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:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT05130151
Eligibility Criteria:
Inclusion Criteria:
1. Adolescents (aged 15-19 years): Self-report during enrollment and confirmed by school personnel or local community leader.
2. Residing in the greater Masaka region in southern Uganda: Self-report during enrollment and confirmed by school personnel or local community leader.
3. Own a mobile phone: Self-report during enrollment and confirmed visually by project director or research assistant.
4. People who have the cognitive capacity to consent: A potential participant will be included if the researcher conducting the consent process determines that the potential participant has the cognitive capacity to consent. This will be determined by through the review of the consent forms.
5. For Phase II, did not participate. In Phase I: Review of study records.
Exclusion Criteria:
1. People who are not aged 15-19 years: Self-report during enrollment and confirmed by school personnel or local community leader.
2. People who do not reside in the greater Masaka region in southern Uganda: Self-report during enrollment and confirmed by school personnel or local community leader.
3. People who do not own a mobile phone: Self-report during enrollment and confirmed visually by project director or research assistant.
4. People who do not have the cognitive capacity to consent: A potential participant will be excluded if the researcher conducting the consent process determines that the potential participant has a mental deficit or does not have the cognitive capacity to understand the consent process and proposed research.
5. Participants in phase 1 will be excluded from phase 2: Review of study records
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
19 Years
Study:
NCT05130151
Study Brief:
Protocol Section:
NCT05130151