- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01164462
Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM) (DRAG)
연구 개요
상태
정황
상세 설명
Background: Studies have shown that knowing one's own HIV positive status, may lead to a reduction in sexual risk behaviours. The introduction of new forms of rapid HIV testing in urban areas, may be of benefit to the public health sector, notably in identifying primary HIV infection, preventing secondary HIV transmission and decreasing the spread of HIV infection. Studies have also shown that rapid HIV testing, which yields same-day results, enables a greater number of individuals in populations at risk to become aware of their HIV status.
Issue: The working hypothesis is that the current screening system is not sufficiently suitable for MSM. A community-based rapid HIV testing program could better target the high risk MSM population and shorten the delay between risky behaviour and HIV testing.
Design: This intervention could enable the assessment of the feasibility of community-based rapid HIV testing. Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation or Centre de dépistage anonyme et gratuit in French) center testing with community-based rapid testing. A pre-study phase is first realised to characterize those in the MSM population undergoing HIV testing, before promoting and then beginning the survey. During the normal opening hours of five testing centers, clients will be randomized to have a rapid finger-stick blood specimen test or a conventional test. During evenings and week-ends (i.e. when the centers are closed) only community based rapid HIV testing will be proposed.
Schedule: The pre-study phase is planned for the first quarter of 2009. Promotion of the survey will begin one month before the experimental study which in turn will start in the third quarter of 2009 and will run for 7 months. The end of data analyses is planned for the end of 2010.
Outcome: We will compare HIV population exposure, screening history and the frequency of primary HIV infection diagnosis. We expect to find that those MSM who undergo community based HIV testing during evenings or week-ends, is a population who take repeated sexual risks and who have repeated HIV testing. We also expect to find that this form of testing will be characterized in terms of satisfaction as non-inferior compared to the classic one. In the long term, and if the results are confirmed, rapid HIV testing could be extended to strictly community-based sites.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Marseille, 프랑스
- CDAG (Free Anonymous Screening Consultation) center
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Nice, 프랑스
- CDAG (Free Anonymous Screening Consultation) center
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Paris, 프랑스
- CDAG (Free Anonymous Screening Consultation) center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- men who have sex with men
- Age ≥ 18 years
- Able to give written consent
- able to give written authorization for lifting anonymity if there is doubt of results
- Covered by French Social Security
Exclusion Criteria:
- who have had a previous diagnosis of seropositivity
- treated by antiretroviral
- woman
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: A 2
During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test
|
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다른: B group
During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing
|
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다른: A1 group
During the normal opening hours of five testing centers, clients with a conventional test.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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the feasibility of community-based rapid HIV testing. testing with community-based rapid testing
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2차 결과 측정
결과 측정 |
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Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vernay Vaisse Chantal, DGAS DPMIS Marseille
간행물 및 유용한 링크
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. .
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