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

University of North Carolina (UNC)

Status: Completed

Conditions: Malaria

Treatments: Other: Permethrin-treated Lesu (baby wrap); Other: Untreated Lesu (baby wrap)

Study type: Interventional

Funder types: Other

Identifiers

NCT04102592

IGHID 11829 (Other Identifier)

18-1819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin

Treatment:

Other: Permethrin-treated Lesu (baby wrap)

Control Group

Placebo Comparator group

Description:

Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment

Treatment:

Other: Untreated Lesu (baby wrap)