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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT05669534
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Hiv
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • community-friendly health recovery program — BEHAVIORAL
    Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.
  • Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis — DRUG
    Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.

Study Details

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).

Key Dates

Start date
Mar 1, 2023
Status verified
Mar 2025
Primary completion
Jan 31, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Condition 1
    Standard CHRP Intervention Components
  • Experimental: Condition 2
    Standard CHRP Intervention Components and Information Processing Components
  • Experimental: Condition 3
    Standard CHRP Intervention Components and Memory Components
  • Experimental: Condition 4
    Standard CHRP Intervention Components, Information Processing Components, and Memory Components
  • Experimental: Condition 5
    Standard CHRP Intervention Components, Executive Functioning Components
  • Experimental: Condition 6
    Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components
  • Experimental: Condition 7
    Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components
  • Experimental: Condition 8
    Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components
  • Experimental: Condition 9
    Standard CHRP Intervention Components and Attention Components
  • Experimental: Condition 10
    Standard CHRP Intervention Components, Information Processing Components, and Attention Components
  • Experimental: Condition 11
    Standard CHRP Intervention Components, Memory Components, and Attention Components
  • Experimental: Condition 12
    Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components
  • Experimental: Condition 13
    Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components
  • Experimental: Condition 14
    Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components
  • Experimental: Condition 15
    Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components
  • Experimental: Condition 16
    Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components

Primary Outcome Measure

Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [ Time Frame: PrEP adherence DBS measured at week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
APT FoundationNew HavenConnecticut06519
Brian Sibilio, BS
[email protected]
203-781-4690

Find similar trials in New Haven, CT

By condition
HIV
By specialty
Infectious disease
By research site
APT Foundation· New Haven, CT

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