Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness trial among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or sexual risk behavior.

Study Overview

• Status: Completed
• Conditions: Risk Behavior; HIV; Medication Adherence
• Intervention / Treatment: Behavioral: 3H+ (Holistic Health for HIV); Behavioral: HHRP+ (Holistic Health Recovery Program)

Detailed Description

HIV-infected drug users (DUs) remain a target population as they represent a significant vector for the transmission of new HIV infections (Avants et al., 2004; Margolin et al., 2003), which occur through preventable drug- and sex-related HIV risk behaviors. Though numerous evidence-based HIV risk reduction interventions are now widely available as complete intervention packages, few evidence-based interventions have been designed for implementation within common drug treatment community-based organizations (CBOs), such as methadone maintenance programs (MMPs), where many high-risk HIV-infected drug users seek treatment. Moreover, the few evidence-based interventions that are applicable to drug treatment CBOs are not designed to be "community-friendly" and, hence, are unlikely to be implemented as intended or durable within these critical settings.

The investigators have developed a significantly shortened version of the comprehensive evidence-based Holistic Health Recovery Program (HHRP; Avants et al., 2004; Margolin et al., 2003). This shortened version, Holistic Health for HIV (3H+), has demonstrated feasibility and acceptability as well as preliminary evidence of effectiveness in an uncontrolled study within a resource-limited drug treatment CBO. Therefore, this randomized controlled comparative effectiveness trial (RCT) will test the efficacy and cost-effectiveness of 3H+ versus the original gold standard evidence-based intervention(EBI), Holistic Health Recovery Program for HIV+s (HHRP+), targeting HIV+ drug users (DUs).

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • APT Foundation

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• HIV positive
• Opioid dependent and enrolled in methadone maintenance treatment
• Report drug- or sex-related HIV risk behavior in previous 6 months
• Able to read and understand the questionnaires, the Audio Computer Assisted Self Interview (ACASI), and consent form
• Available for the full duration of the study with no anticipated circumstances impeding participation
• Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of the PI who is a licensed clinical psychologist in Connecticut.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3H+ Group; 3H+ (Holistic for HIV) group patients will receive the standard of drug treatment care (i.e., methadone maintenance treatment and case management) plus four weekly 60-minute HIV risk reduction groups, and a 60-minute booster session at 12 weeks, led by two facilitators trained and supervised by a licensed clinical psychologist. 3H+ is an HIV risk reduction and ART adherence intervention that provides coping skills training and is delivered in a group modality, addressing high risk drug- and sex-related HIV risk behaviors and ART adherence for opioid-dependent individuals living with HIV.	Behavioral: 3H+ (Holistic Health for HIV); Four weekly HIV-risk reduction groups and an additional booster group held at week twelve summarizing the previous sessions' content, designed for opioid-dependent individuals living with HIV.
Active Comparator: HHRP+ Group; HHRP+ (Holistic Health Recovery Program) is comprised of 12 two-hour weekly manual-guided group sessions with comprehensive HIV risk reduction content that addresses the medical, emotional, and spiritual needs of opioid-dependent individuals living with HIV. Each session is designed to last 2 hours and is co-facilitated by two trained facilitators, who address potential motivational conflicts of HIV+ individuals by providing them with self-protective as well as altruistic reasons for examining and changing their HIV risk behaviors and improving adherence behavior. Material is presented using cognitive remediation strategies.	Behavioral: HHRP+ (Holistic Health Recovery Program); 12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Each Condition With Optimal ART Adherence	Anti-retroviral therapy (ART) adherence was assessed by self-report using the visual analogue scale (VAS). The VAS measures adherence continuously from 0 to 100%, with higher scores indicating better adherence to the medication. A greater number of participants with optimal ART adherence is better. Optimal ART adherence is defined as a score >95% on the visual analog scale (VAS).	Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral Suppression	Number of participants in each condition with viral load suppression at the 6-month assessment point. Viral suppression (VS) is defined as someone having HIV-1 RNA<50 copies/mL. A greater number of participants with VL suppression is a better outcome.	Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data.	Viral load (VL) will be measured in terms of mean change in VL from baseline to the final (9-month) follow-up point. An alternative approach will be the proportion of subjects with a non-detectable (<400 and <50 copies/mL) VL, and mean change in cluster of differentiation 4 (CD4) lymphocyte count. Missing VL will be treated as VL>400 or VL>50 copies/mL.	Over a 9-month period
ART non-adherence factors	Non-adherence factors will be measured these using standardized instruments including the following: Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) criteria for substance use disorders, Mini-International Neuropsychiatric Interview (M.I.N.I.) for depressive symptoms, active drug use (urine toxicology screening using the National Institute on Drug Abuse's 4-panel test measuring heroin, cocaine, oxycodone, benzodiazepines and marijuana levels), and neurocognitive impairment (using the Neurocognitive Impairment Scale).	Over a 9-month period

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute on Drug Abuse (NIDA); Yale University; APT Foundation, Inc.
• Investigators: Principal Investigator: Michael C Copenhaver, Ph.D., University of Connecticut

Publications and helpful links

General Publications

• 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.
• Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003 Mar;22(2):223-8.

Helpful Links

• University of Connecticut Center for Health, Intervention, and Prevention (CHIP)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimated): December 4, 2012

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: HIV; substance use; viral load; CD4; methadone maintenance; Antiretroviral therapy (ART)
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drug Misuse
• Other Study ID Numbers: H12-050; R01DA032290 (U.S. NIH Grant/Contract)