Back to search results

Optimizing HIV Prevention for People Who Inject Drugs on PrEP

This study is for people who inject drugs and are newly taking medication for opioid use disorder (like methadone or buprenorphine) and Pre-Exposure Prophylaxis (PrEP), which is a medicine to prevent HIV. The study is testing different ways to improve how people understand and use information about preventing HIV. You would receive four weekly HIV prevention sessions, and the study will look at how well you take your PrEP medication using dried blood spot tests. To join, you must be 18 or older, meet criteria for opioid dependence, be newly on medication for opioid use disorder, have mild cognitive impairment, and have recently started PrEP. The study aims to enroll 256 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 256 participants. You would be randomly assigned to one of 16 different groups to receive various combinations of behavioral interventions.
What's involved
You would participate in four weekly 45-minute HIV prevention sessions. Your PrEP adherence will be measured using dried blood spots at week 4, and then again at 3 and 6 months after the sessions end.
Compensation
Not stated in the trial record.
Follow-up
Your PrEP adherence will be checked at 3 and 6 months after the intervention sessions are completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05669534

Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP

Recruiting
PHASE4Ages 18+InterventionalPrevention
University of Connecticut
~256 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:community-friendly health recovery programPre-Exposure Prophylaxis and Post-Exposure Prophylaxis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Measured over PrEP adherence DBS measured at week 4
+11 more outcomes measured

Conditions

Hiv
Opioid Use Disorder

Explore related trials

HIV InfectionOpioid Use Disorder

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Michael Copenhaver, PhD · PRINCIPAL_INVESTIGATOR · University of Connecticut

Who to contact

Brian Sibilio, BS
[email protected]
2037814690
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

unable to provide consent
actively suicidal
actively homicidal
actively psychotic
display MoCA scores suggestive of dementia

What this trial measures

  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)PrEP adherence DBS measured at week 4

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)PrEP adherence DBS measured at the 3-month post-intervention follow-up

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)PrEP adherence DBS measured at the 6-month post-intervention follow-up

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)PrEP adherence DBS measured at the 9-month post-intervention follow-up

    Dried Blood Spots will test the amount of active PrEP components in the participants blood.

  • Pre-Exposure Prophylaxis Adherence via pharmacy refill dataPrEP adherence pharmacy refill data measured at week 4

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  • Pre-Exposure Prophylaxis Adherence via pharmacy refill dataPrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  • Pre-Exposure Prophylaxis Adherence via pharmacy refill dataPrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  • Pre-Exposure Prophylaxis Adherence via pharmacy refill dataPrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up

    Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy

  • Pre-Exposure Prophylaxis Adherence via self-report scalePrEP adherence pharmacy self report measured at week 4

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

  • Pre-Exposure Prophylaxis Adherence via self-report scalePrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

  • Pre-Exposure Prophylaxis Adherence via self-report scalePrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence

  • Pre-Exposure Prophylaxis Adherence via self-report scalePrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups

    Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence