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BackgroundCisgender women represent over half of people living with HIV globally. However, current research efforts toward a cure for HIV focus predominantly on cisgender men. The under-representation of women in HIV cure clinical studies is particularly problematic given data suggesting that sex-dependent phenotypes limit scientific discovery.ObjectiveWe aimed to generate considerations to increase the meaningful involvement of women in HIV cure-related research.Materials and methodsWe conducted in-depth interviews with biomedical researchers and community members to better understand factors that could increase the meaningful involvement of women in HIV cure clinical trials. Participants were affiliated with academia, industry, community advisory boards, and community-based organizations, and were identified using listings from the AIDS Clinical Trials Group and the Martin Delaney Collaboratories. We used conventional content analysis to analyze the qualitative data.ResultsWe recruited 27 participants, of whom 11 were biomedical researchers and 16 were community members. Participants included 25 cisgender women, 1 transgender woman, and 1 cisgender man. Key considerations emerged, including the need to ensure that HIV cure studies reflect HIV epidemiologic trends and having accurate representation by sex and gender in HIV cure research. To increase the meaningful involvement of women, recommendations included instituting intentional enrollment goals, frequent and mandatory reporting on enrollment, and incentives for sites to enroll women. Additional themes included the need for agency and self-determination, attention to lived experiences, trauma and healing, and adequate support for women (e.g. logistical, psychosocial, mental, emotional, and physical). Participants noted that women would be willing to participate in HIV cure trials, related procedures (e.g. biopsies), and analytical treatment interruptions. They also expressed a desired for women-centered and holistic clinical trial designs that account for intersectionality.ConclusionsOur empirical inquiry extends recent calls to action to increase diversity of people involved in HIV cure research. Redressing the under-inclusion of women in HIV cure research is an urgent imperative. The entire field must mobilize and reform to achieve this goal. Meaningfully involving women across the gender spectrum in HIV cure research is needed to ensure that interventions are safe, effective, scalable, and acceptable for all people with HIV.

Despite disproportionate incidence and prevalence of HIV among transgender individuals, cisgender women, and racial and ethnic minority groups, all remain underrepresented in HIV cure research. As HIV cure trials are scaled up, there is emerging research on ways to mitigate risks of HIV acquisition for sexual partners of analytical treatment interruption (ATI) trial participants. As such, it is imperative that HIV cure researchers consider the implications of implementing ATIs in populations that are disproportionately affected by HIV, but largely underrepresented in trials to date. In this qualitative study, we sought to derive triangulated perspectives on the social and ethical implications regarding ATIs and partner protection strategies during ATIs among under-represented populations. We conducted 21 in-depth interviews with 5 types of informants: bioethicists, community members [people living with HIV (PLWH) and their advocates], biomedical HIV cure researchers, sociobehavioral scientists, and HIV care providers. We analyzed the data using conventional content analysis and reduced the data to important considerations for implementing ATI trials in diverse communities and settings. Our study revealed the following key themes: (1) attention must be paid to gender and power dynamics in ATI trials; (2) ATI trials should be designed and implemented through the lenses of intersectionality and equity frameworks; (3) ATI trials may have both positive and negative effects on stigma for PLWH and their partners; and (4) partnership dynamics should be considered when designing ATI protocols. Our study generated actionable considerations that could be implemented in ATI trials to promote their acceptability to communities that have been underrepresented in HIV cure research to date. Research teams must invest in robust community and stakeholder engagement to define best practices. Paying attention to representation and equity will also promote better and more equitable implementation of HIV cure strategies once these become ready for rollout.

