Scaling-up the use of sulfadoxine-pyrimethamine for the preventive treatment of malaria in pregnancy: results and lessons on scalability, costs and programme impact from three local government areas in Sokoto State, Nigeria

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Study Justification:
The study aimed to assess the scalability, costs, and impact of scaling up the use of sulfadoxine-pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in Sokoto State, Nigeria. The justification for the study was to determine the feasibility, safety, and affordability of implementing high-impact interventions in low-resource malaria endemic settings, where access to facility-based maternal health services is limited.
Highlights:
1. The study found that it was feasible to scale up the delivery of IPTp-SP interventions to all pregnant women in the intervention areas.
2. The coverage of SP1 (first dose of IPTp-SP) was 95% in the intervention areas, compared to only 26% in the counterfactual area.
3. Measurable SP3+ (three or more doses of IPTp-SP) coverage was 45% in the intervention areas, while it was 0% in the counterfactual area.
4. Increased doses of IPTp-SP were associated with linear increases in newborn head circumference and lower odds of stillbirth.
5. Any antenatal care utilization predicted larger newborn head circumference and lower odds of stillbirth.
Recommendations:
1. Scale up the delivery of IPTp-SP interventions to all pregnant women in malaria endemic areas.
2. Strengthen community education and mobilization efforts to increase awareness and demand for IPTp-SP.
3. Improve the availability and accessibility of SP at health facilities and in communities.
4. Enhance the integration of IPTp-SP interventions with existing antenatal care services.
5. Monitor and evaluate the implementation and impact of IPTp-SP interventions to inform future programming.
Key Role Players:
1. Ministry of Health: Responsible for policy development, coordination, and oversight of malaria control programs.
2. Local Government Authorities: Responsible for implementing and coordinating malaria control interventions at the local level.
3. Community Health Volunteers: Engaged in community education, mobilization, and distribution of SP.
4. Health Facility Staff: Involved in the distribution of SP and provision of antenatal care services.
5. Women’s Development Committees: Support community health volunteers in the distribution of SP and conduct community meetings.
Cost Items:
1. Health Facility Costs: Including staff salaries, training, and infrastructure.
2. Local Government Administration Costs: Including coordination, supervision, and monitoring.
3. Community Health Volunteer Costs: Including training, transportation, and incentives.
4. Women’s Development Committee Costs: Including meeting rentals and support for community meetings.
5. Logistics for SP Distribution: Including transportation and storage of SP.
6. Start-up Costs: Including initial investments in training, equipment, and supplies.
Please note that the cost items mentioned above are budget items and not actual costs. The actual cost estimates can be obtained from the project records and other sources.

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is based on data collected from a project implemented in three local government areas in Sokoto State, Nigeria. The study provides information on the coverage of sulfadoxine-pyrimethamine (SP) distribution to pregnant women, associations between SP dosages and newborn outcomes, and the cost of delivering SP. However, the abstract does not provide details on the study design, sample size, or statistical methods used. To improve the strength of the evidence, the abstract should include these details and provide more information on the representativeness of the study population. Additionally, the abstract could benefit from a clear statement of the study objectives and a summary of the main findings.

Background: Intermittent preventive treatment of malaria in pregnancy with 3+ doses of sulfadoxine-pyrimethamine (IPTp-SP) reduces maternal mortality and stillbirths in malaria endemic areas. Between December 2014 and December 2015, a project to scale up IPTp-SP to all pregnant women was implemented in three local government areas (LGA) of Sokoto State, Nigeria. The intervention included community education and mobilization, household distribution of SP, and community health information systems that reminded mothers of upcoming SP doses. Health facility IPTp-SP distribution continued in three intervention (population 661,606) and one counterfactual (population 167,971) LGAs. During the project lifespan, 31,493 pregnant women were eligible for at least one dose of IPTp-SP. Methods: Community and facility data on IPTp-SP distribution were collected in all four LGAs. Data from a subset of 9427 pregnant women, who were followed through 42 days postpartum, were analysed to assess associations between SP dosages and newborn status. Nominal cost and expense data in 2015 Nigerian Naira were obtained from expenditure records on the distribution of SP. Results: Eighty-two percent (n = 25,841) of eligible women received one or more doses of IPTp-SP. The SP1 coverage was 95% in the intervention LGAs; 26% in the counterfactual. Measurable SP3+ coverage was 45% in the intervention and 0% in the counterfactual LGAs. The mean number of SP doses in the intervention LGAs was 2.1; 0.4 in the counterfactual. Increased doses of IPTp-SP were associated with linear increases in newborn head circumference and lower odds of stillbirth. Any antenatal care utilization predicted larger newborn head circumference and lower odds of stillbirth. The cost of delivering three doses of SP, inclusive of the cost of medicines, was US.93-ce:para.20. Conclusions: It is feasible, safe, and affordable to scale up the delivery of high impact IPTp-SP interventions in low resource malaria endemic settings, where few women access facility-based maternal health services.

