Characterising sources of PM2·5 exposure for school children with asthma: a personal exposure study across six cities in sub-Saharan Africa.

BACKGROUND: Air pollution is the second largest risk to health in Africa, and children with asthma are particularly susceptible to its effects. Yet, there is a scarcity of air pollution exposure data from cities in sub-Saharan Africa. We aimed to identify potential exposure reduction strategies for school children with asthma living in urban areas in sub-Saharan Africa. METHODS: This personal exposure study was part of the Achieving Control of Asthma in Children in Africa (ACACIA) project. Personal exposure to particulate matter (PM) was monitored in school children in six cities in sub-Saharan Africa (Blantyre, Malawi; Durban, South Africa; Harare, Zimbabwe; Kumasi, Ghana; Lagos, Nigeria; and Moshi, Tanzania). Participants were selected if they were aged 12-16 years and had symptoms of asthma. Monitoring was conducted between June 21, and Nov 26, 2021, from Monday morning (approximately 1000 h) to Friday morning (approximately 1000 h), by use of a bespoke backpack with a small air pollution monitoring unit with an inbuilt Global Positioning System (GPS) data logger. Children filled in a questionnaire detailing potential sources of air pollution during monitoring and exposures were tagged into three different microenvironments (school, commute, and home) with GPS coordinates. Mixed-effects models were used to identify the most important determinants of children's PM2·5 (PM <2·5 µm in diameter) exposure. FINDINGS: 330 children were recruited across 43 schools; of these, 297 had valid monitoring data, and 1109 days of valid data were analysed. Only 227 (20%) of 1109 days monitored were lower than the current WHO 24 h PM2·5 exposure health guideline of 15 µg/m3. Children in Blantyre had the highest PM2·5 exposure (median 41·8 µg/m3), whereas children in Durban (16·0 µg/m3) and Kumasi (17·9 µg/m3) recorded the lowest exposures. Children had significantly higher PM2·5 exposures at school than at home in Kumasi (median 19·6 µg/m3vs 14·2 µg/m3), Lagos (32·0 µg/m3vs 18·0 µg/m3), and Moshi (33·1 µg/m3vs 23·6 µg/m3), while children in the other three cities monitored had significantly higher PM2·5 exposures at home and while commuting than at school (median 48·0 µg/m3 and 43·2 µg/m3vs 32·3 µg/m3 in Blantyre, 20·9 µg/m3 and 16·3 µg/m3vs 11·9 µg/m3 in Durban, and 22·7 µg/m3 and 25·4 µg/m3vs 16·4 µg/m3 in Harare). The mixed-effects model highlighted the following determinants for higher PM2·5 exposure: presence of smokers at home (23·0% higher exposure, 95% CI 10·8-36·4), use of coal or wood for cooking (27·1%, 3·9-56·3), and kerosene lamps for lighting (30·2%, 9·1-55·2). By contrast, 37·2% (95% CI 22·9-48·2) lower PM2·5 exposures were found for children who went to schools with paved grounds compared with those whose school grounds were covered with loose dirt. INTERPRETATION: Our study suggests that the most effective changes to reduce PM2·5 exposures in these cities would be to provide paving in school grounds, increase the use of clean fuel for cooking and light in homes, and discourage smoking within homes. The most efficient way to improve air quality in these cities would require tailored interventions to prioritise different exposure-reduction policies in different cities. FUNDING: UK National Institute for Health and Care Research.

Barriers to childhood asthma care in sub-Saharan Africa: a multicountry qualitative study with children and their caregivers.

OBJECTIVES: This study identifies barriers and provides recommendations to improve asthma care in children across sub-Saharan Africa, where qualitative data is lacking despite high rates. DESIGN: One of the aims of our National Institute for Health Research global health research group 'Achieving Control of Asthma in Children in Africa' was to use qualitative thematic analysis of transcribed audio recordings from focus group discussions (FGDs) to describe barriers to achieving good asthma control. SETTING: Schools in Blantyre (Malawi), Lagos (Nigeria), Durban (South Africa), Kampala (Uganda) and Harare (Zimbabwe). PARTICIPANTS: Children (n=136), 12-14 years with either asthma symptoms or a diagnosis and their caregivers participated in 39 FGDs. All were recruited using asthma control questions from the Global Asthma Network survey. RESULTS: There were four key themes identified: (1) Poor understanding, (2) difficulties experienced with being diagnosed, (3) challenges with caring for children experiencing an acute asthma episode and (4) suboptimal uptake and use of prescribed medicines. An inadequate understanding of environmental triggers, a hesitancy in using metred dose inhalers and a preference for oral and alternate medications were identified as barriers. In addition, limited access to healthcare with delays in diagnosis and an inability to cope with expected lifestyle changes was reported. Based on these findings, we recommend tailored education to promote access to and acceptance of metred dose inhalers, including advocating for access to a single therapeutic, preventative and treatment option. Furthermore, healthcare systems should have simpler diagnostic pathways and easier emergency access for asthma. CONCLUSIONS: In a continent with rapidly increasing levels of poorly controlled asthma, we identified multiple barriers to achieving good asthma control along the trajectory of care. Exploration of these barriers reveals several generalisable recommendations that should modify asthma care plans and potentially transform asthma care in Africa. TRIAL REGISTRATION NUMBER: 269211.

A cross-country qualitative analysis of teachers' perceptions of asthma care in sub-Saharan Africa.

Asthma is the most common chronic respiratory disease among school-going adolescents worldwide. However, the burden of severe asthma is highest in Sub-Saharan Africa. This study aimed to explore teachers' perceptions of asthma care across six African countries. We conducted focus group discussions (FGDs) using a semi-structured interview guide. Interviews were audio-recorded, transcribed verbatim and analysed thematically. FGDs were conducted in Kumasi(Ghana), Blantyre (Malawi), Lagos (Nigeria), Durban (South Africa), Kampala (Uganda), and Harare (Zimbabwe) between 01 November 2020 and 30 June 2021. We identified two key themes related to asthma care; barriers to asthma care and suggestions to improve the care of adolescents with asthma. Barriers reported by teachers included a lack of knowledge and skills among themselves, adolescents, and caregivers. In addition, some traditional beliefs of teachers on asthma exacerbated challenges with asthma care in schools. Regarding suggestions, most teachers identified a need for all-inclusive asthma training programmes for teachers, adolescents and caregivers, focusing on acute episodes and mitigating triggers. Utilising teachers with personal experiences with asthma to advocate and support these initiatives was suggested. Further suggestions included the need for annual screening to enable early identification of adolescents with asthma and clarify restrictions on teachers administering asthma medications. Teachers across African schools identify multiple barriers to asthma care. Structured school education programs and annual asthma screening are key to addressing some barriers to care.

Enhanced surveillance for adverse events following immunization during the 2019 typhoid conjugate vaccine campaign in Harare, Zimbabwe.

BACKGROUND: During February 25-March 4, 2019, Zimbabwe's Ministry of Health and Child Care conducted an emergency campaign using 342,000 doses of typhoid conjugate vaccine (TCV) targeting individuals 6 months-15 years of age in eight high-risk suburbs of Harare and up to 45 years of age in one suburb of Harare. The campaign represented the first use of TCV in Africa outside of clinical trials. METHODS: Three methods were used to capture adverse events during the campaign and for 42 days following the last dose administered: (1) active surveillance in two Harare hospitals, (2) national passive surveillance, and (3) a post-campaign coverage survey. RESULTS: Thirty-nine adverse events were identified during active surveillance, including 19 seizure cases (16 were febrile), 16 hypersensitivity cases, 1 thrombocytopenia case, 1 anaphylaxis case, and two cases with two conditions. Only 21 (54%) of 39 patients were hospitalized and 38 recovered without sequelae. Attack rates per 100,000 TCV doses administered were highest for seizures (6.27) and hypersensitivity (5.02). Only 6 adverse events were reported through passive surveillance by facilities other than the two active surveillance hospitals. A total of 177 (10%) of 1,817 vaccinees surveyed reported experiencing an adverse event during the post-campaign coverage survey, of which 25 (14%) sought care. CONCLUSIONS: In line with previous evaluations of TCV, enhanced adverse event monitoring during an emergency campaign supports the safety of TCV. The majority of reported events were minor or resulted in recovery without long-term sequelae. Attack rates for seizures and hypersensitivity were low compared with previous active surveillance studies conducted in Kenya and Burkina Faso. Strengthening adverse event monitoring in Zimbabwe and establishing background rates of conditions of interest in the general population may improve future safety monitoring during new vaccine introductions.

