HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: An adaptive multi-arm, multi-stage cluster randomised trial

Abstract

BackgroundConventional HIV testing services have been less comprehensive in reaching men than in reaching women globally, but HIV self-testing (HIVST) appears to be an acceptable alternative. Measurement of linkage to post-test services following HIVST remains the biggest challenge, yet is the biggest driver of cost-effectiveness. We investigated the impact of HIVST alone or with additional interventions on the uptake of testing and linkage to care or prevention among male partners of antenatal care clinic attendees in a novel adaptive trial.Methods and findingsAn adaptive multi-arm, 2-stage cluster randomised trial was conducted between 8 August 2016 and 30 June 2017, with antenatal care clinic (ANC) days (i.e., clusters of women attending on a single day) as the unit of randomisation. Recruitment was from Ndirande, Bangwe, and Zingwangwa primary health clinics in urban Blantyre, Malawi. Women attending an ANC for the first time for their current pregnancy (regardless of trimester), 18 years and older, with a primary male partner not known to be on ART were enrolled in the trial after giving consent. Randomisation was to either the standard of care (SOC; with a clinic invitation letter to the male partner) or 1 of 5 intervention arms: the first arm provided women with 2 HIVST kits for their partners; the second and third arms provided 2 HIVST kits along with a conditional fixed financial incentive of $3 or $10; the fourth arm provided 2 HIVST kits and a 10% chance of receiving $30 in a lottery; and the fifth arm provided 2 HIVST kits and a phone call reminder for the women’s partners. The primary outcome was the proportion of male partners who were reported to have tested for HIV and linked into care or prevention within 28 days, with referral for antiretroviral therapy (ART) or circumcision accordingly. Women were interviewed at 28 days about partner testing and adverse events. Cluster-level summaries compared each intervention versus SOC using eligible women as the denominator (intention-to-treat). Risk ratios were adjusted for male partner testing history and recruitment clinic. A total of 2,349/3,137 (74.9%) women participated (71 ANC days), with a mean age of 24.8 years (SD: 5.4). The majority (2,201/2,233; 98.6%) of women were married, 254/2,107 (12.3%) were unable to read and write, and 1,505/2,247 (67.0%) were not employed. The mean age for male partners was 29.6 years (SD: 7.5), only 88/2,200 (4.0%) were unemployed, and 966/2,210 (43.7%) had never tested for HIV before. Women in the SOC arm reported that 17.4% (71/408) of their partners tested for HIV, whereas a much higher proportion of partners were reported to have tested for HIV in all intervention arms (87.0%–95.4%, p < 0.001 in all 5 intervention arms). As compared with those who tested in the SOC arm (geometric mean 13.0%), higher proportions of partners met the primary endpoint in the HIVST + $3 (geometric mean 40.9%, adjusted risk ratio [aRR] 3.01 [95% CI 1.63–5.57], p < 0.001), HIVST + $10 (51.7%, aRR 3.72 [95% CI 1.85–7.48], p < 0.001), and ph...

HIV self‐testing: breaking the barriers to uptake of testing among men and adolescents in sub‐Saharan Africa, experiences from STAR demonstration projects in Malawi, Zambia and Zimbabwe

“…CBD models varied substantially country‐by‐country , with the Zimbabwe model being based on delivery from mobile teams that supported training and brief (three to four weeks) but intensive HIVST distribution by temporarily employed distributors. CBDs in Malawi and Zambia were employed for 12 months to provide services less intensively.…”

“…Consistent with previous reports , all distribution models had high male participation in each country. Strategies that provide men with greater coverage of HIV testing and care are urgently needed both to address the disproportionately high testing gap and mortality from HIV in men, and also to reduce risk of onward transmission of HIV .…”

“…Introducing the option of HIVST greatly increased the numbers of clients who could be served each day at rural and urban outreach services and consequently increased the number of positive cases identified per counsellor and per site at any given time . A further low‐cost facility‐based model (“secondary distribution”), where HIVST kits can be delivered to partners by antenatal clinic attendees and newly diagnosed PLHIV is being scaled‐up under STAR in Malawi and Zimbabwe and is discussed further in the accompanying manuscript relating to social harms in this issue .…”

“…HIV positive index clients diagnosed at the HTS site were offered self‐test kits for secondary distribution to all their sexual partners for the purposes of index‐testing . Clients taking kits for secondary distribution were talked through the process of supporting their partner to use and interpret the kit correctly, how to access follow‐on HIV services, and the need to maintain voluntariness .…”

Exploring social harms during distribution of HIV self‐testing kits using mixed‐methods approaches in Malawi

“…HIV self‐testing (HIVST) can increase HIV testing coverage and frequency . Several studies in Malawi have shown HIVST to be highly acceptable and able to reach first‐time testers, young people (aged 16 to 25), men and couples and partners , with acceptable linkage into facility‐based services when combined with facilitated linkage strategies . As with any form of HIV testing, however, potential social harms (SHs) must be anticipated and mitigated .…”