Clinical trial NCT04102592: Getting Malaria "Off the Back" of Women and Children in Western Uganda
Official title: IGHID 11829 - Getting Malaria "Off the Back" of Women and Children in Western Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: Malaria
P. Falciparum
Permethrin
Rapid diagnostic test
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Conservation, Food, and Health Foundation
First posted: 2019-09-25
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to control (25) or intervention group (25)
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Reported change in frequency of use of lesu
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Incidence of symptomatic malaria episodes among children
timeFrame: 12 weeks
measure: Incidence of P. falciparum malaria parasitemia among children
timeFrame: 12 weeks
measure: Change in mosquito salivary antigen response among children
timeFrame: Baseline, 12 weeks
measure: Change in mosquito salivary antigen response among mothers
timeFrame: Baseline, 12 weeks
measure: Changes in hemoglobin levels among children
timeFrame: Baseline, 12 weeks
measure: Changes in hemoglobin levels among mothers
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Bugoye
country: Uganda
facility: Bugoye Level III Health Centre
state: Kasese
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ross Boyce, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyce RM, Muhindo E, Baguma E, Muhindo R, Shem B, Francois R, Hawke S, Shook-Sa BE, Ntaro M, Nalusaji A, Nyehangane D, Reyes R, Juliano JJ, Siedner MJ, Staedke SG, Mulogo EM. Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda. Malar J. 2022 Feb 23;21(1):63. doi: 10.1186/s12936-022-04086-w.