NCT04545905

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

Completed Last updated 12 December 2022

What this trial tests

trial testing ANC surveillance in Malaria in 13,350 participants. Completed in 31 July 2022.

Timeline

22 September 2020

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	PATH
Status	Completed
Study type	OBSERVATIONAL
Enrollment	13,350
Start date	22 September 2020
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across Burkina Faso

Drugs / interventions tested

• ANC surveillance

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

PATH — full company profile →

Who can join

20 and older, female only, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Determine the prevalence of malaria infection and coverage of malaria control interventions among pregnant women attending their first ANC visit.
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. Analyze the correlation between health seeking and net use/access in the ANC surveillance and health seeking behavior compared to the cross-sectional survey

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.