ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial.

BACKGROUND: Use of medical devices represents a unique opportunity to facilitate scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The ShangRing, a circumcision device prequalified by WHO, is approved for use in adults and adolescents and requires topical anaesthesia only. We aimed to investigate the safety and efficacy of the ShangRing versus the Mogen clamp for EIMC in infants across eastern sub-Saharan Africa. METHODS: In this multicentre, non-inferiority, open-label, randomised controlled trial, we enrolled healthy male infants (aged <60 days), with a gestational age of at least 37 weeks and a birthweight of at least 2·5 kg, from 11 community and referral centres in Kenya, Tanzania, and Uganda. Infants were randomly assigned (1:1) by a computer-generated text message service to undergo EIMC by either the ShangRing or the Mogen clamp. The primary endpoint was safety, defined as the number and severity of adverse events (AEs), analysed in the intention-to-treat population (all infants who underwent an EIMC procedure) with a non-inferiority margin of 2% for the difference in moderate and severe AEs. This trial is registered with Clinical. TRIALS: gov, NCT03338699, and is complete. FINDINGS: Between Sept 17, 2018, and Dec 20, 2019, a total of 1420 infants were assessed for eligibility, of whom 1378 (97·0%) were enrolled. 689 (50·0%) infants were randomly assigned to undergo EIMC by ShangRing and 689 (50·0%) by Mogen clamp. 43 (6·2%) adverse events were observed in the ShangRing group and 61 (8·9%) in the Mogen clamp group (p=0·078). The most common treatment-related AE was intraoperative pain (Neonatal Infant Pain Scale score ≥5), with 19 (2·8%) events in the ShangRing and 23 (3·3%) in the Mogel clamp group. Rates of moderate and severe AEs were similar between both groups (29 [4·2%] in the ShangRing group vs 30 [4·4%] in the Mogen clamp group; difference -0·1%; one-sided 95% CI upper limit of 1·7%; p=0·89). No treatment-related deaths were reported. INTERPRETATION: Use of the ShangRing device for EIMC showed safety, achieved high caregiver satisfaction, and did not differ from the Mogen clamp in other key measures. The ShangRing could be used by health systems and international organisations to further scale up EIMC across sub-Saharan Africa. FUNDING: Bill & Melinda Gates Foundation.

Why do pregnant women in Iringa region in Tanzania start antenatal care late? A qualitative analysis.

BACKGROUND: When started early in pregnancy and continued up till childbirth, antenatal care (ANC) can be effective in reducing adverse pregnancy outcomes. While the proportion of women who attend ANC at least once in low income countries is high, most pregnant women attend their first ANC late. In Tanzania, while over 51% of pregnant women complete ≥4 visits, only 24% start within the first trimester. This study aimed to understand the factors that lead to delay in seeking ANC services among pregnant women in Tanzania. METHODS: This qualitative descriptive case study was conducted in two rural districts in Iringa Region in Tanzania. A total of 40 focus group discussions (FGDs) were conducted involving both male and female participants in 20 villages. In addition, 36 semi-structured interviews were carried out with health care workers, members of health facility committees and community health workers. Initial findings were further validated during 10 stakeholders' meetings held at ward level in which 450 people participated. Data were analysed using thematic approach. RESULTS: Key individual and social factors for late ANC attendance included lack of knowledge of the importance of early visiting ANC, previous birth with good outcome, traditional gender roles, fear of shame and stigma, and cultural beliefs about pregnancy. Main factors which inhibit early ANC attendance in Kilolo and Mufindi districts include spouse accompany policy, rude language of health personnel and shortage of health care providers. CONCLUSIONS: Traditional gender roles and cultural beliefs about pregnancy as well as health system factors continue to influence the timing of ANC attendance. Improving early ANC attendance, therefore, requires integrated interventions that address both community and health systems barriers. Health education on the timing and importance of early antenatal care should also be strengthened in the communities. Additionally, while spouse accompany policy is important, the implementation of this policy should not infringe women's rights to access ANC services.

How Can Childbirth Care for the Rural Poor Be Improved? A Contribution from Spatial Modelling in Rural Tanzania.

INTRODUCTION: Maternal and perinatal mortality remain a challenge in resource-limited countries, particularly among the rural poor. To save lives at birth health facility delivery is recommended. However, increasing coverage of institutional deliveries may not translate into mortality reduction if shortage of qualified staff and lack of enabling working conditions affect quality of services. In Tanzania childbirth care is available in all facilities; yet maternal and newborn mortality are high. The study aimed to assess in a high facility density rural context whether a health system organization with fewer delivery sites is feasible in terms of population access. METHODS: Data on health facilities' location, staffing and delivery caseload were examined in Ludewa and Iringa Districts, Southern Tanzania. Geospatial raster and network analysis were performed to estimate access to obstetric services in walking time. The present geographical accessibility was compared to a theoretical scenario with a 40% reduction of delivery sites. RESULTS: About half of first-line health facilities had insufficient staff to offer full-time obstetric services (45.7% in Iringa and 78.8% in Ludewa District). Yearly delivery caseload at first-line health facilities was low, with less than 100 deliveries in 48/70 and 43/52 facilities in Iringa and Ludewa District respectively. Wide geographical overlaps of facility catchment areas were observed. In Iringa 54% of the population was within 1-hour walking distance from the nearest facility and 87.8% within 2 hours, in Ludewa, the percentages were 39.9% and 82.3%. With a 40% reduction of delivery sites, approximately 80% of population will still be within 2 hours' walking time. CONCLUSIONS: Our findings from spatial modelling in a high facility density context indicate that reducing delivery sites by 40% will decrease population access within 2 hours by 7%. Focused efforts on fewer delivery sites might assist strengthening delivery services in resource-limited settings.