From a public health perspective, there is no more compelling crisis in the world today than the HIV epidemic in the developing world. This is a Phase III community-level randomized controlled study, in which 32 communities in Africa (Tanzania, Zimbabwe, and South Africa) and 14 communities in Thailand will be randomized to either a community-based HIV voluntary counseling and testing (CBVCT) intervention or clinic-based standard VCT (SVCT). 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 three 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. Thus, a community-level sampling approach as opposed to a cohort design is used to evaluate outcomes. ? ? The primary aim (Aim 1) is to test the hypothesis that communities receiving 2-1/2 years of CBVCT, relative to communities receiving 2-1/2 years of SVCT, will have significantly lower prevalence of recent HIV infection. In addition, we propose the following secondary aim (Aim 2) to test the hypotheses that CBVCT communities, relative to SVCT communities, will at the end of the intervention period report significantly: a) less HIV risk behavior; b) higher rates of HIV testing; c) more favorable social norms regarding HIV testing; d) more frequent discussions about HIV; e) more frequent disclosure of HIV status; f) less HIV-related stigma; and g) less HIV-related social harm. Finally, because of the importance of cost-effectiveness data to host and donor countries, we propose to assess (Aim 3) the incremental cost-effectiveness of CBVCT compared to SVCT. ? ? A random sample of persons between the ages of 18 and 32 years of age from each community will be selected at baseline and post-intervention for measuring primary and secondary endpoints.
Aim 1 will be evaluated by comparing the post-intervention prevalence of recent infection measured by the sensitive/less sensitive HIV assay on all positive HIV blood samples in the two arms of the study.
Aim 2 will be evaluated by comparing a variety of behavioral measures at baseline and post-intervention.
Aim 3 will be evaluated in terms of cost per HIV infection averted and disability-adjusted life years saved ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01MH066687-01A1
Application #
6655346
Study Section
Special Emphasis Panel (ZRG1-AARR-7 (02))
Program Officer
Gordon, Christopher M
Project Start
2003-09-30
Project End
2008-06-30
Budget Start
2003-09-30
Budget End
2004-06-30
Support Year
1
Fiscal Year
2003
Total Cost
$972,893
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Salazar-Austin, N; Kulich, M; Chingono, A et al. (2018) Age-Related Differences in Socio-demographic and Behavioral Determinants of HIV Testing and Counseling in HPTN 043/NIMH Project Accept. AIDS Behav 22:569-579
Fogel, Jessica M; Clarke, William; Kulich, Michal et al. (2017) Antiretroviral Drug Use in a Cross-Sectional Population Survey in Africa: NIMH Project Accept (HPTN 043). J Acquir Immune Defic Syndr 74:158-165
Mahiané, Severin Guy; Laeyendecker, Oliver (2017) Segmented polynomials for incidence rate estimation from prevalence data. Stat Med 36:334-344
Richter, Linda; Makusha, Tawanda; Komárek, Arnošt et al. (2016) Exploring the Impact of Childhood Abuse on HIV Social and Attitudinal Factors Among Adults With and Without this History in Sub-Saharan Africa: Findings from NIMH Project Accept (HPTN 043). AIDS Behav 20:737-45
Kevany, Sebastian; Khumalo-Sakutukwa, Gertrude; Singh, Basant et al. (2016) Global Health Diplomacy, Monitoring & Evaluation, and the Importance of Quality Assurance & Control: Findings from NIMH Project Accept (HPTN 043): A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Pos PLoS One 11:e0149335
Piwowar-Manning, Estelle; Fogel, Jessica M; Richardson, Paul et al. (2015) Performance of the fourth-generation Bio-Rad GS HIV Combo Ag/Ab enzyme immunoassay for diagnosis of HIV infection in Southern Africa. J Clin Virol 62:75-9
Mindry, Deborah L; Knight, Lucia; van Rooyen, Heidi (2015) Men's moralising discourses on gender and HIV risk in rural KwaZulu-Natal, South Africa. Cult Health Sex 17:1035-48
Fogel, Jessica M; Piwowar-Manning, Estelle; Donohue, Kelsey et al. (2015) Determination of HIV Status in African Adults With Discordant HIV Rapid Tests. J Acquir Immune Defic Syndr 69:430-8
Daniels, Joseph; Komárek, Arnošt; Makusha, Tawanda et al. (2014) Effects of a community intervention on HIV prevention behaviors among men who experienced childhood sexual or physical abuse in four African settings: findings from NIMH Project Accept (HPTN 043). PLoS One 9:e99643
Coates, Thomas J; Kulich, Michal; Celentano, David D et al. (2014) 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 2:e267-77

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