Program National de Santé Oculaire
Niamey, Niger
NCT Number: NCT04774991
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.
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Notify Me1 month and older
All sexes
Interventional
Phase 4
Niamey, Niger
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
At the community-level, eligibility includes:
At the individual-level, eligibility includes:
Exclusion criteria
At the community-level, eligibility includes:
At the individual-level, eligibility includes:
Azithromycin will be administered as a single dose in oral suspension form for children as follows:
Other names: Zithromax
Time frame: 6 months
Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population
Time frame: 6 months
Program costs as captured by routine administrative data collection during the study period and by micro-costing activities
Time frame: 6 months
Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team
Time frame: 6 months
Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution
University of California, San Francisco
Other
Acronym: AVENIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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