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
Sponsor study identifier
NIH
Secondary identifiers
interventional
192,814
4 countries
5
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 20, 2005
Actual (reported)September 2011
Actual (reported)September 2011
Actual (reported)Prevalence of recent HIV infection
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
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
Comparison communities will receive standard clinic-based 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.
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
University of Zimbabwe
Harare, Zimbabwe
Coates TJ, Kulich M, Celentano DD, Zelaya CE, Chariyalertsak S, Chingono A, Gray G, Mbwambo JK, Morin SF, Richter L, Sweat M, van Rooyen H, McGrath N, Fiamma A, Laeyendecker O, Piwowar-Manning E, Szekeres G, Donnell D, Eshleman SH; NIMH Project Accept (HPTN 043) study team. Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial. Lancet Glob Health. 2014 May;2(5):e267-77. doi: 10.1016/S2214-109X(14)70032-4. Epub 2014 Apr 8.
Laeyendecker O, Piwowar-Manning E, Fiamma A, Kulich M, Donnell D, Bassuk D, Mullis CE, Chin C, Swanson P, Hackett J Jr, Clarke W, Marzinke M, Szekeres G, Gray G, Richter L, Alexandre MW, Chariyalertsak S, Chingono A, Celentano DD, Morin SF, Sweat M, Coates T, Eshleman SH. Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). PLoS One. 2013 Jul 11;8(7):e68349. doi: 10.1371/journal.pone.0068349. Print 2013.
David Celentano, ScD, MHS
Johns Hopkins University
Thomas J Coates, PhD
University of California, Los Angeles
Stephen F Morin, PhD
University of California, San Francisco
Michael Sweat, PhD
Medical University of South Carolina
192,814 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Effectiveness of the Diaphragm for HIV Prevention
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Piwowar-Manning E, Fiamma A, Laeyendecker O, Kulich M, Donnell D, Szekeres G, Robins-Morris L, Mullis CE, Vallari A, Hackett J Jr, Mastro TD, Gray G, Richter L, Alexandre MW, Chariyalertsak S, Chingono A, Sweat M, Coates T, Eshleman SH. HIV surveillance in a large, community-based study: results from the pilot study of Project Accept (HIV Prevention Trials Network 043). BMC Infect Dis. 2011 Sep 24;11:251. doi: 10.1186/1471-2334-11-251.
Sweat M, Morin S, Celentano D, Mulawa M, Singh B, Mbwambo J, Kawichai S, Chingono A, Khumalo-Sakutukwa G, Gray G, Richter L, Kulich M, Sadowski A, Coates T; Project Accept study team. Community-based intervention to increase HIV testing and case detection in people aged 16-32 years in Tanzania, Zimbabwe, and Thailand (NIMH Project Accept, HPTN 043): a randomised study. Lancet Infect Dis. 2011 Jul;11(7):525-32. doi: 10.1016/S1473-3099(11)70060-3. Epub 2011 May 3.
Michal Kulich, PhD
Charles University, Czech Republic
Deborah Donnell, PhD
SCHARP, Fred Hutchinson Cancer Research Center
Linda Richter, PhD
Human Sciences Research Council
Glenda Gray, MBBCH, FCPaeds(SA)
University of Witwatersrand, South Africa
Jessie Mbwambo, MD
Muhimbili University
Alfred Chingono, MSc
University of Zimbabwe
Suwat Chariyalertsak, MD, DrPH
Chiang Mai University
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)Last Updated
December 12, 2013
Record last verified: 2013-12
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