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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT04930367
Eligibility Criteria:
Adolescents and young adults living with HIV (AYAHIV):
Inclusion Criteria:
1. HIV-positive, per medical records and confirmed by health facility staff
2. Age 10 to 24 years
3. Registered as a patient at study site
4. Aware of HIV+ status
5. Provision of signed and dated informed consent form
6. For adolescents under 18 years of age, informed assent and parental informed consent to participate in the study
7. Stated willingness to comply with all study procedures
Exclusion Criteria:
1\. Has an acute medical condition requiring immediate medical care
Caregivers of AYAHIV:
Inclusion Criteria:
1. Age 18 years and older
2. Attending a caregiver-specific support group
3. Willingness to be audio-recorded
Healthcare Workers (HCW) and Key Informants (KI):
Inclusion Criteria:
1. Age 18 years and older
2. Involved in the provision, management, or oversight of adolescent-focused HIV services at the 12 specified study sites
3. Willingness to be audio-recorded
For all study participants (AYAHIV, caregivers, HCW and KI):
Exclusion Criteria:
Any other condition, including but not limited to alcohol or substance abuse and uncontrolled medical condition and/or allergies, that, in the opinion of the study team, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
24 Years
Study:
NCT04930367
Study Brief:
Protocol Section:
NCT04930367