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NIMH Project Accept is an HIV prevention trial in which 34 communities in Africa (in South Africa, Tanzania, and Zimbabwe) and 14 communities in Thailand 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.

NIMH Project Accept is funded as a National Institute of Mental Health (NIMH) Cooperative Agreement (grants 5U01MH066687, 5U01MH066688, 5U01MH066701, and 5U01MH066702) involving the NIMH and several U.S. and international institutions. The HIV Prevention Trials Network (HPTN) is also providing support to the project (HPTN 043)); support has also been provided by the Office of AIDS Research of the National Institutes of Health.

Research Sites

The study is being conducted at 5 sites in sub-Saharan Africa and Thailand.

In Africa, there are 2 sites in South Africa (Vulindlela, KwaZulu-Natal; and Soweto), and 1 site each in Tanzania (Kisarawe district) and Zimbabwe (Mutoko district). At each of the South African and Zimbabwean sites, 8 communities will participate in the study; 10 communities will participate at the Tanzanian site.

The Thailand site is located in Chiang Mai Province, and will have 14 communities participating.

Within each research site, participating communities will be randomized to receive either the CBVCT intervention plus SVCT, or SVCT alone.

Timeline

The entire study, from planning work through data analysis, is scheduled to last 8 years. The intervention component of the study will last 3 years. Research funding and planning began in October of 2003; the study is scheduled to continue through 2011.

Collaborating Institutions

• National Institute of Mental Health (Division of AIDS and Health and Behavior Research)
NIMH Cooperative Agreement (NIMH grants 1U01MH066687, 1U01MH066688, 1U01MH066701, and 1U01MH066702)
Christopher M. Gordon, PhD, Program Officer

• HIV Prevention Trials Network

HPTN Protocol 043

• Chiang Mai University, Research Institute for Health Sciences

Chiang Mai, Thailand
Suwat Chariyalertsak, MD, DrPH, Principal Investigator
Surasing Visrutaratna, PhD
Surinda Kawichai, PhD, MSc

• Human Sciences Research Council

Durban, South Africa
Linda Richter, PhD, Principal Investigator
Salim Abdool Karim, MBChB, PhD
Janet Frohlich, DCur
Heidi Van Rooyen, MA

• Muhimbili University College of Health Sciences

Dar es Salaam, Tanzania
Jessie Mbwambo, MD, Principal Investigator
G.P. Kilonzo, MD, FRCP, MMed, MBChB, BA

• University of the Witwatersrand/Chris Hani Baragwanath Hospital

Soweto, South Africa
Glenda Gray, MBBCH, FCPaeds(SA), Principal Investigator
James McIntyre, MBChB, MRCOG
Precious Modiba, MA (SW)

• University of Zimbabwe

Harare, Zimbabwe
Alfred Chingono, MSc, Principal Investigator
Andrew Timbe, MEd
Godfrey Woelk, PhD, MCOMMH, BSc

• Johns Hopkins University, Bloomberg School of Public Health

Baltimore, MD, U.S.A.
David Celentano, ScD, MHS, Principal Investigator
Michael Sweat, PhD, Principal Investigator
Chris Beyrer, MD, MPH
Becky Genberg, MPH
Surinda Kawichai, PhD, MSc
Basant Singh, Bsc, Msc
Carla E. Zelaya, PhD, MSc

• Medical University of South Carolina

Charleston, SC, U.S.A.
Michael Sweat, PhD, Principal Investigator
Kathryn Curran, MHS
Marta Mulawa
Basant Singh, Bsc, Msc

• University of California, Los Angeles

Los Angeles, CA, U.S.A.
Thomas J. Coates, PhD, Principal Investigator
Agnès Fiamma, MIPH
Greg Szekeres

• University of California, San Francisco

San Francisco, CA, U.S.A.
Stephen F. Morin, PhD, Principal Investigator
Adam, W. Carrico, PhD
Sebastian Kevany, MPH
Gertrude Khumalo-Sakutukwa, MSW, MMS
Tim Lane, PhD, MPH

• University of North Carolina at Chapel Hill

Chapel Hill, NC, U.S.A.
Suzanne Maman, PhD
Audrey Pettifor, PhD, MPH

• International Center for Research on Women

Washington, DC, U.S.A.
Katherine Fritz, PhD, MPH

• Charles University

Prague, Czech Republic
Michal Kulich, PhD

• Statistical Center for HIV/AIDS Research & Prevention,

Fred Hutchinson Cancer Research Center
Seattle, WA, U.S.A.
Deborah Donnell, PhD

Greg Szekeres
UCLA David Geffen School of Medicine
Division of Infectious Diseases
10940 Wilshire Boulevard
Suite 1220, Box 957320
Los Angeles, CA 90024-3916
U.S.A.

Phone: 310-794-3579
Fax: 310-794-2795
Email: gszekeres@mednet.ucla.edu