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

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 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 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.

Keywords: HIV/AIDS; Malawi; Self-testing; Zambia.

Conflict of interest statement

Ethics approval and consent to participate

All research participants will provide verbal or written consent for participation. In Malawi, participants will provide verbal consent to participate in the shortened household surveys. Written informed consent (for adults ages 18 years and older) or assent with parental consent (for adolescents ages 16–17 years) will be obtained from participants in the extended household survey. In Zambia, all survey participants will provide written consent and young adults (ages 16–17 years) will provide assent with parental consent. (Materials used for informed consent/assent are online at: http://hivstar.lshtm.ac.uk/protocols/).

Ethical permission for the STAR-Malawi trial was granted by the University of Malawi College of Medicine Research and Ethics Committee in February 2016 and by the London School of Hygiene and Tropical Medicine in April 2016. It is registered with clinicaltrials.gov (NCT02718274).

Ethical permission for the STAR-Zambia trial was granted by the University of Zambia Biomedical Research Ethics Committee in February 2016 and the Zambian Medical Regulatory Authority (ZAMRA) in July 2016. It was approved by the London School of Hygiene and Tropical Medicine in May 2016. It is registered with clinicaltrials.gov (NCT02793804).

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Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Flow chart, HIV STAR-Malawi

Fig. 2

Flow chart, HIV STAR-Zambia

Fig. 3

Diagram of Malawi clinic area