Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine (IMPACT)

Yale University

Status: Completed

Conditions: Opioid-use Disorder; Hiv

Treatments: Other: Integration of HIV and PWID services

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04927091

1R01DA043125-01 (U.S. NIH Grant/Contract)

2000020067

Details and patient eligibility

About

A randomized controlled trial to:

1. To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
2. Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.

Full description

Original outcomes were edited and Implementation outcomes were added November 2023.

Enrollment: 1,458 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PWID
• Interested in MMT
• Meets DSM-V criteria for Opioid Dependence

Exclusion criteria

• Not willing to consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,458 participants in 3 patient groups

Specialty Addiction Clinic

No Intervention group

ECHO-IC/QI-enhanced primary care clinic

Experimental group

Treatment:

Other: Integration of HIV and PWID services

ECHO-IC/QI-enhanced primary care clinic with Pay for Performance

Active Comparator group

Treatment:

Other: Integration of HIV and PWID services