RECRUITING
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Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
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).
Conditions:
🦠 Hiv 🦠 Opioid Use Disorder
🗓️ Study Start (Actual) 1 March 2023
🗓️ Primary Completion (Estimated) 1 January 2027
✅ Study Completion (Estimated) 1 January 2027
👥 Enrollment (Estimated) 256
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 December 2022
  • First Submitted that Met QC Criteria 19 December 2022
  • First Posted 3 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 June 2023
  • Last Update Posted 15 June 2023
  • Last Verified June 2023
I'm interested ...!!