El Centro Hispano
Durham, North Carolina, 27701, United States
Location status: Recruiting
Location contact
Alma Ortega
SUB_INVESTIGATOR
Emilia Ismael-Simental
SUB_INVESTIGATOR
Orlando Martinez J Peer Navigator
CONTACT
Recruiting
NCT Number: NCT07218211
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Lenacapavir long-acting
DrugCulturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)
Other names: Yeztugo, Lenacapavir injection, PrEP, Injectable PrEP
Primary outcomes
-
Acceptability of the intervention measured by questionnaire
Time frame: 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
Time frame: 6 months and 12 months
Evaluated using programmatic indicators including recruitment rate, adherence and retention.
-
Sustainability of the intervention
Time frame: 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.
Time frame: 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 outcomes
-
Persistence at 6 months
Time frame: 6 months
Persistence will be measured by the proportion of participants remaining on continuous, appropriately dosed lenacapavir at 6 months.
-
Adherence
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months and 12 months
How would you describe your health in general? (Excellent, Very good, Good, Fair, Poor)
-
Safety measured by Adverse events
Time frame: 6 months and 12 months
Prevalence of adverse events, such as injection site reactions.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Duke University
Other
Collaborators
- Gilead Sciences
Registry information
Official study title
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
Acronym: INCLUSION
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Oct 20, 2025
- Registry last updated
- Aug 26, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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