Clinical trial NCT04774991: Azithromycin for Child Survival in Niger: Delivery Trial
Official title: Azithromycin for Child Survival in Niger: Delivery Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mortality
Child Health
Implementation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger
First posted: 2021-03-01
Enrollment: 10925
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Coverage
timeFrame: 6 months
Secondary outcomes:
measure: Program Costs
timeFrame: 6 months
measure: Fidelity of intervention rollout
timeFrame: 6 months
measure: Acceptability of intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Niamey
country: Niger
facility: Program National de Santé Oculaire
Study officials:
affiliation: University of California, San Francisco
name: Tom M Lietman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kieran S O'Brien, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: