Addition of HIV self-test kits to partner notification services to increase HIV testing of male partners of pregnant women in Zambia: two parallel randomised trials

• Published in: The Lancet global health 2021-12, Vol.9 (12), p.e1719-e1729
• Main Authors: Mutale, Wilbroad, Freeborn, Kellie, Graybill, Lauren A, Lusaka, Mildred M, Mollan, Katie R, Mweemba, Oliver, Kasaro, Margaret, Lungu, Rose, Kumwenda, Andrew, Saidi, Friday, Powers, Kimberly A, Maman, Suzanne, Rosenberg, Nora E, Chi, Benjamin H
• Format: Article
• Language: English
• Subjects: Adult; Contact Tracing - methods; Disease Transmission, Infectious - prevention & control; Female; HIV Infections - diagnosis; HIV Infections - prevention & control; HIV Testing - methods; Humans; Male; Patient Acceptance of Health Care - psychology; Pregnancy; Prenatal Care - methods; Self-Testing; Sexual Partners - psychology; Young Adult; Zambia
• ISSN: 2214-109X; 2214-109X
• DOI: 10.1016/S2214-109X(21)00393-4

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. 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. 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 tri