Cost estimates of diarrhea hospitalizations among children <5 years old in Zimbabwe.

INTRODUCTION: Diarrhoea is a leading killer of children <5 years old, accounting for 480,000 deaths in 2017. Zimbabwe introduced Rotarix into its vaccination program in 2014. In this evaluation, we estimate direct medical, direct non-medical, and indirect costs attributable to a diarrhea hospitalization in Zimbabwe after rotavirus vaccine introduction. METHODS: Children <5 years old admitted to Harare Central Hospital from June 2018 to April 2019 with acute watery diarrhea were eligible for this evaluation. A 3-part structured questionnaire was used to collect data by interview from the child's family and by review of the medical record. A stool specimen was also collected and tested for rotavirus. Direct medical costs were the sum of medications, consumables, diagnostic tests, and service delivery costs. Direct non-medical costs were the sum of transportation, meals and lodging for caregivers. Indirect costs are the lost income for household members. RESULTS: A total of 202 children were enrolled with a median age of 12 months (IQR: 7-21) and 48 (24%) had malnutrition. Children were sick for a median of 2 days and most had received outpatient medical care prior to admission. The median monthly household income was higher for well-nourished children compared to malnourished children (p < 0.001). The median total cost of a diarrhea illness resulting in hospitalization was $293.74 (IQR: 188.42, 427.89). Direct medical costs, with a median of $251.74 (IQR: 155.42, 390.96), comprised the majority of the total cost. Among children who tested positive for rotavirus, the median total illness cost was $243.78 (IQR: 160.92, 323.84). The median direct medical costs were higher for malnourished than well-nourished children (p < 0.001). CONCLUSION: Direct medical costs are the primary determinant of diarrhea illness costs in Zimbabwe. The descriptive findings from this evaluation are an important first step in calculating the cost effectiveness of rotavirus vaccine.

Achieving Control of Asthma in Children in Africa (ACACIA): protocol of an observational study of children's lung health in six sub-Saharan African countries.

INTRODUCTION: Little is known about asthma control in the rising number of African children who suffer from this condition. The Achieving Control of Asthma in Children in Africa (ACACIA) study is an observational study collecting evidence about paediatric asthma in urban areas of Ghana, Malawi, Nigeria, South Africa, Uganda and Zimbabwe. The primary objectives are: (1) to identify 3000 children aged between 12 years and 14 years with asthma symptoms; and (2) to assess their asthma control, current treatment, knowledge of and attitudes to asthma and barriers to achieving good control. Secondary objective is to develop interventions addressing identified barriers to good symptom control. METHODS AND ANALYSIS: Each centre will undertake screening to identify 500 school children with asthma symptoms using questions from the Global Asthma Network's questionnaire. Children identified to have asthma symptoms will fill in a digital survey, including: Asthma Control Test, questions on medication usage and adherence, medical care, the Brief-Illness Perception questionnaire and environmental factors. Exhaled nitric oxide testing and prebronchodilator and postbronchodilator spirometry will be performed. A subgroup of children will participate in focus group discussions. Results will be analysed using descriptive statistics and comparative analysis. Informed by these results, we will assess the feasibility of potential interventions, including the adaption of a UK-based theatre performance about asthma attitudes and digital solutions to improve asthma management. ETHICS AND DISSEMINATION: The ACACIA study has been reviewed by the Queen Mary University of London Ethics of Research Committee in the UK. All African centres have received local ethical approval for this study. Study results will be published in academic journals and at conferences. Study outputs will be communicated to the public via newsfeeds on the ACACIA website and Twitter, and through news media outlets and other local dissemination. TRIAL REGISTRATION NUMBER: 269211.

Monovalent Rotavirus Vaccine Effectiveness Against Rotavirus Hospitalizations Among Children in Zimbabwe.

