Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand
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|ClinicalTrials.gov Identifier: NCT00203749|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Community-Based HIV VCT Behavioral: Standard clinic-based VCT||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192814 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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
Behavioral: Community-Based HIV VCT
COMMUNITY MOBILIZATION. This component of the intervention uses community outreach to enhance the uptake of VCT, thus increasing the rate of HIV testing and frequency of discussions about HIV and reducing stigma through community education and mobilization.
EASY ACCESS TO VCT. This component is designed to remove practical barriers and increase safety of VCT. Mobile vans or temporary units set up at local community sites will provide free, anonymous VCT in specific, chosen sites where people gather, such as market areas, shopping centers, and community centers.
POST-TEST SUPPORT SERVICES. This component is designed to build psychosocial support to improve the quality of life for individuals diagnosed with HIV. The expected outcomes include a reduction in social harm, an increase in social support through disclosure to those most likely to provide support, and a reduction in internalized stigma. Social support should also decrease the behavioral risk of further transmission.
Active Comparator: 2
Comparison communities will receive standard clinic-based VCT
Behavioral: Standard clinic-based VCT
Control communities will receive Standard Clinic-Based VCT (SVCT) instead of the community-based VCT (CBVCT) intervention. Each of these communities will have access to SVCT that reflects local access to health care. The training for VCT counselors will be the same in the CBVCT and SVCT communities; however, no active recruitment for participation in the SVCT services will be made beyond the standard procedures of each clinic for informing patients of services (e.g., telling individual patients that VCT is available, posting of a flyer in the clinic announcing VCT availability, etc). As such, no active outreach or community mobilization will be conducted by the study staff in the SVCT settings (although it is possible that such activities will occur due to local initiative).
- Prevalence of recent HIV infection [ Time Frame: Measured at Year 3 ]
- Less HIV risk behavior [ Time Frame: Measured at Year 3 ]
- Higher rates of HIV testing [ Time Frame: Measured at Year 3 ]
- More favorable social norms regarding HIV testing [ Time Frame: Measured at Year 3 ]
- More frequent discussions about HIV [ Time Frame: Measured at Year 3 ]
- More frequent disclosure of HIV status [ Time Frame: Measured at Year 3 ]
- Less HIV-related stigma [ Time Frame: Measured at Year 3 ]
- Fewer HIV-related life events [ Time Frame: Measured at Year 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203749
|University of the Witwatersrand|
|Soweto, Johannesburg, Gauteng, South Africa|
|Human Sciences Research Council|
|Pietermaritzburg, KwaZulu-Natal, South Africa|
|Dar es Salaam, Tanzania|
|Chiang Mai University|
|Chiang Mai, Thailand|
|University of Zimbabwe|
|Principal Investigator:||David Celentano, ScD, MHS||Johns Hopkins University|
|Principal Investigator:||Thomas J Coates, PhD||University of California, Los Angeles|
|Principal Investigator:||Stephen F Morin, PhD||University of California, San Francisco|
|Principal Investigator:||Michael Sweat, PhD||Medical University of South Carolina|
|Principal Investigator:||Michal Kulich, PhD||Charles University|
|Principal Investigator:||Deborah Donnell, PhD||SCHARP, Fred Hutchinson Cancer Research Center|
|Principal Investigator:||Linda Richter, PhD||Human Sciences Research Council|
|Principal Investigator:||Glenda Gray, MBBCH, FCPaeds(SA)||University of Witwatersrand, South Africa|
|Principal Investigator:||Jessie Mbwambo, MD||Muhimbili University|
|Principal Investigator:||Alfred Chingono, MSc||University of Zimbabwe|
|Principal Investigator:||Suwat Chariyalertsak, MD, DrPH||Chiang Mai University|