NIMH Project Accept: A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192,814
- 试验地点
- 5
- 主要终点
- Prevalence of recent HIV infection
研究概览
简要总结
This study will evaluate the effectiveness of a combination of clinic- and community-based voluntary counseling and testing programs in preventing HIV in African and Thai communities.
详细描述
NIMH Project Accept is an HIV prevention trial in which 48 communities (10 in Tanzania [Kisarawe], 8 in Zimbabwe [Mutoko], 8 in South Africa/Vulindlela, 8 in South Africa/Soweto and 14 in Thailand [Chiang Mai]) are being randomized to receive either a community-based HIV voluntary counseling and testing (CBVCT) intervention plus standard clinic-based VCT (SVCT), or SVCT alone. The CBVCT intervention has three major strategies: (1) to make VCT more available in community settings; (2) to engage the community through outreach; and (3) to provide post-test support. These strategies are designed to change community norms and reduce risk for HIV infection among all community members, irrespective of whether they participated directly in the intervention.
A community-level intervention based on modifying community norms can change the environmental context in which people make decisions about HIV risk, and has the potential to alter the course of the HIV epidemic in developing countries. This is the first international randomized controlled Phase III trial to determine the efficacy of a behavioral/social science intervention with an HIV incidence endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Baseline Assessment:
- •Persons may be included in the baseline behavioral assessment if they meet all of the following criteria:
- •Reside in a community selected for the study
- •Are randomly selected and invited to participate from households that are themselves randomly selected and invited to participate
- •Aged 18-32 years
- •Has lived in the community at least 4 months in the past year
- •Sleeps regularly in their household at least 2 nights per week
- •Able and willing to provide verbal informed consent
- •Qualitative Cohort:
- •Persons may be included in the qualitative cohort if they meet all of the following criteria:
- •Participated in the baseline behavioral assessment
- •Aged 18-32 years at enrollment
- •Have not been away from the community for more than two months at a time in the last two years
- •Able and willing to provide written informed consent
- •Intervention:
- •Persons may access community-based counseling and testing (in CBVCT communities) through the study if they meet all of the following criteria:
- •>16 years of age
- •Able and willing to provide verbal informed consent
- •Persons may access post-test support through the study if they meet all of the following criteria:
- •>16 years of age
- •Able and willing to provide verbal informed consent
- •Proof of having been tested for HIV at a Project Accept CBVCT venue, irrespective of test result
- •Persons may access standard clinic-based counseling and testing (in both SVCT and CBVCT communities) through the study if they meet all of the following criteria:
- •>16 years of age
- •Able and willing to provide verbal informed consent
- •Post-Intervention Assessment:
- •Persons may be included in the post-intervention assessment if they meet all of the following criteria:
- •Reside in a community selected for the study
- •Are randomly selected to be offered to participate from households that are themselves randomly selected to be offered to participate
- •Aged 18-32 years
- •Has lived in the community at least 4 months in the past year
- •Sleeps regularly in their household at least 2 nights per week
- •Able and willing to provide informed consent (written for biological assessment; verbal for behavioral assessment)
排除标准
- •Baseline Assessment:
- •Persons will be excluded from the baseline behavioral assessment if they meet any of the following criteria:
- •Are not a member of the study community or are not randomly selected to be offered to participate
- •Are below 18 or above 32 years of age
- •Has not lived in the community at least 4 months in the past year
- •Does not sleep regularly in their household at least 2 nights per week
- •Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment
- •Qualitative Cohort:
- •Persons will be excluded from the qualitative cohort if they meet any of the following criteria:
- •Not a participant in the baseline behavioral assessment
- •Less than 18 or greater than 32 years of age at enrollment
- •Have been away from the community for more than two months at a time in the last two years
- •Demonstrate signs of being visibly distraught, emotionally unstable, or under the influence of psychoactive agents that would invalidate the consent process or otherwise contraindicate participation in the qualitative assessment
- •Have concrete plans to leave the community, thus removing possibility of follow up
- •Intervention:
- •Persons will be excluded from accessing counseling and testing (CBVCT) through the study (and will be referred to existing alternate services) if they meet any of the following criteria:
- •<16 years of age
- •Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation
- •Persons will be excluded from accessing post-test support through the study (and will be referred to existing alternate services) if they meet any of the following criteria:
- •<16 years of age
- •Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation
- •<16 years of age
- •Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation
- •Post-Intervention Assessment:
- •Persons will be excluded from the post-intervention assessment if they meet any of the following criteria:
- •Are not a member of the study community or are not randomly selected to be offered to participate
- •Are below 18 or above 32 years of age
- •Has not lived in the community at least 4 months in the past year
- •Does not sleep regularly in their household at least 2 nights per week
- •Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the assessment
研究组 & 干预措施
1
Intervention communities will receive the community-based VCT intervention community mobilization, mobile VCT, and post-test support services), as well as standard clinic-based VCT
干预措施: Community-Based HIV VCT (Behavioral)
2
Comparison communities will receive standard clinic-based VCT
干预措施: Standard clinic-based VCT (Behavioral)
结局指标
主要结局
Prevalence of recent HIV infection
时间窗: Measured at Year 3
次要结局
- Less HIV-related stigma(Measured at Year 3)
- Less HIV risk behavior(Measured at Year 3)
- Higher rates of HIV testing(Measured at Year 3)
- More favorable social norms regarding HIV testing(Measured at Year 3)
- More frequent discussions about HIV(Measured at Year 3)
- More frequent disclosure of HIV status(Measured at Year 3)
- Fewer HIV-related life events(Measured at Year 3)
研究者
Thomas J. Coates
Professor of Medicine
University of California, Los Angeles