the use of novel delivery systems to deliver genes to local tissues, resulting in the sustained production of systemically acting antivirals such as broadly neutralizing antibodies 124 , 125 and CD4 mimetics 126 . Finally, attempts are being made to directly target integrated proviruses with technologies such as CRISPR–Cas9 and recombinases 127 , 128 . This approach remains conceptually challenging in view of the disparate locations of latently infected cells, the absence of specific markers to target delivery, the heterogeneity of proviral sequences (the majority of which are defective), and the risk of off-target effects.

Examples of ex vivo (left) and in vivo (right) gene therapy approaches that have been tested in people with HIV on ART. Ex vivo strategies include gene editing to either delete or inactivate CCR5 or HIV provirus in CD4 + -enriched T cells using gene-editing tools such as zinc finger nucelases (ZFN) or CRISPR–Cas9. Alternatively, autologous T cells can be modified to express a CAR that can recognize HIV envelope, and this can then be reinfused into the participant. In vivo strategies, on the other hand, do not require external manipulation of cells; nanoparticles or viral vectors (such as adeno-associated virus (AAV)), which encapsulate mRNA or DNA, respectively, for the relevant gene to be expressed are administered directly to the patient. These approaches have recently been successful using lipid nanoparticles that contain mRNA encoding CRISPR–Cas9 135 or for expression of anti-HIV broadly neutralizing antibodies such as PG9 or VRC07 (ref. 125 ). PBMCs, peripheral blood mononuclear cells; PLWH, person living with HIV.

Many emerging cell and gene therapies are designed to target viral proteins/epitopes that are expressed in abundance on the surface of tumor cells, for example CD19 for the treatment of lymphoma 129 . Various forms of the HIV viral envelope protein (gp120 trimers and monomers, gp41) are expressed on the surface of infected cells, while multiple peptides are presented via HLA molecules. These antigens are expressed at levels well below that of many cancer antigens now being successfully targeted in the clinic. Cell-based therapies such as CAR T cells, once infused into the patient, will only persist and differentiate if there is sufficient antigenic exposure; however, the levels of antigen during ART may be too low 130 . Removal of ART after infusion of CAR T cells (or similar products) could be used to expand these cells in vivo, or more potent latency-reversing agents could be used to enhance envelope protein expression. In addition, novel adjuvants could expand CAR T cells even when the antigen burden is low, as was recently demonstrated in the nonhuman primate model 131 .

The challenges here are primarily those of delivery to relevant cells. In addition to developing methods to target specific cells, which are common problems faced by all potential in vivo gene therapies, targeting latent proviruses also presents the problem of a lack of robust cell surface markers to identify cells harboring such proviruses. Progress in both of these areas will be needed to develop strategies to deliver gene-editing reagents to latently infected cells. Some promising in vivo delivery strategies for CRISPR–Cas9 have included adeno-associated virus to target the SIV virus in nonhuman primates on ART 127 , as well as using engineered CD4 +  cell-homing messenger RNA (mRNA)-containing lipid nanoparticles in mouse models of HIV infection 132 .

Long-term in vivo secretion of antibodies or antibody-like molecules can be achieved following gene therapy vector delivery of antibody cassettes to tissues such as muscle and liver, where enhanced production of antibodies is needed, rather than specific delivery to infected CD4 +  T cells. This can be achieved through direct intramuscular injection leading to uptake in the muscle or, alternatively, intravenous injection, which will allow for uptake in the liver. Ectopic expression of these antibodies in liver or muscle cells fails to recapitulate aspects of natural antibody production, such as responsiveness to antigen and ongoing somatic hypermutation. Therefore, editing the B cell Ig locus itself to express antibodies presents an alternative and attractive gene-editing strategy 133 , 134 .

Sustained production of these antivirals could result in sustained (perhaps lifelong) control of the virus. Many barriers to success exist. Antidrug antibodies that target and clear the vectors often form rapidly 125 , limiting the ability to deliver multiple doses. Advances in mRNA encapsulation within lipid nanoparticles may potentially revolutionize delivery of gene therapy, allowing for delivery of mRNA encoding CRISPR–Cas9 and related guide RNAs in vivo, as has recently been successfully demonstrated in the treatment of transthyretin amyloidosis 135 . Also, antibodies targeting multiple antigens will likely need to be produced at high levels to prevent virus replication and escape.

