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

Child Mortality Clinical Trial

— REACH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016895
• Other study ID #: 1743615
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2024
• Source: FHI 360
• Contact: Lisa Dulli, PhD
• Phone: 9193213542
• Email: ldulli[@]fhi360.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140000
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 11 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Mortality

Intervention

Drug:
• Single-dose azithromycin
Bi-annual mass, community-based distribution of single-dose azithromycin to children ages 1 to 11 months.

Locations

Country	Name	City	State
Côte D'Ivoire	Community-based service delivery	Abidjan

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Ministère de la Santé et de l´Hygiène Publique (Côte d'Ivoire)

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of eligible population covered by intervention	coverage of the intervention's target population (reach) with azithromycin in targeted health districts	three years
Primary	Infant mortality rate	Rate of child deaths among children under 1 year of age per 1,000 population	three years
Primary	Implementation fidelity	Proportion of intervention activities are carried out as planned	three years
Secondary	Cost of the program as a whole	Program costs will be calculated based on the following inputs: personnel, supplies/recurrent goods, capital goods, travel/transport, space, services, and training	three years
Secondary	Cost per child treated	Program costs per child treated	three years
Secondary	Cost per death averted	Program costs per death averted	three years