Erratum to: Progress Note 2024: Curing HIV; Not in My Lifetime or Just Around the Corner?

[This corrects the article DOI: 10.20411/pai.v8i2.665.].

Progress Note 2024: Curing HIV; Not in My Lifetime or Just Around the Corner?

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.

"I don't regret it at all. It's just I wish the process had a bit more humanity to it a bit more holistic": a qualitative, community-led medication abortion study with Black and Latinx Women in Georgia, USA.

Traditional family planning research has excluded Black and Latinx leaders, and little is known about medication abortion (MA) among racial/ethnic minorities, although it is an increasingly vital reproductive health service, particularly after the fall of Roe v. Wade. Reproductive justice (RJ) community-based organisation (CBO) SisterLove led a study on Black and Latinx women's MA perceptions and experiences in Georgia. From April 2019 to December 2020, we conducted key informant interviews with 20 abortion providers and CBO leaders and 32 in-depth interviews and 6 focus groups (n = 30) with Black and Latinx women. We analysed data thematically using a team-based, iterative approach of coding, memo-ing, and discussion. Participants described multilevel barriers to and strategies for MA access, wishing that "the process had a bit more humanity … [it] should be more holistic." Barriers included (1) sociocultural factors (intersectional oppression, intersectional stigma, and medical experimentation); (2) national and state policies; (3) clinic- and provider-related factors (lack of diverse clinic staff, long waiting times); and (4) individual-level factors (lack of knowledge and social support). Suggested solutions included (1) social media campaigns and story-sharing; (2) RJ-based policy advocacy; (3) diversifying clinic staff, offering flexible scheduling and fees, community integration of abortion, and RJ abortion funds; and (4) social support (including abortion doulas) and comprehensive sex education. Findings suggest that equitable MA access for Black and Latinx communities in the post-Roe era will require multi-level intervention, informed by community-led evidence production; holistic, de-medicalised, and human rights-based care models; and intersectional RJ policy advocacy.

Considerations for Increasing Racial, Ethnic, Gender, and Sexual Diversity in HIV Cure-Related Research with Analytical Treatment Interruptions: A Qualitative Inquiry.

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.

Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project.

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.

Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064).

BACKGROUND: We sought to understand the multilevel syndemic factors that are concurrently contributing to the HIV epidemic among women living in the US. We specifically examined community, network, dyadic, and individual factors to explain HIV vulnerability within a socioecological framework. METHODS: We gathered qualitative data (120 interviews and 31 focus groups) from a subset of women ages 18-44 years (N = 2,099) enrolled in the HPTN 064 HIV seroincidence estimation study across 10 US communities. We analyzed data from 4 diverse locations: Atlanta, New York City (the Bronx), Raleigh, and Washington, DC. Data were thematically coded using grounded theory methodology. Intercoder reliability was assessed to evaluate consistency of team-based coding practices. RESULTS: The following themes were identified at 4 levels including 1) exosystem (community): poverty prevalence, discrimination, gender imbalances, community violence, and housing challenges; 2) mesosystem (network): organizational social support and sexual concurrency; 3) microsystem (dyadic): sex exchange, interpersonal social support, intimate partner violence; and 4) individual: HIV/STI awareness, risk taking, and substance use. A strong theme emerged with over 80 % of responses linked to the fundamental role of financial insecurity underlying risk-taking behavioral pathways. CONCLUSIONS: Multilevel syndemic factors contribute to women's vulnerability to HIV in the US. Financial insecurity is a predominant theme, suggesting the need for tailored programming for women to reduce HIV risk. TRIAL REGISTRATION: Clinicaltrials.gov, NCT00995176.

An Integrated Service Delivery Model to Identify Persons Living with HIV and to Provide Linkage to HIV Treatment and Care in Prioritized Neighborhoods: A Geotargeted, Program Outcome Study.

