Recruiting

PrEP

Sponsor:

University of Connecticut

Code:

NCT05669534

Conditions

Hiv

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

community-friendly health recovery program

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Study Details

Brief summary:

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 ID

NCT05669534

Start date

Mar 1, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

community-friendly health recovery program

Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.

Primary outcome measure

  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [ Time Frame: PrEP adherence DBS measured at week 4 ]
  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [ Time Frame: PrEP adherence DBS measured at the 3-month post-intervention follow-up ]
  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [ Time Frame: PrEP adherence DBS measured at the 6-month post-intervention follow-up ]
  • Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS) [ Time Frame: PrEP adherence DBS measured at the 9-month post-intervention follow-up ]
  • Pre-Exposure Prophylaxis Adherence via pharmacy refill data [ Time Frame: PrEP adherence pharmacy refill data measured at week 4 ]
  • Pre-Exposure Prophylaxis Adherence via pharmacy refill data [ Time Frame: PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up ]
  • Pre-Exposure Prophylaxis Adherence via pharmacy refill data [ Time Frame: PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up ]
  • Pre-Exposure Prophylaxis Adherence via pharmacy refill data [ Time Frame: PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up ]
  • Pre-Exposure Prophylaxis Adherence via self-report scale [ Time Frame: PrEP adherence pharmacy self report measured at week 4 ]
  • Pre-Exposure Prophylaxis Adherence via self-report scale [ Time Frame: PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups ]
  • Pre-Exposure Prophylaxis Adherence via self-report scale [ Time Frame: PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups ]
  • Pre-Exposure Prophylaxis Adherence via self-report scale [ Time Frame: PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups ]

Central Contacts and Locations

Central contacts

Brian Sibilio, BS

2037814690brian.sibilio@uconn.edu

Tanya Adler, MS

2037814690tanya.adler@uconn.edu

Locations

APT Foundation

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Brian Sibilio, BS

2037814690brian.sibilio@uconn.edu

More Information

Sponsor

University of Connecticut

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • people who inject drugs
  • HIV
  • cognitive dysfunction
  • pre-exposure prophylaxis
  • multiphase optimization strategy
  • medication for opioid use disorder
  • opioid use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Connecticut on 2026-06-15.