- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05368675
Medication-assisted Treatment for Injecting Drug Users in Vietnam (OIT-HCMC)
A Pilot Implementation Project of Methadone and Suboxone® for Injecting Drug Users in Ho Chi Minh City, Vietnam
연구 개요
상세 설명
The drug treatment and HIV research literature of the past 20 years provides strong support for the ability of drug treatment programs to reduce the frequency of drug use, risk behaviors, and incidence of new infections. Findings from these studies also suggest that drug users living with HIV who remain in medication assisted treatment (MAT) and cease drug use are significantly more likely to achieve sustained viral suppression and consequently less likely to transmit HIV. While these data are strong and consistent, they are all derived from countries with highly developed drug and HIV treatment systems. Little data exist regarding the challenges of implementing and integrating new strategies for MAT with linkages to HIV care in resource-limited settings with developing drug and HIV treatment systems.
The proposed project will take place in Ho Chi Minh City (HCMC), Vietnam. In HCMC, 51.8 % of IDUs are estimated to be HIV positive (HCMC Provincial AIDS Committee (PAC) 2009). Methadone maintenance treatment (MMT) for IDUs started as a pilot program in 2008 in Haiphong and HCMC, two of the highest prevalence provinces for injecting drug use. By December 2009, 784 patients were under MMT and 235 were receiving ARV. 30% of patients under MMT are HIV+ (HCMC PAC, 2009). The National goal is to have 80,000 drug users in methadone treatment by 2015. There are currently no buprenorphine/naloxone treatment programs in Vietnam.
The proposed project evaluate the implementation of an MAT program (both methadone and buprenorphine/naloxone) integrated within an HIV treatment setting. This is the first project to establish and evaluate the implementation a buprenorphine/naloxone (Suboxone) treatment program in Vietnam. Participants were enrolled in the integrated MAT program that included drug and risk counseling, and for those who are living with HIV, HIV treatment. Participant'received care for 12 months and then transitioned to community treatment program. The study assessed barriers to implementation.
Primary measures consisted of facilitators and barriers to implementation and retention in MAT generally and Suboxone treatment specifically. The following specific aims are evaluated:
- Establish a new integrated MAT treatment program within and HIV treatment setting in HCMC;
- Evaluate barriers and facilitators to implementation of integrated MAT/HIV treatment;
- Evaluate patient retention and medication adherence in integrated MAT/HIV Care;
- Estimate the costs and benefits of MAT treatment strategies.
연구 유형
등록 (실제)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
• 18 or more years of age
- Meets DSM-5 criteria for opiate use disorder
- Positive urine drug screen for heroin or other opiates
- Interested in methadone maintenance or Suboxone® treatment for opiate use disorder
- Injected heroin within past 30 days by self-report, documented by "tracks" or puncture marks
- Willingness and ability to give informed consent and otherwise participate
- Provision of adequate locator information
Exclusion Criteria:
• Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder
- Known neurological, cardiovascular, renal, or other medical disorder that is likely to impair or make the patient's participation hazardous
- Physiologically dependent on alcohol, benzodiazepines, or other sedative type drugs
- Pending legal charges with likely incarceration within next 12 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Retention in treatment program at 12 months
기간: 12 months
|
Percentage of participants who stay in treatment for 12 months
|
12 months
|
|
Adherence in treatment program at 12 months
기간: 12 months
|
Missing doses of treatment during time in the study
|
12 months
|
|
Cost of 12-month treatment program
기간: 12 months
|
Cost of 12 months of the treatment program evaluated with the Drug Abuse Treatment Cost Analysis Program (DATCAP)
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in substance use from baseline to 12-month follow-up
기간: 12 months
|
Evaluation of the change in substance use between baseline and 12-month follow-up assessed by weekly self-report and urine drug screen
|
12 months
|
|
Viral load suppression for people living with HIV
기간: 12 months
|
Percentage of participants living with HIV with a suppressed viral load at 12 months
|
12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Charles P O'Brien, MD, PhD, University of Pennsylvania
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
- R01DA033671 (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
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