Spatial Repellents for Aedes-borne Virus Control in Sri Lanka (NCT05452447) | Clinical Trial Compass
CompletedNot Applicable
Spatial Repellents for Aedes-borne Virus Control in Sri Lanka
Sri Lanka6,949 participantsStarted 2023-03-02
Plain-language summary
The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of a single SR product, in reducing DENV infection and active Aedes-borne virus (ABV) disease in human cohorts. The study design will be a prospective, cluster randomized controlled trial (cRCT). Although not a specific objective of this project, an overall goal is to allow for official recommendations (or not) from the World Health Organization (WHO) for the use of SRs in public health. A WHO global policy recommendation will establish evaluation systems of SR products to regulate efficacy evaluations, thereby increasing quality, overall use and a consequent reduction in disease.
Who can participate
Age range
6 Months
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.
LONGITUDINAL SEROCONVERSION Individual Level
Inclusion Criteria:
* ≥ 4 - 16 years of age
* Plans to stay in residence and/or study area for a minimum of 24 months
* Resident of household or frequent visitor (\~20% of day hours in house / month)
Exclusion Criteria:
* \< 4 and \> 16 years of age
* Plans to leave residence and/or study area within next 24 months
* Temporary visitor to household (\<20% of day hours in house/ month)
FEBRILE SURVEILLANCE Household Level
Inclusion Criteria:
* Adult head of households agrees to census, health visits and logging resident symptoms when febrile (or in the case of suspected Zika in the absence of fever, presenting with rash, arthralgia, arthritis or non-purulent conjunctivitis).
* Individuals spend a minimum of 4hrs per week during the daytime hours or sleep in the house.
Exclusion Criteria:
* Adult head of households does not agree to census, health visits or logging symptoms of residents.
* Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
* Sites where no residents spend time during the day (i.e. work 7d a week outside the home).
FEBRILE SURVEILLANCE Individual Level
Inclusion Criteria:
* ≥ 6mo of age.
* Fever at the time of presentation or report of feverishness within the previous 24 hours or presenting with a rash, arthralgia, arthritis or non-purulent conjunctivitis (suspicion of ZIKA determined by project physician)
* Individual who spen…
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
Incidence of Aedes-borne virus (ABV) infection in the 'longitudinal cohort'.