NCT07658976Not yet recruitingPhase 3
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 7 Oct 2024
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2029
- Lead sponsor
- HIV Prevention Trials Network
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT07658976
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 1 Sept 2026 to the primary completion date, 1 Sept 2029
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
- Currently on doxycycline for STI PEP
- Prior diagnosis of HIV infection
Other illness
- Tetracycline allergy
- 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
Other
- Participated in HPTN 113-01
- Plans to move away from the study area within the next year
- Has ever used CAB-LA or other long-acting PrEP agent
Who the study is looking for
- Men ages 18 - 29 years
- Men who are in communities most affected by the HIV epidemic
- Willing and able to provide informed consent
- Reports having anal sex with men in the last 6 months
- Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:
- Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed
- Reporting 2 or more male partners, regardless of condom use
- Reporting gonorrhea, chlamydia, or syphilis diagnosis
- Any stimulant use (e.g., cocaine, amphetamines)
- Not on PrEP within the past 3 months due to participant choice
- Interested in learning more about PrEP or starting PrEP
- No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm
- Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages
- Must not share the mobile phone used for their participation in the study
- Able to read and write
Age in the registry: 18 years to 29 years · Sex: Male · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion Huesped CRS Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto de Pesquisa Clinicaq Evandro Chagas CRS Coordinator of this site? Confirm its status | Manguinhos | Brazil | Unknown status |
| San Miguel CRS Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| UCLA Vine Street Clinic Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Bronx Prevention Research Center CRS Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.