BACKGROUND: Rotavirus is a leading cause of mortality among children <5 years old. We evaluated monovalent rotavirus vaccine effectiveness (VE) under conditions of routine use at 2 surveillance sites in Harare, Zimbabwe, after vaccine introduction in May 2014. METHODS: Children aged <5 years hospitalized or treated in the accident and emergency department (A&E) for acute watery diarrhea were enrolled for routine surveillance. Copies of vaccination cards were collected to document vaccination status. Among children age-eligible to receive rotavirus vaccine, we estimated VE, calculated as 1 - odds ratio, using a test-negative case-control design. RESULTS: We included 903 rotavirus-positive cases and 2685 rotavirus-negative controls in the analysis; 99% had verified vaccination status. Rotavirus-positive children had more severe diarrhea than rotavirus-negative children; 61% of cases and 46% of controls had a Vesikari score ≥11 (P < .01). Among cases and controls, 31% and 37%, respectively, were stunted for their age (P < .01). Among children 6-11 months old, adjusted 2-dose VE against hospitalization or treatment in A&E due to rotavirus of any severity was 61% (95% confidence interval [CI], 21%-81%) and 68% (95% CI, 13%-88%) against severe rotavirus disease. Stratified by nutritional status, adjusted VE was 45% (95% CI, -148% to 88%) among stunted infants and 71% (95% CI, 29%-88%) among infants with a normal height for age. CONCLUSIONS: Monovalent rotavirus vaccine is effective in preventing hospitalizations due to severe rotavirus diarrhea among infants in Zimbabwe, providing additional evidence for countries considering rotavirus vaccine introduction that live, oral rotavirus vaccines are effective in high-child-mortality settings.

Distribution of rotavirus genotypes associated with acute diarrhoea in Zimbabwean children less than five years old before and after rotavirus vaccine introduction.

BACKGROUND: Sentinel surveillance for diarrhoea is important to monitor changes in rotavirus epidemiological trends and circulating genotypes among children under 5 years before and after vaccine introduction. The Zimbabwe Ministry of Health and Child Care introduced rotavirus vaccine in national immunization program in May 2014. METHODS: Active hospital-based surveillance for diarrhoea was conducted at 3 sentinel sites from 2008 to 2016. Children aged less than 5 years, who presented with acute gastroenteritis as a primary illness and who were admitted to a hospital ward or treated at the emergency unit, were enrolled and had a stool specimen collected and tested for rotavirus by enzyme immunoassay (EIA). Genotyping of positive stools was performed using reverse-transcription polymerase chain reaction and genotyping assays. Pre-vaccine introduction, 10% of all positive stool specimens were genotyped and all adequate positive stools were genotyped post-vaccine introduction. RESULTS: During the pre-vaccine period, a total of 6491 acute gastroenteritis stools were collected, of which 3016 (46%) tested positive for rotavirus and 312 (10%) of the rotavirus positive stools were genotyped. During the post-vaccine period, a total of 3750 acute gastroenteritis stools were collected, of which 937 (25%) tested positive for rotavirus and 784 (84%) were genotyped. During the pre-vaccine introduction the most frequent genotype was G9P[8] (21%) followed by G2P[4] (12%), G1P[8] (6%), G2P[6] (5%), G12P[6] (4%), G9P[6] (3%) and G8P[4] (3%). G1P[8] (30%) was most dominant two years after vaccine introduction followed by G9P[6] (20%), G2P[4] (15%), G9P[8] (11%) and G1P[6] (4%). CONCLUSION: The decline in positivity rate is an indication of early vaccine impact. Diversity of circulating strains underscores the importance of continued monitoring and strain surveillance after vaccine introduction.

Reduction in Diarrhea- and Rotavirus-related Healthcare Visits Among Children <5 Years of Age After National Rotavirus Vaccine Introduction in Zimbabwe.

