NCT01741311

Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: University of Connecticut · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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).

Conditions

• Risk Behavior
• Medication Adherence
• HIV

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2012-12-04
• Last updated: 2025-08-08
• Results posted: 2025-08-08

Locations

1 site across 1 country: United States