Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP).

INTRODUCTION: Black and Hispanic/Latinx cisgender men who have sex with men (MSM), transgender women, transgender men, and gender nonbinary (TGNB) individuals have been historically underrepresented in HIV pre-exposure prophylaxis (PrEP) clinical trials. There is an urgent need for ongoing engagement with communities that have been the most impacted by HIV and diverse representation in clinical trials. Here we describe strategic approaches undertaken in the PURPOSE 2 trial to optimize engagement of underrepresented individuals. METHODS AND RESULTS: PURPOSE 2 is an ongoing Phase 3 trial evaluating the safety and efficacy of lenacapavir as PrEP in cisgender MSM and TGNB individuals. In PURPOSE 2, we used a multipronged approach aimed at enriching participation of underrepresented individuals. We conducted a review to identify evidence-informed recommendations from literature, engaged with stakeholders, and established the Global Community Advisory and Accountability Group (GCAG) to represent the needs of the community. Insights from stakeholders and GCAG members resulted in an expansion of the study population to include transgender men, gender nonbinary persons, and adolescents, and evaluation of population-specific outcomes. Feedback from stakeholders and GCAG members also informed investigator and site selection; these were selected based on prior experience working with persons from diverse racial, ethnic and gender identities, and estimates of local HIV incidence. Site selection was also expanded to include community-based clinics with services tailored towards Black, Hispanic/Latinx, and TGNB populations. We established a study-wide recruitment goal of 50% Black MSM and 20% Hispanic/Latinx MSM in US sites and 20% transgender women globally. Site-specific recruitment goals were also developed based on local demographics and HIV incidence. Mandatory trainings included Good Participatory Practice guidelines, gender inclusivity, and antiracism. CONCLUSION: While further work is needed to achieve equitable representation, the strategies we describe may serve as a framework for future clinical trials. TRIAL REGISTRATION: Clinical Trial Number: NCT04925752.

Association between HIV and blood pressure in adults and role of body weight as a mediator: Cross-sectional study in Uganda.

The authors sought to describe the association between human immunodeficiency virus (HIV) and blood pressure (BP) levels, and determined the extent to which this relationship is mediated by body weight in a cross-sectional study of HIV-infected and HIV-uninfected controls matched by age, sex, and neighborhood. Mixed-effects models were fit to determine the association between HIV and BP and amount of effect of HIV on BP mediated through body mass index. Data were analyzed from 577 HIV-infected and 538 matched HIV-uninfected participants. HIV infection was associated with 3.3 mm Hg lower systolic BP (1.2-5.3 mm Hg), 1.5 mm Hg lower diastolic BP (0.2-2.9 mm Hg), 0.3 m/s lower pulse wave velocity (0.1-0.4 mm Hg), and 30% lower odds of hypertension (10%-50%). Body mass index mediated 25% of the association between HIV and systolic BP. HIV infection was inversely associated with systolic BP, diastolic BP, and pulse wave velocity. Comprehensive community-based programs to routinely screen for cardiovascular risk factors irrespective of HIV status should be operationalized in HIV-endemic countries.

An intervention to support HIV preexposure prophylaxis adherence in HIV-serodiscordant couples in Uganda.

BACKGROUND: Daily preexposure prophylaxis (PrEP) is an effective HIV prevention strategy, but adherence is required for maximum benefit. To date, there are no empirically supported PrEP adherence interventions. This article describes the process of developing a PrEP adherence intervention and presents results on its impact on adherence. METHODS: The Partners PrEP Study was a placebo-controlled efficacy trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among uninfected members of HIV-serodiscordant couples. An ancillary adherence study was conducted at 3 study sites in Uganda. Participants with <80% adherence as measured by unannounced pill count received an additional adherence counseling intervention based on Lifesteps, an evidence-based HIV treatment adherence intervention, based on principles of cognitive-behavioral theory. FINDINGS: Of the 1147 HIV-seronegative participants enrolled in the ancillary adherence study, 168 (14.6%) triggered the adherence intervention. Of participants triggering the intervention, 62% were men; median age was 32.5 years. The median number of adherence counseling sessions was 10. Mean adherence during the month before the intervention was 75.7% and increased significantly to 84.1% in the month after the first intervention session (P < 0.001). The most frequently endorsed adherence barriers at session 1 were travel and forgetting. INTERPRETATION: A PrEP adherence intervention was feasible in a clinical trial of PrEP in Uganda and PrEP adherence increased after the intervention. Future research should identify PrEP users with low adherence for enhanced adherence counseling and determine optimal implementation strategies for interventions to maximize PrEP effectiveness.