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

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:

• Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
• A cross-sectional, post-MDA coverage survey
• 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:

• 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.
• Estimate coverage of the intervention's target population (1 to 11 month-olds) with azithromycin in pilot districts.
• 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.
• 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.

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