Abstract
INTRODUCTION: Reaching men aged 20-35 years, the group at greatest risk of HIV, with voluntary medical male circumcision (VMMC) remains a challenge. We assessed the impact of two VMMC demand creation approaches targeting this age group in a randomised controlled trial (RCT). METHODS: We conducted a 2×2 factorial RCT comparing arms with and without two interventions: (1) standard demand creation augmented by human-centred design (HCD)-informed approach; (2) standard demand creation plus offer of HIV self-testing (HIVST). Interpersonal communication (IPC) agents were the unit of randomisation. We observed implementation of demand creation over 6 months (1 May to 31 October 2018), with number of men circumcised assessed over 7 months. The primary outcome was the number of men circumcised per IPC agent using the as-treated population of actual number of months each IPC agent worked. We conducted a mixed-methods process evaluation within the RCT. RESULTS: We randomised 140 IPC agents, 35 in each arm. 132/140 (94.3%) attended study training and 105/132 (79.5%) reached at least one client during the trial period and were included in final analysis. There was no evidence that the HCD-informed intervention increased VMMC uptake versus no HCD-informed intervention (incident rate ratio (IRR) 0.87, 95% CI 0.38 to 2.02; p=0.75). Nor did offering men a HIVST kit at time of VMMC mobilisation (IRR 0.65, 95% CI 0.28 to 1.50; p=0.31). Among IPC agents that reported reaching at least one man with demand creation, both the HCD-informed intervention and HIVST were deemed useful. There were some challenges with trial implementation; <50% of IPC agents converted any men to VMMC, which undermined our ability to show an effect of demand creation and may reflect acceptability and feasibility of the interventions. CONCLUSION: This RCT did not show evidence of an effect of HCD-informed demand intervention or HIVST on VMMC uptake. Findings will inform future design and implementation of demand creation evaluations. TRIAL REGISTRATION NUMBER: PACTR201804003064160.