Program National de Santé Oculaire
Niamey, Niger
NCT Number: NCT07712263
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
Trial opening soon.
Get NotifiedAll sexes
Interventional
Not applicable
Niamey, Niger
Niger is implementing azithromycin mass drug administration for child survival through door-to-door delivery by community health workers to children 1 to 59 months of age every 6 months. In areas with a high burden of seasonal malaria, integrating delivery of Guardian spatial emanators into this existing platform may provide an efficient way to add malaria prevention to an established community-based campaign. Guardian is a passive spatial emanator intended to reduce mosquito exposure indoors. Although spatial emanators have shown protective efficacy in previous studies, there is limited evidence on the feasibility, acceptability, and cost of integrating them into large-scale public health delivery systems in seasonal malaria settings.
This study is a randomized implementation study nested within AVENIR II. Selected Centre de Santé Intégré catchment areas participating in AVENIR II in high-malaria-transmission areas of Niger will be randomized to either integrated delivery of Guardian plus azithromycin mass drug administration or to standard azithromycin mass drug administration without Guardian integration. Within catchment areas assigned to integrated delivery, community health workers will conduct door-to-door visits to eligible households, provide malaria prevention messaging, determine the number of Guardian devices needed for the household, install the devices, and document delivery. Participating health centers in integrated areas will also receive Guardian devices.
The study will evaluate implementation outcomes including the proportion of households reached, the proportion of eligible households and health centers receiving Guardian, the proportion of eligible children receiving azithromycin in integrated and non-integrated areas, time required for delivery, fidelity to protocol, acceptability among households and community health workers, product placement over time, bioefficacy and active ingredient monitoring, and program costs. The study will also compare malaria-related clinic visits among children under 5 years of age in integrated and non-integrated catchment areas using routine health facility data. Data sources will include treatment records, fidelity observations, coverage evaluation surveys, repeated longitudinal monitoring surveys, cost records, and routine clinic data.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spatial emanators are a new intervention for malaria prevention, designed to passively release volatile active ingredients that repel or incapacitate mosquitoes before they bite.
Time frame: 1 month after distribution
Proportion of eligible households in intervention CSI catchment areas that received Guardian spatial emanators during the distribution period.
Time frame: 1 month after distribution
Acceptability of integrated delivery of Guardian spatial emanators with azithromycin mass drug administration as perceived by households and community health workers, assessed by qualitative surveys.
Time frame: 12 months after distribution
Proportion of households with correct placement of all installed Guardian spatial emanators, measured through longitudinal supervision visits
Time frame: During the distribution period (1 week)
Proportion of households in participating CSI catchment areas that were reached with program messaging about Guardian spatial emanators during the distribution period
Time frame: During the distribution period (1 week)
Proportion of eligible children who received azithromycin mass drug administration in CSI catchment areas assigned to integrated Guardian delivery and in CSI catchment areas assigned to non-integrated delivery
Time frame: During the distribution period (1 week)
Time required for delivery at the household level in integrated and non-integrated CSI catchment areas.
Time frame: during study preparation and completion (1 year)
Average cost per Guardian spatial emanator delivered during implementation in CSI catchment areas assigned to the intervention
Time frame: 12 month after distribution
Incidence of malaria-related clinic visits among children under 5 years of age in participating CSI catchment areas, assessed through CSI data collection and aggregation using District Health Information Software 2 (DHIS2)
Contact information is provided by the study sponsor or research team.
Andrea R Picariello, MPH
CONTACT
Elodie J Lebas
CONTACT
University of California, San Francisco
Other
Acronym: GUARD-AV
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.
Published trials that share one or more normalized conditions with this study.
NCT07430592
Infections, Malaria
Iquitos, Loreto, Peru
View Trial DetailsNCT07713602
Infections, Malaria
View Trial DetailsNCT07246525
Infections, Malaria
Kampala, Uganda
View Trial DetailsNCT07548021
Infections, Malaria
Kigali, Rwanda
View Trial Details