BACKGROUND: In Zimbabwe, rotavirus accounted for 41%-56% of acute diarrhea hospitalizations before rotavirus vaccine introduction in 2014. We evaluated rotavirus vaccination impact on acute diarrhea- and rotavirus-related healthcare visits in children. METHODS: We examined monthly and annual acute diarrhea and rotavirus test-positive hospitalizations and Accident and Emergency Department visits among children <60 months of age at 3 active surveillance hospitals during 2012-2016; we compared prevaccine introduction (2012-2013) with postvaccine introduction (2015 and 2016) data for 2 of the hospitals. We examined monthly acute diarrhea hospitalizations by year and age group for 2013-2016 from surveillance hospital registers and monthly acute diarrhea outpatient visits reported to the Ministry of Health and Child Care during 2012-2016. RESULTS: Active surveillance data showed winter seasonal peaks in diarrhea- and rotavirus-related visits among children <60 months of age during 2012-2014 that were substantially blunted in 2015 and 2016 after vaccine introduction; the percentage of rotavirus test-positive visits followed a similar seasonal pattern and decrease. Hospital register data showed similar pre-introduction seasonal variation and post-introduction declines in diarrhea hospitalizations among children 0-11 and 12-23 months of age. Monthly variation in outpatient diarrhea-related visits mirrored active surveillance data patterns. At 2 surveillance hospitals, the percentage of rotavirus-positive visits declined by 40% and 43% among children 0-11 months of age and by 21% and 33% among children 12-23 months of age in 2015 and 2016, respectively. CONCLUSION: Initial reductions in diarrheal illness among children <60 months of age, particularly among those 0-11 months of age, after vaccine introduction are encouraging. These early results provide evidence to support continued rotavirus vaccination and rotavirus surveillance in Zimbabwe.

Unpacking early infant male circumcision decision-making using qualitative findings from Zimbabwe.

BACKGROUND: Early infant male circumcision (EIMC) has been identified as a key HIV prevention intervention. Exploring the decision-making process for adoption of EIMC for HIV prevention among parents and other key stakeholders is critical for designing effective demand creation interventions to maximize uptake, roll out and impact in preventing HIV. This paper describes key players, decisions and actions involved in the EIMC decision-making process. METHODS: Two complementary qualitative studies explored hypothetical and actual acceptability of EIMC in Zimbabwe. The first study (conducted 2010) explored hypothetical acceptability of EIMC among parents and wider family through focus group discussions (FGDs, n = 24). The follow-up study (conducted 2013) explored actual acceptability of EIMC among parents through twelve in-depth interviews (IDIs), four FGDs and short telephone interviews with additional parents (n = 95). Short statements from the telephone interviews were handwritten. FGDs and IDIs were audio-recorded, transcribed and translated into English. All data were thematically coded. RESULTS: Study findings suggested that EIMC decision-making involved a discussion between the infant's parents. Male and female participants of all age groups acknowledged that the father had the final say. However, discussions around EIMC uptake suggested that the infant's mother could sometimes covertly influence the father's decision in the direction she favoured. Discussions also suggested that fathers who had undergone voluntary medical male circumcision were more likely to adopt EIMC for their sons, compared to their uncircumcised counterparts. Mothers-in-law/grandparents were reported to have considerable influence. Based on study findings, we describe key EIMC decision makers and attempt to illustrate alternative outcomes of their key actions and decisions around EIMC within the Zimbabwean context. CONCLUSIONS: These complementary studies identified critical players, decisions and actions involved in the EIMC decision-making process. Findings on who influences decisions regarding EIMC in the Zimbabwean context highlighted the need for EIMC demand generation interventions to target fathers, mothers, grandmothers, other family members and the wider community.

Perspectives of Parents and Health Care Workers on Early Infant Male Circumcision Conducted Using Devices: Qualitative Findings From Harare, Zimbabwe.

BACKGROUND: The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend early infant male circumcision (EIMC) for prevention of HIV. Here, we present findings from a qualitative study in Zimbabwe that assessed parental and health care workers' perspectives of EIMC conducted using devices. METHODS: This qualitative study was nested within a trial of EIMC devices. Between January and May 2013, we held 4 focus group discussions (FGDs) and 12 in-depth interviews with parents and 12 in-depth interviews with clinicians (7 trial clinicians and 5 non-trial clinicians). We also conducted 95 short telephone interviews with parents who had arranged to bring their sons for EIMC but then defaulted. RESULTS: Parents who had adopted EIMC spoke of their initial anxieties about the procedure. Additionally, they commented on both the procedure and outcome. Parents who decided against EIMC cited fear of harm, specifically the infant's death, penile injury, and excessive pain. Misperceptions about male circumcision in general and EIMC specifically were a significant barrier to EIMC adoption and were prevalent among health care workers as well as parents. In particular, the findings suggest strong parental concerns about the fate of the discarded foreskin. Parents who chose EIMC for their newborn sons felt that the procedure was safe and expressed satisfaction with the outcome. For their part, health care workers largely thought that EIMC was safe and that the outcome was aesthetically pleasing. They also felt that it would be feasible to offer wide-scale EIMC for HIV prevention in the public sector; they recommended strategies to increase EIMC uptake, in addition to highlighting a few concerns. CONCLUSIONS: The qualitative study enables us to better understand parental and health care workers' perspectives of EIMC conducted using devices, especially their perspectives on EIMC safety, feasibility, acceptability, and barriers. These findings will be used to design demand-generation activities that support wider adoption of EIMC.