BACKGROUND: Recent studies have demonstrated that high human immunodeficiency virus (HIV) prevalence (2.1%) rates exist in "high-risk areas" of US cities that are comparable to rates in developing nations. Community-based interventions (CBIs) have demonstrated potential for improving HIV testing in these areas, thereby facilitating early entry and engagement in the HIV continuum of care. By encouraging neighborhood-based community participation through an organized community coalition, Project LINK sought to demonstrate the potential of the CBI concept to improve widespread HIV testing and referral in an area characterized by high poverty and HIV prevalence with few existing HIV-related services. OBJECTIVE: This study examines the influence of Project LINK to improve linkage-to-care and HIV engagement among residents of its target neighborhoods. METHODS: Using a venue-based sampling strategy, survey participants were selected from among all adult participants aged 18 years or more at Project LINK community events (n=547). We explored multilevel factors influencing continuum-of-care outcomes (linkage to HIV testing and CBI network referral) through combined geospatial-survey analyses utilizing hierarchical linear model methodologies and random-intercept models that adjusted for baseline effect differences among zip codes. The study specifically examined participant CBI utilization and engagement in relation to individual and psychosocial factors, as well as neighborhood characteristics including the availability of HIV testing services, and the extent of local prevention, education, and clinical support services. RESULTS: Study participants indicated strong mean intention to test for HIV using CBI agencies (mean 8.66 on 10-point scale [SD 2.51]) and to facilitate referrals to the program (mean 8.81 on 10-point scale [SD 1.86]). Individual-level effects were consistent across simple multiple regression and random-effects models, as well as multilevel models. Participants with lower income expressed greater intentions to obtain HIV tests through LINK (P<.01 across models). HIV testing and CBI referral intention were associated with neighborhood-level factors, including reduced availability of support services (testing P<.001), greater proportion of black/African Americans (testing and referral P<.001), and reduced socioeconomic capital (testing P=.017 and referral P<.001). Across models, participants expressing positive attitudes toward the CBI exhibited greater likelihood of engaging in routine HIV testing (P<.01) and referring others to HIV care (P<.01). Transgender individuals indicated greater intent to refer others to the CBI (P<.05). These outcomes were broadly influenced by distal community-level factors including availability of neighborhood HIV support organizations, population composition socioeconomic status, and high HIV prevalence. CONCLUSIONS: Project LINK demonstrated its potential as a geotargeted CBI by evidencing greater individual intention to engage in HIV testing, care, and personal referrals to its coalition partner organizations. This study highlights important socioecological effects of US-based CBIs to improve HIV testing and initiate acceptable mechanisms for prompt referral to care among a vulnerable population.

Community-based program to prevent HIV/STD infection among heterosexual black women.

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.

Efficacy of a single-session HIV prevention intervention for black women: a group randomized controlled trial.

SisterLove Inc., a community-based organization (CBO) in Atlanta, Georgia, evaluated the efficacy of its highly interactive, single-session HIV prevention intervention for black women, the Healthy Love Workshop (HLW). HLW is delivered to pre-existing groups of women (e.g., friends, sororities) in settings of their choosing. Eligible groups of women were randomly assigned to receive the intervention (15 groups; 161 women) or a comparison workshop (15 groups; 152 women). Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups. Among sexually active women at the 3-month follow-up, HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner, and to have used condoms at last vaginal, anal or oral sex with any male partner. At the 6-month follow-up, HLW participants were more likely to report condom use at last vaginal, anal or oral sex with any male partner, and having an HIV test and receiving their test results. The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention. This study also demonstrates that a CBO can develop and deliver a culturally appropriate, effective HIV prevention intervention for the population it serves and, with adequate resources and technical assistance, rigorously evaluate its intervention.

A prevention response that fits America's epidemic: community perspectives on the status of HIV prevention in the United States.

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.

An extended model of reasoned action to understand the influence of individual- and network-level factors on African Americans' participation in HIV vaccine research.

In the United States, the number and proportion of HIV/AIDS cases among black/African Americans continue to highlight the need for new biomedical prevention interventions, including an HIV vaccine, microbicide, or new antiretroviral (ARV) prevention strategies such as pre-exposure prophylaxis (PrEP) to complement existing condom usage, harm reduction methods, and behavioral change strategies to stem the HIV epidemic. Although black/African Americans are disproportionately impacted by HIV/AIDS, their participation in HIV clinical research continues to have unique challenges. We theorize that interaction among multilevel factors creates ideal alignment for minority participation in HIV clinical studies. Thus, we initially set out to test an extended model of reasoned action with 362 participants to understand the interplay of sociopsychological and network-level considerations influencing minority participation in HIV prevention research efforts. In this study, we linked the intrapersonal dimensions of attitudes, beliefs, and normative concerns to community-level components, appraisal of involvement with the clinical research organization, an entity which operates within a networked structure of community partner agencies, and identification with coalition advocacy aims. Various participatory outcomes were explored including involvement in future HIV vaccine community functions, participation in community promotion of HIV vaccine research, and community mobilization. Three-stage least squares estimates indicated similar findings across three models. Significant effects demonstrate the importance of positive attitudes toward HIV vaccine research, favorable health research beliefs, perceived social support for participation, HIV/AIDS issue engagement, and perceived relevance of the clinical research site's mission and values. Identification of these nuanced pathway effects provides implications for tailored community program development.