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)
Number of participants who provided identification of barriers to providing lenacapavir at a Latine community-based organization
Qualitative identification: "What gets in the way of people in your community starting PrEP? Staying on PrEP?"
Number of participants who provided recommendations to address barriers to providing lenacapavir at a Latine community-based organization
Qualitative identification: "Recommendations to address these barriers?"
Number of participants who provided identification of facilitators to providing lenacapavir at a Latine community-based organization
Qualitative identification: "What factors support people in your community?"
Acceptability as measured by the number of participants who answered "yes" to select modified acceptability questions from Abbreviated Acceptability Rating Profile (AARP)
AARP items will help quantify acceptability and will help validate community perceptions: "I believe lenacapavir injections are an effective way to prevent HIV", "I would be willing to receive lenacapavir injections in the future when this study is complete", "Receiving lenacapavir in a community setting fits my lifestyle and preferences", "I feel comfortable receiving lenacapavir injections from professionals working with El Centro", "I would recommend lenacapavir to a friend who is at risk for HIV", "I found lenacapavir preferable to oral PrEP", "Compared to a daily pill, I feel that injectable PrEP gives me more privacy", "I am concerned about possible side effects from lenacapavir injections", "Compared to a daily pill, I feel that injectable PrEP reduces concerns about being judged by others"
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.
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Duke University
Lead sponsor
Gilead Sciences
Collaborator
