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Summary Background Testing men for HIV during their partner’s pregnancy can guide couples-based HIV prevention and treatment, but testing rates remain low. We investigated a combination approach, using evidence-based strategies, to increase HIV testing in male partners of HIV-positive and HIV-negative pregnant women. Methods We did two parallel, unmasked randomised trials, enrolling pregnant women who had an HIV-positive test result documented in their antenatal record (trial 1) and women who had an HIV-negative test result documented in their antenatal record (trial 2) from an antenatal setting in Lusaka, Zambia. Women in both trials were randomly assigned (1:1) to the intervention or control groups using permuted block randomisation. The control groups received partner notification services only, including an adapted version for women who were HIV-negative; the intervention groups additionally received targeted education on the use of oral HIV self-test kits for their partners, along with up to five oral HIV self-test kits. At the 30 day follow-up we collected information from pregnant women about their primary male partner’s HIV testing in the previous 30 days at health-care facilities, at home, or at any other facility. Our primary outcome was reported male partner testing at a health facility within 30 days following randomisation using a complete-case approach. Women also reported male partner HIV testing of any kind (including self-testing at home) that occurred within 30 days. Randomisation groups were compared via probability difference with a corresponding Wald-based 95% CI. The trial is registered at ClinicalTrials.gov ( NCT04124536 ) and all enrolment and follow-up has been completed. Findings From Oct 28, 2019, to May 26, 2020, 116 women who were HIV-positive (trial 1) and 210 women who were HIV-negative (trial 2) were enrolled and randomly assigned to study groups. Retention at 30 days was 100 (86%) in trial 1 and 200 (95%) in trial 2. Women in the intervention group were less likely to report facility-based male partner HIV testing in trial 1 (3 [6%] of 47 vs 15 [28%] of 53, estimated probability difference −21·9% [95% CI −35·9 to −7·9%]) and trial 2 (3 [3%] of 102 vs 33 [34%] of 98, estimated probability difference −30·7% [95% CI −40·6 to −20·8]). However, reported male partner HIV testing of any kind was higher in the intervention group than in the control group in trial 1 (36 [77%] of 47 vs 19 [36%] of 53, estimated probability difference 40·7% [95% CI 23·0 to 58·4%]) and trial 2 (80 [78%] of 102 vs 54 [55%] of 98, estimated probability difference 23·3% [95% CI 10·7 to 36·0%]) due to increased use of HIV self-testing. Overall, 14 male partners tested HIV-positive. Across the two trials, three cases of intimate partner violence were reported (two in t...

Background Point-of-care (POC) early infant diagnosis (EID) provides same-day results and the potential for immediate initiation of antiretroviral therapy (ART). Methods We conducted a pragmatic trial at six public clinics in Zambia. HIV-exposed infants were individually randomized to either: (a) POC EID – on-site testing with the Alere q HIV-1/2 Detect or (b) enhanced standard of care (SOC) EID – off-site testing at a public laboratory. HIV-infected infants were referred for ART and followed for 12 months. Our primary outcome was defined as alive, in care, and virally suppressed at 12 months. Results Between March 2016 and November 2018, we randomized 4,000 HIV-exposed infants to POC (n=1,989) or SOC (n=2,011). All but two infants in the POC group received same-day results, while the median time to result in the SOC group was 27 (IQR: 22-30) days. Eighty-one (2%, 95% CI: 1.6–2.5%) infants were diagnosed with HIV. Although ART initiation was high, there were 15 (19%) deaths, 15 (19%) follow-up losses, and 31 (38%) virologic failures. By 12 months, only 20 of 81 (25%, 95% CI: 15–34%) HIV-infected infants were alive, in care, and virally suppressed: 13 (30%, 95% CI: 16–43%) infants in the POC group vs. 7 (19%, 95% CI: 6–32%) in the SOC group (RR: 1.56, 95% CI: 0.7–3.50). Conclusions POC EID eliminated diagnostic delays and accelerated ART initiation but did not translate into definitive improvement in 12-month outcomes. In settings where centralized EID is well functioning, POC EID is unlikely to improve pediatric HIV outcomes.

Background Mothers living with human immunodeficiency virus (HIV) should be guided to practise safe childbirth, provide appropriate infant feeding, return infants for repeat HIV testing and administer for the required period, protective antiretroviral (ARV) medication (post-exposure prophylaxis [PEP]) to their infants. Although several studies have explored challenges related to the prevention of mother-to-child transmission (PMTCT), no studies were found that focused specifically on the mother and PEP. Objectives To explore and understand the challenges experienced by mothers in Lusaka, Zambia, whilst providing their children with PEP. Methods This study utilised a qualitative methodology and a descriptive design. Fifteen semi-structured individual interviews were conducted with mothers who gave PEP to their infants. Study evaluation made use of Creswell’s six steps of data analysis. Results Women experienced numerous challenges. Challenges of an individual and social nature included ‘negative’ emotions, misconceptions and a lack of understanding of PEP. Post-exposure prophylaxis was sometimes burdensome and partner involvement often limited. Cultural, religious practices and stigma deterred some women from continuing PEP. Healthcare challenges included time-consuming appointments and protracted waiting periods. Clinic organisation was often inefficient and complicated by stock-outs of essential medication such as nevirapine. Healthcare workers were at times stigmatising towards mothers living with HIV and their infants. The counselling support provided by the healthcare workers was felt to be inadequate in the face of the burden of PEP. Conclusion Post-exposure prophylaxis as part of the PMTCT programme is key to eliminating mother-to-child transmission of HIV. Postnatal support for women administering PEP to their children can be enhanced through counselling that is person- and family-centred is culturally sensitive and offers differentiated services that include PEP, integrated mother-and-child healthcare and access to support groups.

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