Open Access Highly Accessed Research article

HIV Surveillance in a Large, Community-Based Study: Results from the Pilot Study of Project Accept (HIV Prevention Trials Network 043)

Estelle Piwowar-Manning1, Agnes Fiamma2, Oliver Laeyendecker34, Michal Kulich5, Deborah Donnell6, Greg Szekeres2, Laura Robins-Morris6, Caroline E Mullis,3, Ana Vallari7, John Hackett7, Timothy D Mastro8, Glenda Gray9, Linda Richter10, Michel W Alexandre11, Suwat Chariyalertsak12, Alfred Chingono,13, Michael Sweat14, Thomas Coates2 and Susan H Eshleman1*

Author Affiliations

1 Dept. of Pathology, Johns Hopkins Univ. School of Medicine, Baltimore, MD, USA

2 Program in Global Health, Univ. of California at Los Angeles, Los Angeles, CA, USA

3 Dept. of Medicine, Johns Hopkins Univ. School of Medicine, Baltimore, MD, USA

4 Laboratory of Immunoregulation, NIAID, NIH, Baltimore, MD, USA

5 Dept. of Probability and Statistics, Faculty of Mathematics and Physics, Charles University in Prague, Czech Republic

6 Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

7 Infectious Diseases Research, Abbott Diagnostics, Abbott Park, IL, USA

8 FHI 360, Durham, NC, USA

9 Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital/University of the Witwatersrand, Johannesburg, South Africa

10 Human Sciences Research Council, Durban, South Africa

11 Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

12 Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand

13 Dept. of Psychiatry, School of Medicine, University of Zimbabwe, Harare, Zimbabwe

14 Dept. of Psychiatry and Behavioral Sciences, the Medical University of South Carolina, Charleston, SC, USA

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BMC Infectious Diseases 2011, 11:251  doi:10.1186/1471-2334-11-251

Published: 24 September 2011

Abstract

Background

Project Accept is a community randomized, controlled trial to evaluate the efficacy of community mobilization, mobile testing, same-day results, and post-test support for the prevention of HIV infection in Thailand, Tanzania, Zimbabwe, and South Africa. We evaluated the accuracy of in-country HIV rapid testing and determined HIV prevalence in the Project Accept pilot study.

Methods

Two HIV rapid tests were performed in parallel in local laboratories. If the first two rapid tests were discordant (one reactive, one non-reactive), a third HIV rapid test or enzyme immunoassay was performed. Samples were designated HIV NEG if the first two tests were non-reactive, HIV DISC if the first two tests were discordant, and HIV POS if the first two tests were reactive. Samples were re-analyzed in the United States using a panel of laboratory tests.

Results

HIV infection status was correctly determined based on-in country testing for 2,236 (99.5%) of 2,247 participants [7 (0.37%) of 1,907 HIV NEG samples were HIV-positive; 2 (0.63%) of 317 HIV POS samples were HIV-negative; 2 (8.3%) of 24 HIV DISC samples were incorrectly identified as HIV-positive based on the in-country tie-breaker test]. HIV prevalence was: Thailand: 0.6%, Tanzania: 5.0%, Zimbabwe 14.7%, Soweto South Africa: 19.4%, Vulindlela, South Africa: 24.4%, (overall prevalence: 14.4%).

Conclusions

In-country testing based on two HIV rapid tests correctly identified the HIV infection status for 99.5% of study participants; most participants with discordant HIV rapid tests were not infected. HIV prevalence varied considerably across the study sites (range: 0.6% to 24.4%).

Trial Registration

ClinicalTrials.gov registry number NCT00203749.