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

NCT ID: NCT04617626

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1735 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2021-01-31

Brief 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.

Detailed 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.

Conditions

Child Mortality; Azithromycin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Azithromycin

All children ages 1 to 5 months in the targeted health district will be offered a single dose of azithromycin suspension dosed at 20 mg per kg of weight in place of the standard tetracycline ointment, during a mass drug administration targeting trachoma prevention and treatment. All children ages 6 months and older, and all adults already receive the single dose of azithromycin during the MDA event. For this pilot study, single dose of azithromycin is being extended to include the 1 to 5 month old population as well.

Group Type: OTHER

Azithromycin

Intervention Type: DRUG

Single dose of azithromycin suspension

Interventions

Azithromycin

Single dose of azithromycin suspension

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 5 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Program for the Fight Against Neglected Tropical Diseases, Côte d'Ivoire

UNKNOWN

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boundiali Health District

Boundiali, Savanes District, Côte d’Ivoire

Countries

Côte d’Ivoire

References

Dulli L, Toure F, Mama AD, Evens E, Murray K, Dje NN, Kone S, Sadate-Ngatchou P, Bovary A, Eichleay M, Jean-Baptiste M, Meite A. 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 in Cote d'Ivoire. PLOS Glob Public Health. 2024 Jul 10;4(7):e0003426. doi: 10.1371/journal.pgph.0003426. eCollection 2024.

Reference Type: DERIVED

PMID: 38985785 (View on PubMed)

Other Identifiers

1575564

Identifier Type: -

Identifier Source: org_study_id