Integrating the Guardian Spatial Emanator Within AVENIR II (NCT07712263) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Integrating the Guardian Spatial Emanator Within AVENIR II
Niger150,000 participantsStarted 2026-12-01
Plain-language summary
This study will evaluate the implementation of integrating Guardian spatial emanators into the existing AVENIR II azithromycin mass drug administration program in Niger. The objective is to assess whether Guardian can be feasibly, acceptably, and effectively delivered through the same community-based platform already used for door-to-door azithromycin distribution to children 1 to 59 months of age.
Selected health center catchment areas in high-malaria-transmission settings in Niger will be randomized to integrated delivery or non-integrated delivery. The study will measure implementation outcomes including reach, coverage, acceptability, fidelity to protocol, costs, and product placement over time, and will also assess malaria-related clinic visits among children under 5 years of age using routine health facility data
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Centre de Santé Intégré (CSI) catchment area participating in the AVENIR II azithromycin mass drug administration program
* Located in a high malaria transmission setting in the study area
* Randomly selected from the eligible pool for participation
* Household located within a selected CSI catchment area
* Verbal consent provided by the head of household for household-level study activities
* Verbal consent provided by the CSI chief for CSI-level participation
Exclusion Criteria:
* CSI catchment area not participating in the AVENIR II azithromycin mass drug administration program
* Household not located within a selected CSI catchment area
* Refusal of verbal consent by the head of household
* Refusal of verbal consent by the CSI chief for CSI-level participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of eligible households that received spatial emanators
Timeframe: 1 month after distribution
2
Acceptability of the integrated delivery
Timeframe: 1 month after distribution
3
Proportion of households with correct product placement