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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102592
• Other study ID #: 18-1819
• Secondary ID: IGHID 11829
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: March 4, 2020

Study information

• Verified date: February 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• Permethrin-treated Lesu (baby wrap)
0.5% permethrin application
• Untreated Lesu (baby wrap)
Matching untreated lesu

Locations

Country	Name	City	State
Uganda	Bugoye Level III Health Centre	Bugoye	Kasese

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Conservation, Food, and Health Foundation

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported change in frequency of use of lesu	Self-reported, includes discontinuation of use	Baseline, 12 weeks
Secondary	Incidence of symptomatic malaria episodes among children	As defined by typical symptoms including fever, malaise, and convulsions.	12 weeks
Secondary	Incidence of P. falciparum malaria parasitemia among children	As determined by quantitative PCR	12 weeks
Secondary	Change in mosquito salivary antigen response among children		Baseline, 12 weeks
Secondary	Change in mosquito salivary antigen response among mothers		Baseline, 12 weeks
Secondary	Changes in hemoglobin levels among children		Baseline, 12 weeks
Secondary	Changes in hemoglobin levels among mothers		Baseline, 12 weeks