REACH2: Implementation Research on Bi-Annual Mass Distribution of Azithromycin to Children 1-11 Months in Côte d'Ivoire

Not Applicable

Completed

• Conditions: Child Mortality
• Interventions: Drug: Single-dose azithromycin

• Registration Number: NCT05016895
• Lead Sponsor: FHI 360

Brief Summary

REACH2 is a three-year implementation research study designed to examine the implementation through a mass drug administration platform of bi-annual single-dose azithromycin to reduce child mortality among children ages 1 to 11 months who reside in high child mortality settings.

Detailed Description

The aim of the study is to provide the government of Côte d'Ivoire and other stakeholders the information needed to understand what is required to bring bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings to scale using the existing MDA platform used for trachoma and other neglected tropical diseases.

Design: The serial cross-sectional study will be carried out in 19 health districts in coordination with the trachoma MDAs over the course of three years. The intervention under study will involve a public health campaign of bi-annual distribution of single-dose azithromycin, including:

1. Expanded coverage with azithromycin during annual trachoma MDAs to children 1-5 months of age when delivered at the same time as the annual trachoma MDA, which already covers children 6-11 months, followed by

2. Stand-alone MDAs targeting children 1 to 11 months delivered at the approximately 6-month interval between annual trachoma MDAs, or bi-annually in areas where the annual trachoma MDAs are phased out.

To study scale up of these intervention activities, the investigators will systematically collect data, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) implementation science framework. Data collection activities will involve:

1. Analyses of routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the REACH activities are being integrated

2. Periodic, cross-sectional, post-MDA surveys to verify coverage and examine exposure to project information/messaging

3. Qualitative data collection through in-depth interviews (IDI) and/or focus group discussions (FGD) with parents or primary caregivers of children ages 1 to 11 months in the 19 health districts, and district-level MDA implementers to explore issues of acceptability, communication, challenges and areas for improvement in implementation.

Further, after the first round of the annual trachoma MDA scheduled to take place in July 2021, a round of focus groups will be carried out with parents of children ages 1-11 months and local implementers to inform message development for the public health campaign.

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Study Start: 2021-08-27
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 767535

Inclusion Criteria

• Ages 1 to 11 months
• Resident in targeted community

Exclusion Criteria

• Children below 3.0 kg (3rd centile for healthy 1-month old infants in the WHO growth charts)
• Appears seriously 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
• prior allergic reaction to medication likely to be a macrolide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bi-annual single dose azithromycin	Single-dose azithromycin	Mass, community-based distribution of single dose azithromycin solution (200 mg/5ml) dosed at 20 mg/kg weight to all eligible infants ages 1 to 11 months twice yearly (approximately 6 months apart)

Primary Outcome Measures

Name	Time	Method
Implementation fidelity	three years	Proportion of intervention activities are carried out as planned
Infant mortality rate	three years	Rate of child deaths among children under 1 year of age per 1,000 population
% of eligible population covered by intervention	three years	coverage of the intervention's target population (reach) with azithromycin in targeted health districts

Secondary Outcome Measures

Name	Time	Method
Cost per death averted	three years	Program costs per death averted
Cost per child treated	three years	Program costs per child treated
Cost of the program as a whole	three years	Program costs will be calculated based on the following inputs: personnel, supplies/recurrent goods, capital goods, travel/transport, space, services, and training

Trial Locations

Locations (1)

FHI 360; 🇨🇮 Abidjan, Côte D'Ivoire