Kangaroo mother care: EN-BIRTH multi-country validation study.

BACKGROUND: Kangaroo mother care (KMC) reduces mortality among stable neonates ≤2000 g. Lack of data tracking coverage and quality of KMC in both surveys and routine information systems impedes scale-up. This paper evaluates KMC measurement as part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. METHODS: The EN-BIRTH observational mixed-methods study was conducted in five hospitals in Bangladesh, Nepal and Tanzania from 2017 to 2018. Clinical observers collected time-stamped data as gold standard for mother-baby pairs in KMC wards/corners. To assess accuracy, we compared routine register-recorded and women's exit survey-reported coverage to observed data, using different recommended denominator options (≤2000 g and ≤ 2499 g). We analysed gaps in quality of provision and experience of KMC. In the Tanzanian hospitals, we assessed daily skin-to-skin duration/dose and feeding frequency. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine register design, filling and use. RESULTS: Among 840 mother-baby pairs, compared to observed 100% coverage, both exit-survey reported (99.9%) and register-recorded coverage (92.9%) were highly valid measures with high sensitivity. KMC specific registers outperformed general registers. Enablers to register recording included perceptions of data usefulness, while barriers included duplication of data elements and overburdened health workers. Gaps in KMC quality were identified for position components including wearing a hat. In Temeke Tanzania, 10.6% of babies received daily KMC skin-to-skin duration/dose of ≥20 h and a further 75.3% received 12-19 h. Regular feeding ≥8 times/day was observed for 36.5% babies in Temeke Tanzania and 14.6% in Muhimbili Tanzania. Cup-feeding was the predominant assisted feeding method. Family support during admission was variable, grandmothers co-provided KMC more often in Bangladesh. No facility arrangements for other family members were reported by 45% of women at exit survey. CONCLUSIONS: Routine hospital KMC register data have potential to track coverage from hospital KMC wards/corners. Women accurately reported KMC at exit survey and evaluation for population-based surveys could be considered. Measurement of content, quality and experience of KMC need consensus on definitions. Prioritising further KMC measurement research is important so that high quality data can be used to accelerate scale-up of high impact care for the most vulnerable.

Electronic data collection for multi-country, hospital-based, clinical observation of maternal and newborn care: EN-BIRTH study experiences.

BACKGROUND: Observation of care at birth is challenging with multiple, rapid and potentially concurrent events occurring for mother, newborn and placenta. Design of electronic data (E-data) collection needs to account for these challenges. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study to assess measurement of indicators for priority maternal and newborn interventions and took place in five hospitals in Bangladesh, Nepal and Tanzania (July 2017-July 2018). E-data tools were required to capture individually-linked, timed observation of care, data extraction from hospital register-records or case-notes, and exit-survey data from women. METHODS: To evaluate this process for EN-BIRTH, we employed a framework organised around five steps for E-data design, data collection and implementation. Using this framework, a mixed methods evaluation synthesised evidence from study documentation, standard operating procedures, stakeholder meetings and design workshops. We undertook focus group discussions with EN-BIRTH researchers to explore experiences from the three different country teams (November-December 2019). Results were organised according to the five a priori steps. RESULTS: In accordance with the five-step framework, we found: 1) Selection of data collection approach and software: user-centred design principles were applied to meet the challenges for observation of rapid, concurrent events around the time of birth with time-stamping. 2) Design of data collection tools and programming: required extensive pilot testing of tools to be user-focused and to include in-built error messages and data quality alerts. 3) Recruitment and training of data collectors: standardised with an interactive training package including pre/post-course assessment. 4) Data collection, quality assurance, and management: real-time quality assessments with a tracking dashboard and double observation/data extraction for a 5% case subset, were incorporated as part of quality assurance. Internet-based synchronisation during data collection posed intermittent challenges. 5) Data management, cleaning and analysis: E-data collection was perceived to improve data quality and reduce time cleaning. CONCLUSIONS: The E-Data system, custom-built for EN-BIRTH, was valued by the site teams, particularly for time-stamped clinical observation of complex multiple simultaneous events at birth, without which the study objectives could not have been met. However before selection of a custom-built E-data tool, the development time, higher training and IT support needs, and connectivity challenges need to be considered against the proposed study or programme's purpose, and currently available E-data tool options.

