Azithromycin for Child Survival in Niger: Delivery Trial

Phase 4

Recruiting

• Conditions: Mortality; Child Health; Implementation
• Interventions: Drug: Azithromycin for Oral Suspension

• Registration Number: NCT04774991
• Lead Sponsor: University of California, San Francisco

Brief Summary

This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.

Detailed Description

Azithromycin distribution has been shown to reduce mortality in children 1-59 months. This trial aims to contribute evidence on viable approaches to implementation as high mortality countries consider this intervention to improve child survival. From a pool of eligible rural and peri-urban communities in the Dosso Region in Niger, 80 will be randomly selected and randomized to receive door-to-door or fixed-point delivery of a single dose of azithromycin distribution to children 1-59 months of age via community health workers biannually. Treatment coverage, costs and cost-effectiveness, and feasibility and acceptability will be compared by arm.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Study Start: 2021-06-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12057

Inclusion Criteria

At the community-level, eligibility includes:

• Location in one of the 80 Dosso communities randomly selected for the delivery trial
• Population 250 to 2,499*
• Distance > 5 km from the district headquarters town
• Verbal consent of community leader(s)

At the individual-level, eligibility includes:

• Age 1-59 months
• Primary residence in a study community
• Verbal consent of caregiver/guardian for study participation
• Weight ≥ 4 kg

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Exclusion Criteria

At the community-level, eligibility includes:

• Inaccessible or unsafe for study team
• "Quartier" designation on national census *Population size as estimated from the most recent national census or projections

At the individual-level, eligibility includes:

• Known allergy to macrolides

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithro 1-59 door-to-door	Azithromycin for Oral Suspension	Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers
Azithro 1-59 fixed point	Azithromycin for Oral Suspension	Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers

Primary Outcome Measures

Name	Time	Method
Treatment Coverage	6 months	Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population

Secondary Outcome Measures

Name	Time	Method
Fidelity of intervention rollout	6 months	Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team
Program Costs	6 months	Program costs as captured by routine administrative data collection during the study period and by micro-costing activities
Acceptability of intervention	6 months	Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution

Trial Locations

Locations (1)

Program National de Santé Oculaire; 🇳🇪 Niamey, Niger