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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Mortality; Implementation; Child Health

Treatments: Drug: Azithromycin for Oral Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT04774991

19-28387B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,925 patients

Sex: All

Ages: 1+ month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,925 participants in 2 patient groups

Azithro 1-59 fixed point

Active Comparator group

Description:

Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers

Treatment:

Drug: Azithromycin for Oral Suspension

Azithro 1-59 door-to-door

Active Comparator group

Description:

Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers

Treatment:

Drug: Azithromycin for Oral Suspension