Skip to main content
OpenTrials
Completed

NCT Number: NCT04102592

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bugoye Level III Health Centre

Bugoye, Kasese, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Permethrin-treated Lesu (baby wrap)

Other

0.5% permethrin application

Untreated Lesu (baby wrap)

Other

Matching untreated lesu

Other names: Placebo

Primary outcomes

  1. Reported change in frequency of use of lesu

    Time frame: Baseline, 12 weeks

    Self-reported, includes discontinuation of use

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Conservation, Food, and Health Foundation

Registry information

Official study title

IGHID 11829 - Getting Malaria "Off the Back" of Women and Children in Western Uganda

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2019
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.