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临床试验/NCT01164462
NCT01164462已完成不适用

Feasibility and Limitations of Offering Community Based Rapid HIV Testing to Men Who Have Sex With Men (MSM)

French National Agency for Research on AIDS and Viral Hepatitis3 个研究点 分布在 1 个国家目标入组 357 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
357
试验地点
3
主要终点
the feasibility of community-based rapid HIV testing. testing with community-based rapid testing

研究概览

简要总结

Objective: This research agreement brings together French and Canadian teams of scientists, HIV testing centers and community based partners. The aim is to explore the feasibility and limitations of offering community based rapid HIV testing to men who have sex with men (MSM).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • who have had a previous diagnosis of seropositivity
  • treated by antiretroviral

研究组 & 干预措施

B group

Other

During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing

干预措施: blood test: rapid finger-stick blood specimen test (Biological)

B group

Other

During evenings and week-ends (i.e. when the centers are closed) only community based with rapid HIV testing

干预措施: blood test: conventional test (Biological)

A1 group

Other

During the normal opening hours of five testing centers, clients with a conventional test.

干预措施: blood test: conventional test (Biological)

A 2

Other

During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test

干预措施: blood test: rapid finger-stick blood specimen test (Biological)

A 2

Other

During the normal opening hours of five testing centers, clients with a rapid finger-stick blood specimen test

干预措施: blood test: conventional test (Biological)

结局指标

主要结局

the feasibility of community-based rapid HIV testing. testing with community-based rapid testing

次要结局

  • Moreover it could compare traditional CDAG (Free Anonymous Screening Consultation) center

研究者

发起方
French National Agency for Research on AIDS and Viral Hepatitis
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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