Azithromycin for Child Survival in Niger: Delivery Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Azithromycin for Child Survival in Niger: Delivery Trial

Conditions
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Mortality, Child Health, Implementation

Intervention / Treatment
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* Drug: Azithromycin for Oral Suspension


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The AVENIR delivery trial is a two-armed, cluster-randomized trial in the Dosso region in Niger. 80 Communities will be randomized in a 1:1 allocation to either door-to-door delivery or fixed-point delivery of azithromycin to children 1-59 months of age.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azithro 1-59 fixed point<br>Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers | Drug: Azithromycin for Oral Suspension<br>* Azithromycin will be administered as a single dose in oral suspension form for children as follows: Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) For children 1 to <12 months of age, weight-based dosing will be used For children 12 to 59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.<br>* Other names: Zithromax;|
| Active Comparator: Azithro 1-59 door-to-door<br>Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers | Drug: Azithromycin for Oral Suspension<br>* Azithromycin will be administered as a single dose in oral suspension form for children as follows: Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) For children 1 to <12 months of age, weight-based dosing will be used For children 12 to 59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.<br>* Other names: Zithromax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Coverage | Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population | 6 months | 

Secondary Outcome Measures

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