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

Neuman, Melissa, Indravudh, Pitchaya, Chilongosi, Richard, d’Elbée, Marc, Desmond, Nicola ORCID: https://orcid.org/0000-0002-2874-8569, Fielding, Katherine, Hensen, Bernadette, Johnson, Cheryl, Mkandawire, Phillip, Mwinga, Alwyn, Nalubamba, Mutinta, Ncube, Gertrude, Nyirenda, Lot, Nyrienda, Rose, Kampe, Eveline Otte im, Taegtmeyer, Miriam ORCID: https://orcid.org/0000-0002-5377-2536, Terris-Prestholt, Fern, Weiss, Helen A., Hatzold, Karin, Ayles, Helen and Corbett, Elizabeth L. (2018) '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'. BMC Public Health, Vol 18, e1234.

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Abstract

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 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 period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care.

Discussion
The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa.
Trial registration
Clinicaltrials.gov, Malawi: NCT02718274, 18 March 2016; Zambia: NCT02793804, 3 June 2016. Protocol date: 21 February 2018.

Item Type:	Article
Subjects:	W General Medicine. Health Professions > Health Services. Patients and Patient Advocacy > W 85 Patients. Attitude and compliance W General Medicine. Health Professions > Health Services. Patients and Patient Advocacy > W 84 Health services. Delivery of health care WA Public Health > WA 30 Socioeconomic factors in public health (General) WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503.1 Diagnosis WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503.4 Epidemiology
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department Clinical Sciences & International Health > International Public Health Department
Digital Object Identifer (DOI):	https://doi.org/10.1186/s12889-018-6120-3
Depositing User:	Rachel Dominguez
Date Deposited:	22 Nov 2018 16:46
Last Modified:	17 Oct 2019 10:52
URI:	https://archive.lstmed.ac.uk/id/eprint/9660

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