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Pre-exposure Prophylaxis (PrEP) for Health
NCT04430257 · View on ClinicalTrials.gov ↗
Study Summary
This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.
Conditions Studied
Interventions
- BEHAVIORAL Motivational interviewing
- OTHER HIV and PrEP education
- BEHAVIORAL Problem-solving and planning
- BEHAVIORAL Patient navigation
- OTHER PrEP information
Study Locations (2)
Massachusetts
- AIDS Action — Cambridge
- Greater Lawrence Family Health Center — Lawrence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2026-05-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04430257
The ClinicalTrials.gov registry entry for NCT04430257 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Substance Dependence appearing as the primary indexed condition, and to 5 interventions — of which Motivational interviewing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04430257 reports 2 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04430257 about?
NCT04430257 is a clinical study titled "Pre-exposure Prophylaxis (PrEP) for Health". This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Ma...
What is the current status of trial NCT04430257?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2021-09-02. Estimated completion is 2026-05-15.
What conditions does trial NCT04430257 study?
This clinical trial studies the following conditions: Substance Dependence, HIV (Human Immunodeficiency Virus). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04430257?
The interventions under investigation include: Motivational interviewing (BEHAVIORAL), HIV and PrEP education (OTHER), Problem-solving and planning (BEHAVIORAL), Patient navigation (BEHAVIORAL), PrEP information (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04430257?
This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04430257 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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