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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- FHI 360
- Enrollment
- 767,535
- Locations
- 1
- Primary Endpoint
- Implementation fidelity
Study Overview
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:
- 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
- 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:
- Analyses of routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the REACH activities are being integrated
- Periodic, cross-sectional, post-MDA surveys to verify coverage and examine exposure to project information/messaging
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 11 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Bi-annual 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)
Intervention: Single-dose azithromycin (Drug)
Outcomes
Primary Outcomes
Implementation fidelity
Time Frame: three years
Proportion of intervention activities are carried out as planned
Infant mortality rate
Time Frame: three years
Rate of child deaths among children under 1 year of age per 1,000 population
% of eligible population covered by intervention
Time Frame: three years
coverage of the intervention's target population (reach) with azithromycin in targeted health districts
Secondary Outcomes
- Cost per death averted(three years)
- Cost per child treated(three years)
- Cost of the program as a whole(three years)