Clinical trial NCT04617626: Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mortality
Azithromycin
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: National Program for the Fight Against Neglected Tropical Diseases, Côte d'Ivoire
First posted: 2020-11-05
Enrollment: 1735
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of children 1 to 11 months reached with single-dose azithromycin
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Boundiali
country: Côte D'Ivoire
facility: Boundiali Health District
state: Savanes Region
Study officials:
References: