HIV Surveillance in a Large, Community-Based Study: Results from the Pilot Study of Project Accept (HIV Prevention Trials Network 043)
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
BMC Infectious Diseases 2011, 11:251 doi:10.1186/1471-2334-11-251Published: 24 September 2011
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.
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.
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%).
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%).
ClinicalTrials.gov registry number NCT00203749.