Advances in T cell manufacturing are expected, driven by cancer CAR T cell therapies, which will also benefit HIV therapies. Similarly, advances occurring in gene therapy treatments for genetic diseases, such as hemoglobinopathies, are catalyzing safer and nongenotoxic conditioning for HSPC transplants, for example based on drug–antibody conjugates. Practicality will also be enhanced by moving toward using allogeneic off-the-shelf products.

Gene and cell therapies now require a shift towards a practical focus, identifying ways to expand use, reduce costs, and allow deployment in resource-limited settings. This could be achieved through abbreviated ex vivo cell manufacturing, including automated closed-system devices (‘gene therapy in a box’), to produce product in a place-of-care setting 136 . While still in the early stages of development, in vivo gene therapy also presents exciting possibilities to significantly expand access by eliminating the need for external manipulation of cells and associated technological requirements.

The unique context of perinatal HIV infection necessitates pediatric-specific strategies to achieve ART-free remission in children. The case of the Mississippi child, who started therapy ~30 hours after birth and achieved remission off ART for 27 months before virus rebounded 137 , 138 , raised the possibility that remission for children can be attained. Subsequent reports of early-treated pediatric cases with long-term (>12 years) virological control off ART have provided examples of post-treatment control in children 139 , 140 .

The nature of the reservoir in children is unique from that in adults. For example, naive CD4 +  T cells are a more important reservoir for the virus in children 141 , 142 . Further development of infant nonhuman primate models for evaluating ART and cure strategies will contribute to our understanding of the HIV reservoir and how to target it in the unique setting of infancy and immune development, but an understanding of the limitations of this model is also crucially important 141 , 142 , 143 , 144 , 145 .

Many of the recent advances in understanding HIV persistence during ART in adults, including frequency and transcriptional activity of intact virus, clonal expansion, sites of proviral integration, and inducibility, need to be applied to studies of children. Optimizing methods that can be adapted to small blood volumes are also needed.

In the context of childhood infection, clarity is needed on how latency is established in naive T cells, susceptibility of these cells to latency reversal, propensity for T cells to clonally expand, and the relative contribution of clonally expanded cells to viral rebound following cessation of ART. It is still unclear whether integration sites and reactivation potential are different in children, and whether these change with age. Given that initial studies suggest a less-inducible reservoir in cases of perinatal infection 146 , it is especially important to determine how to maximize latency reversal in children. The optimal timing of these interventions (for example, at the time of early ART initiation) could potentially limit the pool of infected cells that persist on ART; such approaches can be explored in a nonhuman primate model.

As in adults, better tools are needed to assess the impact of cure interventions in children, including quantification of HIV persistence and in-depth cellular immune profiling. There is a particular need for noninvasive tools, such as total body imaging, to assess central nervous system and other tissue-based reservoirs. It will also be important to identify biomarkers for post-treatment control, including the degree of reduction or alteration in the composition of the latent reservoir that may be predictive of pediatric remission or cure 147 . Finally, preclinical studies in infant nonhuman primates that test new interventions to reduce or eliminate persistent HIV and/or induce viral remission after ART interruption are needed to inform the development of HIV remission and cure intervention strategies. Early therapy alone is insufficient to reliably achieve a cure or long-term remission in children. Novel approaches, including earlier administration and use of more potent antiretroviral drugs, therapeutic vaccines, or other immunotherapeutics, such as broadly neutralizing antibodies and/or innate-immune-enhancing agents, will be necessary.

Research directed toward an HIV cure intertwines critical social, behavioral, and ethical aspects that must be incorporated in the scientific agenda. This research takes place within particular social contexts and communities that shape its permissibility and appropriateness. Accordingly, affected communities must be meaningfully engaged throughout the research process; social and behavioral factors must be interrogated and taken into account because they affect research feasibility, community support for the research, and the well-being of participants and other stakeholders. Research must also address the many ethical issues associated with developing a therapy, particularly since viable options for treatment are already available. Sufficient funding for research toward social, behavioral, and ethical aspects of a cure and for community involvement is therefore essential.

Substantial progress using more conceptual and normative approaches has also been made regarding the ethical issues associated with the interruption of ART 148 , 149 . Similarly, there has been attention focused on acceptable risk thresholds for research 150 . Finally, given the important role of treatment as prevention, efforts have focused on the ethics of partner-protection measures 151 .

Community engagement in HIV cure research is still suboptimal in many settings, being mostly been limited to advisory boards typically comprised of scientifically literate individuals. Capacity to discuss HIV cure research and to evaluate its potential implications for local and global communities must be built within diverse community groups. Communities should be empowered and supported through education and engagement at all levels of the research process to help shape the HIV cure research agenda and allow for potential study participants to have a voice in trial design 152 .

Since HIV cure research is highly complex and nuanced, there is also a need to ensure understanding of it among other key stakeholders, including Institutional Review Boards (IRBs) and clinicians. For example, IRBs need to appreciate the implications of ATIs for partners who they may not see as within their remit, and clinicians need to understand the rationale for ATIs in the research setting.

Attention must focus on broad representation (for example, age, race and ethnicity, gender and sexuality, geographic location, risk behaviors) in research. Diversity in participation is essential during the development of interventions aimed at complete HIV elimination or durable ART-free control. This necessitates research directed at understanding the reasons for under-representation of certain groups of people in HIV cure research. For example, cisgender and transgender women, as well as individuals of some racial and ethnic backgrounds, are less likely to participate in HIV-cure-focused clinical trials 153 . This highlights the need for more nuanced and theoretically engaged research to understand how gender, race, and other characteristics shape engagement with HIV cure research 154 . At the same time, legal and social considerations unique to each context must be identified and addressed. For example, local laws, stigma, and access to healthcare affect research involving the interruption of ART.

There is also a need to better define ethical considerations involved in the selection of populations of interest in which promising cure strategies will be tested. For example, should priority be given to testing new interventions in individuals who initiated treatment during acute infection over those who began treatment during chronic infection? What are the best means to identify and manage the ethical considerations in pediatric HIV cure research? In addition, what measures ought to be taken to ensure that recruitment is not skewed toward people with HIV in resource-limited settings? Further, ethical questions of equity and justice related to the distribution of safe and effective cure interventions must consider acceptability, scalability, and cost-effectiveness. The COVID-19 pandemic has raised unique considerations for research participants, staff, and communities 155 . Given the rapidly changing nature of the pandemic and the availability of COVID-19 vaccines and other treatments, there is a need to continually revise and assess the safety and feasibility of HIV cure research efforts.

During the study design phase, early engagement is needed in communities where research is being considered in order to determine the nature and acceptability of research-related risks. Similarly, stakeholder perceptions should be elicited to guide the development of target product profiles (the minimal and optimal characteristics of a new therapeutic intervention), as recently done for an HIV cure 5 . In especially complex clinical studies, formative research should be used to help develop a robust, informed consent process. Furthermore, nested social and behavioral research (basic, elemental, supportive, integrative) is needed to enhance understanding of the actual experiences of trial participants as well as of sexual partners of participants. These data will help provide a check on current practices, as well as provide a foundation for future efforts aimed at improving them.

Several of the key topics addressed in the previous sections are prerequisites for the development of successful cure strategies and interventions. To date, most HIV cure research has been restricted to high-income countries with relatively low HIV burden and has most often engaged men who have sex with men. HIV strains are genetically and biologically diverse, and host mechanisms of antiviral immunity required for durable control may differ by sex, geography, and ethnicity. Basic discovery research and clinical trials in resource-limited settings must be strengthened and will require enabling infrastructure development and capacity building.

In the next decade, we expect to see a greater understanding of HIV reservoirs, an increasing number of clinical trials and hopefully reports of individuals who achieved long-term remission with less intensive and more widely applicable strategies. On the basis of the current understanding and lessons from ART, it is likely that combinations of these approaches may be the first approach to be implemented. Inclusion of knowledge from fields such as oncology and COVID-19 could also greatly facilitate progress. Finally, open and responsible communication about trials and realistic expectations will remain important. Although safety is the highest priority, with increasing number of clinical trials, there is an increase in the possibility of adverse events which will need to be appropriately managed while allowing the field to advance.

This global scientific strategy, in combination with the recently developed target product profile 5 , will assist with guiding the field toward a widely applicable, acceptable, and affordable cure. The establishment of the HIV Cure Africa Acceleration Partnership 152 will hopefully enable broader engagement and facilitate rapid implementation of any successes into low- and middle-income settings. Fortunately, the resources for such work remain available, and the field is highly committed to making the long-term commitments necessary to develop an effective and scalable remission or cure strategy.

