Trial reportPloS one2022
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).
Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04925752 (A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.
- Lenacapavir as pre-exposure prophylaxis for HIV prevention.The Cochrane database of systematic reviews · 2026Pooled it
- Brief Report: Associations Between Gender and Solicited Adverse Events After Passive Infusion of VRC01 or Placebo in HVTN 704/HPTN 085.Journal of acquired immune deficiency syndromes (1999) · 2025Trial
- Beyond cultural competency: Applying an antiracism lens to LGBTQ+ care and health.Journal of public health research · 2026Article
- Acceptability and Use of Digital Health and Artificial Intelligence-Enabled Chatbots for Sexual and Reproductive Health Among Lesbian, Bisexual, and Queer Women of Color in the United States: Cross-Sectional Survey Study.Journal of medical Internet research · 2025Article
- Preexposure Prophylaxis Prescription Dispensation Status and HIV-1 Acquisition.JAMA network open · 2025Observational
- Barriers and Facilitators to PrEP Adherence among Transgender and Non-binary Individuals: A Mixed-Methods Analysis of Psychosocial Factors and Health Belief Model Constructs.AIDS and behavior · 2025Article
- Lenacapavir for HIV Prevention: A Commitment to Equitable Access and Partnership by Gilead Sciences.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- Considerations for capsid-targeting antiretrovirals in pre-exposure prophylaxis.Trends in molecular medicine · 2025Review
- Innovation in Providing Equitable Pre-exposure Prophylaxis Services in the United States: Expanding Access in Nontraditional Settings.Journal of acquired immune deficiency syndromes (1999) · 2025Article
- A roadmap for engagement and inclusion of LGBTQIA+ people in clinical research.Nature medicine · 2025Article
- Preparing for the Implementation of Long-Acting Injectable Cabotegravir for HIV Pre-Exposure Prophylaxis Within the Brazilian Public Health System (ImPrEP CAB Brasil): Qualitative Study.JMIR public health and surveillance · 2024Article
- Transgender people in clinical trials of drugs and biologics: An analysis of ClinicalTrials.gov from 2007 to 2023.British journal of clinical pharmacology · 2024Article
- Long-acting HIV Treatments: Study Design, Logistics, and Access.Open forum infectious diseases · 2024Review
- Pre-Exposure Prophylaxis and HIV Prevention Among Key Populations in Nigeria.International journal of MCH and AIDS · 2024Article
- A commentary on forging a path for CHANGE: culturally focused HIV training for the next generation in pursuit of equity.Critical public health · 2024Article
- Article
- A toolkit for capturing a representative and equitable sample in health research.Nature medicine · 2023Article
- Mixed methods implementation research to understand success of intensive combination approach to roll back the epidemic in Nigerian adolescents) (iCARE Nigeria) HIV testing uptake and linkage to care among young men focusing on young men who have sex with men in Ibadan.AIDS research and therapy · 2023Article
- Stakeholders' Perspectives About Cultural Strategies to Support PrEP for Latino Sexual Minority Men.AIDS education and prevention : official publication of the International Society for AIDS Education · 2023Article
- Highlights on the Development, Related Patents, and Prospects of Lenacapavir: The First-in-Class HIV-1 Capsid Inhibitor for the Treatment of Multi-Drug-Resistant HIV-1 Infection.Medicina (Kaunas, Lithuania) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 8 institutions in 2 countries.
Funding
Abstract
introductionBlack 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
resultsPURPOSE 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.
conclusionWhile further work is needed to achieve equitable representation, the strategies we describe may serve as a framework for future clinical trials.
trial registrationClinical Trial Number: NCT04925752.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.