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)

Abstract

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.

Inclusion of Transgender and Gender Diverse People in Phase III Trials: Examples from HIV Pharmacologic Prevention Studies

“…The PURPOSE-2 enrollment goal is 3,000 adults, with investigators establishing a 20% study-wide enrollment goal for transgender women based on country-specific HIV prevalence estimates specifically for transgender women. 52 PURPOSE-2 enrollment is open to transgender men and nonbinary individuals. However, investigators could not set data-driven enrollment goals for these populations due to a lack of local-level HIV incidence data for these populations.…”

“…52 The PURPOSE-2 study team utilized several evidence-based approaches to engage historically under-represented individuals during protocol development. 52 These efforts included engaging US and global stakeholders through a Global Community Advisory and Accountability Group and including members of the priority population within the study team. Although the investigators did not specify a plan to stratify the primary end point (HIV incidence) between transgender women and cisgender men, 53 the study design indicates a positive movement toward inclusion of TGD people throughout study design and completion.…”

“…58 PURPOSE-2 expanded its priority populations to include transgender men and nonbinary people based on community advisory board feedback. 52 Still, more work is needed to include these populations in phase III HIV trials. Phase III trials should consider opportunities to enrich for all populations at risk of acquiring HIV, including transmasculine and nonbinary persons.…”

HIV Prevention Utilizing Long-acting Injectables

“…30 Purpose-2 was purposefully designed by the study team to include the participation of underrepresented individuals with a goal of enrolling 50% black MSM and 20% Hispanic/Latinx MSM. 31…”

Barriers to PrEP Uptake in Two Spirit, Gay, Bisexual, Trans and Queer Men, and Non-Binary People in Canada

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Indigenous or ethnoracial minority Two-Spirit, Gay, Bisexual, Trans, Queer men, and Non-Binary (2SGBTQ+) people in Canada are underrepresented in PrEP use within 2SGBTQ+ samples due to health & social inequities. [1,2] We examined barriers to PrEP use for sub-populations of HIV-negative 2SGBTQ+ people based on Indigeneity or ethnoracial identity, and gender diversity, using a strengths-based approach; by this, we examined which groups of people significantly reported fewer barriers compared to other Indigenous and ethnoracial people.

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