NCT04102592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

March 17, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

September 23, 2019

Last Update Submit

March 15, 2021

Conditions

Malaria

Keywords

MalariaP. FalciparumPermethrinRapid diagnostic test

Outcome Measures

Primary Outcomes (1)

  • Reported change in frequency of use of lesu

    Self-reported, includes discontinuation of use

    Baseline, 12 weeks

Secondary Outcomes (6)

  • Incidence of symptomatic malaria episodes among children

    12 weeks

  • Incidence of P. falciparum malaria parasitemia among children

    12 weeks

  • Change in mosquito salivary antigen response among children

    Baseline, 12 weeks

  • Change in mosquito salivary antigen response among mothers

    Baseline, 12 weeks

  • Changes in hemoglobin levels among children

    Baseline, 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Permethrin-treated Lesu (baby wrap)

Control Group

PLACEBO COMPARATOR

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

Other: Untreated Lesu (baby wrap)

Interventions

Permethrin-treated Lesu (baby wrap)OTHER

0.5% permethrin application

Intervention Group
Untreated Lesu (baby wrap)OTHER

Matching untreated lesu

Also known as: Placebo
Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Mother or child with HIV (and thus taking cotrimoxazole prophylaxis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bugoye Level III Health Centre

Bugoye, Kasese, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 35197060DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Ross Boyce, MD, MSc

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized to control (25) or intervention group (25)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

October 28, 2019

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

March 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR, 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.

Locations

UG(1)