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| ID | Type | Description | Link |
|---|---|---|---|
| IGHID 11829 | Other Identifier | University of North Carolina at Chapel Hill |
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| Name | Class |
|---|---|
| Conservation, Food, and Health Foundation | UNKNOWN |
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This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda.
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.
This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin |
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| Control Group | Placebo Comparator | Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permethrin-treated Lesu (baby wrap) | Other | 0.5% permethrin application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reported change in frequency of use of lesu | Self-reported, includes discontinuation of use | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic malaria episodes among children | As defined by typical symptoms including fever, malaise, and convulsions. | 12 weeks |
| Incidence of P. falciparum malaria parasitemia among children |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ross Boyce, MD, MSc | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bugoye Level III Health Centre | Bugoye | Kasese | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35197060 | Derived | 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. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication
The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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Participants will be randomized to control (25) or intervention group (25)
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| Untreated Lesu (baby wrap) |
| Other |
Matching untreated lesu |
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As determined by quantitative PCR
| 12 weeks |
| Change in mosquito salivary antigen response among children | Baseline, 12 weeks |
| Change in mosquito salivary antigen response among mothers | Baseline, 12 weeks |
| Changes in hemoglobin levels among children | Baseline, 12 weeks |
| Changes in hemoglobin levels among mothers | Baseline, 12 weeks |
| D000079426 |
| Vector Borne Diseases |