The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.
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 .
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.
Single group
Lenacapavir long-acting
DrugCulturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)
Acceptability of the intervention measured by questionnaire
Measured using an adapted Abbreviated Acceptability Rating Profile. Items are rated on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree); higher scores indicate greater acceptability of the intervention.
Feasibility of the intervention measured by programmatic indicators
Evaluated using programmatic indicators including recruitment rate, adherence and retention.
Sustainability of the intervention
Number of providers who found the intervention feasible as measured by the Program Sustainability Assessment Tool (PSAT). The PSAT will provide a structured way to assess organizational capacity and sustainability for scale up. It has a score range of 0 to 40, where a higher score indicates greater feasibility.
The persistence on lenacapavir among participants receiving care at El Centro Hispano at 12 months.
Persistence will be defined as the proportion of participants remaining on continuous, appropriately dosed lenacapavir at each follow-up visit. Appropriately dosed lenacapavir is defined as either on-time injection (within 28 weeks after the last injection) or with oral tablets taken as a bridge according to Package Insert instructions.
Persistence at 6 months
Persistence will be measured by the proportion of participants remaining on continuous, appropriately dosed lenacapavir at 6 months.
Adherence
Adherence measured by participants receiving each lenacapavir injection within 28 weeks after the last injectionParticipants requiring oral bridging due to delayed injections will be considered persistent but not fully adherent to the scheduled injection protocol. This is measured at 6 months and at 12 months.
Retention
Retention, defined as continued receipt of appropriately dosed lenacapavir at El Centro Hispano, rather than transfer to care to another clinical site.
Continuation
Continuation, defined as continued receipt of lenacapavir at El Centro Hispano, regardless of whether gaps in coverage occurred. This is measured at 12 months.
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Duke University
Lead sponsor
Gilead Sciences
Collaborator
