중독 치료 및 HIV 서비스를 우크라이나의 1차 진료소에 통합 (IMPACT)
A randomized controlled trial to:
- 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.
- 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.
연구 개요
상세 설명
Original outcomes were edited and Implementation outcomes were added November 2023.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Kyiv, 우크라이나
- European Institute for Public Health Policy
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- PWID
- Interested in MMT
- Meets DSM-V criteria for Opioid Dependence
Exclusion Criteria:
- Not willing to consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 전문 중독 클리닉
|
|
|
실험적: ECHO-IC/QI 강화 1차 진료 클리닉
|
Co-location of clinical services for HIV and PWID patients |
|
활성 비교기: 성과에 따라 지불하는 ECHO-IC/QI 강화 1차 진료 클리닉
|
Co-location of clinical services for HIV and PWID patients |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Average Percentage of Recommended Quality Health Indicator Services Accessed by Participants to Assess Efficacy
기간: 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. Data presented here is for adjusted average values of services accessed at 24 months. |
every 6 months up to 24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Average Percentage of Recommended Primary Quality Health Indicator Services Accessed to Assess Efficacy
기간: every 6 months up to 24 months
|
The total average percentage of Primary 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. Data presented here is for adjusted average values of services accessed at 24 months. |
every 6 months up to 24 months
|
|
Average Percentage of Recommended Specialty Quality Health Indicator Services Accessed to Assess Efficacy
기간: every 6 months up to 24 months
|
The total average percentage of Specialty(encompasses HIV, TB and MMT) 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. Data presented here is for adjusted average values of services accessed at 24 months. |
every 6 months up to 24 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Frederick Altice, MD, Yale University
간행물 및 유용한 링크
일반 간행물
- Machavariani E, Esserman D, Dumchev K, Filippovych M, Pykalo I, Ivasiy R, Madden LM, Bromberg DJ, Haddad M, Morozova O, Oliveros D, Ahmad B, Dvoriak S, Altice FL. Integrating Methadone Services Into Primary Care in Ukraine: Two-Year Outcomes From a Randomized Trial. Ann Intern Med. 2026 Feb;179(2):177-186. doi: 10.7326/ANNALS-25-01764. Epub 2025 Dec 9.
- Machavariani E, Bromberg DJ, Dumchev K, Esserman D, Earnshaw VA, Pykalo I, Filippovich M, Ivasiy R, Ahmad B, Long J, Haddad MS, Madden LM, Oliveros D, Dvoriak S, Altice FL. Decrease in provider stigma is associated with improved quality health indicators among individuals receiving methadone in primary care centers in Ukraine. Int J Drug Policy. 2025 Feb;136:104682. doi: 10.1016/j.drugpo.2024.104682. Epub 2024 Dec 19.
- Machavariani E, Dumchev K, Pykalo I, Filippovych M, Ivasiy R, Esserman D, Madden LM, Bromberg DJ, Haddad M, Morozova O, Ahmad B, Gomez DO, Farnum SO, Dvoriak S, Altice FL. Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine. Contemp Clin Trials. 2024 Nov;146:107690. doi: 10.1016/j.cct.2024.107690. Epub 2024 Sep 14.
- Pashchenko O, Bromberg DJ, Dumchev K, LaMonaca K, Pykalo I, Filippovych M, Esserman D, Polonsky M, Galvez de Leon SJ, Morozova O, Dvoriak S, Altice FL. Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial. PLOS Glob Public Health. 2022 Nov 2;2(11):e0000344. doi: 10.1371/journal.pgph.0000344. eCollection 2022.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2000020067
- 1R01DA043125-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .