RESULTS
deaths, death, letterMale HIV status
MISCARRIAGE
Between 14 November 2018, and 19 March 2020, we screened 806 and enrolled 500 PWLHIV; reasons for ineligibility are shown in Figure CONSORT diagram for Obumu Study.Baseline characteristics of pregnant women living with HIV.Male partner's HIV status is reported among women who reported knowing if her partner had ever tested for HIV.The median age of men was 31 years (IQR 27–36), 52% were ≥5 years older than their female partner and the median duration of partnership was 38.0 months (IQR 21.0–73.0) (Table Women's self‐reported delivery of HIVST or invitation letterMale HIV status at enrolmentAmong men enrolled in Obumu StudyTime to male partner enrolment from randomization of female partner.Demographic and baseline characteristics of male partners who tested and enrolled, overall and by randomization arm of female partnerOf the 51 newly identified male partners living with HIV, 86.9% and 92.3% of men in the intervention and SOC arms started ART before or during the study. Among 185 male partners without HIV, 58.6% and 66.1%, respectively, of male partners of women randomized to the intervention and SOC arms started PrEP. There was no difference in male partner ART/PrEP initiation by randomization arm: 32.2% (105/326) and 34.0% (53/156), respectively (HR 0.96; 95% CI: 0.69–1.33) (Figure Proportion of men who initiated ARV or PrEP by study arm.At baseline, 159 women (31.8%) reported HIV status disclosure to their partner—34.8% and 26.8% of women in the HIVST and SOC arms, respectively (Table Woman's disclosure of HIV status to her male partner
VS at 12 months post‐partum was not associated with HIV status disclosure at baseline (adjusted relative risk [aRR] 1.00; 95% CI: 0.80–1.26), baseline VS (aRR 1.17; 95% CI: 0.93–1.47) or male partner initiation of ART or PrEP (aRR 1.06; 95% CI: 0.84–1.34). We examined interactions between the woman's VL at baseline and male partner's initiation of PrEP/ART on maternal VS at 12 months post‐partum and found no effect modification (Of 472 women with pregnancy outcomes recorded, 434 (91.9%) gave birth to a live infant, 14 (3.0%) to a stillborn, 15 (3.2%) had a neonatal death and 9 (1.9%) had a miscarriage. Two infants (0.4%) were diagnosed with HIV at the 6‐month post‐partum visit (HIV incidence 1.46%; 95% CI: 0.18%–5.28% per year). For one infant, maternal VL was 887,000 copies/ml at this visit. For the other infant, maternal VL was 1040 and <50 copies/ml at the enrolment and 6‐month post‐partum visits, respectively. Most infants (425; 90.0%) were HIV negative, and 26 infants (5.5%) were not tested due to 15 neonatal deaths, 4 stillborn births and 7 live‐born infants lost to follow‐up.Six women (1.2%) reported social harms, five in the HIVST arm and one in the SOC arm. Three cases were resolved after counselling and three resulted in partnership dissolution (Table 