Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes.

OBJECTIVES: To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. METHODS: We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing. RESULTS: Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends. CONCLUSIONS: The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.

Is Male Involvement in ANC and PMTCT Associated with Increased Facility-Based Obstetric Delivery in Pregnant Women?

Ensuring that pregnant women are delivering in a health facility and are attended to by skilled birth attendants is critical to reducing maternal and infant morbidity and mortality. This study sought to determine the associations between male involvement in antenatal care (ANC) services and pregnant women delivering at health facilities and being attended to by skilled birth attendants as well as attending postnatal care. This was a retrospective cohort study using secondary analysis of program data. We reviewed health records of all pregnant women who attended antenatal services irrespective of HIV status between March and December 2012 in 10 health facilities in three provinces of Zambia. An extraction questionnaire was used to collect sociodemographic and clinical information from registers used in services for maternal neonatal child health as well as delivery. Using logistic regression, we calculated the odds ratios (OR) and 95% confidence intervals (CI) of the association between (1) male involvement and delivery at a health facility by a skilled birth attendant and (2) male involvement and women's attendance at postnatal services. We found that more women who had been accompanied by their male partner during ANC delivered at a health facility than those who had not been accompanied (88/220 = 40% vs. 543/1787 = 30.4%, respectively; OR 1.53, 95% CI: 1.15-2.04). Also, we noted that a greater proportion of the women who returned for postnatal visits had been accompanied by their partner at ANC visits, compared to those women who came to ANC without their partner (106/220 = 48.2% vs. 661/1787 = 37.0%, respectively; OR 1.58, 95% CI: 1.20-2.10). Male involvement seems to be a key factor in women's health-seeking behaviours and could have a positive impact on maternal and infant morbidity and mortality.