Clinical trial NCT02758353: The Impact of Sulphadoxine-Pyrimethamine Use At Scale on Newborn Outcomes in Nigeria
Official title: Scaling up the Use of Sulphadoxine-Pyrimethamine for the Preventive Treatment of Malaria in Pregnancy: Results and Lessons on Scalability, Costs and Program From Three Local Government Areas in Sokoto State, Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Stillbirths
Keywords: Malaria in Pregnancy
Nigeria
Sulfadoxine-Pyrimethamine
Scale up
Primary Health Care
Lead sponsor: JSI Research & Training Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Federal Ministry of Health, Nigeria
First posted: 2016-05-02
Enrollment: 31493
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test the feasibility of the scale-up of sulphadoxine- pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the introduction of community-based distribution of SP in addition to ongoing health facility distribution during antenatal care (ANC) visits. In addition, the study examined for the effect of SP use by participants during pregnancy on the head circumference of live newborns and on the odds of a baby being a stillborn. Finally, the investigators also sought to quantify the costs associated with program scale up SP to deliver at least three doses of SP per participant via a government operated distribution program.

Detailed description: Study Objectives

The study objectives were to:

1. Examine scale-up mechanisms that enable increased SP coverage through community-based primary health care delivery, without reducing facility uptake of SP.
2. Examine community acceptance of SP and the likelihood of long-term community-sustained demand.
3. Document associations, if any, between increased SP coverage and improved intrauterine conditions for newborn, as measured by head circumference increments and declines in still birth rates.
4. Estimate the costs of delivering SP at scale per woman for a three doses or higher regimen.

Study Location and Relevant Contextual Information

The study was undertaken in four LGAs: Dange Shuni Goronyo and Silame (combined 2015 population, according to official Sokoto State estimates = 661,606) LGAs which were purposively selected as intervention LGAs; and Yabo LGA, the fourth (2015 population, according to official Sokoto State estimates = 167,971), was purposively selected as the counterfactual LGA. The selection criteria were that all LGAs had a high prevalence of malaria in pregnancy and that at one LGA each in the intervention group, was selected from each of the State's three senatorial zones.

Sampling Size Considerations

Given the intention of the study to examine the prospects of scaling up an already existing program, to reach all eligible pregnant participants, no sampling regimen was included in this study.

Data Collection Procedures

The community-based health volunteer (CBHV) system has an inbuilt data collection system managed by a community drug keeper (CDK) and a supervising facility-based health worker to monitor distribution at the community level. Investigators used an outcome form to collect data. Data captured in the outcome form included the condition of the newborn and mother at birth, of the newborn at birth-live birth or stillbirth-at days 7, 14 and 28 postpartum. For this study, the investigators modified the outcome form to also capture the number of SP doses a participant received and date/month the participant got them. The modified outcome form also collected data on a pregnant participant's primipara status, ANC status, gestation in months at time of delivery, the state of newborns (live or stillborn), sex of the newborn and head circumference measurements.

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 facto providers of primary health care in Nigeria, to deliver SP-related services at both the community and facility level, including start-up costs. Six cost centers were included in the analyses: health facility, LGA technical administration, CBHV supervisors, ward development committees, CBHV, and logistics for SP distribution.

Data Quality Procedures

Twelve teams of four data quality auditors, independent of other project staff, were recruited to track data quality obtained from communities. Each team comprised of three females and one supervisor. Over the life of the project, the teams visited all the participants recorded with at least one birth-that occurred during the project-in the 42 wards of the three intervention and one counterfactual LGAs. The data auditors also sought for and compiled information on omitted mothers and births. The auditors were expected to directly inquire of a participant-or an informed family member - in the event of a maternal death-if a CBHV and CBHV Supervisor visited, the status of newborns, alive or stillborn, and if head circumference was measured within seven days among live births. With participants' responses as the gold standard, births, status of births, and confirmed head circumference measurements were verified.

Statistical Analyses

Programmatic data was used to assess the coverage of SP doses during pregnancy in the intervention and counterfactual LGA's. Univariate and multivariate analyses were used by investigators to test associations between doses of SP and newborn head circumference and the odds of stillbirth. These analyses were conducted in Statistical Analysis System (SAS) v.9 and excel.

For cost data, the investigators calculated two ratios: cost per dose and cost per woman served, disaggregated by number of SP doses in the intervention and and counterfactual group. Analyses were conducted in Excel®.

Eligibility criteria: Inclusion Criteria:

1. Participants must be pregnant.
2. Pregnant participants must have experienced quickening in course of gestation.
3. Participants must reside in an intervention or a counterfactual LGA.

Exclusion Criteria:

1. Non-pregnant residents in a counterfactual or an intervention LGA.
2. Non-residents of counterfactual or intervention LGA.

Primary outcomes:
measure: Percentage of participants that got SP coverage among all pregnant women
timeFrame: Up to 7 months
Secondary outcomes:
measure: Cost per Woman served with SP in Nigeria Naira
timeFrame: Up to 7 months
measure: Cost per SP dose delivered in Nigeria Naira
timeFrame: Up to 12 months
measure: Incidence of Stillbirths in stillbirths per 1000 term births
timeFrame: Up to 7 months
measure: Head circumference of Newborn in millimeters
timeFrame: Up to 7 months
Other outcomes:
Locations:
Study officials:
affiliation: John Snow, Inc.
name: Nosa G Orobaton, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
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