Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial

By Kathryn Dovel, Frackson Shaba, O Agatha Offorjebe, Kelvin Balakasi, Mike Nyirenda, Khumbo Phiri, Sundeep K Gupta, Vincent Wong, Chi-Hong Tseng,  Brooke Nichols  Refiloe Cele  Eric Lungu, Tobias Masina, Thomas J Coates, Risa M Hoffman  |  | 

HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi.
Methods: In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.

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