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Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire

REACH Côte d'Ivoire: Feasibility and Acceptability of Integrating Mass Distribution of Azithromycin to Children 1-11 Months Into a Trachoma Mass Drug Administration Campaign to Reduce Child Mortality

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04617626
Acronym
REACH
Enrollment
1735
Registered
2020-11-05
Start date
2020-11-20
Completion date
2021-01-31
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azithromycin, Child Mortality

Brief 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.

Detailed 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.

Interventions

DRUGAzithromycin

Single dose of azithromycin suspension

Sponsors

National Program for the Fight Against Neglected Tropical Diseases, Côte d'Ivoire
CollaboratorUNKNOWN
FHI 360
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 5 Months
Healthy volunteers
Yes

Inclusion criteria

For expanded azithromycin access during the MDA Inclusion Criteria: * Child aged 1 month (at least 30 days) to less than 6 months at the beginning of the week of the MDA intervention * Resident in study communities

Exclusion criteria

* Children below 3.0 kg * Appears severely ill at the time of the MDA (per the CDD's assessment) * Unable to swallow liquid delivered through a needle-less syringe because of physical limitations * Known allergy to macrolides, including azithromycin, based on the primary caregiver's report of prior adverse reaction to medication likely to be a macrolide

Design outcomes

Primary

MeasureTime frameDescription
Proportion of children 1 to 11 months reached with single-dose azithromycin1 weekThe proportion of children 1 to 11 months of age who receive a single dose of azithromycin during the MDA in the target health district.

Countries

Côte d’Ivoire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026