Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso

NCT04545905 | Completed

• 2 other identifiers: 1588786INV-003761
• Study Type: observational
• Target: 13,350
• Locations: 1 country
• Sites: 1

Brief Summary

Burkina Faso will be deploying next-generation ITNs through mass campaigns in pre-determined provinces. As part of New Nets Project's initiative to catalyze the market introduction of next-generation ITNs, enhanced surveillance activities will be conducted to support observational impact analyses. As part of this enhanced surveillance, malaria infection prevalence is being measured through annual cross-sectional surveys during peak transmission periods using rapid diagnostic tests (RDTs) in children aged 6 to 59 months (under 5 years). It will also include strengthened routine data collection at all health facilities in the districts. The present study aims to leverage the planned cross-sectional surveys and strengthened routine data conducted by the New Nets Project in three of the study districts (Banfora, Gaoua, and Orodara) to assess (1) whether the malaria infection prevalence data collected during antenatal care (ANC) surveillance correlates with these estimates of community infection prevalence in children 6 to 59 months and (2) if intervention coverage data (particularly ITN ownership and use) collected from ANC surveillance are valid and representative of the population as a whole. These additional data could catalyze a new model of surveillance for malaria, and greatly simplify evaluation of the impact of new interventions, as ANC surveillance could potentially replace or supplement cross-sectional household surveys and provide more granular and timely data. All pregnant women attending first ANC visit at seven health facilities in each study district and who are 20 years old or older or in a union will be eligible for enrollment. Potential participants will be approached during their visit by a health facility worker. During group counselling sessions at initial intake, women will be informed of this pilot surveillance activity, and written informed consent will be obtained from each woman individually prior to routine ANC testing. All consenting women attending ANC first visit at a participating health facilities will be tested for malaria using an RDT and asked to complete a study questionnaire which will include questions about the participant's net use, and care seeking behavior. It is expected to take 15 minutes to complete. Women who test positive for malaria will be given treatment according to national guidelines. There is no additional benefit to individual participants. The specific objectives of this ANC surveillance pilot are to:

1. 1.Determine the prevalence of malaria infection and coverage of malaria control interventions among pregnant women attending their first ANC visit.
2. 2.Assess the correlation between ANC surveillance parasite prevalence from this study, malaria incidence measured from health facilities, and parasite prevalence collected by the New Nets Project during cross-sectional household surveys.
3. 3.Analyze the correlation between health seeking and net use/access in the ANC surveillance and health seeking behavior compared to the cross-sectional survey

Conditions

Malaria

Keywords

Antenatal care; Surveillance; Malaria; Epidemiology; Net use; Net coverage; Prevalence

Outcome Measures

Primary Outcomes (1)

• ANC malaria infection prevalence

  Malaria infection prevalence among pregnant women attending their first antenatal care visit.

  August 2020 to December 2022

Secondary Outcomes (1)

• Correlation between cross-sectional and ANC population indicator values

  August 2020 to December 2022

Study Arms (1)

Pregnant women attending first ANC visit

Pregnant women attending their first ANC visit at selected health facilities in Gaoua, Banfora, and Orodara districts.

Diagnostic Test: ANC surveillance

Interventions

ANC surveillance DIAGNOSTIC_TEST

Clinic-based testing of all pregnant women during antenatal care visits.

Pregnant women attending first ANC visit

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohorts will be selected from three districts in Burkina Faso: Banfora, Gaoua, Orodara. Malaria is endemic in Burkina Faso, with heightened transmission June and October. The overall malaria incidence per 1,000 people is 722 in Gaoua, 729 in Banfora, and 631 in Orodara. The 2017 Malaria Indicator Survey found that malaria prevalence was 16.9% in children under five, a significant decrease from the 45.7% found during the 2014 survey, though the survey took place after the peak transmission season and could be much higher. Insecticide treated nets are the primary vector control method to prevent malaria and are distributed during mass campaigns, antenatal care and Expanded Programme on Immunizations visits, and in the private sector. Four rounds of seasonal malaria chemoprevention is given to children 3 to 59 months of age between July and October throughout much of the country. An indoor residual spray program was recently restarted 2012 and now covers three high-burden districts.

You may qualify if:

• Attending ANC first visit at participating health facility
• Pregnant women 20 years or older
• Pregnant women under 20 years old and considered an emancipated

You may not qualify if:

• Women with signs of severe malaria as determined by the ANC clinician

Sponsors & Collaborators

• PATH: lead
• Centre national de recherche et de formation sur le paludisme: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, 01 BP 2208, Burkina Faso

Location

Related Publications (3)

• Lindblade KA, Steinhardt L, Samuels A, Kachur SP, Slutsker L. The silent threat: asymptomatic parasitemia and malaria transmission. Expert Rev Anti Infect Ther. 2013 Jun;11(6):623-39. doi: 10.1586/eri.13.45.

  PMID: 23750733 BACKGROUND

• van Eijk AM, Hill J, Noor AM, Snow RW, ter Kuile FO. Prevalence of malaria infection in pregnant women compared with children for tracking malaria transmission in sub-Saharan Africa: a systematic review and meta-analysis. Lancet Glob Health. 2015 Oct;3(10):e617-28. doi: 10.1016/S2214-109X(15)00049-2. Epub 2015 Aug 19.

  PMID: 26296450 BACKGROUND

• German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN; Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001 Jul 27;50(RR-13):1-35; quiz CE1-7.

  PMID: 18634202 BACKGROUND

Related Links

• ICF. The DHS Program STATcompiler. Funded by USAID.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Joseph Wagman, PhD

  PATH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 11, 2020
• Study Start: September 22, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-09

Locations

BU (1)