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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithro 1-59 fixed point | Active Comparator | Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers |
|
| Azithro 1-59 door-to-door | Active Comparator | Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin for Oral Suspension | Drug | Azithromycin will be administered as a single dose in oral suspension form for children as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Coverage | Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Program Costs | Program costs as captured by routine administrative data collection during the study period and by micro-costing activities | 6 months |
| Fidelity of intervention rollout | Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team |
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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:
• Known allergy to macrolides
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| Name | Affiliation | Role |
|---|---|---|
| Tom M Lietman, MD | University of California, San Francisco | Principal Investigator |
| Kieran S O'Brien, PhD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Program National de Santé Oculaire | Niamey | Niger |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37967058 | Derived | Arzika AM, Maliki R, Amza A, Karamba A, Gallo N, Aichatou B, Sara II, Beidi D, Haroun LM, Oumarou F, Lebas E, Peterson B, Colby E, Nguyen W, Liu Z, Fitzpatrick MC, Arnold BF, Lietman TM, O'Brien KS; AVENIR Study Group. Comparison of door-to-door and fixed-point delivery of azithromycin distribution for child survival in Niger: A cluster-randomized trial. PLOS Glob Public Health. 2023 Nov 15;3(11):e0002559. doi: 10.1371/journal.pgph.0002559. eCollection 2023. |
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Data underlying outcomes publications will be made publicly available.
Individual participant data will be made available after publication of the outcomes and will be made available indefinitely
Once made available, the data will be open access.
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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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.
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In the delivery trial, participants, implementers, and outcome assessors will not be actively masked from the delivery approach given the nature of the intervention.
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|
|
| 6 months |
| Acceptability of intervention | Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution | 6 months |
| Organic Chemicals |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |