AVENIR: Azithromycin for Child Survival in Niger: Delivery Trial

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04774991
Collaborator
Bill and Melinda Gates Foundation (Other), Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger (Other)
12,057
1
2
40.1
300.3

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
  • Drug: Azithromycin for Oral Suspension
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

Study Type:
Interventional
Anticipated Enrollment :
12057 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
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.
Primary Purpose:
Treatment
Official Title:
Azithromycin for Child Survival in Niger: Delivery Trial
Actual Study Start Date :
Jun 28, 2021
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Program Costs [6 months]

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

    2. Fidelity of intervention rollout [6 months]

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

    3. Acceptability of intervention [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    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.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04774991
    Other Study ID Numbers:
    • 19-28387B
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022