Comparative Cost of Early Infant Male Circumcision by Nurse-Midwives and Doctors in Zimbabwe.

BACKGROUND: The 14 countries that are scaling up voluntary male medical circumcision (VMMC) for HIV prevention are also considering early infant male circumcision (EIMC) to ensure longer-term reductions in HIV incidence. The cost of implementing EIMC is an important factor in scale-up decisions. We conducted a comparative cost analysis of EIMC performed by nurse-midwives and doctors using the AccuCirc device in Zimbabwe. METHODS: Between August 2013 and July 2014, nurse-midwives performed EIMC on 500 male infants using AccuCirc in a field trial. We analyzed the overall unit cost and identified key cost drivers of EIMC performed by nurse-midwives and compared these with costing data previously collected during a randomized noninferiority comparison trial of 2 devices (AccuCirc and the Mogen clamp) in which doctors performed EIMC. We assessed direct costs (consumable and nonconsumable supplies, device, personnel, associated staff training, and waste management costs) and indirect costs (capital and support personnel costs). We performed one-way sensitivity analyses to assess cost changes when we varied key component costs. RESULTS: The unit costs of EIMC performed by nurse-midwives and doctors in vertical programs were US$38.87 and US$49.77, respectively. Key cost drivers of EIMC were consumable supplies, personnel costs, and the device price. In this cost analysis, major cost drivers that explained the differences between EIMC performed by nurse-midwives and doctors were personnel and training costs, both of which were lower for nurse-midwives. CONCLUSIONS: EIMC unit costs were lower when performed by nurse-midwives compared with doctors. To minimize costs, countries planning to scale up EIMC should consider using nurse-midwives, who are in greater supply than doctors and are the main providers at the primary health care level, where most infants are born.

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.

Cryptococcal Meningitis Presenting as a Complication in HIV-infected Children: A Case Series From Sub-Saharan Africa.

Cryptococcal meningitis is a leading infectious disease worldwide as a result of the high burden of HIV and AIDS, although its cumulative incidence is very low in children compared with that in adults. Very few studies involving the disease in children have been reported including sub-Saharan Africa, with the highest prevalence of HIV-infected children in the world. We summarize 5 cases of children diagnosed with cryptococcal meningitis at a tertiary hospital in Harare, Zimbabwe, between October 1, 2013, and September 30, 2014.

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.

Estimating the Cost of Early Infant Male Circumcision in Zimbabwe: Results From a Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp.

BACKGROUND: Safe and cost-effective programs for implementing early infant male circumcision (EIMC) in Africa need to be piloted. We present results on a relative cost analysis within a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. METHODS: Between January and June 2013, male infants who met inclusion criteria were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 allocation ratio. We evaluated the overall unit cost plus the key cost drivers of EIMC using both AccuCirc and Mogen clamp. Direct costs included consumable and nonconsumable supplies, device, personnel, associated staff training, and environmental costs. Indirect costs comprised capital and support personnel costs. In 1-way sensitivity analyses, we assessed potential changes in unit costs due to variations in main parameters, one at a time, holding all other values constant. RESULTS: The unit costs of EIMC using AccuCirc and Mogen clamp were $49.53 and $55.93, respectively. Key cost drivers were consumable supplies, capacity utilization, personnel costs, and device price. Unit prices are likely to be lowest at full capacity utilization and increase as capacity utilization decreases. Unit prices also fall with lower personnel salaries and increase with higher device prices. CONCLUSIONS: EIMC has a lower unit cost when using AccuCirc compared with Mogen clamp. To minimize unit costs, countries planning to scale-up EIMC using AccuCirc need to control costs of consumables and personnel. There is also need to negotiate a reasonable device price and maximize capacity utilization.