From the HRS database, 25,572 women who were eligible for SP between April and November in the three intervention LGAs, were identified. Based on actual numbers, 94% of pregnant women in the intervention LGAs became eligible for SP1 between April and November. In the intervention LGAs, the number of pregnant women eligible to receive SP1, was used as a denominator to calculate SP1, SP2 and SP3+ coverage (Table 4). Determining the number of women eligible for SP1 between April and November 2015, and differences between project mapping and official projections aMean percentage of women becoming eligible for SP1 in the intervention LGA’s bEstimated using the mean percentage of pregnant women that became eligible for SP1 in the intervention LGAs In the counterfactual group, the number of pregnant women eligible to receive SP1 over the life of the project was estimated. Using the official population estimate for Yabo LGA, from the Sokoto State Government (167,971) and assuming that 5% of the population was pregnant, there were an estimated 8399 pregnant women in Yabo, in 2015. Prorating that number for the 8 months of the project, there were an estimated 6299 pregnant women in Yabo between April and November 2015. Assuming Yabo would have the same percentage of women eligible for SP1, as found in the intervention areas (94%) it was estimated that there was a total of 5921 women eligible for SP1 during the project lifespan (Table 4). This estimate as the denominator to calculate SP1 and SP2 coverage. Univariate and bivariate analyses were performed to compare intervention and counterfactual LGAs on the number of SP doses and source of SP. Analyses were conducted in Excel spreadsheet®. Programmatic data extracted from outcome forms were available for 9241 live births in intervention and counterfactual LGAs between April and November. Head circumference (analyzed in mm) of live newborns measured within 7 days of birth, was available for 6720 (73%) of live births. Head circumference data were missing for 2521 live newborns. Of these, 1721 (19%) mother-newborn dyads missed initially, were identified during the data quality review in October. For the remaining 800 newborns, head circumferences were not measured within 7 days postpartum. Independent variables used in this analysis were guided by prevailing epidemiological evidence base and by what was feasible to collect by CBHV supervisors. These included the sex of newborn, gravidity of mothers, successive doses of SP, exposure to ANC, month of delivery and gestational age at birth. Globally, female newborns have smaller head circumferences than male newborns [15]. Primigravida women are at higher risk for placental malarial infection, [35]. Table 1 presents how each of these variables was coded in the analyses. Variables used to understand the impact of SP interventions on head circumference among 6720 live newborns, born between May and November 2015 Univariate analyses tested for any associations between a given independent variable and the mean head circumference of live newborns. Unadjusted t tests were used to assess any differences within each predictor variable and newborn head circumference. Unadjusted tests of correlations between mean head circumference and doses of IPTp-SP, and month of birth, were performed. Mean newborn head circumferences were used to assess correlations in the number of IPTp-SP doses over the project period in the intervention and counterfactual LGAs. A multivariate linear regression model was used to test for the impact of SP doses and other variables on head circumference. Analyses were performed with Excel® and SAS v. 9.4. Data extracted from outcome forms were available for 9453 term births in both the intervention and control LGAs between April and November. To examine the impact of IPTp-SP doses on the incidence of stillbirths, all confirmed pregnancies that ended in miscarriage and abortion, or were delivered before 8 months of gestational age (n = 99) were excluded. If the newborn was stillborn, it was coded as “1”; if it was a live birth, it was coded as “0.” Stillbirth rates (SBR), per 1000 births, and correlations between SBR and doses of SP were calculated. Unadjusted and adjusted logistic regression modelling was used to predict the odds with 95% confidence intervals, of having a stillbirth among women who ingested different doses of SP, according to exposure to intervention, those who attended at least one ANC visit, gravidity of mothers, those who gave birth in a facility vs those who gave birth at home, and those who gave birth later (July–November) vs. those who gave birth earlier (April–June). Multivariate logistic regression analysis was used to assess whether these associations would hold after controlling for other variables in the model. Analyses were conducted in Excel® and SAS v9.4. Table 2 presents each variable as coded in the analyses. Variables used to understand the associations between SP interventions and stillbirths between April and November 2015 (n = 9453) Nominal cost and expense data in 2015 Nigerian Naira (NGN) directly related to community and facility distribution of SP in the intervention and counterfactual LGAs were obtained from project records and other sources. The cost estimates obtained are what it would cost the state government and LGAs as de jure providers of primary health care in Nigeria, to deliver SP-related services at both the community and facility level, including start-up costs. Estimates were limited to a 12-month horizon. Different degrees of contributions by each service component at facility and community levels, towards the delivery of SP at facility and community levels, were assumed. Table 3 lists the assumptions about the magnitude of contributions by each level of care to SP distribution. For this purpose, six cost centers were included in the analysis: health facility, LGA technical administration, CBHV supervisors, WDC, CBHV, and logistics for SP distribution. Table 3 provides a summary of each cost center, and their relative contribution towards SP distribution the activities involved; these were costed. Twenty-two work days per month were assumed. Published government salary schedules were used to compute government officers’ salary costs. Governments officers’ salary costs included time spent at monthly LGA level review meetings in each LGA attended by representatives of wards. At the community level, costs were attributed to WDCs and to CBHVs. There was a WDC and one CBHV supervisor in each ward. WDCs supported CBHVs in the distribution of SP and supervised CBHV, as well as ad hoc community meetings that were called to tackle issues that could undermine the demand or supply sides of the programme. CBHV-related costs also included level of effort, transportation for SP distribution and monthly rentals of meeting rooms for ward-level CBHV review meetings also attended by LGA officials. Costs associated with the transportation and distribution of SP to 42 health facilities were captured in central storage costs. Cost centers by level of care and magnitude of their component costs associated with SP distribution Two ratios were calculated: cost per dose and cost per woman served, disaggregated by number of SP doses in the intervention and counterfactual group. Ratios were obtained from annualized costs derived in each LGA, intervention and counterfactual, the total as well as the disaggregated number of SP doses distributed, and from the total number of women served.