Uterotonics for prevention of postpartum haemorrhage: EN-BIRTH multi-country validation study.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of preventable maternal mortality worldwide. The World Health Organization (WHO) recommends uterotonic administration for every woman after birth to prevent PPH. There are no standardised data collected in large-scale measurement platforms. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) is an observational study to assess the validity of measurement of maternal and newborn indicators, and this paper reports findings regarding measurement of coverage and quality for uterotonics. METHODS: The EN-BIRTH study took place in five hospitals in Bangladesh, Nepal and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data. We compared observation data for uterotonics to routine hospital register-records and women's report at exit-interview survey. We analysed the coverage and quality gap for timing and dose of administration. The register design was evaluated against gap analyses and qualitative interview data assessing the barriers and enablers to data recording and use. RESULTS: Observed uterotonic coverage was high in all five hospitals (> 99%, 95% CI 98.7-99.8%). Survey-report underestimated coverage (79.5 to 91.7%). "Don't know" replies varied (2.1 to 14.4%) and were higher after caesarean (3.7 to 59.3%). Overall, there was low accuracy in survey data for details of uterotonic administration (type and timing). Register-recorded coverage varied in four hospitals capturing uterotonics in a specific column (21.6, 64.5, 97.6, 99.4%). The average coverage measurement gap was 18.1% for register-recorded and 6.0% for survey-reported coverage. Uterotonics were given to 15.9% of women within the "right time" (1 min) and 69.8% within 3 min. Women's report of knowing the purpose of uterotonics after birth ranged from 0.4 to 64.9% between hospitals. Enabling register design and adequate staffing were reported to improve routine recording. CONCLUSIONS: Routine registers have potential to track uterotonic coverage - register data were highly accurate in two EN-BIRTH hospitals, compared to consistently underestimated coverage by survey-report. Although uterotonic coverage was high, there were gaps in observed quality for timing and dose. Standardisation of register design and implementation could improve data quality and data flow from registers into health management information reporting systems, and requires further assessment.

Assessment of the validity of the measurement of newborn and maternal health-care coverage in hospitals (EN-BIRTH): an observational study.

BACKGROUND: Progress in reducing maternal and neonatal deaths and stillbirths is impeded by data gaps, especially regarding coverage and quality of care in hospitals. We aimed to assess the validity of indicators of maternal and newborn health-care coverage around the time of birth in survey data and routine facility register data. METHODS: Every Newborn-BIRTH Indicators Research Tracking in Hospitals was an observational study in five hospitals in Bangladesh, Nepal, and Tanzania. We included women and their newborn babies who consented on admission to hospital. Exclusion critiera at admission were no fetal heartbeat heard or imminent birth. For coverage of uterotonics to prevent post-partum haemorrhage, early initiation of breastfeeding (within 1 h), neonatal bag-mask ventilation, kangaroo mother care (KMC), and antibiotics for clinically defined neonatal infection (sepsis, pneumonia, or meningitis), we collected time-stamped, direct observation or case note verification data as gold standard. We compared data reported via hospital exit surveys and via hospital registers to the gold standard, pooled using random effects meta-analysis. We calculated population-level validity ratios (measured coverage to observed coverage) plus individual-level validity metrics. FINDINGS: We observed 23 471 births and 840 mother-baby KMC pairs, and verified the case notes of 1015 admitted newborn babies regarding antibiotic treatment. Exit-survey-reported coverage for KMC was 99·9% (95% CI 98·3-100) compared with observed coverage of 100% (99·9-100), but exit surveys underestimated coverage for uterotonics (84·7% [79·1-89·5]) vs 99·4% [98·7-99·8] observed), bag-mask ventilation (0·8% [0·4-1·4]) vs 4·4% [1·9-8·1]), and antibiotics for neonatal infection (74·7% [55·3-90·1] vs 96·4% [94·0-98·6] observed). Early breastfeeding coverage was overestimated in exit surveys (53·2% [39·4-66·8) vs 10·9% [3·8-21·0] observed). "Don't know" responses concerning clinical interventions were more common in the exit survey after caesarean birth. Register data underestimated coverage of uterotonics (77·9% [37·8-99·5] vs 99·2% [98·6-99·7] observed), bag-mask ventilation (4·3% [2·1-7·3] vs 5·1% [2·0-9·6] observed), KMC (92·9% [84·2-98·5] vs 100% [99·9-100] observed), and overestimated early breastfeeding (85·9% (58·1-99·6) vs 12·5% [4·6-23·6] observed). Inter-hospital heterogeneity was higher for register-recorded coverage than for exit survey report. Even with the same register design, accuracy varied between hospitals. INTERPRETATION: Coverage indicators for newborn and maternal health care in exit surveys had low accuracy for specific clinical interventions, except for self-report of KMC, which had high sensitivity after admission to a KMC ward or corner and could be considered for further assessment. Hospital register design and completion are less standardised than surveys, resulting in variable data quality, with good validity for the best performing sites. Because approximately 80% of births worldwide take place in facilities, standardising register design and information systems has the potential to sustainably improve the quality of data on care at birth. FUNDING: Children's Investment Fund Foundation and Swedish Research Council.

