Recruiting

Lenacapavir

Sponsor:

Duke University

Code:

NCT07218211

Conditions

HIV Prevention

HIV Pre-exposure Prophylaxis

HIV Prevention Program

HIV Prevention and Care

HIV Pre-exposure Prophylaxis Use

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lenacapavir long-acting

Study Details

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.

Conditions

HIV Prevention

HIV Pre-exposure Prophylaxis

HIV Prevention Program

HIV Prevention and Care

HIV Pre-exposure Prophylaxis Use

Study ID

NCT07218211

Start date

Jan 13, 2026

Status verified date

Oct, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Long-acting Injectable PrEP (lenacapavir) program

Community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW)

Interventions

Lenacapavir long-acting

Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)

Primary outcome measure

  • Acceptability of the intervention measured by questionnaire [ Time Frame: 6 and 12 months ]
  • Feasibility of the intervention measured by programmatic indicators [ Time Frame: 6 months and 12 months ]
  • Sustainability of the intervention [ Time Frame: 6 months and 12 months ]
  • The persistence on lenacapavir among participants receiving care at El Centro Hispano at 12 months. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Iris Navarro Clinical Research Coordinator

919-660-3940inclusion@duke.edu

Locations

El Centro Hispano

Recruiting

Durham, North Carolina, United States, 27701

Contacts

Orlando Martinez J Peer Navigator

1(919) 687-4635jomartinez@elcentronc.org

More Information

Sponsor

Duke University

Last update posted

Aug 26, 2026

Last verified

Oct, 2025

Keywords

  • Long-acting Injectable PrEP
  • Lenacapavir
  • PrEP
  • PrEP injections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-26.