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NCT07335289 · ClinicalTrials.gov registry record · NA
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
A NA study, sponsored by Massachusetts General Hospital.
- Not yet
- Registry status
- NA
- Development phase
- 400
- Enrollment target
NCT07335289: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT07335289 is a NA study that has not yet begun recruiting, run by Massachusetts General Hospital. The registered enrollment target is 400 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07335289, a NA study, has not yet begun recruiting, sponsored by Massachusetts General Hospital.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
Study Summary
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP. The primary hypothesis is that giving participants choice in follow-up location will improve PrEP persistence compared to a clinic-only model. Secondary analyses will evaluate safety of rapid testing, acceptability, and participant costs. Exploratory analyses will assess HIV incidence and resistance. Findings from PrEP4U will provide essential evidence to guide scalable, equitable, person-centered delivery models for lenacapavir PrEP in the U.S. and globally.
Interventions
- OTHER Choice of follow up
- OTHER Follow up via standard clinic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2027-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07335289
The ClinicalTrials.gov registry entry for NCT07335289 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Choice of follow up is the first listed.
NCT07335289 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07335289 about?
NCT07335289 is a clinical study titled "PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence". PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study a...
What is the current status of trial NCT07335289?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2026-06-30. Estimated completion is 2027-02-01.
What interventions are being tested in trial NCT07335289?
The interventions under investigation include: Choice of follow up (OTHER), Follow up via standard clinic (OTHER).
Who is sponsoring clinical trial NCT07335289?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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