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NCT07199335 · ClinicalTrials.gov registry record · Phase 4
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
A Phase 4 study of HIV and Substance Use Disorder (SUD), sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT07199335: Recruiting Phase 4 study of HIV and Substance Use Disorder (SUD), sponsored by Massachusetts General Hospital.
NCT07199335 is a Phase 4 study of HIV and Substance Use Disorder (SUD) that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 100 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07199335, a Phase 4 study of HIV and Substance Use Disorder (SUD), is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are risk for HIV through known sexual risk.
Primary Outcome
For the primary analysis, investigators will calculate the proportion of study participants who achieve PrEP persistence at 7 months post-initiation. Investigators will then calculate 95% confidence intervals around the proportion.
Conditions Studied
Interventions
- DRUG APRETUDE (cabotegravir)
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Fenway Health - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-02-24 |
| Est. Completion | 2028-12 |
| Phase | Phase 4 |
What NCT07199335 shows while recruiting
NCT07199335 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 1 intervention - of which APRETUDE (cabotegravir) is the first listed.
NCT07199335 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07199335 about?
NCT07199335 is a clinical study titled "Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs". The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are risk for HIV through known sexual risk.
What is the current status of trial NCT07199335?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2026-02-24. Estimated completion is 2028-12.
What conditions does trial NCT07199335 study?
This clinical trial studies the following conditions: HIV, Substance Use Disorder (SUD), Injection Drug Use.
What interventions are being tested in trial NCT07199335?
The interventions under investigation include: APRETUDE (cabotegravir) (DRUG).
Who is sponsoring clinical trial NCT07199335?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07199335 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07199335's enrollment target sits among peer trials
100 150th of 303 higher than 142 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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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