Malaria Prevalence Around Maferinyah, Guinea

NCT04105855 | Completed

• 2 other identifiers: 99991914119-I-N141
• Study Type: observational
• Target: 3,392
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Many women in Sub-Saharan Africa get malaria while they are pregnant. Plasmodium falciparum is a parasite that can cause malaria. Placental malaria (PM) caused by P. falciparum can cause anemia or death in first-time mothers. In infants, it can cause low birth weight, premature birth, or other problems. Some women don t show any signs of having PM. This makes it harder to know if they might have it. Researchers want to learn how much the seasons affect the number of women and infants who get PM as well as the severity of the disease. To do this, they are going to test women and babies who visit a health center in Guinea. Objective: To learn the seasonal burden of P. falciparum infection in pregnant women and otherwise healthy infants. Eligibility: Pregnant women ages 18 years and older (or emancipated minors) and infants ages 6-12 months. Design: Participants will include women and infants who visit the health center in Maf(SqrRoot)(Registered Trademark)rinyah, Guinea, for routine care. They can take part only once per pregnancy. For screening, mothers will talk about their medical history. They will talk about their past pregnancies and their current pregnancy. They will answer questions about where they live and what they do to keep from getting malaria. Babies will be screened with their medical history and demographic information. Participants will also give a blood sample. Adults will have a finger stick. Children will have a heel stick. Or they will have blood taken from a vein. Participation will last for 1 visit to the health center.

Conditions

Malaria

Keywords

Organism; Seasonal; Blood Smear; Burden; Infections; Natural History

Outcome Measures

Primary Outcomes (1)

• Estimate of the seasonal burden of Plasmodium falciparum infection among pregnant women and otherwise healthy infants

  seasonal burden of Plasmodium falciparum infection

  3 years

Secondary Outcomes (1)

• Estimate of the frequency of parasitemia due to non-falciparum malaria

  3 years

Study Arms (2)

Older Infants

Infants age 6-12 months presenting for routine healthy visits

Pregnant Women

Women 18 years and older (and emancipated minors) presenting for routine antenatal visits

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women 18 years of age and older (including emancipated minors) and 6-12 month old infants presenting for routine visits at Maf(SqrRoot)(Registered Trademark)rinyah Health Centers

You may qualify if:

• For pregnant women, a study participant must satisfy the following criteria to be enrolled in this study:
• Pregnant women greater than or equal to 18 years of age (or emancipated minors) reporting for routine antenatal care at the health center without acute illness
• The study participant understands the study and gives informed consent for participation
• Willingness to share a positive test result for malaria or helminths with the health center in Maf(SqrRoot)(Registered Trademark)rinyah so treatment can be initiated if necessary
• Willingness to allow stored laboratory specimens to be used for future research
• For children, a study participant must satisfy the following criteria to be enrolled in this study:
• Children 6-12 months of age at time of visit presenting for routine care at the health center without acute illness
• The parent or guardian understands the study and gives informed consent for participation of their child
• Willingness of parent/guardian to share a positive test result for malaria or helminths with the health center in Maferinyah so treatment can be initiated if necessary
• Willingness of parent/guardian to allow stored laboratory specimens to be used for future research

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Maferinyah Rural Health Training and Research Center

Maferinyah, Guinea

Location

Related Publications (2)

• Kwan JL, Seitz AE, Fried M, Lee KL, Metenou S, Morrison R, Kabyemela E, Nutman TB, Prevots DR, Duffy PE. Seroepidemiology of helminths and the association with severe malaria among infants and young children in Tanzania. PLoS Negl Trop Dis. 2018 Mar 26;12(3):e0006345. doi: 10.1371/journal.pntd.0006345. eCollection 2018 Mar.

  PMID: 29579050 BACKGROUND

• Rogerson SJ, Desai M, Mayor A, Sicuri E, Taylor SM, van Eijk AM. Burden, pathology, and costs of malaria in pregnancy: new developments for an old problem. Lancet Infect Dis. 2018 Apr;18(4):e107-e118. doi: 10.1016/S1473-3099(18)30066-5. Epub 2018 Jan 31.

  PMID: 29396010 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Finger prick/heel stick samples and peripheral blood

MeSH Terms

Conditions

Malaria; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Patrick E Duffy, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: July 13, 2020
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

GU (1)