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Acknowledgements

We acknowledge the generous contribution of all the participants in the working groups, the key opinion leaders who read and provided feedback on the strategy, participants in the online survey and secretarial support from the International AIDS Society. S.R.L. and S.G.D. are funded by National Institutes of Health Delaney AIDS Research Enterprise (DARE) Collaboratory (UM1AI126611 and UM1AI164560). S.R.L. is also funded by the National Health and Medical Research Council (NHMRC; grant number GNT1149990) of Australia and the Australian Centre for HIV and Hepatitis. R.B.J. is funded by the NIH UM1AI64565. C.T.T. is funded by the South African Research Chairs Initiative of the Department of Science and Innovation and National Research Foundation of South Africa (grant 84177). O.L. is funded by the ANRS, Sidaction, University Paris Saclay, Inserm, and CEA (Commissariat à l’Energie Atomique). P.C. is funded by the NIH (HL156247 and AI164561); N.A. is funded by the NIH Delaney CARE Collaboratory 1UM1AI126619 and from R01AI134363; T.N. is funded by the South African Research Chairs Initiative of the Department of Science and Innovation and National Research Foundation of South Africa (grant 64809), The Bill and Melinda Gates Foundation (INV-033558), the International AIDS Vaccine Initiative (UKZNRSA1001) and DFG German-African Network grant (grant number AL 1043/6-1).

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Authors and affiliations.

University of California San Francisco, San Fransisco, CA, USA

Steven G. Deeks & Steven Deeks

UNC HIV Cure Center, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA

• Nancie Archin

University of Southern California, Los Angeles, CA, USA

• Paula Cannon

HIV i-Base, London, UK

Simon Collins

Weill Cornell Medicine, Cornell University, New York, NY, USA

• R. Brad Jones

Aidsfonds, Amsterdam, the Netherlands

Marein A. W. P. de Jong & Marein de Jong

University Paris Saclay, AP-HP, Bicêtre Hospital, UMR1184 INSERM CEA, Le Kremlin Bicêtre, Paris, France

• Olivier Lambotte

International AIDS Society, Geneva, Switzerland

Rosanne Lamplough

Africa Health Research Institute and University of KwaZulu-Natal, Durban, South Africa

• Thumbi Ndung’u

University College London, London, UK

Ragon Institute of MGH, MIT and Harvard University, Cambridge, MA, USA

Thumbi Ndung’u & Krista Dong

Berman Institute of Bioethics and Department of Medicine, Johns Hopkins University, Baltimore, MD, USA

• Jeremy Sugarman

National Institute for Communicable Diseases and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

• Caroline T. Tiemessen

UZ Ghent, Ghent, Belgium

• Linos Vandekerckhove

Victorian Infectious Diseases Service, The Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia

Sharon R. Lewin

Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia

Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia

Sharon R. Lewin & Sharon Lewin

UKZN, Durban, South Africa

Zaza Ndhlovu

Centre de Recherche du CHUM and Université de Montréal, Montreal, Canada

Nicolas Chomont

BC Centre for Excellence in HIV/AIDS, Faculty of Health Sciences, Simon Fraser University, Vancouver, Canada

Zabrina Brumme

Sun Yat-sen University, Guangzhou, China

ViiV Healthcare, Branford, CT, USA

Luke Jasenosky

Treatment Action Group, New York, NY, USA

Richard Jefferys

Institut Pasteur, Université de Paris, Unité HIV, Inflammation et Persistance, Paris, France

Aurelio Orta-Resendiz

National Cancer Institute, Center for Cancer Research, Bethesda, MD, USA

Frank Mardarelli

UMC Utrecht, Utrecht, the Netherlands

Monique Nijhuis

Perelmann School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

Katharine Bar & Pablo Tebas

Merck & Co., Inc., Department of Infectious Disease & Vaccines, Kenilworth, NJ, USA

Bonnie Howell

European AIDS treatment group (EATG), Zurich, Switzerland

Alex Schneider

1CONICET – Universidad de Buenos Aires. Instituto de Investigaciones, Biomédicas en Retrovirus y SIDA (INBIRS), Buenos Aires, Argentina

Gabriela Turk

Facultad de Medicina, Departamento de Microbiología, Parasitología e Inmunología, Buenos Aires, Argentina

