Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy (NCT07658976) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
United States, Argentina, Brazil400 participantsStarted 2026-09-01
Plain-language summary
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 participate
Age range
18 Years – 29 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the efficacy of the 3P mHealth package on PrEP uptake among participants
Timeframe: 52 weeks
2
To determine the efficacy of the 3P mHealth package on PrEP adherence among participants
Timeframe: Weeks 20, 36, and 52
3
To assess doxycycline PEP uptake and associated factors
Timeframe: Week 52
4
To assess doxycycline PEP use and associated factors
Timeframe: Weeks 20, 36, and 52
5
To assess doxycycline PEP acceptability and associated factors
Timeframe: Week 52
6
To assess the incidence of HIV infections among participants choosing to use CAB-LA