Improving HIV prevention for people who inject drugs on PrEP
Official title: Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Run by University of Connecticut · NCT05669534 · Data updated 2026-11-12
This study is testing new ways to help people who inject drugs and are on HIV prevention medication to better understand and use information about staying safe from HIV.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | University of Connecticut Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | January 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT05669534 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are newly prescribed medication for opioid use disorder, have mild cognitive impairment, and have recently initiated PrEP.
✕Probably not a fit
Patients who are unable to provide consent, actively suicidal, or have severe cognitive impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to optimize HIV prevention strategies for people who inject drugs (PWID) who are newly prescribed medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP). A total of 256 participants will be randomized into one of 16 intervention conditions that combine core behavioral components with additional strategies focused on enhancing attention, executive functioning, memory, and information processing. The goal is to improve participants' ability to process and utilize HIV prevention information, ultimately leading to better motivation, behavioral skills, and safer behaviors. The study employs a multiphase optimization strategy to assess the effectiveness of these combined interventions.
Why it matters
Potential benefit: If successful, this study could significantly enhance HIV prevention efforts among PWID, leading to reduced transmission rates and improved health outcomes.
How similar studies have gone: Other studies have shown promise in using behavioral interventions to improve health outcomes in similar populations, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * being 18 years or older * meeting DSM-V criteria for opioid dependence and being newly prescribed and adherent to Medication for Opioid Use Disorder (e.g., methadone, buprenorphine) at the APT Foundation, Inc. * showing mild cognitive impairment based on the Montreal Cognitive Assessment (MoCA) screening * having initiated Pre-Exposure Prophylaxis (PrEP) within the past week * confirming HIV-negative status through proof of PrEP prescription * reporting unsafe injection drug use practices or unprotected sex within the past 3 months * having a cell phone * being able to read and understand in English Exclusion Criteria: * unable to provide consent * actively suicidal * actively homicidal * actively psychotic * display MoCA scores suggestive of dementia
Where it's running
-
APT Foundation
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Michael Copenhaver, PhD — University of Connecticut
- Study coordinator: Brian Sibilio, BS
- Email: brian.sibilio@uconn.edu
- Phone: 2037814690
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
HEAT telemedicine program for HIV and addiction care
This project will try a telemedicine program to deliver addiction treatment to adults living with HIV in Alabama who report opioid or stimulant misuse.
-
Innovative e-Health interventions for HIV and substance use in women involved in the justice system
This study is testing a new online tool to help women in the justice system access HIV prevention and opioid treatment more easily, comparing it to a simpler version of the tool.
-
CBD for Opioid Dependence and Pain on Buprenorphine
This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.
-
Cebranopadol for opioid withdrawal in adults with chronic pain
This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.
-
emPath platform pilot to link and keep adults with opioid use disorder in care in Durham
This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.
-
Project SHIELD 2.0: Police Education to Support Public Health in Kentucky
Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.