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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT06030856
Eligibility Criteria:
Inclusion Criteria:
* For the full cohort, all participants must:
* Be cis-gender adolescent females (16-20 years of age)
* Be literate
* Currently sexually active
* Be willing to participate in in-person and virtual study visits
* Not be pregnant or planning to be pregnant for the next 6 months
* Be HIV-negative but not ready to initiate PrEP at the screening and enrolment visit
* Have used PrEP with subsequent discontinuation within the last 6 months
* Have no contraindications to oral PrEP per self-report
* Have no indication of possible acute HIV infection, according to South African PrEP guidelines
* Have their own personal smart phone
* Willing to provide written informed consent/assent to participate in this study
For the subset invited to qualitative interviews, all participants must be:
• Willing to participate in an IDI at/before their month 6 visit (study exit visit)
Exclusion Criteria:
* Potential AGYW participants who meet any of the following criteria will be excluded from the study:
* At Screening and Enrollment, parent/guardian (for those participants \<18 years) is unwilling to provide written informed consent
* At Screening and Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
* Is not willing to comply with study procedures
* As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
* Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
20 Years
Study:
NCT06030856
Study Brief:
Protocol Section:
NCT06030856