%0 Journal Article %T Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study %A Augustine T. Choko  %A Peter MacPherson  %A Emily L. Webb  %A Barbara A. Willey  %A Helena Feasy  %A Rodrick Sambakunsi  %A Aaron Mdolo  %A Simon D. Makombe  %A Nicola Desmond  %A Richard Hayes %J PLOS Medicine %D 2015 %I Public Library of Science (PLoS) %R 10.1371/journal.pmed.1001873 %X Background Home-based HIV testing and counselling (HTC) achieves high uptake, but is difficult and expensive to implement and sustain. We investigated a novel alternative based on HIV self-testing (HIVST). The aim was to evaluate the uptake of testing, accuracy, linkage into care, and health outcomes when highly convenient and flexible but supported access to HIVST kits was provided to a well-defined and closely monitored population. Methods and Findings Following enumeration of 14 neighbourhoods in urban Blantyre, Malawi, trained resident volunteer-counsellors offered oral HIVST kits (OraQuick ADVANCE Rapid HIV-1/2 Antibody Test) to adult (≡16 y old) residents (n = 16,660) and reported community events, with all deaths investigated by verbal autopsy. Written and demonstrated instructions, pre- and post-test counselling, and facilitated HIV care assessment were provided, with a request to return kits and a self-completed questionnaire. Accuracy, residency, and a study-imposed requirement to limit HIVST to one test per year were monitored by home visits in a systematic quality assurance (QA) sample. Overall, 14,004 (crude uptake 83.8%, revised to 76.5% to account for population turnover) residents self-tested during months 1每12, with adolescents (16每19 y) most likely to test. 10,614/14,004 (75.8%) participants shared results with volunteer-counsellors. Of 1,257 (11.8%) HIV-positive participants, 26.0% were already on antiretroviral therapy, and 524 (linkage 56.3%) newly accessed care with a median CD4 count of 250 cells/米l (interquartile range 159每426). HIVST uptake in months 13每24 was more rapid (70.9% uptake by 6 mo), with fewer (7.3%, 95% CI 6.8%每7.8%) positive participants. Being ※forced to test§, usually by a main partner, was reported by 2.9% (95% CI 2.6%每3.2%) of 10,017 questionnaire respondents in months 1每12, but satisfaction with HIVST (94.4%) remained high. No HIVST-related partner violence or suicides were reported. HIVST and repeat HTC results agreed in 1,639/1,649 systematically selected (1 in 20) QA participants (99.4%), giving a sensitivity of 93.6% (95% CI 88.2%每97.0%) and a specificity of 99.9% (95% CI 99.6%每100%). Key limitations included use of aggregate data to report uptake of HIVST and being unable to adjust for population turnover. Conclusions Community-based HIVST achieved high coverage in two successive years and was safe, accurate, and acceptable. Proactive HIVST strategies, supported and monitored by communities, could substantially complement existing approaches to providing early HIV diagnosis and periodic repeat testing to %U http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001873