Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT01741311
Status
Completed

Conditions

  • HIV
  • Medication Adherence
  • Risk Behavior

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 3H+ (Holistic Health for HIV) — BEHAVIORAL
    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.
  • HHRP+ (Holistic Health Recovery Program) — BEHAVIORAL
    12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.

Study Details

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.

Key Dates

Start date
Sep 30, 2012
Status verified
Aug 2025
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018

Study Design

Enrollment
106 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
APT FoundationNew HavenConnecticut06511-

Find similar trials in New Haven, CT

By condition
HIV
By specialty
Infectious disease
By research site
APT Foundation· New Haven, CT

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