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Completed

NCT Number: NCT04927091

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Institute for Public Health Policy

Kyiv, Ukraine

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not willing to consent

Treatment and study plan

Integration of HIV and PWID services

Other

Co-location of clinical services for HIV and PWID patients

Primary outcomes

  1. Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy

    Time frame: 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 outcomes

  1. Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy

    Time frame: 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.

  2. Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy

    Time frame: 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.

  3. Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Ukrainian Institute on Public Health Policy

Registry information

Acronym: IMPACT

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2021
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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