Based on the provided information, some potential innovations to improve access to maternal health include:

1. Mobile Health (mHealth) Applications: Develop and implement mobile applications that provide pregnant women with information on maternal health, including reminders for prenatal visits and medication intake, as well as access to teleconsultations with healthcare providers.

2. Community Health Workers (CHWs): Train and deploy CHWs to provide education and support to pregnant women in remote or underserved areas. CHWs can conduct home visits, provide antenatal care, and distribute essential medications like sulfadoxine-pyrimethamine.

3. Telemedicine: Establish telemedicine services to enable pregnant women to consult with healthcare providers remotely. This can help overcome geographical barriers and improve access to specialized care, especially in areas with limited healthcare facilities.

4. Public-Private Partnerships: Foster collaborations between the government, private sector, and non-profit organizations to improve the availability and affordability of maternal health services. This can involve initiatives such as subsidized medication distribution, public awareness campaigns, and capacity building for healthcare providers.

5. Supply Chain Management: Implement efficient supply chain management systems to ensure the timely availability of essential medications, like sulfadoxine-pyrimethamine, in healthcare facilities. This can involve using technology for inventory management, forecasting, and distribution.

6. Health Information Systems: Strengthen health information systems to collect and analyze data on maternal health indicators. This can help identify gaps in service delivery, monitor progress, and inform evidence-based decision-making for improving access to maternal health services.

7. Financial Incentives: Introduce financial incentives, such as conditional cash transfers or health insurance schemes, to encourage pregnant women to seek antenatal care and deliver in healthcare facilities. This can help reduce financial barriers and increase utilization of maternal health services.

8. Community Engagement: Engage communities in promoting maternal health by raising awareness, addressing cultural barriers, and involving community leaders in advocating for improved access to maternal health services.

9. Task Shifting: Train and empower lower-level healthcare providers, such as nurses and midwives, to perform certain tasks traditionally done by doctors. This can help alleviate the shortage of skilled healthcare professionals and improve access to maternal health services in resource-constrained settings.

