Background: HIV self-testing (HIVST) increases testing coverage in community settings in sub-Saharan Africa, but scalability is a challenge due to resource constraints. Outpatient departments provide an ideal space to integrate HIVST into low-resource health systems due to high client volume and long wait-times. We evaluated an HIVST intervention in outpatient waiting-spaces of hospitals and health centres in Malawi.
Methods: A cluster randomized trial was conducted at 15 health facilities in Central/Southern Malawi between September2017-January2018. Facilities were randomized 1:1:1:
(1) routine provider initiated testing and counseling (PITC);
(2) Optimized PITC (additional provider trainings and job-aids); and
(3) HIVST (including Oraquick HIV self-test® demonstration, distribution, and kit use in outpatient waiting-spaces, private spaces for interpretation, and optional post-test counseling).
The primary outcome was HIV-testing among outpatients. Exit surveys were conducted with a random sample of outpatients.
Results: 5,675 outpatients completed an exit survey. There were no differences by arm (Table). 52% of outpatients in the HIVST arm tested for HIV compared to 14% in Optimized PITC (AOR:6.6 p< 0.001) and 12% in PITC (AOR:7.6 p< 0.001). For HIVST, 60% of outpatients in need of testing (defined as tested> 12months ago and never tested HIV-positive) were tested compared to 18% in Optimized PITC and 16% in PITC. There was no significant difference in the proportion of clients tested who reported previously testing HIV-positive (≤ 1% for all arms). Positivity rates did not differ by arm, however, HIVST was associated with a higher absolute number of new positives identified compared to Optimized PITC (AOR:2.9, p=0.01) and PITC (AOR:4.1, p=0.002). Participants who were tested by HIVST were more likely to want to test again using the same method and more likely to recommend testing to others compared to those tested by Optimized PITC or PITC. No adverse events were reported in the HIVST arm.
Conclusions: Facility-based HIVST in outpatient waiting-spaces dramatically increased HIV testing and identification of HIV-infected persons among outpatients in Malawi, with minimal risk for loss of confidentiality or adverse events. Analyses for linkage to care are underway. Evaluations of routine program implementation are needed to determine best strategies to take facility-based HIVST to scale.

Table. Participant characteristics and outcomes across three arms of a HIVST study targeting outpatient clients (n=5,675)
[Table. Participant characteristics and outcomes across three arms of a HIVST study targeting outpatient clients (n=5,675)]