Azithromycin for Child Survival in Niger: Delivery Trial

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Bill and Melinda Gates Foundation; Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

At the community-level, eligibility includes:

• Location in one of the 80 Dosso communities randomized 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 ≥ 3.0 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