- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00479141
A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China
A Cluster-Randomized Trail to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life (QOL) For HIV-Positive Villagers in Rural China
연구 개요
상세 설명
Over the past decade, the rates of HIV infection and death due to HIV/AIDS have been steadily increasing in China. The China Comprehensive AIDS Response (China CARES) program was developed in 2003 in order to help poor counties and those with severe epidemic problems increase public awareness and improve knowledge about epidemic diseases such as HIV. Currently, behavioral interventions focusing on individual skills training and self-efficacy building for HIV infected individuals are not included in China CARES. Fuyang, Anhui Province, China has a high rate of HIV infected individuals, many of whom were former plasma donors (FPDs) and would benefit from HIV skills training.
In 2004, CIPRA conducted a study (CIPRA CH 002A), entitled "A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China," which provided insight into HIV infected individuals in Fuyang, Anhui Province, China. According to the results of CIRPA CH 002A, most HIV infected individuals described their QOL as poor. The factors affecting their poor QOL include poverty, poor health, stigma and discrimination. Participants in the CIPRA CH 002A study showed interest in learning more about HIV/AIDS disease and treatment. This study will last 18 months. HIV infected participants and their families will attend eight 2-hour group skills training sessions during Weeks 1 through 8, and booster sessions every two months during Months 3 through 15. Popular Opinion Leaders (POL) participants will attend 4 weeks of 2-hour training sessions about anti-stigma and anti-discrimination, followed by support meetings every 2 months during Months 2 through 13. Some participants will complete cross-sectional surveys evaluating the levels of stigma and discrimination in the community at study entry and at Months 6 and 12 following completion of POL training. All participants will complete follow-up visits at Months 6 and 12.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beijing, 중국, 100050
- Fuyang CDC Office
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for HIV Infected Individuals:
- HIV infected
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Willing to provide location information
Inclusion Criteria for Family members of HIV Infected Individuals:
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Family member of HIV infected participant
Inclusion Criteria for POLs:
- Identified as an influential member of the community
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Willing to attend training and follow-up meetings Note: Both HIV infected and non HIV infected individuals may participate as POLs
Inclusion Criteria for Cross-Sectional Survey Participants:
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Randomly selected and invited to participate in study
Exclusion Criteria for HIV Infected Individuals:
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Has not made contact with study staff after three attempts
Exclusion Criteria for Family Members of HIV Infected Individuals:
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
Exclusion Criteria for POLs:
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
Exclusion Criteria for Cross-Sectional Survey Participants:
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Has not made contact with study staff after three attempts
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1
HIV infected participants and their families
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Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15
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실험적: 2
Popular Opinion Leaders (POL) participants
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Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants
기간: Throughout study
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Throughout study
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Level of stigma among community members, including HIV knowledge
기간: Throughout study
|
Throughout study
|
공동 작업자 및 조사자
수사관
- 연구 의자: Zunyou Wu, MD, PhD, Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
- 연구 의자: Jie Xu, MD, MS, MPH, Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .