Hiv, Opioid-use Disorder
Conditions
Brief summary
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.
Detailed description
Original outcomes were edited and Implementation outcomes were added November 2023.
Interventions
OTHERIntegration of HIV and PWID services
Co-location of clinical services for HIV and PWID patients
Sponsors
Ukrainian Institute on Public Health Policy
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PWID * Interested in MMT * Meets DSM-V criteria for Opioid Dependence
Exclusion criteria
* Not willing to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy | every 6 months up to 24 months | The total average percentage of the 17 recommended Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: General medical examination; blood analysis; urine analysis; cardiogram; mammogram; cervical cancer screening; prostate cancer screening; hepatitis B screening; hepatitis C screening; HIV screening; CD4 or viral load; ART treatment; TB screening; TB treatment; received take-home MMT; adequate MMT dose; on MMT for 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy | every 6 months up to 24 months | The total average percentage of the 3 HIV Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: HIV screening; CD4 or viral load; ART treatment. |
| Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy | every 6 months up to 24 months | The total average percentage of the 3 HIV Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: received take-home MMT; adequate MMT dose; on MMT for 12 months. |
| Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy | every 6 months up to 24 months | The total average percentage of the 2 HIV Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: TB screening; TB treatment. |
Countries
Ukraine
Outcome results
None listed