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

Hiv Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04927091
• Other study ID #: 2000020067
• Secondary ID: 1R01DA043125-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1458
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PWID

• Interested in MMT

• Meets DSM-V criteria for Opioid Dependence

Exclusion Criteria:

• Not willing to consent

Related Conditions & MeSH terms

• Hiv
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Other:
• Integration of HIV and PWID services
Co-location of clinical services for HIV and PWID patients

Locations

Country	Name	City	State
Ukraine	European Institute for Public Health Policy	Kyiv

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), Ukrainian Institute on Public Health Policy

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy	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.	every 6 months up to 24 months
Secondary	Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy	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.	every 6 months up to 24 months
Secondary	Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy	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.	every 6 months up to 24 months
Secondary	Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy	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.	every 6 months up to 24 months