Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04241705
Eligibility Criteria:
Inclusion Criteria:
* Woreda-level: Of the 19 woredas with malaria risk, the ten woredas with the highest annual parasite incidence (API) in 2018 will be eligible for the study.
* For Kebeles:
* Kebeles in East Hararghe Zone targeted for implementation of elimination activities by the Ethiopian Federal Ministry of Health where there is ongoing PMI-supported malaria surveillance;
* Kebeles with reported API between 1 and 50;
* Kebeles in malarious districts with comparable optimization of malaria control interventions.
* For individual participants:
* All residents of the intervention study kebeles diagnosed with malaria at health facilities (index case) or reside within 100-meter radius with the index case and has NONE of the exclusion criteria listed below
* Able to provide informed written consent
Exclusion Criteria:
* For kebeles: Kebeles planning on starting for the first time or discontinuing indoor residual spraying (IRS) campaigns in the next two years.
* For individual participants:
* Children less than 6 months of age or \<5 kg
* Known allergy or history of adverse reaction or chronic/congenital disease contra indicated to any of the intervention drugs: PQ, AL or CQ
* Individuals with severe malnutrition or signs of severe disease, with evidence of any organ failure or Hgb level \< 8gm/dl
* Household members already covered by the intervention less or equal to one month before
In addition, the following individuals will be excluded from receiving primaquine:
* Phenotypically G6PD deficient individuals
* Pregnant women
* Lactating women breastfeeding infants less than 6 months of age or with unknown G6PD status
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT04241705
Study Brief:
Protocol Section:
NCT04241705