Azithromycin for Child Survival in Niger: Delivery Trial

University of California, San Francisco10,925 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

10,925

Conditions

Mortality Child Health Implementation

Interventions

Azithromycin for Oral SuspensionDRUG

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.

Eligibility

Sex: ALLMin age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Program National de Santé Oculaire

Niamey, Niger

Outcomes

Primary Outcomes

Treatment Coverage

Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population

Time frame: 6 months

Secondary Outcomes

Program Costs

Program costs as captured by routine administrative data collection during the study period and by micro-costing activities

Time frame: 6 months

Fidelity of intervention rollout

Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team

Time frame: 6 months

Acceptability of intervention

Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution

Time frame: 6 months

Data from ClinicalTrials.gov

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