Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04617626 |
| Other study ID # |
1575564 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 20, 2020 |
| Est. completion date |
January 31, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
FHI 360 |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to gather preliminary evidence on the operational feasibility and
acceptability of integrating bi-annual mass drug administration (MDA) of single-dose
azithromycin for children ages 1 to 11 months in high child mortality settings in Côte. The
cross-sectional study will be carried out in conjunction with a single trachoma MDA in
selected villages within one health district. Data on feasibility and acceptability will be
collected through three main activities:
1. Analyses of existing routine monitoring, process, and adverse drug reaction data from
the trachoma MDA platform into which the pilot activities are being integrated
2. A cross-sectional, post-MDA coverage survey
3. Qualitative data collection among targeting parents or primary caregivers of children
ages 1 to 11 months in the pilot districts, and district-level MDA implementers,
regarding the proposed azithromycin program.
Description:
Purpose: The aim of the study is to gather preliminary evidence on the operational
feasibility and acceptability of integrating bi-annual mass drug administration (MDA) of
single-dose azithromycin for children ages 1 to 11 months in high child mortality settings in
Côte d'Ivoire into the existing trachoma MDA platform to inform large scale implementation.
Design: The cross-sectional study will be carried out in conjunction with a single trachoma
MDA in selected villages within one health district. Data on feasibility and acceptability
will be collected through three main activities:
1. Analyses of existing routine monitoring, process, and adverse drug reaction data from
the trachoma MDA platform into which the pilot activities are being integrated
2. A cross-sectional, post-MDA coverage survey
3. Qualitative data collection among targeting parents or primary caregivers of children
ages 1 to 11 months in the pilot districts, and district-level MDA implementers,
regarding the proposed azithromycin program.
Population: For expanded use of azithromycin: Infants ages 1 to 5 months who reside in one
pilot district in high under-5 years child mortality regions in Côte d'Ivoire (approximately
2,800 to be enrolled).
Post-MDA coverage survey and interviews for acceptability: Parents/primary caregivers of
infants aged 1 to 11 months who reside in the two pilot districts will be targeted for the
post-MDA coverage survey and in-depth interviews (n=up to 24) to explore acceptability
(approximately 275 to be enrolled).
Feasibility and acceptability from implementers' perspectives: Focus group discussions will
target community-based drug distributors (CDDs) and in-depth interviews will target CDD
supervisors, both to explore operational feasibility. (A maximum of 48 CDDs and 12 CDD
supervisors approximately) Pilot Site : Boundiali Health District in Bagoué Region, among the
high under-5 child mortality regions in Côte d'Ivoire.
Duration: Planning - 6 months; Training and implementation of the pilot intervention - 3
weeks; Post-MDA research - 1 month; Data analysis and reporting - 2 months.
Objectives: The study is designed to:
1. Examine the extent to which activities are carried out as planned (fidelity) during the
pilot implementation and the factors that affect the processes and results.
2. Estimate coverage of the intervention's target population (1 to 11 month-olds) with
azithromycin in pilot districts.
3. Assess the level of understanding and acceptability of the strategy among those involved
in implementation and among the parents/primary caregivers of children targeted by the
intervention.
4. Document challenges to implementation and costs of the pilot activity to make
recommendations for scale-up.
Endpoints: A final pilot activity report summarizing findings including recommended
approaches for scale-up, will be developed after results are shared with the REACH technical
working group to inform guidance on scale-up.
