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NCT07658976 · ClinicalTrials.gov registry record · Phase 3
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
A Phase 3 study, sponsored by HIV Prevention Trials Network.
- Not yet
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
NCT07658976: Clinical Trial Phase 3 study, sponsored by HIV Prevention Trials Network.
NCT07658976 is a Phase 3 study that has not yet begun recruiting, run by HIV Prevention Trials Network. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07658976, a Phase 3 study, has not yet begun recruiting, sponsored by HIV Prevention Trials Network.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
Study 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
Primary Outcome
PrEP uptake is defined as the proportion of enrolled participants who elect to initiate PrEP (with a documented PrEP dispensation by the site) at any time during the 52 weeks of follow-up. Participants who did not initiate PrEP before loss to follow-up will be classified as non-initiators. PrEP uptake will be assessed at Week 52 for each study arm with 95% confidence limits computed using the binomial distribution. A logistic regression model will be used to compare PrEP uptake between the study
Interventions
- DRUG HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
- DRUG STI PEP - Doxycycline as Doxy-PEP
- BEHAVIORAL 3P mHealth package
- BEHAVIORAL Handout about HIV PrEP options available at the site
- BEHAVIORAL Standard-of-care HIV PrEP counseling from qualified study staff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2029-09-01 |
| Phase | Phase 3 |
What is known before NCT07658976 opens enrollment
NCT07658976 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 5 interventions - of which HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA is the first listed.
NCT07658976 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07658976 about?
NCT07658976 is a clinical study titled "Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy". 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
What is the current status of trial NCT07658976?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2026-09-01. Estimated completion is 2029-09-01.
What interventions are being tested in trial NCT07658976?
The interventions under investigation include: HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA (DRUG), STI PEP - Doxycycline as Doxy-PEP (DRUG), 3P mHealth package (BEHAVIORAL), Handout about HIV PrEP options available at the site (BEHAVIORAL), Standard-of-care HIV PrEP counseling from qualified study staff (BEHAVIORAL).
Who is sponsoring clinical trial NCT07658976?
This trial is sponsored by HIV Prevention Trials Network, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07658976's enrollment target sits among peer trials
400 922nd of 2000 higher than 1,039 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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