Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

University of Connecticut

Status: Completed

Conditions: Medication Adherence; Risk Behavior; HIV

Treatments: Behavioral: 3H+ (Holistic Health for HIV); Behavioral: HHRP+ (Holistic Health Recovery Program)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01741311

H12-050

R01DA032290 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

106 participants in 2 patient groups

3H+ Group

Experimental group

Description:

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.

Treatment:

Behavioral: 3H+ (Holistic Health for HIV)

HHRP+ Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: HHRP+ (Holistic Health Recovery Program)