Child Health, Implementation, Mortality
Conditions
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.
Interventions
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.
Sponsors
Bill and Melinda Gates Foundation
Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
In the delivery trial, participants, implementers, and outcome assessors will not be actively masked from the delivery approach given the nature of the intervention.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Program Costs | 6 months | Program costs as captured by routine administrative data collection during the study period and by micro-costing activities |
Countries
Niger
Outcome results
None listed