Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy

Part of paid clinical trials in Los Angeles, California.

Sponsor
HIV Prevention Trials Network
Study ID
NCT07658976
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 29 Years
Healthy Volunteers
Accepted

Interventions

  • HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA — DRUG
    Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
  • STI PEP - Doxycycline as Doxy-PEP — DRUG
    Doxycycline as doxy-PEP for STI prevention
  • 3P mHealth package — BEHAVIORAL
    Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making
  • Handout about HIV PrEP options available at the site — BEHAVIORAL
    Handout about HIV PrEP options available at the site
  • Standard-of-care HIV PrEP counseling from qualified study staff — BEHAVIORAL
    Standard-of-care HIV PrEP counseling from qualified study staff

Study Details

Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 3P mHealth package
    HIV PrEP, doxy-PEP, 3P mHealth package (3P: MyPrEP + PrEPmate + PrEPsmart tools) to assist with PrEP uptake and adherence decision making, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
  • Active Comparator: Standard-of-care services
    HIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site

Primary Outcome Measure

To determine the efficacy of the 3P mHealth package on PrEP uptake among participants [ Time Frame: 52 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCLA Vine Street ClinicLos AngelesCalifornia90095
Jesse Clark, MD
[email protected]
323-461-3106
Bronx Prevention Research Center CRSThe BronxNew York10451
Ellen Morrison
[email protected]
212-305-6328

Find similar trials in Los Angeles, CA

By condition
HIV
By specialty
Infectious disease
By research site
UCLA Vine Street Clinic· Los Angeles, CABronx Prevention Research Center CRS· The Bronx, NY

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