Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs

NCT03282890 | Completed Results DMC

• 2 other identifiers: H17-200R01DA044867
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and HIV risk reduction among high risk PWUD.

Conditions

Risk Behavior; HIV/AIDS; Medication Adherence; Substance Abuse

Keywords

HIV; Substance Abuse; Pre-Exposure Prophylaxis; HIV Risk Behavior; Methadone Maintenance

Outcome Measures

Primary Outcomes (1)

• Pre-exposure Prophylaxis (PrEP) Adherence Behavior

  The Pre-exposure prophylaxis (PrEP) adherence behavior scale is an 11-item categorical self-report measure designed to assess how confident a participant is about properly taking their PrEP medication (e.g., "How confident are you that you could make PrEP part of your daily routine?"). The scale requires participants to respond to each of the 11 items about adherence by selecting whether they are either 'Not at all confident', 'Somewhat confident', 'Moderately confident', 'Very confident', or 'Completely confident' about the behavior. The 11 items are summed to create a total score, with higher scores indicating a better PrEP adherence behavior outcome. The possible range of total scores is 0-44.

  This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.

Secondary Outcomes (1)

• HIV Risk Reduction Behavior

  This was assessed immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.

Study Arms (2)

CHRP-BB

EXPERIMENTAL

Patients assigned to the CHRP-BB will receive a weekly HIV risk reduction and PrEP adherence group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. It is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP-BB, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction and PrEP adherence. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).

Other: CHRP-BB

Control Condition

NO INTERVENTION

The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).

Interventions

CHRP-BB OTHER

The CHRP-BB intervention is a theory-based, manual-guided, HIV risk reduction and PrEP adherence intervention. It is an integrated evidence-based intervention that uses a coping skills training approach to primary prevention and is delivered in a small group modality by two trained intervention facilitators using a motivational enhancement therapeutic style to address high risk drug- and sex-related HIV risk behaviors and PrEP adherence. Importantly, the CHRP-BB intervention includes specific behavioral and mHealth strategies designed and tested to accommodate difficulties stemming from moderate to severe neuro-cognitive impairment (NCI).

CHRP-BB

Eligibility Criteria

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

You may qualify if:

• Meet DSM-V criteria for opioid-dependence and are enrolled in methadone maintenance drug treatment at the APT Foundation, Inc.
• Were confirmed to be HIV-negative and started on PrEP in the past week
• Report unsafe injection drug use practices or unprotected sex within the past 3 months
• Have a cell phone
• Are able to read and understand the questionnaires, ACASI, and informed consent form
• Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., pending charges, jail term).

You may not qualify if:

• Have an untreated bipolar or psychotic disorder
• Are actively suicidal or homicidal as assessed by trained research staff under the supervision of a licensed clinical psychologist
• Cannot speak English

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute on Drug Abuse (NIDA): collaborator
• APT Foundation, Inc.: collaborator

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06511, United States

Location

Related Publications (11)

• Shrestha R, Altice F, Karki P, Copenhaver M. Developing an Integrated, Brief Biobehavioral HIV Prevention Intervention for High-Risk Drug Users in Treatment: The Process and Outcome of Formative Research. Front Immunol. 2017 May 11;8:561. doi: 10.3389/fimmu.2017.00561. eCollection 2017.

  PMID: 28553295 BACKGROUND

• Shrestha R, Karki P, Altice FL, Huedo-Medina TB, Meyer JP, Madden L, Copenhaver M. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017 Apr 1;173:107-116. doi: 10.1016/j.drugalcdep.2016.12.023. Epub 2017 Feb 2.

  PMID: 28214391 BACKGROUND

• Huedo-Medina TB, Shrestha R, Copenhaver M. Modeling a Theory-Based Approach to Examine the Influence of Neurocognitive Impairment on HIV Risk Reduction Behaviors Among Drug Users in Treatment. AIDS Behav. 2016 Aug;20(8):1646-57. doi: 10.1007/s10461-016-1394-x.

  PMID: 27052845 BACKGROUND

• Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.

  PMID: 1594721 BACKGROUND

• Shrestha R, Huedo-Medina TB, Altice FL, Krishnan A, Copenhaver M. Examining the Acceptability of mHealth Technology in HIV Prevention Among High-Risk Drug Users in Treatment. AIDS Behav. 2017 Nov;21(11):3100-3110. doi: 10.1007/s10461-016-1637-x.

  PMID: 28025735 BACKGROUND

• Copenhaver MM, Lee IC, Margolin A. Successfully integrating an HIV risk reduction intervention into a community-based substance abuse treatment program. Am J Drug Alcohol Abuse. 2007;33(1):109-20. doi: 10.1080/00952990601087463.

  PMID: 17366251 BACKGROUND

• Copenhaver MM, Lee IC, Baldwin P. A randomized controlled trial of the community-friendly health recovery program (CHRP) among high-risk drug users in treatment. AIDS Behav. 2013 Nov;17(9):2902-13. doi: 10.1007/s10461-013-0539-4.

  PMID: 23835735 BACKGROUND

• Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4.

  PMID: 15050083 BACKGROUND

• Shrestha R, Karki P, Altice FL, Dubov O, Fraenkel L, Huedo-Medina T, Copenhaver M. Measuring Acceptability and Preferences for Implementation of Pre-Exposure Prophylaxis (PrEP) Using Conjoint Analysis: An Application to Primary HIV Prevention Among High Risk Drug Users. AIDS Behav. 2018 Apr;22(4):1228-1238. doi: 10.1007/s10461-017-1851-1.

  PMID: 28695388 BACKGROUND

• Shrestha R, Karki P, Huedo-Medina TB, Copenhaver M. Intent to Use Preexposure Prophylaxis (PrEP), HIV Risk Behaviors, and Self-Report Neurocognitive Symptoms by High-Risk Drug Users: A Mediation Analysis. J Assoc Nurses AIDS Care. 2017 Jul-Aug;28(4):612-621. doi: 10.1016/j.jana.2017.04.005. Epub 2017 Apr 19.

  PMID: 28478870 BACKGROUND

• Shrestha R, Altice FL, Huedo-Medina TB, Karki P, Copenhaver M. Willingness to Use Pre-Exposure Prophylaxis (PrEP): An Empirical Test of the Information-Motivation-Behavioral Skills (IMB) Model among High-Risk Drug Users in Treatment. AIDS Behav. 2017 May;21(5):1299-1308. doi: 10.1007/s10461-016-1650-0.

  PMID: 27990587 BACKGROUND

Related Links

• University of Connecticut Institute for Collaboration on Health, Intervention, and Policy (InCHIP)

MeSH Terms

Conditions

Risk-Taking; Acquired Immunodeficiency Syndrome; Medication Adherence; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavior; 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; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This study examines an innovative approach, as the first PrEP-focused intervention tailored to the cognitive profiles of individuals on MOUD, but there are some limitations worth mentioning. This study only recruited participants who could understand, speak, and read the English language, and participants who had a phone for communicating daily text messages in English. Future studies should measure cognitive functioning more frequently in order to improve the precision of this measurement.

Results Point of Contact

• Title: Dr. Michael Copenhaver
• Organization: UConn

michael.copenhaver@uconn.edu

860-208-3632

Study Officials

• Michael Copenhaver, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: November 20, 2017
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)