Makerere University, Makerere, Uganda

Rose Nabatanzi

John Hopkins School of Medicine, Baltimore, MD, USA

Joel Blankson

ICATS, UNC School of Medicine, Chapel Hill, NC, USA

J. Victor Garcia

Emory University School of Medicine, Yerkes National Primate Research Center, Atlanta, GA, USA

• Mirko Paiardini

ViiV Healthcare, London, UK

Jan van Lunzen

Chelsea and Westminster Hospital NHS Foundation Trust, London, UK

Christina Antoniadi

Laboratório de AIDS e Imunologia Molecular, Instituto Oswaldo Cruz, Rio de Janeiro, Brazil

Fernanda Heloise Côrtes

Scripps Research Institute, Jupiter, FL, USA

Susana Valente

Aarhus University Hospital, Aarhus, Denmark

Ole S. Søgaard

Universidade Federal de Sao Paulo, Sao Paulo, Brazil

Ricardo Sobhie Diaz

Gladstone Institute of Virology, University of California San Francisco, San Francisco, CA, USA

Melannie Ott

USAHIV Drug Discovery, ViiV Healthcare, Qura Therapeutics, and UNC HIV Cure Center, University of North Carolina at Chapel Hill, Research Triangle Park, NC, USA

Richard (Rick) Dunham

EATG, Berlin, Germany

Siegfried Schwarze

Queen’s University, Kingston, Ontario, Canada

Santiago Perez Patrigeon

MUJHU Care limited, Kampala, Uganda

Josephine Nabukenya

The Rockefeller University, New York, NY, USA

Marina Caskey

IrsiCaixa AIDS Research Institute, HUGTIP, Badalona, Barcelona, Spain

Beatriz Mothe

Chinese Academy of Sciences, National Clinical Research Center for Infectious Diseases, Division of Treatment and Care, National Center for AIDS/STD Control and Prevention, Beijing, China

Fu Sheng Wang

Imperial College London, Department of Infectious Disease, Faculty of Medicine, London, UK

Sarah Fidler

Gilead Sciences, Foster City, CA, USA

Devi SenGupta

European AIDS Treatment Group (EATG), Brussels, Belgium

Stephan Dressler

University of North Carolina Project Malawi, Lilongwe, Malawi

Mitch Matoga

Fred Hutchinson Cancer Research Center, Seattle, WA, USA

Hans-Peter Kiem

Joint Clinical Research Centre, Kampala, Uganda

Cissy Kityo

Caring Cross, Gaithersburg, MD, USA

Boro Dropulic

University of Washington, Seattle, WA, USA

Michael Louella

Advanced Medical and Dental Institute, Universiti Sains Malaysia, Pulau Pinang, Malaysia

Kumitaa Theva Das

Johns Hopkins University School of Medicine, Baltimore, MD, USA

Deborah Persaud

Emory University School of Medicine and Children’s Healthcare of Atlanta, Atlanta, GA, USA

Ann Chahroudi

University of Massachusetts, Worcester, MA, USA

Katherine Luzuriaga

Chulalongkorn University, Bangkok, Thailand

Thanyawee Puthanakit

ImmunityBio, Inc, Culver City, CA, USA

Jeffrey Safrit

Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana

Gaerolwe Masheto

UNC Gillings School of Global Public Health, Chapel Hill, NC, USA

Karine Dubé

La Trobe University, Melbourne, Australia

Jennifer Power

AVAC, New York, NY, USA

Jessica Salzwedel

VARG, Chiang Mai, Thailand

Udom Likhitwonnawut

UCSD AntiViral Research Center, Delaney AIDS Research Enterprise/UCSF, Palm Springs, CA, USA

Jeff Taylor

Social Policy, Gender Identity, and Sexual Orientation Studies Association (SPoD), University of Lucerne MSc Health Sciences, Istanbul, Turkey

Oguzhan Latif Nuh

Rakai Health Sciences Program, Rakai, Uganda

Edward Nelson Kankaka

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Core Leadership Group

• Steven Deeks
• , Sharon Lewin
• , Marein de Jong
• , Rosanne Lamplough
•  & Simon Collins

Working Group 1 (Understanding HIV reservoirs)

• , Zaza Ndhlovu
• , Nicolas Chomont
• , Zabrina Brumme
• , Luke Jasenosky
• , Richard Jefferys
•  & Aurelio Orta-Resendiz

Working Group 2 (HIV reservoir measurement)