Labour and delivery ward register data availability, quality, and utility - Every Newborn - birth indicators research tracking in hospitals (EN-BIRTH) study baseline analysis in three countries.

BACKGROUND: Countries with the highest burden of maternal and newborn deaths and stillbirths often have little information on these deaths. Since over 81% of births worldwide now occur in facilities, using routine facility data could reduce this data gap. We assessed the availability, quality, and utility of routine labour and delivery ward register data in five hospitals in Bangladesh, Nepal, and Tanzania. This paper forms the baseline register assessment for the Every Newborn-Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. METHODS: We extracted 21 data elements from routine hospital labour ward registers, useful to calculate selected maternal and newborn health (MNH) indicators. The study sites were five public hospitals during a one-year period (2016-17). We measured 1) availability: completeness of data elements by register design, 2) data quality: implausibility, internal consistency, and heaping of birthweight and explored 3) utility by calculating selected MNH indicators using the available data. RESULTS: Data were extracted for 20,075 births. Register design was different between the five hospitals with 10-17 of the 21 selected MNH data elements available. More data were available for health outcomes than interventions. Nearly all available data elements were > 95% complete in four of the five hospitals and implausible values were rare. Data elements captured in specific columns were 85.2% highly complete compared to 25.0% captured in non-specific columns. Birthweight data were less complete for stillbirths than live births at two hospitals, and significant heaping was found in all sites, especially at 2500g and 3000g. All five hospitals recorded count data required to calculate impact indicators including; stillbirth rate, low birthweight rate, Caesarean section rate, and mortality rates. CONCLUSIONS: Data needed to calculate MNH indicators are mostly available and highly complete in EN-BIRTH study hospital routine labour ward registers in Bangladesh, Nepal and Tanzania. Register designs need to include interventions for coverage measurement. There is potential to improve data quality if Health Management Information Systems utilization with feedback loops can be strengthened. Routine health facility data could contribute to reduce the coverage and impact data gap around the time of birth.

"Every Newborn-BIRTH" protocol: observational study validating indicators for coverage and quality of maternal and newborn health care in Bangladesh, Nepal and Tanzania.

BACKGROUND: To achieve Sustainable Development Goals and Universal Health Coverage, programmatic data are essential. The Every Newborn Action Plan, agreed by all United Nations member states and >80 development partners, includes an ambitious Measurement Improvement Roadmap. Quality of care at birth is prioritised by both Every Newborn and Ending Preventable Maternal Mortality strategies, hence metrics need to advance from health service contact alone, to content of care. As facility births increase, monitoring using routine facility data in DHIS2 has potential, yet validation research has mainly focussed on maternal recall surveys. The Every Newborn - Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aims to validate selected newborn and maternal indicators for routine tracking of coverage and quality of facility-based care for use at district, national and global levels. METHODS: EN-BIRTH is an observational study including >20 000 facility births in three countries (Tanzania, Bangladesh and Nepal) to validate selected indicators. Direct clinical observation will be compared with facility register data and a pre-discharge maternal recall survey for indicators including: uterotonic administration, immediate newborn care, neonatal resuscitation and Kangaroo mother care. Indicators including neonatal infection management and antenatal corticosteroid administration, which cannot be easily observed, will be validated using inpatient records. Trained clinical observers in Labour/Delivery ward, Operation theatre, and Kangaroo mother care ward/areas will collect data using a tablet-based customised data capturing application. Sensitivity will be calculated for numerators of all indicators and specificity for those numerators with adequate information. Other objectives include comparison of denominator options (ie, true target population or surrogates) and quality of care analyses, especially regarding intervention timing. Barriers and enablers to routine recording and data usage will be assessed by data flow assessments, quantitative and qualitative analyses. CONCLUSIONS: To our knowledge, this is the first large, multi-country study validating facility-based routine data compared to direct observation for maternal and newborn care, designed to provide evidence to inform selection of a core list of indicators recommended for inclusion in national DHIS2. Availability and use of such data are fundamental to drive progress towards ending the annual 5.5 million preventable stillbirths, maternal and newborn deaths.

Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania.

BACKGROUND: We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%. METHODS AND FINDINGS: In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant's life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0-27) per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9-1.2, p = 0.339). Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7,008, OR 1.4, CI 1.3-1.6, p < 0.001), feeding only breast milk for the first 3 d (90% of 7,557 versus 79% of 7,307, OR 2.2, 95% CI 1.8-2.7, p < 0.001), and clean hands for home delivery (92% of 1,351 versus 88% of 1,799, OR 1.5, 95% CI 1.0-2.3, p = 0.033). Facility delivery improved dramatically in both groups from 41% of 22,243 in 2007 and was 82% of 7,820 versus 75% of 7,553 (OR 1.5, 95% CI 1.2-2.0, p = 0.002) in intervention and comparison wards in 2013. Methodological limitations include our inability to rule out some degree of leakage of the intervention into the comparison areas and response bias for newborn care behaviours. CONCLUSION: Neonatal mortality remained high despite better care practices and childbirth in facilities becoming common. Public health action to improve neonatal survival in this setting should include a focus on improving the quality of facility-based childbirth care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01022788.

Timeliness and completeness of vaccination and risk factors for low and late vaccine uptake in young children living in rural southern Tanzania.

BACKGROUND: We studied coverage and timeliness of vaccination and risk factors for low and delayed vaccine uptake in children aged <2 years in rural Tanzania. METHODS: We used data from a cluster survey conducted in 2004, which included 1403 children. Risk factors were analysed by log-binomial regression adjusted for the clustering. The analysis was restricted to BCG, first and third dose of Diphtheria-Tetanus-Pertussis vaccines (DTP-1 and DTP-3) and first dose of measles-containing vaccine (MCV-1). RESULTS: Coverage for BCG, DTP-1, DTP-3 and MCV-1 was 94%, 96%, 90% and 86%, respectively. Delayed vaccination (>1 month after the recommended age) occurred in 398/1205 (33%) children for BCG, 404/1189 (34%) for DTP-1, 683/990 (69%) for DTP-3 and 296/643 (46%) for MCV-1. Coverage was lower for all vaccines except DTP-1 in children living ≥5 km from a healthcare facility. Delayed uptake was associated with poverty. Low and delayed MCV-1 vaccination was associated with low maternal education. Delayed BCG vaccination was associated with ethnicity and rainy season. CONCLUSION: Despite reasonably high vaccination coverage, we observed substantial vaccination delays, particularly for DTP-3 and MCV-1. We found specific factors associated with low and/or delayed vaccine uptake. These findings can help to improve strategies to reach children who remain inadequately protected.

Neonatal deaths in rural southern Tanzania: care-seeking and causes of death.

Introduction. We report cause of death and care-seeking prior to death in neonates based on interviews with relatives using a Verbal Autopsy questionnaire. Materials and Methods. We identified neonatal deaths between 2004 and 2007 through a large household survey in 2007 in five rural districts of southern Tanzania. Results. Of the 300 reported deaths that were sampled, the Verbal Autopsy (VA) interview suggested that 11 were 28 days or older at death and 65 were stillbirths. Data was missing for 5 of the reported deaths. Of the remaining 219 confirmed neonatal deaths, the most common causes were prematurity (33%), birth asphyxia (22%) and infections (10%). Amongst the deaths, 41% (90/219) were on the first day and a further 20% (43/219) on day 2 and 3. The quantitative results matched the qualitative findings. The majority of births were at home and attended by unskilled assistants. Conclusion. Caregivers of neonates born in health facility were more likely to seek care for problems than caregivers of neonates born at home. Efforts to increase awareness of the importance of early care-seeking for a premature or sick neonate are likely to be important for improving neonatal health.

