Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire
Condition: Child Mortality; Azithromycin
Study type: Interventional

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.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): Single dose of azithromycin suspension
Intervention MeSH terms: Azithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research