Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Substance Dependence and HIV (Human Immunodeficiency Virus), sponsored by Brown University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PrEP uptake will be assessed via medical/pharmacy records
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 |
What NCT04430257 shows while recruiting
NCT04430257 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 183-participant average among 5 other Substance Dependence trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Substance Dependence
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.
-
Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
ACTIVE NOT RECRUITING · NA
-
Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care
ACTIVE NOT RECRUITING · NA
-
Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)
ACTIVE NOT RECRUITING · NA
-
Developing a Telehealth Model to Improve Treatment Access for Rural Veterans With Substance Use Disorders
ACTIVE NOT RECRUITING · NA
-
Group Therapy for Women Prisoners With Comorbid Substance Use and Depression
COMPLETED · NA
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
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
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