The Impact of Sulphadoxine-Pyrimethamine Use At Scale on Newborn Outcomes in Nigeria

Malaria Clinical Trial

— MIPP-NG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758353
• Other study ID #: JSI-MIPP-NG #1
• Status: Completed
• Phase: N/A
• First received: April 26, 2016
• Last updated: April 28, 2016
• Start date: April 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: JSI Research & Training Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nigeria: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31493
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria
• Stillbirths

Intervention

Drug:
• Community distribution of SP
SP delivered at both the community and facility level by trained CBHVs in three LGAs.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
JSI Research & Training Institute, Inc.	Bill and Melinda Gates Foundation, Federal Ministry of Health, Nigeria

References & Publications (11)

Blencowe H, Cousens S, Jassir FB, Say L, Chou D, Mathers C, Hogan D, Shiekh S, Qureshi ZU, You D, Lawn JE; Lancet Stillbirth Epidemiology Investigator Group. National, regional, and worldwide estimates of stillbirth rates in 2015, with trends from 2000: a systematic analysis. Lancet Glob Health. 2016 Feb;4(2):e98-e108. doi: 10.1016/S2214-109X(15)00275-2. Epub 2016 Jan 19. — View Citation

Dellicour S, Tatem AJ, Guerra CA, Snow RW, ter Kuile FO. Quantifying the number of pregnancies at risk of malaria in 2007: a demographic study. PLoS Med. 2010 Jan 26;7(1):e1000221. doi: 10.1371/journal.pmed.1000221. — View Citation

Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, Newman RD. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis. 2007 Feb;7(2):93-104. Review. — View Citation

McClure EM, Goldenberg RL, Dent AE, Meshnick SR. A systematic review of the impact of malaria prevention in pregnancy on low birth weight and maternal anemia. Int J Gynaecol Obstet. 2013 May;121(2):103-9. doi: 10.1016/j.ijgo.2012.12.014. Epub 2013 Mar 13. Review. — View Citation

Menendez C, Ordi J, Ismail MR, Ventura PJ, Aponte JJ, Kahigwa E, Font F, Alonso PL. The impact of placental malaria on gestational age and birth weight. J Infect Dis. 2000 May;181(5):1740-5. Epub 2000 May 15. — View Citation

Onwujekwe O, Chima R, Okonkwo P. Economic burden of malaria illness on households versus that of all other illness episodes: a study in five malaria holo-endemic Nigerian communities. Health Policy. 2000 Nov 17;54(2):143-59. — View Citation

Partnership RBM. Roll Back Malaria Annual Report 2013 [Internet]. [cited 2016 Feb 21]. Available from: http://www.rollbackmalaria.org/files/files/resources/RBM-Annual-Report- 2013(1).pdf

Radeva-Petrova D, Kayentao K, ter Kuile FO, Sinclair D, Garner P. Drugs for preventing malaria in pregnant women in endemic areas: any drug regimen versus placebo or no treatment. Cochrane Database Syst Rev. 2014 Oct 10;10:CD000169. doi: 10.1002/14651858.CD000169.pub3. Review. — View Citation

Villar J, Cheikh Ismail L, Victora CG, Ohuma EO, Bertino E, Altman DG, Lambert A, Papageorghiou AT, Carvalho M, Jaffer YA, Gravett MG, Purwar M, Frederick IO, Noble AJ, Pang R, Barros FC, Chumlea C, Bhutta ZA, Kennedy SH; International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st). International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project. Lancet. 2014 Sep 6;384(9946):857-68. doi: 10.1016/S0140-6736(14)60932-6. — View Citation

WHO. Consensus Statement: Optimizing the Delivery of Malaria-inPregnancy Interventions [Internet]. 2013 [cited 2016 Feb 21]. Available from: http://www.pmi.gov/docs/default-source/default-document-library/toolscurricula/consensusreport_malariapregnancy.pdf?sfvrsn=4

WHO. World Malaria Report 2015 [Internet]. 2015. Available from: http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf?ua=1

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants that got SP coverage among all pregnant women	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	No
Secondary	Cost per Woman served with SP in Nigeria Naira	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	No
Secondary	Cost per SP dose delivered in Nigeria Naira	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	No
Secondary	Incidence of Stillbirths in stillbirths per 1000 term births	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	No
Secondary	Head circumference of Newborn in millimeters	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	No