🏛️ Verified NIH Record • Updated 2026-06-15
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy (NCT07658976)
🟡 Not Yet Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: HIV Prevention Trials Network
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (10 items).
Location: UCLA Vine Street Clinic — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participated in HPTN 113-01
- Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
- Plans to move away from the study area within the next year
- Currently on doxycycline for STI PEP
- Has ever used CAB-LA or other long-acting PrEP agent
- Tetracycline allergy
- Prior diagnosis of HIV infection
- Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results
- Any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- UCLA Vine Street Clinic — Los Angeles, California
- Bronx Prevention Research Center CRS — The Bronx, New York
- Fundacion Huesped CRS — Buenos Aires,
- Instituto de Pesquisa Clinicaq Evandro Chagas CRS — Manguinhos, Rio de Janeiro
- San Miguel CRS — Lima,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.