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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
192,814
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.
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).
University of the Witwatersrand
Soweto, Johannesburg, Gauteng, South Africa
Human Sciences Research Council
Pietermaritzburg, KwaZulu-Natal, South Africa
Muhimbili University
Dar es Salaam, Tanzania
Chiang Mai University
Chiang Mai, Chiang Mai, Thailand
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
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University of Zimbabwe
Harare, Zimbabwe