Abstract
BackgroundDespite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women.MethodsA phase II, adaptive, multi-arm, multi-stage cluster randomised trial, randomising antenatal clinic (ANC) days to six different trial arms. Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care (SOC) arm (invitation letter to the male partner offering HIV testing) or one of five intervention arms offering oral HIV self-test kits. Three of the five intervention arms will additionally offer the male partner a financial incentive (fixed or lottery amount) conditional on linkage after self-testing with one arm testing phone call reminders.Assuming that 25% of male partners link to care or prevention in the SOC arm, six clinic days, with a harmonic mean of 21 eligible participants, per arm will provide 80% power to detect a 0.15 absolute difference in the primary outcome. Cluster proportions will be analysed by a cluster summaries approach with adjustment for clustering and multiplicity.DiscussionThis trial applies adaptive methods which are novel and efficient designs. The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future. Although small, this trial will potentially present good evidence on the type of effective interventions for improving linkage into ART or prevention. The trial results will also have important policy implications on how to implement HIVST targeting male partners of pregnant women who are accessing ANC for the first time while paying particular attention to safety concerns. Contamination may occur if women in the intervention arms share their self-test kits with women in the SOC arm.Trial registrationISRCTN, ID: 18421340. Registered on 31 March 2016.
Highlights
Despite large-scale efforts to diagnose people living with Human immunodeficiency virus (HIV), 54% remain undiagnosed in subSaharan Africa
The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future
Women and their male partners will be excluded if they received couple or partner HIV testing in the current pregnancy; if either are aged below 18 years of age; if the male partner is reported to be HIV positive by the pregnant woman; if already recruited in this trial; and if not urban Blantyre resident
Summary
Design This is a phase II, adaptive, MAMS CRT using ANC day as the unit of randomisation. As a phase II trial the study is intended to investigate efficacy relating to uptake of testing and subsequent HIV services by the male partner, safety outcomes, and to provide an estimate of acceptability to the pregnant woman. All women attending for antenatal care for the first time at these PHCs and their male partners will be eligible for participation (see Additional file 1). Women and their male partners will be excluded if they received couple or partner HIV testing in the current pregnancy; if either are aged below 18 years of age; if the male partner is reported to be HIV positive by the pregnant woman; if already recruited in this trial; and if not urban Blantyre resident. In the final intervention arm, male partners will receive a phone call, through a number given to the study team by the
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