Malaria Clinical Trial
Official title:
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
Verified date | September 2022 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 13350 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Attending ANC first visit at participating health facility - Pregnant women 20 years or older - Pregnant women under 20 years old and considered an emancipated Exclusion Criteria: • Women with signs of severe malaria as determined by the ANC clinician |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Centre National de Recherche et de Formation sur le Paludisme | Ouagadougou |
Lead Sponsor | Collaborator |
---|---|
PATH | Centers for Disease Control and Prevention, Centre national de recherche et de formation sur le paludisme |
Burkina Faso,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ANC malaria infection prevalence | Malaria infection prevalence among pregnant women attending their first antenatal care visit. | August 2020 to December 2022 | |
Secondary | Correlation between cross-sectional and ANC population indicator values | District-level correlation between indicator values estimated from the ANC population and similar estimates from contemporary household cross-sectional surveys conducted by the New Nets Project. These indicators include: RDT confirmed malaria infection prevalence, net access, net use (household), net use (children under 5), prevalence of fever, malaria health care seeking (testing), malaria health care seeking (treatment). | August 2020 to December 2022 |
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