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

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).

Study Overview

• Status: Recruiting
• Conditions: Hiv; Opioid Use Disorder
• Intervention / Treatment: Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Detailed Description

Participants will be randomized to one of 16 conditions. In addition to receiving the Core Components of the CHRP behavioral intervention, participants will receive one of the sixteen combinations of four compensatory components that show promise in terms of enhancing the ability to process and utilize HIV prevention content (see conceptual figure above), and that are not currently part of CHRP. The Attention Component includes: (a) Increasing frequency of sessions (more than once per week); (b) Distributed practice (spreading out information across sessions); (c) More structured sessions (well-organized objectives shared with patients); (d) Introducing new information during closure (foreshadow content of next session). The Executive Function Component includes the following strategies: (a) Associating behavior with situational cues (anticipate risky situations); (b) Linking actions to a triggering cue (storytelling techniques using imagery); (c) Planning (identify and organize steps required to meet goal) and (d) Valuing future events (recognize the benefits of drug treatment). Similarly, the Memory Component involves: (a) Memory aids (reminders and cues to be used between sessions); (b) Summarizing/reiterating information (frequent review throughout sessions); (c) Prospective memory (emphasize routine, develop cues, elaborate on positive behaviors); and (d) Environmental engineering (prepare for adverse events). Lastly, the Information Processing Component includes: (a) Mixed methods of presentation (verbal, visual, and hands-on); (b) Simple language (clear, concrete examples aligned with health literacy level); (c) Present content slowly (allow extra time for responses); and (d Immediate feedback following assessment (oral/ written).Of particular note, the investigators are using this framework to examine all combinations of these components (rather than merely testing all four) to promote ecological validity and future implementation. Specifically, our approach will help determine the most resource-efficient intervention, as there are many barriers to adding components to standard of care in these clinical settings. For example, if components targeting only two domains can produce equivalent outcomes as components targeting four, the former would be identified as preferred

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brian Sibilio, BS; Phone Number: 2037814690; Email: brian.sibilio@uconn.edu
• Study Contact Backup: Name: Tanya Adler, MS; Phone Number: 2037814690; Email: tanya.adler@uconn.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • APT Foundation
      • Contact: Brian Sibilio, BS; Phone Number: 203-781-4690; Email: brian.sibilio@uconn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Condition 1; Standard CHRP Intervention Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 2; Standard CHRP Intervention Components and Information Processing Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 3; Standard CHRP Intervention Components and Memory Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 4; Standard CHRP Intervention Components, Information Processing Components, and Memory Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 5; Standard CHRP Intervention Components, Executive Functioning Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 6; Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 7; Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 8; Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 9; Standard CHRP Intervention Components and Attention Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 10; Standard CHRP Intervention Components, Information Processing Components, and Attention Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 11; Standard CHRP Intervention Components, Memory Components, and Attention Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 12; Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 13; Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 14; Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 15; Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP
Experimental: Condition 16; Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components	Behavioral: community-friendly health recovery program; Participants will receive 4 weekly 45 minute sessions HIV prevention sessions.; Other Names: CHRP; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis; Participants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.; Other Names: PrEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)	Dried Blood Spots will test the amount of active PrEP components in the participants blood.	PrEP adherence DBS measured at week 4
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)	Dried Blood Spots will test the amount of active PrEP components in the participants blood.	PrEP adherence DBS measured at the 3-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)	Dried Blood Spots will test the amount of active PrEP components in the participants blood.	PrEP adherence DBS measured at the 6-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)	Dried Blood Spots will test the amount of active PrEP components in the participants blood.	PrEP adherence DBS measured at the 9-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data	Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy	PrEP adherence pharmacy refill data measured at week 4
Pre-Exposure Prophylaxis Adherence via pharmacy refill data	Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy	PrEP adherence pharmacy refill data measured at the 3-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data	Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy	PrEP adherence pharmacy refill data measured at the 6-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via pharmacy refill data	Pharmacy refill data confirms the participants has refilled their PrEP prescription at local pharmacy	PrEP adherence pharmacy refill data measured at the 9-month post-intervention follow-up
Pre-Exposure Prophylaxis Adherence via self-report scale	Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence	PrEP adherence pharmacy self report measured at week 4
Pre-Exposure Prophylaxis Adherence via self-report scale	Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence	PrEP adherence pharmacy self report measured at the 3-month post-intervention follow-ups
Pre-Exposure Prophylaxis Adherence via self-report scale	Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence	PrEP adherence pharmacy self report measured at the 6-month post-intervention follow-ups
Pre-Exposure Prophylaxis Adherence via self-report scale	Self-reported PrEP adherence is measured on a scale of 0-100, the higher the score the greater the adherence	PrEP adherence pharmacy self report measured at the 9-month post-intervention follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV risk behaviors questionnaire	Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.	HIV risk behaviors measured at Week 1
HIV risk behaviors questionnaire	Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.	HIV risk behaviors measured at Week 4
HIV risk behaviors questionnaire	Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.	HIV risk behaviors measured at the 3-month post-intervention follow-up
HIV risk behaviors questionnaire	Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.	HIV risk behaviors measured at the 6-month post-intervention follow-up
HIV risk behaviors questionnaire	Self-report oof "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.	HIV risk behaviors measured at the 9-month post-intervention follow-up
HIV prevention IMB model constructs questionnaire	self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills	HIV prevention IMB model constructs measured at Week 1
HIV prevention IMB model constructs questionnaire	self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills	HIV prevention IMB model constructs measured at Week 4
HIV prevention IMB model constructs questionnaire	self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills	HIV prevention IMB model constructs measured at the 3-month post-intervention follow-up
HIV prevention IMB model constructs questionnaire	self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills	HIV prevention IMB model constructs measured at the 6-month post-intervention follow-up
HIV prevention IMB model constructs questionnaire	self report of (a) information - HIV risk- and PrEP-related knowledge; (b) motivation - readiness to change and intentions to change PrEP adherence and change HIV risk behavior; (c) behavioral skills - PrEP adherence skills and HIV risk reduction skills	HIV prevention IMB model constructs measured at the 9-month post-intervention follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at Week 1
Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at twice weekly during the 4-week intervention phase
Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at 3-month follow-up
Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at 6-month follow-up
Drug Test via Urine toxicology	Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses	conducted at 9-month follow-up

Collaborators and Investigators

• Sponsor: University of Connecticut
• Investigators: Principal Investigator: Michael Copenhaver, PhD, University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: HIV; opioid use disorder; cognitive dysfunction; pre-exposure prophylaxis; multiphase optimization strategy; medication for opioid use disorder; people who inject drugs
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: H22-0121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results will be available upon request.
• IPD Sharing Time Frame: Immediately following publication. No end date
• IPD Sharing Access Criteria: Proposals should be directed to Michael.Copenhaver@uconn.edu To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes