Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07218211
Phase
PHASE4
Status
Recruiting

Conditions

  • HIV Pre-exposure Prophylaxis
  • HIV Pre-exposure Prophylaxis Use
  • HIV Prevention
  • HIV Prevention Program
  • HIV Prevention and Care

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lenacapavir long-acting — DRUG
    Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)

Study Details

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.

Key Dates

Start date
Jan 13, 2026
Status verified
Oct 2025
Primary completion
Jan 5, 2027
Completion
Jan 5, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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)

Primary Outcome Measure

Number of participants who provided identification of barriers to providing lenacapavir at a Latine community-based organization [ Time Frame: up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
El Centro HispanoDurhamNorth Carolina27701
Orlando Martinez J Peer Navigator
919-687-4635
Emilia Ismael-Simental (SUB_INVESTIGATOR)
Alma Ortega (SUB_INVESTIGATOR)

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