HIV PreventionPhase 4INCLUSIONNCT07218211
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
A Phase 4 study testing Lenacapavir long-acting in people with HIV Prevention and HIV Pre-exposure Prophylaxis, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HIV Pre-exposure Prophylaxis, HIV Prevention Program
- What is being tested?
- Lenacapavir long-acting
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 31 Jul 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
El Centro Hispano
Durham, North Carolina, 27701
Orlando Martinez J Peer Navigator, 1(919) 687-4635, jomartinez@elcentronc.org
Emilia Ismael-Simental
About this study
Official 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
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.
Read the 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.
- Conditions
- HIV Prevention, HIV Pre-exposure Prophylaxis, HIV Prevention Program, HIV Prevention and Care, HIV Pre-exposure Prophylaxis Use
- Being tested
- Lenacapavir long-acting
- Keywords
- Long-acting Injectable PrEP, Lenacapavir, PrEP, PrEP injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenacapavir long-actingDrug
Also called Yeztugo, Lenacapavir injection, PrEP, Injectable PrEP
Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)
| Study group | Role | What they receive |
|---|---|---|
| Long-acting Injectable PrEP (lenacapavir) program | Other | Community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW) Receives: Drug: Lenacapavir long-acting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 and 12 months
Feasibility of the intervention measured by programmatic indicators
Evaluated using programmatic indicators including recruitment rate, adherence and retention.
Measured: 6 months and 12 months
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.
Measured: 6 months and 12 months
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.
Measured: 12 months
Secondary outcomes (7)
Persistence at 6 months
Persistence will be measured by the proportion of participants remaining on continuous, appropriately dosed lenacapavir at 6 months.
Measured: 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.
Measured: 6 months and 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.
Measured: 6 months and 12 months
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.
Measured: 12 months
Patient Satisfaction measured by questionnaire
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.
Measured: 6 months and 12 months
Quality of Life measured by questionnaire
How would you describe your health in general? (Excellent, Very good, Good, Fair, Poor)
Measured: 6 months and 12 months
Safety measured by Adverse events
Prevalence of adverse events, such as injection site reactions.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start13 Jan 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Tonia Poteat, PhD, Principal investigator, Duke University Medical Center - Professor in the School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218211
- Sponsor's protocol ID
- PRO00118575
- Acronym
- INCLUSION
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No