The Impact of Sulphadoxine-Pyrimethamine Use At Scale on Newborn Outcomes in Nigeria (MIPP-NG)

April 28, 2016 updated by: Nosa Orobaton, JSI Research & Training Institute, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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®.

Study Type

Interventional

Enrollment (Actual)

31493

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community distribution of SP
All the eligible pregnant women were reached with SP either at health clinic and/or at community/household level with sulphadoxine-pyrimethamine (SP). Alerts and reminders were sent to them by community-based health volunteers ahead of subsequent SP doses.
Drug: Community distribution of SP
SP delivered at both the community and facility level by trained CBHVs in three LGAs.
Other Names:
  • Community Distribution of SP to eligible participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants that got SP coverage among all pregnant women
Time Frame: Up to 7 months
The percentage SP coverage among all pregnant participants and by number of SP doses ingested. The outcome form will be used to obtain an aggregate number of women that received SP. The total number of eligible women will be obtained from either an enumeration of eligible women in the intervention LGA, or by population estimation in the counterfactual LGA.
Up to 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost per Woman served with SP in Nigeria Naira
Time Frame: Up to 7 months
This will be obtained from costing data produced by the study and the total number of participants served as derived from the outcome forms.
Up to 7 months
Cost per SP dose delivered in Nigeria Naira
Time Frame: Up to 12 months
This will be obtained from costing data produced by the study and the total number of SP doses given as derived from the outcome forms.
Up to 12 months
Incidence of Stillbirths in stillbirths per 1000 term births
Time Frame: Up to 7 months
Stillbirth is a delivery that occurred after 7 months of gestation in which a baby was birthed without any signs of life (no breathing, no movement, and no sound) as reported by a participant or an informed family member.
Up to 7 months
Head circumference of Newborn in millimeters
Time Frame: Up to 7 months
Head circumference of live newborns was measured within 7 days postpartum by CBHV. The information will be aggregated from individual outcome forms.
Up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JSI Research & Training Institute, Inc.

Collaborators

Bill and Melinda Gates Foundation
Federal Ministry of Health, Nigeria

Investigators

  • Principal Investigator: Nosa G Orobaton, MD, DrPH, John Snow, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSI-MIPP-NG #1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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