Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). 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.
Primary Outcome
Proportion of participants in the PrEP Choice arm versus the PrEP Clinic arm who successfully receive the second on-time injection
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 |
What is known before NCT07335289 opens enrollment
NCT07335289 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Choice of follow up is the first listed.
NCT07335289 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07335289's enrollment target sits among peer trials
400 246th of 2000 higher than 1,734 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01665326 · 400 participants
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- NCT02108054 · 400 participants · NA
Behavioral and Functional Task Development, Implementation, and Testing
- NCT02216500 · 400 participants · NA
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
- NCT02250352 · 400 participants
Core Biopsies for Establishing a Breast Tumor Tissue Repository
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI