Improving HIV prevention for people who inject drugs on PrEP
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
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 |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Connecticut Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05669534 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are unable to provide consent, actively suicidal, or have severe cognitive impairments may not benefit from this study.
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 performed: Other studies have shown promise in using behavioral interventions to improve health outcomes in similar populations, suggesting that this approach may be effective.
Eligibility criteria
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 this trial is running
New Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.