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

Child Mortality Clinical Trial

Official title: The Resiliency Through Azithromycin for Children Project: Implementation Research on Bi-Annual Mass Distribution of Azithromycin to Children 1-11 Months in Côte d'Ivoire

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Child Mortality

• NCT number: NCT05016895
• Study type: Interventional
• Source: FHI 360
• Contact: Lisa Dulli, PhD
• Phone: 9193213542
• Email: ldulli@fhi360.org
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2021
• Completion date: February 28, 2024