10. Quality Improvement Initiatives: Implement quality improvement initiatives in healthcare facilities to ensure the provision of safe and effective maternal health services. This can involve training healthcare providers, improving infrastructure, and strengthening infection prevention and control measures.
AI Innovations Description
Based on the provided information, the recommendation to improve access to maternal health is to scale up the use of sulfadoxine-pyrimethamine (SP) for the preventive treatment of malaria in pregnancy. This intervention has been shown to reduce maternal mortality and stillbirths in malaria-endemic areas. The project implemented in Sokoto State, Nigeria included community education and mobilization, household distribution of SP, and community health information systems to remind mothers of upcoming SP doses. Health facility distribution of SP also continued.

The results of the project showed that 82% of eligible women received one or more doses of IPTp-SP. The coverage of SP1 was 95% in the intervention areas compared to 26% in the counterfactual area. Measurable coverage of SP3+ was 45% in the intervention areas and 0% in the counterfactual area. Increased doses of IPTp-SP were associated with linear increases in newborn head circumference and lower odds of stillbirth. Any antenatal care utilization also predicted larger newborn head circumference and lower odds of stillbirth.

The cost of delivering three doses of SP, including the cost of medicines, was US$93.20. This indicates that scaling up the delivery of high impact IPTp-SP interventions in low-resource malaria-endemic settings is feasible, safe, and affordable.

To implement this recommendation, it is important to prioritize community education and mobilization to raise awareness about the benefits of IPTp-SP and ensure that pregnant women have access to SP. Household distribution of SP can be done to reach women who may not have easy access to health facilities. Additionally, community health information systems can be established to remind mothers of upcoming SP doses and encourage adherence to the treatment regimen. Collaboration between community health workers, health facilities, and local government authorities is crucial for the successful implementation of this intervention.
AI Innovations Methodology
Based on the provided information, here are some potential recommendations for improving access to maternal health:

1. Strengthen community education and mobilization: Increase efforts to educate and mobilize communities about the importance of maternal health and the available services. This can be done through community health workers, local leaders, and community-based organizations.

2. Expand household distribution of maternal health supplies: Implement a system for distributing maternal health supplies, such as prenatal vitamins, iron supplements, and mosquito nets, directly to households. This can help ensure that pregnant women have access to these essential items.

3. Enhance community health information systems: Develop and implement community health information systems that can remind pregnant women of upcoming appointments, provide information about maternal health services, and track their progress throughout pregnancy. This can be done through mobile phone applications, text messaging, or community-based health workers.

4. Improve access to antenatal care: Strengthen efforts to increase the utilization of antenatal care services. This can be achieved by reducing barriers to access, such as distance, cost, and cultural beliefs, and by promoting the benefits of regular antenatal check-ups.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could be developed as follows:

1. Define the indicators: Identify key indicators that will measure the impact of the recommendations on improving access to maternal health. This could include indicators such as the percentage of pregnant women receiving antenatal care, the percentage of pregnant women receiving essential maternal health supplies, and the percentage of pregnant women attending all recommended appointments.

2. Collect baseline data: Gather baseline data on the current status of access to maternal health services in the target population. This could involve conducting surveys, interviews, or reviewing existing data sources.

3. Develop a simulation model: Create a simulation model that incorporates the recommendations and their potential impact on the identified indicators. This model should take into account factors such as population size, geographical distribution, and existing healthcare infrastructure.

4. Input data and run simulations: Input the baseline data into the simulation model and run multiple simulations to estimate the potential impact of the recommendations on improving access to maternal health. This could involve varying parameters such as the coverage of community education efforts, the effectiveness of household distribution systems, and the utilization of antenatal care services.

5. Analyze results: Analyze the results of the simulations to determine the potential impact of the recommendations on the identified indicators. This could involve comparing the simulated outcomes to the baseline data and identifying any significant improvements or changes.

6. Refine and validate the model: Refine the simulation model based on the analysis of the results and validate it using additional data sources or expert input. This will help ensure the accuracy and reliability of the simulation.

7. Communicate findings and make recommendations: Present the findings of the simulation and use them to make recommendations for improving access to maternal health. This could involve sharing the results with relevant stakeholders, such as policymakers, healthcare providers, and community leaders, and advocating for the implementation of the recommended interventions.

By following this methodology, it is possible to simulate the potential impact of the recommendations on improving access to maternal health and inform decision-making processes for implementing effective interventions.

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