Once a death sentence, HIV is now considered a manageable chronic disease due to the development of antiretroviral therapy (ART) regimens with minimal toxicity and a high barrier for genetic resistance. While highly effective in arresting AIDS progression and rendering the virus untransmissible in people living with HIV (PLWH) with undetectable viremia (U=U) [1, 2]), ART alone is incapable of eradicating the "reservoir" of resting, latently infected CD4 + T cells from which virus recrudesces upon treatment cessation. As of 2022 estimates, there are 39 million PLWH, of whom 86% are aware of their status and 76% are receiving ART [3]. As of 2017, ART-treated PLWH exhibit near normalized life expectancies without adjustment for socioeconomic differences [4]. Furthermore, there is a global deceleration in the rate of new infections [3] driven by expanded access to pre-exposure prophylaxis (PrEP), HIV testing in vulnerable populations, and by ART treatment [5]. Therefore, despite outstanding issues pertaining to cost and access in developing countries, there is strong enthusiasm that aggressive testing, treatment, and effective viral suppression may be able to halt the ongoing HIV epidemic (ie, UNAIDS' 95-95-95 targets) [6-8]; especially as evidenced by recent encouraging observations in Sydney [9]. Despite these promising efforts to limit further viral transmission, for PLWH, a "cure" remains elusive; whether it be to completely eradicate the viral reservoir (ie, cure) or to induce long-term viral remission in the absence of ART (ie, control; Figure 1). In a previous salon hosted by Pathogens and Immunity in 2016 [10], some researchers were optimistic that a cure was a feasible, scalable goal, albeit with no clear consensus on the best route. So, how are these cure strategies panning out? In this commentary, 8 years later, we will provide a brief overview on recent advances and failures towards identifying determinants of viral persistence and developing a scalable cure for HIV. Based on these observations, and as in the earlier salon, we have asked several prominent HIV cure researchers for their perspectives., Competing Interests: JH and MP have active collaborations with Merck & Co., Inc., and routinely receive antiretroviral compounds for nonhuman primate studies from ViiV Healthcare and Gilead Sciences, but the authors declare no financial stake. MML has received competitive grant funding from Gilead., (Copyright © 2024 Pathogens and Immunity.)

Heterosexual non-Hispanic black women in the United States are far more affected than women of other races or ethnicities by human immunodeficiency virus (HIV). SisterLove, Inc., a community-based organization in Atlanta, Georgia, responded to this disparity early in the epidemic by creating the Healthy Love HIV and sexually transmitted disease (STD) prevention intervention in 1989. Since then, SisterLove has been delivering the intervention to black women in metropolitan Atlanta. This report describes successful efforts by SisterLove, Inc., to develop, rigorously evaluate, and demonstrate the efficacy of Healthy Love, a 3-4-hour interactive, educational workshop, to reduce HIV- and sexually transmitted disease-related risk behaviors among heterosexual black women. On the basis of the evaluation findings, CDC packaged the intervention materials for use by service provider organizations in their efforts to reduce HIV disparities that affect black women in metropolitan Atlanta, the South, and the United States. This report also describes initiatives by SisterLove after the efficacy study to increase the potential effectiveness and reach of the Healthy Love intervention and further address HIV-related disparities that affect black women. CDC's Office of Minority Health and Health Equity selected the intervention analysis and discussion that follows to provide an example of a program that might be effective in reducing HIV-related disparities in the United States. The results of the randomized controlled efficacy trial highlight the potential of culturally tailored, interactive group intervention efforts to reduce health disparities. CDC's support for evaluating and packaging SisterLove's intervention materials, and making the materials available (www.effectiveinterventions.org) for use by service provider organizations, are important contributions toward efforts to address HIV-related disparities that affect black women.

HIV prevention services have succeeded in limiting HIV incidence in the United States but have not prevented HIV from becoming a devastating epidemic in the communities most affected. The National HIV/AIDS Strategy represents an important opportunity to improve domestic HIV prevention efforts and to begin to reduce HIV incidence over time. Elements that are essential to improving HIV incidence outcomes include greater transparency and accountability in use of HIV prevention funds; scaling up programming for those most at risk; fostering and evaluating community-based HIV prevention efforts; and looking beyond individual behavior change programming by putting a greater emphasis on structural, network, and policy interventions. To overcome years of stagnation on HIV prevention outcomes, we need a response characterized by accountability, appropriate targeting, and sufficient scale.