HIV Self-testing Africa (STAR) Malawi: General Population - A Cluster Randomized Trial of Providing HIV and Self-testing Kits Through Community-based Distribution Agents

The aim of this project is to investigate the incremental costs and health benefits of adding HIVST to the remit of existing cadres of community volunteers in the general population in Malawi.

Specific objectives are to:

1. Validate the use of the OraQuick HIVST product in rural settings, establish preferences and social harms reporting systems, and conduct baseline surveys.
2. Carry out a pragmatic cluster-randomised trial with ART clinics and their catchment populations, including CBDAs, as the unit of randomisation.
3. Evaluate the impact of adding HIVST into the remit of VMMC mobilisers on demand for VMMC
4. Establish the expected costs and benefits of introducing HIVST to Malawi through economic and mathematical modelling.
5. Conduct interviews with policy-makers to prepare for national scale-up of HIVST and support the market introduction of quality-assured HIVST products.

CRCT METHODOLOGY/STUDY DESIGN

First stage randomization: HIVST v. SOC. The main study will be a cluster-randomised trial in up to 5 high HIV prevalence districts (provisionally Blantyre, Machinga, Mwanza, Neno and Thyolo) that already have community-based reproductive health services provided by PSI under funding provided by the German Technical Cooperation Agency (GTZ). This programme supports volunteers to socially-market reproductive and child health products in villages, with products stored and managed by collaborating primary care clinics. The unit of randomisation is the Primary Care + ART Clinic and surrounding catchment area villages to clinic. CBDAs in the HIVST Arm villages will be trained to provide HIVST services as well as reproductive health services. CBDAs in the SOC Arm villages will remain with reproductive health services only. Two separate units of evaluation will be pre-defined before randomisation: one or two evaluation villages that will have baseline-final household surveys, and a wider catchment area including all villages with CBDA activities.