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

NCT05669534 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: H22-0121
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (10)

• HIV risk behaviors questionnaire

  HIV risk behaviors measured at Week 1

• HIV risk behaviors questionnaire

  HIV risk behaviors measured at Week 4

• HIV risk behaviors questionnaire

  HIV risk behaviors measured at the 3-month post-intervention follow-up

• HIV risk behaviors questionnaire

  HIV risk behaviors measured at the 6-month post-intervention follow-up

• HIV risk behaviors questionnaire

  HIV risk behaviors measured at the 9-month post-intervention follow-up

Other Outcomes (5)

• Drug Test via Urine toxicology

  conducted at Week 1

• Drug Test via Urine toxicology

  conducted at twice weekly during the 4-week intervention phase

• Drug Test via Urine toxicology

  conducted at 3-month follow-up

Study Arms (16)

Condition 1

ACTIVE COMPARATOR

Standard CHRP Intervention Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 2

EXPERIMENTAL

Standard CHRP Intervention Components and Information Processing Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 3

EXPERIMENTAL

Standard CHRP Intervention Components and Memory Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 4

EXPERIMENTAL

Standard CHRP Intervention Components, Information Processing Components, and Memory Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 5

EXPERIMENTAL

Standard CHRP Intervention Components, Executive Functioning Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 6

EXPERIMENTAL

Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 7

EXPERIMENTAL

Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 8

EXPERIMENTAL

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 9

EXPERIMENTAL

Standard CHRP Intervention Components and Attention Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 10

EXPERIMENTAL

Standard CHRP Intervention Components, Information Processing Components, and Attention Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 11

EXPERIMENTAL

Standard CHRP Intervention Components, Memory Components, and Attention Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 12

EXPERIMENTAL

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 13

EXPERIMENTAL

Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 14

EXPERIMENTAL

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 15

EXPERIMENTAL

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Condition 16

EXPERIMENTAL

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components

Behavioral: community-friendly health recovery program; Drug: Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis

Interventions

community-friendly health recovery program BEHAVIORAL

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

Also known as: CHRP

Condition 1; Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8; Condition 9

Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis DRUG

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

Also known as: PrEP

Condition 1; Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8; Condition 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to provide consent
• actively suicidal
• actively homicidal
• actively psychotic
• display MoCA scores suggestive of dementia

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06519, United States

RECRUITING

Related Publications (1)

• Mistler CB, Shrestha R, Gunstad J, Collins L, Madden L, Huedo-Medina T, Sibilio B, Copenhaver NM, Copenhaver M. Application of the multiphase optimisation strategy (MOST) to optimise HIV prevention targeting people on medication for opioid use disorder (MOUD) who have cognitive dysfunction: protocol for a MOST study. BMJ Open. 2023 Jun 30;13(6):e071688. doi: 10.1136/bmjopen-2023-071688.

  PMID: 37399447 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Opioid-Related Disorders; Cognitive Dysfunction

Interventions

Pre-Exposure Prophylaxis; Post-Exposure Prophylaxis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Michael Copenhaver, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Sibilio, BS

CONTACT

2037814690; brian.sibilio@uconn.edu

Tanya Adler, MS

CONTACT

2037814690; tanya.adler@uconn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multiphase Optimization Strategy

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 3, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date
• Access Criteria: Proposals should be directed to Michael.Copenhaver@uconn.edu To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)