Azithromycin for Child Survival in Niger: Delivery Trial (AVENIR)

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.

Study Overview

• Status: Completed
• Conditions: Mortality; Child Health; Implementation
• Intervention / Treatment: Drug: Azithromycin for Oral Suspension

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 Type: Interventional
• Enrollment (Actual): 10925
• Phase: Phase 4

Contacts and Locations

Study Locations

• Niger
  • Niamey, Niger
    • Program National de Santé Oculaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Zithromax
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: Zithromax

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: 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; Principal Investigator: Kieran S O'Brien, PhD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin
• Other Study ID Numbers: 19-28387B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data underlying outcomes publications will be made publicly available.
• IPD Sharing Time Frame: Individual participant data will be made available after publication of the outcomes and will be made available indefinitely
• IPD Sharing Access Criteria: Once made available, the data will be open access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes