Clinical trial NCT05016895: REACH2: Implementation Research on Bi-Annual Mass Distribution of Azithromycin to Children 1-11 Months in Côte d'Ivoire
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mortality
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Ivory Coast
First posted: 2021-08-23
Enrollment: 767535
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: % of eligible population covered by intervention
timeFrame: three years
measure: Infant mortality rate
timeFrame: three years
measure: Implementation fidelity
timeFrame: three years
Secondary outcomes:
measure: Cost of the program as a whole
timeFrame: three years
measure: Cost per child treated
timeFrame: three years
measure: Cost per death averted
timeFrame: three years
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: FHI 360
Study officials:
affiliation: FHI 360
name: Lisa Dulli, PhD
role: PRINCIPAL_INVESTIGATOR
References: