Getting Malaria "Off the Back" of Women and Children in Western Uganda
NCT ID: NCT04102592
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2019-10-28
2020-03-04
Brief Summary
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The purpose of the study is to assess the feasibility and tolerability of using insecticide-treated lesus to reduce the incidence of P. falciparum malaria infection among infants.
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Detailed Description
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The first phase will consist of a series of focus group sessions with mothers of young children and their male partners to gain further insight into lesu use, to include location of purchase and frequency of washing, as well as exploring initial perceptions of insecticide-treated clothing and inform the protocols for the open-label study.
The second phase will consist of a prospective, open-label study. Twenty-five (25) mothers and their young children will be provided with insecticide-treated lesus and twenty-five (25) controls who will be provided untreated lesus. After an initial visit, bi-weekly follow up, including finger-prick blood collections will continue for a period of twelve (12) weeks.
Collected blood spots will be transported to Epicentre for real-time PCR to identify sub-microscopic parasitemia and to the French Research Institute for Development (https://en.ird.fr) in Marseille, France for quantification of the mosquito salivary antigen (gSG6-P1 peptide). Remaining samples will be stored for future analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Group
Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin
Permethrin-treated Lesu (baby wrap)
0.5% permethrin application
Control Group
Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment
Untreated Lesu (baby wrap)
Matching untreated lesu
Interventions
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Permethrin-treated Lesu (baby wrap)
0.5% permethrin application
Untreated Lesu (baby wrap)
Matching untreated lesu
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
FEMALE
Yes
Sponsors
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Conservation, Food, and Health Foundation
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Ross Boyce, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Bugoye Level III Health Centre
Bugoye, Kasese, Uganda
Countries
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References
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Boyce RM, Muhindo E, Baguma E, Muhindo R, Shem B, Francois R, Hawke S, Shook-Sa BE, Ntaro M, Nalusaji A, Nyehangane D, Reyes R, Juliano JJ, Siedner MJ, Staedke SG, Mulogo EM. Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda. Malar J. 2022 Feb 23;21(1):63. doi: 10.1186/s12936-022-04086-w.
Other Identifiers
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IGHID 11829
Identifier Type: OTHER
Identifier Source: secondary_id
18-1819
Identifier Type: -
Identifier Source: org_study_id
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