AVENIR: Azithromycin for Child Survival in Niger: Delivery Trial
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Azithro 1-59 fixed point 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
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.
Other Names:
|
Active Comparator: Azithro 1-59 door-to-door 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Program Costs [6 months]
Program costs as captured by routine administrative data collection during the study period and by micro-costing activities
- Fidelity of intervention rollout [6 months]
Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team
- Acceptability of intervention [6 months]
Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution
Eligibility Criteria
Criteria
Inclusion Criteria:
At the community-level, eligibility includes:
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Location in one of the 80 Dosso communities randomly selected for the delivery trial
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Population 250 to 2,499*
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Distance > 5 km from the district headquarters town
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Verbal consent of community leader(s)
At the individual-level, eligibility includes:
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Age 1-59 months
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Primary residence in a study community
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Verbal consent of caregiver/guardian for study participation
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Weight ≥ 4 kg
Exclusion Criteria:
At the community-level, eligibility includes:
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Inaccessible or unsafe for study team
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"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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Program National de Santé Oculaire | Niamey | Niger |
Sponsors and Collaborators
- University of California, San Francisco
- Bill and Melinda Gates Foundation
- Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger
Investigators
- Principal Investigator: Tom M Lietman, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-28387B