Investigator Area
(Password required)

NIMH Project Accept (HPTN 043) was an HIV prevention trial in which 34 communities in Africa (in South Africa, Tanzania, and Zimbabwe) and 14 communities in Thailand were 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 had 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 (HPTN 043) was sponsored by the U.S. National Institute of Mental Health as a cooperative agreement, through contracts U01MH066687 (Johns Hopkins University – David Celentano, PI); U01MH066688 (Medical University of South Carolina – Michael Sweat, PI); U01MH066701 (University of California, Los Angeles – Thomas J. Coates, PI); and U01MH066702 (University of California, San Francisco – Stephen F. Morin, PI). In addition, this work was supported as HPTN Protocol 043 through contracts U01AI068613/UM1AI068613 (HPTN Network Laboratory – Susan Eshleman, PI); U01AI068617/UM1AI068617 (SCHARP – Deborah Donnell, PI); and U01AI068619/UM1AI068619 (HIV Prevention Trials Network – Sten Vermund/Wafaa El-Sadr, PIs) of the Division of AIDS of the U.S. National Institute of Allergy and Infectious Diseases; and by the Office of AIDS Research of the U.S. National Institutes of Health.

Research Sites

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

In Africa, there were 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 participated in the study; 10 communities participated at the Tanzanian site.

The Thailand site was located in Chiang Mai Province, and had 14 communities participating.

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

Timeline

The entire study, from planning work through data analysis, lasted 10 years. The intervention component of the study lasted 3 years. Research funding and planning began in October of 2003; data analyisis concluded in 2012, with study results presented in 2013.

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

Contracts U01AI068613/UM1AI068613 (HPTN Network Laboratory – Susan Eshleman, PI); U01AI068617/UM1AI068617 (SCHARP – Deborah Donnell, PI); and U01AI068619/UM1AI068619 (HIV Prevention Trials Network – Sten Vermund, PI)

• 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, PhD, MA

• Muhimbili University of Health and Allied 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
Gavin Robertson, MEd

• University of Zimbabwe

Harare, Zimbabwe
Alfred Chingono, MSc, Principal Investigator
Tendayi Jubenkanda, Bsc Hons (Psychology)
Godfrey Woelk, PhD, MCOMMH, BSc

• Johns Hopkins University, Bloomberg School of Public Health

Baltimore, MD, U.S.A.
David Celentano, ScD, MHS, Principal Investigator
Chris Beyrer, MD, MPH
Surinda Kawichai, PhD, MSc
Carla E. Zelaya, PhD, MSc

• Medical University of South Carolina

Charleston, SC, U.S.A.
Michael Sweat, PhD, Principal Investigator
Marta Mulawa
Andrew M. Sadowski
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 Program in Global Health
9911 West Pico Blvd., Suite 955
Los Angeles, CA 90035-2703
U.S.A.

Phone: +1- 310-557-3044
Fax: +1-310-557-3679
Email: gszekeres@mednet.ucla.edu