The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations

作者：Melissa Neuman, Pitchaya Indravudh, Richard Chilongosi, Marc d’Elbée, Nicola Desmond, Katherine Fielding, Bernadette Hensen, Cheryl Johnson, Phillip Mkandawire, Alwyn Mwinga, Mutinta Nalubamba, Gertrude Ncube, Lot Nyirenda, Rose Nyrienda, Eveline Otte im Kampe, Miriam Taegtmeyer, Fern Terris‐Prestholt, Helen A. Weiss, Karin Hatzold, Helen Ayles, Elizabeth L. Corbett · 发表于：BMC Public Health · 年份：2018 · DOI：10.1186/s12889-018-6120-3 · 被引用次数：40 · 研究领域：HIV/AIDS Research and Interventions、HIV Research and Treatment、HIV/AIDS drug development and treatment

BACKGROUND: Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. METHODS: Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention...