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

NCT04724161 | Completed

• 1 other identifier: 1594989
• Study Type: observational
• Target: 19,215
• Locations: 1 country
• Sites: 1

Brief Summary

This study outlines a plan for conducting a routine assessment of malaria infection prevalence and intervention coverage using antenatal care (ANC) attendees. This will be a non-randomized assessment of the potential to use pregnant women attending their first ANC visit as a pragmatic sentinel population to monitor prevalence of malaria and the coverage of malaria control interventions. The use of a questionnaire, to include standard malaria rapid diagnostic testing, will be piloted with consenting women attending their first ANC visit at 21 individual health facilities across three of the New Net Project pilot study districts in western Mozambique: seven facilities each from Changara, Chemba, and Guro Districts. The results of the ANC questionnaires will be analyzed to see how well they correlate to similar malaria prevalence and intervention coverage estimates obtained during the contemporary community-based cross-sectional surveys administered during New Net Project pilot evaluation activities. As part of the New Nets Project, Mozambique is deploying next-generation ITNs through mass campaigns in pre-determined provinces. The present study aims to leverage planned New Nets Project cross-sectional surveys and strengthened routine case surveillance data in three of the study districts (Changara, Guro, and Chemba) to assess (1) whether the malaria infection prevalence data collected during ANC surveillance correlates with the cross-sectional survey 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 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 facility 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.

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 ANC visit.

  December 2020 to December 2022

Secondary Outcomes (1)

• Correlation between cross-sectional and ANC population indicator values

  December 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 Changara, Guro, and Chemba districts.

Diagnostic Test: ANC surveillance

Interventions

ANC surveillance DIAGNOSTIC_TEST

Clinic-based testing of all pregnant women during antenatal care visits using national standards and commercially available malaria rapid diagnostic tests

Pregnant women attending first ANC visit

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from among all women attending select ANC clinics in three districts in Mozambique: Changara, Guro, and Chemba.

You may qualify if:

• Attending ANC first visit at participating health facility
• Pregnant women 18 years or older
• Pregnant women ages 12 to 17 accompanied by a legal guardian who can provide consent

You may not qualify if:

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

Sponsors & Collaborators

• PATH: lead
• Ministry of Health, Mozambique: collaborator
• Tropical Health LLP: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Programa Nacional de Controle da Malaria, Ministry of Health

Maputo, Mozambique

Location

Related Publications (5)

• 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

• Mayor A, Menendez C, Walker PGT. Targeting Pregnant Women for Malaria Surveillance. Trends Parasitol. 2019 Sep;35(9):677-686. doi: 10.1016/j.pt.2019.07.005. Epub 2019 Aug 5.

  PMID: 31395496 BACKGROUND

• 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

• Ataguba JE. A reassessment of global antenatal care coverage for improving maternal health using sub-Saharan Africa as a case study. PLoS One. 2018 Oct 5;13(10):e0204822. doi: 10.1371/journal.pone.0204822. eCollection 2018.

  PMID: 30289886 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

Related Links

• ICF. The DHS Program STATcompiler. Funded by USAID.
• Ministério da Saúde (MISAU), Instituto Nacional de Estatística (INE), and ICF. Survey of Indicators on Immunization, Malaria and HIV/AIDS in Mozambique (IMASIDA) 2015.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Baltazar Candrinho, MD

  Programa Nacional de Controle da Malaria, Ministry of Health

  PRINCIPAL INVESTIGATOR

• 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: January 21, 2021
• First Posted: January 26, 2021
• Study Start: December 9, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-09

Locations

MO (1)