DISCUSSION
HIV disease, HIV and two‐thirds, Zambian HIV serodifferent couples, fast‐track HIV, viremia, HIV status disclosure
SECONDARY, HIV DISEASE, VIREMIA
In this RCT of secondary distribution of HIVST to male partners by PLWHIV in Uganda, which was compared to SOC invitation letters for fast‐track HIV testing at the study clinic, almost half (47%) of male partners were tested for HIV and two‐thirds of male partners started PrEP if HIV negative or ART if HIV positive. We observed no difference in partner HIV clinic testing rates by the proportion of male partners who initiated PrEP/ART, or in maternal VS at 12 months post‐partum. Two infants acquired HIV from mothers with detectable viremia. Encouragingly, the intervention was associated with very few social harms.This study is unique in the focus on PWLHIV and linkage through partner testing to ART/PrEP. Prior studies of HIVST secondary distribution were conducted primarily among women without HIV who do not face potential social harms from disclosure and consequently have fewer barriers to approaching male partners. In addition, most prior studies relied on self‐report of HIVST distribution and partner testing, whereas our primary outcome was based on clinic‐based HIV testing, allowing ART/PrEP counselling and linkage‐to‐care. Almost half of the male partners tested for HIV; testing prevalence among men in Eastern Africa ranges from 9% in Madagascar to 81% in Rwanda [Antenatal clinics are key settings for reaching male partners and providing interventions that decrease HIV transmission risk. In East and Southern Africa, HIV testing and treatment gaps are larger among men than women for whom opt‐out HIV testing is part of routine clinical care [Our finding that 88% of male partners with HIV started ART nearly aligns with the UNAIDS target of 95% of men with HIV initiating ART by 2025. Reaching men with HTS and linking them to care is essential to meeting global HIV goals as men are more likely than women to be diagnosed with advanced HIV disease [More than half of the men in this study tested HIV negative and were thus in serodifferent partnerships with PWLHIV. Approximately 60% of HIV‐negative men started PrEP. Men partnered with virally suppressed women received counselling about undetectable = untransmittable (U = U) and could opt out of taking PrEP if monogamous. Both men who seroconverted had female partners with suppressed VL suggesting HIV acquisition outside the study partnership. Men may acquire HIV from other partners during pregnancy/post‐partum. Genital inflammation/ulceration (adjusted hazard ratio [aHR] = 8.52), reporting ≥1 outside sexual partner (aHR = 3.86) and alcohol consumption (aHR = 3.84) significantly increased HIV acquisition risk among Zambian HIV serodifferent couples [We found no association between female HIV status disclosure and VS. Studies of disclosure and VS in SSA PMTCT programmes have produced mixed results, with some studies showing benefit [PWLHIV reported concerns that providing either HIVST or an invitation letter could lead her partner to question her HIV status or result in loss of economic support, housing and social support if she disclosed. By study exit, the proportion of women who disclosed her status had almost doubled to 59%, which was similar by arm, and indicates the benefits of providing women with status disclosure support. Few social harms were reported by PWLHIV, perhaps because we screened out women with IPV history.The strengths of our trial include the randomized design, large sample size, high retention and objective ascertainment of male partner outcomes (HIVST distribution, confirmatory testing and ART/PrEP initiation). Our study has limitations. PWLHIV were excluded if they reported IPV in the prior year so these results may not be generalizable to PMTCT programmes which do not screen women for IPV. As the HIVST arm allowed men to test at home, the proportion who tested may be underestimated by the number who came to the clinic for confirmatory HIV testing and study enrolment. Phone outreach may have biased the outcome of male partner testing to the null by increasing testing in the SOC arm, given that typically clinics do not actively conduct outreach to partners of PWLHIV.