Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire

Child Mortality Clinical Trial

— REACH  

Official title:

REACH Côte d'Ivoire: Feasibility and Acceptability of Integrating Mass Distribution of Azithromycin to Children 1-11 Months Into a Trachoma Mass Drug Administration Campaign to Reduce Child Mortality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617626
• Other study ID #: 1575564
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2021
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to gather preliminary evidence on the operational feasibility and acceptability of integrating bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings in Côte. The cross-sectional study will be carried out in conjunction with a single trachoma MDA in selected villages within one health district. Data on feasibility and acceptability will be collected through three main activities:

1. Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated

2. A cross-sectional, post-MDA coverage survey

3. Qualitative data collection among targeting parents or primary caregivers of children ages 1 to 11 months in the pilot districts, and district-level MDA implementers, regarding the proposed azithromycin program.

Description:

Purpose: The aim of the study is to gather preliminary evidence on the operational feasibility and acceptability of integrating bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings in Côte d'Ivoire into the existing trachoma MDA platform to inform large scale implementation.

Design: The cross-sectional study will be carried out in conjunction with a single trachoma MDA in selected villages within one health district. Data on feasibility and acceptability will be collected through three main activities:

1. Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated

2. A cross-sectional, post-MDA coverage survey

3. Qualitative data collection among targeting parents or primary caregivers of children ages 1 to 11 months in the pilot districts, and district-level MDA implementers, regarding the proposed azithromycin program.

Population: For expanded use of azithromycin: Infants ages 1 to 5 months who reside in one pilot district in high under-5 years child mortality regions in Côte d'Ivoire (approximately 2,800 to be enrolled).

Post-MDA coverage survey and interviews for acceptability: Parents/primary caregivers of infants aged 1 to 11 months who reside in the two pilot districts will be targeted for the post-MDA coverage survey and in-depth interviews (n=up to 24) to explore acceptability (approximately 275 to be enrolled).

Feasibility and acceptability from implementers' perspectives: Focus group discussions will target community-based drug distributors (CDDs) and in-depth interviews will target CDD supervisors, both to explore operational feasibility. (A maximum of 48 CDDs and 12 CDD supervisors approximately) Pilot Site : Boundiali Health District in Bagoué Region, among the high under-5 child mortality regions in Côte d'Ivoire.

Duration: Planning - 6 months; Training and implementation of the pilot intervention - 3 weeks; Post-MDA research - 1 month; Data analysis and reporting - 2 months.

Objectives: The study is designed to:

1. Examine the extent to which activities are carried out as planned (fidelity) during the pilot implementation and the factors that affect the processes and results.

2. Estimate coverage of the intervention's target population (1 to 11 month-olds) with azithromycin in pilot districts.

3. Assess the level of understanding and acceptability of the strategy among those involved in implementation and among the parents/primary caregivers of children targeted by the intervention.

4. Document challenges to implementation and costs of the pilot activity to make recommendations for scale-up.

Endpoints: A final pilot activity report summarizing findings including recommended approaches for scale-up, will be developed after results are shared with the REACH technical working group to inform guidance on scale-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1735
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 5 Months

Eligibility

For expanded azithromycin access during the MDA

Inclusion Criteria:

• Child aged 1 month (at least 30 days) to less than 6 months at the beginning of the week of the MDA intervention

• Resident in study communities

Exclusion Criteria:

• Children below 3.0 kg

• Appears severely 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

Related Conditions & MeSH terms

• Azithromycin
• Child Mortality

Intervention

Drug:
• Azithromycin
Single dose of azithromycin suspension

Locations

Country	Name	City	State
Côte D'Ivoire	Boundiali Health District	Boundiali	Savanes Region

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	National Program for the Fight Against Neglected Tropical Diseases, Côte d'Ivoire

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children 1 to 11 months reached with single-dose azithromycin	The proportion of children 1 to 11 months of age who receive a single dose of azithromycin during the MDA in the target health district.	1 week