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NCT05669534RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
256 (estimated)
First submitted
5 Dec 2022
Start date
1 Mar 2023
Primary completion date
Jan 2027
Lead sponsor
University of Connecticut
Diseases
HIV
NCT number
NCT05669534

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 256
  • From 1 Mar 2023 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • display MoCA scores suggestive of dementia

Other

  • unable to provide consent
  • actively suicidal
  • actively homicidal
  • actively psychotic

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
APT Foundation
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.