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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19215

Last updated 2022-12-12

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

ANC surveillance

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

Sponsors & Collaborators

Principal Investigators

  • Baltazar Candrinho, MD · Programa Nacional de Controle da Malaria, Ministry of Health

  • Joseph Wagman, PhD · PATH

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Mozambique

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724161 on ClinicalTrials.gov