• , Frank Mardarelli
• , Monique Nijhuis
• , Katharine Bar
• , Bonnie Howell
• , Alex Schneider
• , Gabriela Turk
•  & Rose Nabatanzi

Working Group 3 (Mechanisms of virus control)

• , Joel Blankson
• , J. Victor Garcia
• , Mirko Paiardini
• , Jan van Lunzen
• , Christina Antoniadi
•  & Fernanda Heloise Côrtes

Working Group 4 (Targeting the provirus)

• , Susana Valente
• , Ole S. Søgaard
• , Ricardo Sobhie Diaz
• , Melannie Ott
• , Richard (Rick) Dunham
• , Siegfried Schwarze
• , Santiago Perez Patrigeon
•  & Josephine Nabukenya

Working Group 5 (Targeting the immune system)

• , Marina Caskey
• , Beatriz Mothe
• , Fu Sheng Wang
• , Sarah Fidler
• , Devi SenGupta
• , Stephan Dressler
•  & Mitch Matoga

Working Group 6 (Cell and gene therapy)

• , Hans-Peter Kiem
• , Pablo Tebas
• , Cissy Kityo
• , Boro Dropulic
• , Michael Louella
•  & Kumitaa Theva Das

Working Group 7 (Paediatric remission and cure)

• , Deborah Persaud
• , Ann Chahroudi
• , Katherine Luzuriaga
• , Thanyawee Puthanakit
• , Jeffrey Safrit
•  & Gaerolwe Masheto

Working Group 8: (Social, behavioral and ethical aspects of cure)

• , Karine Dubé
• , Jennifer Power
• , Jessica Salzwedel
• , Udom Likhitwonnawut
• , Jeff Taylor
• , Oguzhan Latif Nuh
• , Krista Dong
•  & Edward Nelson Kankaka

Contributions

S.G.D., S.R.L., M.D.J. and R.L. developed the method for generating the strategy and oversaw the governance and establishment of the working groups. All authors on the masthead were members of the steering group. All authors of the IAS Global Scientific Strategy writing group contributed to the writing and approved the submitted version of the manuscript. Members of the IAS Global Scientific Strategy working groups are identified in the list at the end of the manuscript.

Corresponding authors

Correspondence to Steven G. Deeks or Sharon R. Lewin .

Ethics declarations

Competing interests.

S.G.D. receives research support from Gilead and Merck. He is a member of the scientific advisory boards for BryoLogyx, Enochian Biosciences and Tendel. He has consulted for AbbVie, Biotron, Eli Lilly, GSK/ViiV and Immunocore; J.S. is a member of Merck KGaA’s Ethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA’s Ethics Advisory Panel; a member of Aspen Neurosciences Clinical Advisory Panel; a member of a Merck Data Monitoring Committee; a consultant to Biogen; and a consultant to Portola Pharmaceuticals Inc. None of these activities are related to the issues discussed in this manuscript; T.N. has received research funding from Gilead Sciences; O.L. has been paid expert testimony and consultancy fees from BMS France, MSD, Astra Zeneca; consultancy fees from Incyte, Sobi, grants from ViiV and Gilead; L.V. receives research grants from J&J, ViiV Healthcare and Gilead Sciences; P.C. is a member of Gilead’s HIV Cure Advisory Board; S.R.L.’s institution receives funding for investigator initiated research from Gilead, Merck and Viiv. She has research collaborations with BMS, Abbvie and Merck. She has received honoraria paid to her for membership of advisory boards to Gilead, Merck, Viiv, Immunocore, Vaxxinity, Biotron, Esfam and Abivax; R.L. is an employee of the International AIDS Society; M.d.J. was paid as a consultant by the International AIDS Society. S.C., R.B.J., C.T. and N.A. have no interests to declare.

Additional information

Peer review information Nature Medicine thanks Ravindra Gupta and the other, anonymous, reviewers for their contribution to the peer review of this work. Karen O’Leary was the primary editor on this article and managed its editorial process and peer review in collaboration with the rest of the editorial team.

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Deeks, S.G., Archin, N., Cannon, P. et al. Research priorities for an HIV cure: International AIDS Society Global Scientific Strategy 2021. Nat Med 27 , 2085–2098 (2021). https://doi.org/10.1038/s41591-021-01590-5

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Received : 12 September 2021

Accepted : 27 October 2021

Published : 01 December 2021

Issue Date : December 2021

DOI : https://doi.org/10.1038/s41591-021-01590-5

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