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NCT04430257 · ClinicalTrials.gov registry record · NA

Pre-exposure Prophylaxis (PrEP) for Health

A NA study of Substance Dependence and HIV (Human Immunodeficiency Virus), sponsored by Brown University.

Recruiting
Registry status
NA
Development phase
200
Enrollment target
2
Study locations

NCT04430257 is a NA study of Substance Dependence and HIV (Human Immunodeficiency Virus) that is actively recruiting participants, run by Brown University. The registered enrollment target is 200 participants, roughly in line with the 183-participant average among 5 other Substance Dependence trials with a reported enrollment target. The trial reports 2 study locations across 1 state.

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The verdict

NCT04430257, a NA study of Substance Dependence and HIV (Human Immunodeficiency Virus), is actively recruiting participants, sponsored by Brown University.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
2
Study locations

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

Substance Dependence HIV (Human Immunodeficiency Virus)

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

FieldValue
Enrollment Target 200 participants
Start Date 2021-09-02
Est. Completion 2026-05-15
Phase NA

Sponsor

Brown University

231 total trials

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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, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 183-participant average among 5 other Substance Dependence trials with a reported enrollment target. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

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.

NCT04430257 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.

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).

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).

Who is sponsoring clinical trial NCT04430257?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.