Incentivising safe sex: a randomised trial of conditional cash transfers for HIV and sexually transmitted infection prevention in rural Tanzania.

OBJECTIVE: The authors evaluated the use of conditional cash transfers as an HIV and sexually transmitted infection prevention strategy to incentivise safe sex. DESIGN: An unblinded, individually randomised and controlled trial. SETTING: 10 villages within the Kilombero/Ulanga districts of the Ifakara Health and Demographic Surveillance System in rural south-west Tanzania. PARTICIPANTS: The authors enrolled 2399 participants, aged 18-30 years, including adult spouses. INTERVENTIONS: Participants were randomly assigned to either a control arm (n=1124) or one of two intervention arms: low-value conditional cash transfer (eligible for $10 per testing round, n=660) and high-value conditional cash transfer (eligible for $20 per testing round, n=615). The authors tested participants every 4 months over a 12-month period for the presence of common sexually transmitted infections. In the intervention arms, conditional cash transfer payments were tied to negative sexually transmitted infection test results. Anyone testing positive for a sexually transmitted infection was offered free treatment, and all received counselling. MAIN OUTCOME MEASURES: The primary study end point was combined prevalence of the four sexually transmitted infections, which were tested and reported to subjects every 4 months: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium. The authors also tested for HIV, herpes simplex virus 2 and syphilis at baseline and month 12. RESULTS: At the end of the 12-month period, for the combined prevalence of any of the four sexually transmitted infections, which were tested and reported every 4 months (C trachomatis, N gonorrhoeae, T vaginalis and M genitalium), unadjusted RR for the high-value conditional cash transfer arm compared to controls was 0.80 (95% CI 0.54 to 1.06) and the adjusted RR was 0.73 (95% CI 0.47 to 0.99). Unadjusted RR for the high-value conditional cash transfer arm compared to the low-value conditional cash transfer arm was 0.76 (95% CI 0.49 to 1.03) and the adjusted RR was 0.69 (95% CI 0.45 to 0.92). No harm was reported. CONCLUSIONS: Conditional cash transfers used to incentivise safer sexual practices are a potentially promising new tool in HIV and sexually transmitted infections prevention. Additional larger study would be useful to clarify the effect size, to calibrate the size of the incentive and to determine whether the intervention can be delivered cost effectively. TRIAL REGISTRATION NUMBER: NCT00922038 ClinicalTrials.gov.

Human resources for health care delivery in Tanzania: a multifaceted problem.

BACKGROUND: Recent years have seen an unprecedented increase in funds for procurement of health commodities in developing countries. A major challenge now is the efficient delivery of commodities and services to improve population health. With this in mind, we documented staffing levels and productivity in peripheral health facilities in southern Tanzania. METHOD: A health facility survey was conducted to collect data on staff employed, their main tasks, availability on the day of the survey, reasons for absenteeism, and experience of supervisory visits from District Health Teams. In-depth interview with health workers was done to explore their perception of work load. A time and motion study of nurses in the Reproductive and Child Health (RCH) clinics documented their time use by task. RESULTS: We found that only 14% (122/854) of the recommended number of nurses and 20% (90/441) of the clinical staff had been employed at the facilities. Furthermore, 44% of clinical staff was not available on the day of the survey. Various reasons were given for this. Amongst the clinical staff, 38% were absent because of attendance to seminar sessions, 8% because of long-training, 25% were on official travel and 20% were on leave. RCH clinic nurses were present for 7 hours a day, but only worked productively for 57% of time present at facility. Almost two-third of facilities had received less than 3 visits from district health teams during the 6 months preceding the survey. CONCLUSION: This study documented inadequate staffing of health facilities, a high degree of absenteeism, low productivity of the staff who were present and inadequate supervision in peripheral Tanzanian health facilities. The implications of these findings are discussed in the context of decentralized health care in Tanzania.

Evaluating the effectiveness of IPTi on malaria using routine health information from sentinel health centres in southern Tanzania.

