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

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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

Tracking Information
First Submitted Date  ICMJE September 23, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
Reported change in frequency of use of lesu [ Time Frame: Baseline, 12 weeks ]
Self-reported, includes discontinuation of use
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04102592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • Incidence of symptomatic malaria episodes among children [ Time Frame: 12 weeks ]
    As defined by typical symptoms including fever, malaise, and convulsions.
  • Incidence of P. falciparum malaria parasitemia among children [ Time Frame: 12 weeks ]
    As determined by quantitative PCR
  • Change in mosquito salivary antigen response among children [ Time Frame: Baseline, 12 weeks ]
  • Change in mosquito salivary antigen response among mothers [ Time Frame: Baseline, 12 weeks ]
  • Changes in hemoglobin levels among children [ Time Frame: Baseline, 12 weeks ]
  • Changes in hemoglobin levels among mothers [ Time Frame: Baseline, 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Getting Malaria "Off the Back" of Women and Children in Western Uganda
Official Title  ICMJE IGHID 11829 - Getting Malaria "Off the Back" of Women and Children in Western Uganda
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Malaria
Intervention  ICMJE
  • Other: Permethrin-treated Lesu (baby wrap)
    0.5% permethrin application
  • Other: Untreated Lesu (baby wrap)
    Matching untreated lesu
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Intervention Group
    Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin
    Intervention: Other: Permethrin-treated Lesu (baby wrap)
  • Placebo Comparator: Control Group
    Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment
    Intervention: Other: Untreated Lesu (baby wrap)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04102592
Other Study ID Numbers  ICMJE 18-1819
IGHID 11829 ( Other Identifier: University of North Carolina at Chapel Hill )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Conservation, Food, and Health Foundation
Investigators  ICMJE
Principal Investigator: Ross Boyce, MD, MSc University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP