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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Child Mortality
• Intervention / Treatment: Drug: Single-dose azithromycin

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.

• Study Type: Interventional
• Enrollment (Estimated): 140000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Dulli, PhD; Phone Number: 9193213542; Email: ldulli@fhi360.org
• Study Contact Backup: Name: Kate Murray, MPH; Email: kmurray@fhi360.org

Study Locations

• Côte D'Ivoire
  • Abidjan, Côte D'Ivoire
    • Recruiting
    • Community-based service delivery
    • Contact: Fatoumata Touré, MD, PhD; Phone Number: +225-22-40-50-10; Email: ftoure@fhi360.org
    • Principal Investigator: Fatoumata Touré, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 11 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Single-dose azithromycin; Bi-annual mass, community-based distribution of single-dose azithromycin to children ages 1 to 11 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of eligible population covered by intervention	coverage of the intervention's target population (reach) with azithromycin in targeted health districts	three years
Infant mortality rate	Rate of child deaths among children under 1 year of age per 1,000 population	three years
Implementation fidelity	Proportion of intervention activities are carried out as planned	three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cost per child treated	Program costs per child treated	three years
Cost per death averted	Program costs per death averted	three years

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Ministère de la Santé et de l´Hygiène Publique (Côte d'Ivoire)
• Investigators: Principal Investigator: Lisa Dulli, PhD, FHI 360

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: 1743615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Quantitative survey data from the study will be shared. These data contain no individually identifying data.
• IPD Sharing Time Frame: The data will be shared indefinitely within 6 months of the conclusion of the study.
• IPD Sharing Access Criteria: Data will be made publicly available on Harvard Dataverse.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No