BACKGROUND: Intermittent preventive treatment of malaria in infants (IPTi) consists of the administration of a treatment dose of sulphadoxine-pyrimethamine (SP) at the time of routine vaccinations. The use of routine Health Management and Information Services (HMIS) data to investigate the effect of IPTi on malaria, anaemia, and all-cause attendance in children aged 2-11 months presenting to 11 health centres in southern Tanzania is described. METHODS: Clinical diagnosis of malaria was confirmed with a positive blood slide reading from a quality assurance laboratory. Anaemia was defined using two thresholds (mild [Hb<11 g/dL], severe [Hb<8 g/dL]). Incidence rates between IPTi and non-implementing health centres were calculated using Poisson regression, and all statistical testing was based on the t test due to the clustered nature of the data. RESULTS: Seventy two per cent of infants presenting in intervention areas received at least one dose of IPTi--22% received all three. During March 2006-April 2007, the incidence of all cause attendance was two attendances per person, per year (pppy), including 0.2 episodes pppy of malaria, 0.7 episodes of mild and 0.13 episodes of severe anaemia. Point estimates for the effect of IPTi on malaria varied between 18% and 52%, depending on the scope of the analysis, although adjustment for clustering rendered these not statistically significant. CONCLUSIONS: The point estimate of the effect of IPTi on malaria is consistent with that from a large pooled analysis of randomized control trials. As such, it is plausible that the difference seen in health centre data is due to IPTi, even thought the effect did not reach statistical significance. Findings draw attention to the challenges of robust inference of effects of interventions based on routine health centre data. Analysis of routine health information can reassure that interventions are being made available and having desired effects, but unanticipated effects should trigger data collection from representative samples of the target population.

Safety of sulfadoxine/pyrimethamine for intermittent preventive treatment of malaria in infants: evidence from large-scale operational research in southern Tanzania.

Intermittent preventive treatment with sulfadoxine/pyrimethamine (SP) is recommended for malaria prevention in infants (IPTi-SP). Serious adverse events, including Stevens-Johnson syndrome (SJS), have been reported following exposure to SP, but few infant-specific data exist. The safety of IPTi-SP was evaluated as part of a pilot implementation programme in southern Tanzania using three methods: spontaneous adverse event reporting to capture suspected adverse drug reactions (ADR); a census survey documenting rash-related hospital admissions among children < 2 years of age; and verbal autopsies (VA) completed for rash-related deaths in 2-11-month-olds. Approximately 82 000 IPTi-SP doses were administered to approximately 29 000 children. In total, 119 suspected ADRs were reported, 13 in children aged <2 years, only one of whom had received IPTi-SP. The census involved 243 612 households. Only one rash-related admission was reported amongst 1292 children aged 2-11 months, but this child had no history of exposure to SP. Moreover, 30 of 699 deaths in 2-11-month-olds were said to have been associated with a skin rash. The rates of rash-associated death were 0.59/1000 person-years at risk (PYAR) and 1.17/1000 PYAR in intervention and comparison areas, respectively (P = 0.79). VAs did not suggest SJS or any other ADR. We conclude that IPTi-SP is associated with a very low incidence of severe skin reactions. [ClinicalTrials.gov identifier: NCT00152204].

Cluster-randomized study of intermittent preventive treatment for malaria in infants (IPTi) in southern Tanzania: evaluation of impact on survival.

BACKGROUND: Intermittent Preventive Treatment for malaria control in infants (IPTi) consists of the administration of a treatment dose of an anti-malarial drug, usually sulphadoxine-pyrimethamine, at scheduled intervals, regardless of the presence of Plasmodium falciparum infection. A pooled analysis of individually randomized trials reported that IPTi reduced clinical episodes by 30%. This study evaluated the effect of IPTi on child survival in the context of a five-district implementation project in southern Tanzania. [ TRIAL REGISTRATION: clinicaltrials.gov NCT00152204]. METHODS: After baseline household and health facility surveys in 2004, five districts comprising 24 divisions were randomly assigned either to receive IPTi (n = 12) or not (n = 12). Implementation started in March 2005, led by routine health services with support from the research team. In 2007, a large household survey was undertaken to assess the impact of IPTi on survival in infants aged two-11 months through birth history interviews with all women aged 13-49 years. The analysis is based on an "intention-to-treat" ecological design, with survival outcomes analysed according to the cluster in which the mothers lived. RESULTS: Survival in infants aged two-11 months was comparable in IPTi and comparison areas at baseline. In intervention areas in 2007, 48% of children aged 12-23 months had documented evidence of receiving three doses of IPTi, compared to 2% in comparison areas (P < 0.0001). Over the three years of the study there was a marked improvement in survival in both groups. Between 2001-4 and 2005-7, mortality rates in two-11 month olds fell from 34.1 to 23.6 per 1,000 person-years in intervention areas and from 32.3 to 20.7 in comparison areas. In 2007, divisions implementing IPTi had a 14% (95% CI -12%, 49%) higher mortality rate in two-11 month olds in comparison with non-implementing divisions (P = 0.31). CONCLUSION: The lack of evidence of an effect of IPTi on survival could be a false negative result due to a lack of power or imbalance of unmeasured confounders. Alternatively, there could be no mortality impact of IPTi due to low coverage, late administration, drug resistance, decreased malaria transmission or improvements in vector control and case management. This study raises important questions for programme evaluation design.

