Boosting long-acting injectable PrEP use among Latine gay/bisexual men and transgender women in the South
INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP
This project will try giving long-acting injectable PrEP (lenacapavir) through a community clinic to Latine gay and bisexual men and transgender women in Durham to see if people stay on PrEP longer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07218211 on ClinicalTrials.gov |
What this trial studies
This is a mixed-methods hybrid type 3 implementation program that tests a culturally tailored, community-delivered lenacapavir injection program while collecting clinical outcomes. Duke University and El Centro Hispano will integrate lenacapavir delivery on-site and use El Centro Hispano Peer Navigators to provide culturally congruent support for PrEP uptake, adherence, and persistence among Latine GBM and TGW. The primary outcome is persistence on lenacapavir compared with historical persistence at the Duke PrEP Clinic, and the study will use both quantitative measures and qualitative interviews to identify barriers and facilitators. Eligible participants are HIV-negative Latine individuals assigned male at birth who are interested in PrEP and able to consent in English or Spanish.
Who should consider this trial
Good fit: Ideal candidates are HIV-negative Latine gay or bisexual men and transgender women (assigned male at birth), age 18 or older, able to consent in English or Spanish, interested in PrEP, and willing to receive lenacapavir injections at the community site.
Not a fit: People living with HIV, those assigned female at birth, individuals with severe liver or kidney disease, people taking medications that interact with lenacapavir, or those unwilling to switch from oral PrEP are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could increase how long Latine GBM and TGW stay on PrEP and reduce HIV risk in this community.
How similar studies have performed: Other long-acting injectable PrEP (like cabotegravir) has shown strong protection and improved retention, but lenacapavir as a community-delivered injectable PrEP and this specific culturally tailored implementation model are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be assigned male sex at birth. * Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative. * Identify as Hispanic and/or Latine . * Be able to provide informed consent in English or Spanish . * Be 18 years or older . * Weigh at least 77 lbs (35 kg) by self-reported weight. * Interested in PrEP and willing to undergo the study procedures. Exclusion Criteria: * Individuals living with HIV. * Individuals assigned female sex at birth will be excluded. * Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded. * Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded. * Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.
Where this trial is running
Durham, North Carolina
- El Centro Hispano — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Tonia Poteat, PhD — Duke University Medical Center - Professor in the School of Nursing
- Study coordinator: Iris Navarro Clinical Research Coordinator
- Email: inclusion@duke.edu
- Phone: 919-660-3940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.