Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Connecticut
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Number of Participants in Each Condition With Optimal ART Adherence
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
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.
Intervention: 3H+ (Holistic Health for HIV) (Behavioral)
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.
Intervention: HHRP+ (Holistic Health Recovery Program) (Behavioral)
Outcomes
Primary Outcomes
Number of Participants in Each Condition With Optimal ART Adherence
Time Frame: Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.
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).
Secondary Outcomes
- Viral Suppression(Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.)
Investigators
Michael Copenhaver
Professor
University of Connecticut