Introducing a sector-wide pooled fund in a fragile context: mixed-methods evaluation of the health transition fund in Zimbabwe.

IntroductionAid effectiveness and improving its impact is a central policy matter for donors and international organisations. Pooled funding is a mechanism, whereby donors provide financial contributions towards a common set of broad objectives by channelling finance through one instrument. The results of pooled funds as an aid mechanism are mixed, and there is limited data on both methodology for, and results of, assessment of effectiveness of pooled funding.MethodsThis study adapted a conceptual framework incorporating the Paris Principles of Aid Effectiveness and qualitative methods to assess the performance of the Health Transition Fund (HTF) Zimbabwe. 30 key informant interviews, and 20 focus group discussions were conducted with informants drawn from village to national level. Descriptive secondary data analysis of Demographic Health Surveys, Health Management Information Systems (HMIS) and policy reports complemented the study.ResultsThe HTF combined the most optimal option to channel external aid to the health sector in Zimbabwe during a period of socioeconomic and political crisis. It produced results quickly and at scale and enhanced coordination and ownership at the national and subnational level. Flexibility in using the funds was a strong feature of the HTF. However, the initiative compromised on the investment in local capacity and systems, since the primary focus was on restoring essential services within a nearly collapsed healthcare system, rather than building long-term capacity. Significant changes in maternal and newborn health outcomes were observed during the HTF implementation in Zimbabwe.ConclusionA framework which can be used to assess pooled funds was adapted and applied. Future assessments could use this or another framework to provide new evidence regarding effectiveness of pool donor funds although the frameworks should be properly tested and adapted in different contexts

Implementation and Operational Research: A Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp for Early Infant Male Circumcision in Zimbabwe.

BACKGROUND: Early infant male circumcision (EIMC) is a potential key HIV prevention intervention, providing it can be safely and efficiently implemented in sub-Saharan Africa. Here, we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. METHODS: Between January and June 2013, eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 allocation ratio. Participants were followed for 14 days post-EIMC. Primary outcomes for the trial were EIMC safety and acceptability. RESULTS: One hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum (n = 100 AccuCirc; n = 50 Mogen clamp). Twenty-six infants (17%) were born to HIV-infected mothers. We observed 2 moderate adverse events (AEs) [2%, 95% confidence interval (CI): 0.2 to 7.0] in the AccuCirc arm and none (95% CI: 0.0 to 7.1) in the Mogen clamp arm. The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7). As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp. Nearly all mothers (99.5%) reported great satisfaction with the outcome. All mothers, regardless of arm said they would recommend EIMC to other parents, and would circumcise their next son. CONCLUSIONS: This first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents. There was no difference in the rate of AEs by device

Safety, Acceptability, and Feasibility of Early Infant Male Circumcision Conducted by Nurse-Midwives Using the AccuCirc Device: Results of a Field Study in Zimbabwe.

BACKGROUND: For prevention of HIV, early infant male circumcision (EIMC) needs to be scaled up in countries with high HIV prevalence. Routine EIMC will maintain the HIV prevention gains anticipated from current adult male circumcision initiatives. We present here the results of a field study of EIMC conducted in Zimbabwe. METHODS: The study was observational and based on the World Health Organization (WHO) framework for clinical evaluation of male circumcision devices. We recruited parents of newborn male infants between August 2013 and July 2014 from 2 clinics. Nurse-midwives used the AccuCirc device to circumcise eligible infants. We followed participants for 14 days after EIMC. Outcome measures were EIMC safety, acceptability, and feasibility. RESULTS: We enrolled 500 male infants in the field study (uptake 11%). The infants were circumcised between 6 and 60 days postpartum. The procedure took a median of 17 minutes (interquartile range of 5 to 18 minutes). Mothers' knowledge of male circumcision was extensive. Of the 498 mothers who completed the study questionnaire, 91% knew that male circumcision decreases the risk of HIV acquisition, and 83% correctly stated that this prevention is partial. Asked about their community's perception of EIMC, 40% felt that EIMC will likely be viewed positively in their community; 13% said negatively; and 47% said the perception could be both ways. We observed 7 moderate or severe adverse events (1.4%; 95% confidence interval, 0.4% to 2.4%). All resolved without lasting effects. Nearly all mothers (99%) reported great satisfaction with the outcome, would recommend EIMC to other parents, and would circumcise their next sons. CONCLUSION: This first field study in sub-Saharan Africa of the AccuCirc device for EIMC demonstrated that EIMC conducted by nurse-midwives with this device is safe, feasible, and acceptable to parents

Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial.

BACKGROUND: Child stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe. METHODS: We did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940. FINDINGS: Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08-0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28-2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported. INTERPRETATION: Household-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone. FUNDING: Bill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health.The SHINE trial is funded by the Bill & Melinda Gates Foundation (OPP1021542 and OPP113707); UK Department for International Development; Wellcome Trust, UK (093768/Z/10/Z, 108065/Z/15/Z and 203905/Z/16/Z); Swiss Agency for Development and Cooperation; US National Institutes of Health (2R01HD060338-06); and UNICEF (PCA-2017-0002)

Description of visits for participants in both surgical and PrePex device arms.

<p>Description of visits for participants in both surgical and PrePex device arms.</p

Summary of VAS^a pain level at various points in time.

<p>Number and percentages of participants experiencing a given pain level (0, 2, 4, 6, 8).</p

Total procedure time (in minutes) for participants in surgical and PrePex device arms.

<p>Total procedure time (in minutes) for participants in surgical and PrePex device arms.</p

Male circumcision unit cost components for PrePex device and surgical circumcisions for Phase II.

<p>Male circumcision unit cost components for PrePex device and surgical circumcisions for Phase II.</p

Flow chart summarizing the screening and enrollment of the male participant candidates.

<p>Flow chart summarizing the screening and enrollment of the male participant candidates.</p

Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe

<div><p>Male circumcision (MC) for sexually active, HIV-negative men reduces HIV transmission and averts HIV infections. Excluding HIV-positive men from MC decreases access to additional health and hygiene benefits. In settings where HIV-testing is, or is perceived to be, required for MC, testing may reduce MC uptake. Reducing promotion of HIV testing within MC settings and promoting device-based MC may speed MC scale-up. To assess safety and efficacy of PrePex MC device among HIV-positive men, we conducted a one-arm, open-label, prospective study in otherwise healthy HIV-positive men in Zimbabwe.</p><p>Methods</p><p>We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.</p><p>Results</p><p>Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35–49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.</p><p>Conclusion</p><p>Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.</p></div