HIV Prevention, HIV Pre-exposure Prophylaxis, HIV Prevention Program, HIV Prevention and Care, HIV Pre-exposure Prophylaxis Use
Conditions
Keywords
Long-acting Injectable PrEP, Lenacapavir, PrEP, PrEP injections
Brief summary
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.
Detailed description
We propose a mixed methods hybrid type 3 implementation study, which primarily tests an implementation strategy while collecting data on the clinical intervention and related outcomes. Building on existing partnerships between Duke University and El Centro Hispano, we will integrate lenacapavir delivery on-site at El Centro Hispano facilities, leveraging El Centro Hispano Peer Navigators to provide culturally congruent support for PrEP uptake, adherence, and persistence among Latine GBM and TGW.
Interventions
Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)
Sponsors
Duke University
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the intervention measured by questionnaire | 6 and 12 months | 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 | 6 months and 12 months | Evaluated using programmatic indicators including recruitment rate, adherence and retention. |
| Sustainability of the intervention | 6 months and 12 months | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence at 6 months | 6 months | Persistence will be measured by the proportion of participants remaining on continuous, appropriately dosed lenacapavir at 6 months. |
| Adherence | 6 months and 12 months | 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 | 6 months and 12 months | Retention, defined as continued receipt of appropriately dosed lenacapavir at El Centro Hispano, rather than transfer to care to another clinical site. |
| Continuation | 12 months | Continuation, defined as continued receipt of lenacapavir at El Centro Hispano, regardless of whether gaps in coverage occurred. This is measured at 12 months. |
| Patient Satisfaction measured by questionnaire | 6 months and 12 months | Measured with the following 4 questions: 1. Overall, how satisfied are you with lenacapavir (Likert scale)? 2. Would you recommend lenacapavir to others (yes/no)? 3. Overall, how satisfied are you with getting PrEP at El Centro (Likert scale)? 4. Would you recommend getting PrEP at El Centro to others (yes/no)? Items #1 and #3 are rated on a 5-point Likert scale from 1 (Very satisfied) to 5 (Very dissatisfied); lower scores indicate greater patient satisfaction. |
| Quality of Life measured by questionnaire | 6 months and 12 months | How would you describe your health in general? (Excellent, Very good, Good, Fair, Poor) |
| Safety measured by Adverse events | 6 months and 12 months | Prevalence of adverse events, such as injection site reactions. |
Countries
United States
Contacts
CONTACTIris Navarro Clinical Research Coordinator
PRINCIPAL_INVESTIGATORTonia Poteat, PhD
Duke University Medical Center - Professor in the School of Nursing
Outcome results
None listed