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

NCT05016895 | Completed

• 1 other identifier: 1743615
• Study Type: interventional
• Target: 767,535
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Mortality

Outcome Measures

Primary Outcomes (3)

• % 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 Outcomes (3)

• Cost of the program as a whole

  three years

• Cost per child treated

  three years

• Cost per death averted

  three years

Study Arms (1)

Bi-annual single dose azithromycin

EXPERIMENTAL

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

Interventions

Single-dose azithromycin DRUG

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

Bi-annual single dose azithromycin

Eligibility Criteria

• Age: 1 Month - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 1 to 11 months
• Resident in targeted community

You may not qualify if:

• 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

Sponsors & Collaborators

• FHI 360: lead
• Ministry of Health, Ivory Coast: collaborator

Study Sites (1)

FHI 360

Abidjan, Côte d’Ivoire

Location

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Lisa Dulli, PhD

  FHI 360

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 23, 2021
• Study Start: August 27, 2021
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be shared indefinitely within 6 months of the conclusion of the study.
• Access Criteria: Data will be made publicly available on Harvard Dataverse.

Locations

CÔ (1)