Performance of HRP-2 based rapid diagnostic test for malaria and its variation with age in an area of intense malaria transmission in southern Tanzania.

BACKGROUND: The use of malaria rapid diagnostic tests (RDTs) has been widely advocated to improve Plasmodium falciparum diagnosis, especially in settings where quality microscopy is not available. RDTs based on the detection of histidine-rich protein 2 (HRP-2) can remain positive for several weeks after an infection is cured, due to the persistence of HRP-2 antigens. As a result, test specificity may vary between age groups with different prevalence of P. falciparum infection. METHODS: A community-based cross-sectional survey, carried out in southern Tanzania in July and August 2004, evaluated the performance of the Paracheck Pf in comparison with microscopy (number of P. falciparum parasites/200 leucocytes). A sample of 598 individuals living in an area of intense malaria transmission had demographic data collected before an RDT was performed. HRP-2 test sensitivity, specificity, positive and negative predictive values were calculated and compared between distinct age groups, using microscopy as "gold standard". RESULTS: The overall malaria prevalence was 34.3% according to microscopy and 57.2% according to the HRP-2 test. The HRP-2 test had a sensitivity of 96.1%, a specificity of 63.1%, a positive predictive value of 57.6% and a negative predictive value of 96.9%. The test sensitivity was higher (ranging from 98% to 100%) amongst people less than 25 years of age, but decreased to 81.3% in older adults. The HRP-2 test specificity varied between age groups, ranging from 25% among children of five to nine years of age, to 73% among adults aged 25 or more. The test positive predictive value increased with malaria prevalence, while the negative predictive value was consistently high across age groups. CONCLUSIONS: These results suggest that the performance of HRP-2 tests in areas of intense malaria transmission varies by age and the prevalence of P. falciparum infection. The particularly low specificity among children will lead to the over-estimation of malaria infection prevalence in this group.

Community effectiveness of intermittent preventive treatment for infants (IPTi) in rural southern Tanzania.

Intermittent preventive treatment of malaria in infants (IPTi) with sulphadoxine-pyrimethamine shows evidence of efficacy in individually randomized, controlled trials. In a large-scale effectiveness study, IPTi was introduced in April 2005 by existing health staff through routine contacts in 12 randomly selected divisions out of 24 in 6 districts of rural southern Tanzania. Coverage and effects on malaria and anemia were estimated through a representative survey in 2006 with 600 children aged 2-11 months. Coverage of IPTi was 47-76% depending on the definition. Using an intention to treat analysis, parasitemia prevalence was 31% in intervention and 38% in comparison areas (P = 0.06). In a "per protocol" analysis of children who had recently received IPTi, parasite prevalence was 22%, 19 percentage points lower than comparison children (P = 0.01). IPTi can be implemented on a large scale by existing health service staff, with a measurable population effect on malaria, within 1 year of launch.

Intermittent preventive treatment for malaria and anaemia control in Tanzanian infants; the development and implementation of a public health strategy.

Minimizing the time between efficacy studies and public health action is important to maximize health gains. We report the rationale, development and implementation of a district-based strategy for the implementation of intermittent preventive treatment in infants (IPTi) for malaria and anaemia control in Tanzania. From the outset, a research team worked with staff from all levels of the health system to develop a public-health strategy that could continue to function once the research team withdrew. The IPTi strategy was then implemented by routine health services to ensure that IPTi behaviour-change communication materials were available in health facilities, that health workers were trained to administer and to document doses of IPTi, that the necessary drugs were available in facilities and that systems were in place for stock management and supervision. The strategy was integrated into existing systems as far as possible and well accepted by health staff. Time-and-motion studies documented that IPTi implementation took a median of 12.4 min (range 1.6-28.9) per nurse per vaccination clinic. The collaborative approach between researchers and health staff effectively translated research findings into a strategy fit for public health implementation.

Health and survival of young children in southern Tanzania.

BACKGROUND: With a view to developing health systems strategies to improve reach to high-risk groups, we present information on health and survival from household and health facility perspectives in five districts of southern Tanzania. METHODS: We documented availability of health workers, vaccines, drugs, supplies and services essential for child health through a survey of all health facilities in the area. We did a representative cluster sample survey of 21,600 households using a modular questionnaire including household assets, birth histories, and antenatal care in currently pregnant women. In a subsample of households we asked about health of all children under two years, including breastfeeding, mosquito net use, vaccination, vitamin A, and care-seeking for recent illness, and measured haemoglobin and malaria parasitaemia. RESULTS: In the health facility survey, a prescriber or nurse was present on the day of the survey in about 40% of 114 dispensaries. Less than half of health facilities had all seven 'essential oral treatments', and water was available in only 22%. In the household survey, antenatal attendance (88%) and DPT-HepB3 vaccine coverage in children (81%) were high. Neonatal and infant mortality were 43.2 and 76.4 per 1000 live births respectively. Infant mortality was 40% higher for teenage mothers than older women (RR 1.4, 95% confidence interval (CI) 1.1 - 1.7), and 20% higher for mothers with no formal education than those who had been to school (RR 1.2, CI 1.0 - 1.4). The benefits of education on survival were apparently restricted to post-neonatal infants. There was no evidence of inequality in infant mortality by socio-economic status. Vaccine coverage, net use, anaemia and parasitaemia were inequitable: the least poor had a consistent advantage over children from the poorest families. Infant mortality was higher in families living over 5 km from their nearest health facility compared to those living closer (RR 1.25, CI 1.0 - 1.5): 75% of households live within this distance. CONCLUSION: Relatively short distances to health facilities, high antenatal and vaccine coverage show that peripheral health facilities have huge potential to make a difference to health and survival at household level in rural Tanzania, even with current human resources.

The use of personal digital assistants for data entry at the point of collection in a large household survey in southern Tanzania.

BACKGROUND: Survey data are traditionally collected using pen-and-paper, with double data entry, comparison of entries and reconciliation of discrepancies before data cleaning can commence. We used Personal Digital Assistants (PDAs) for data entry at the point of collection, to save time and enhance the quality of data in a survey of over 21,000 scattered rural households in southern Tanzania. METHODS: Pendragon Forms 4.0 software was used to develop a modular questionnaire designed to record information on household residents, birth histories, child health and health-seeking behaviour. The questionnaire was loaded onto Palm m130 PDAs with 8 Mb RAM. One hundred and twenty interviewers, the vast majority with no more than four years of secondary education and very few with any prior computer experience, were trained to interview using the PDAs. The 13 survey teams, each with a supervisor, laptop and a four-wheel drive vehicle, were supported by two back-up vehicles during the two months of field activities. PDAs and laptop computers were charged using solar and in-car chargers. Logical checks were performed and skip patterns taken care of at the time of data entry. Data records could not be edited after leaving each household, to ensure the integrity of the data from each interview. Data were downloaded to the laptop computers and daily summary reports produced to evaluate the completeness of data collection. Data were backed up at three levels: (i) at the end of every module, data were backed up onto storage cards in the PDA; (ii) at the end of every day, data were downloaded to laptop computers; and (iii) a compact disc (CD) was made of each team's data each day.A small group of interviewees from the community, as well as supervisors and interviewers, were asked about their attitudes to the use of PDAs. RESULTS: Following two weeks of training and piloting, data were collected from 21,600 households (83,346 individuals) over a seven-week period in July-August 2004. No PDA-related problems or data loss were encountered. Fieldwork ended on 26 August 2004, the full dataset was available on a CD within 24 hours and the results of initial analyses were presented to district authorities on 28 August. Data completeness was over 99%. The PDAs were well accepted by both interviewees and interviewers. CONCLUSION: The use of PDAs eliminated the usual time-consuming and error-prone process of data entry and validation. PDAs are a promising tool for field research in Africa.