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Getting Malaria "Off the Back" of Women and Children in Western Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102592
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Conservation, Food, and Health Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malaria Other: Permethrin-treated Lesu (baby wrap) Other: Untreated Lesu (baby wrap) Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to control (25) or intervention group (25)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: IGHID 11829 - Getting Malaria "Off the Back" of Women and Children in Western Uganda
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
Drug Information available for: Permethrin

Arm Intervention/treatment
Experimental: Intervention Group
Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin
Other: Permethrin-treated Lesu (baby wrap)
0.5% permethrin application

Placebo Comparator: Control Group
Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment
Other: Untreated Lesu (baby wrap)
Matching untreated lesu
Other Name: Placebo




Primary Outcome Measures :
  1. Reported change in frequency of use of lesu [ Time Frame: Baseline, 12 weeks ]
    Self-reported, includes discontinuation of use


Secondary Outcome Measures :
  1. Incidence of symptomatic malaria episodes among children [ Time Frame: 12 weeks ]
    As defined by typical symptoms including fever, malaise, and convulsions.

  2. Incidence of P. falciparum malaria parasitemia among children [ Time Frame: 12 weeks ]
    As determined by quantitative PCR

  3. Change in mosquito salivary antigen response among children [ Time Frame: Baseline, 12 weeks ]
  4. Change in mosquito salivary antigen response among mothers [ Time Frame: Baseline, 12 weeks ]
  5. Changes in hemoglobin levels among children [ Time Frame: Baseline, 12 weeks ]
  6. Changes in hemoglobin levels among mothers [ Time Frame: Baseline, 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult women (age greater or equal to 18 years) with a healthy child between the ages of 6 months to 18 months from one of four eligible villages

Exclusion Criteria:

  • Mother or child with HIV (and thus taking cotrimoxazole prophylaxis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102592


Contacts
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Contact: Ross Boyce, MD, MSc 919-966-2537 ross_boyce@med.unc.edu
Contact: Edgar Mulogo, PhD, MPH (+256) 772-433-508 emulogo@must.ac.ug

Locations
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Uganda
Bugoye Level III Health Centre Recruiting
Bugoye, Kasese, Uganda
Contact: Shem Bwambale    +256772652361      
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Conservation, Food, and Health Foundation
Investigators
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Principal Investigator: Ross Boyce, MD, MSc University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04102592    
Other Study ID Numbers: 18-1819
IGHID 11829 ( Other Identifier: University of North Carolina at Chapel Hill )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 9 to 36 months following publication
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Malaria
P. Falciparum
Permethrin
Rapid diagnostic test
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action