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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT07101458
Eligibility Criteria:
Inclusion Criteria for the Clinical Trial:
* Adolescents living with HIV aged 10-19 years.
* Adolescents living with HIV who are cognitively able to participate in interviews (based on their medical history).
* Adolescents living with HIV who will have a score \> 13 on the Kessler Screening Scale for Psychological Distress (K6).
Exclusion Criteria for the Clinical Trial:
* Adolescents who refuse to participate.
* Adolescents whose parents/caretakers (for \<18 years) will not consent to their participation.
* Adolescents who will report having suicidal thoughts (i.e., who will respond yes to one item asking if they thought of killing themselves in the last 30days). This exclusion is based on the understanding that the PRISM intervention was not designed to address suicidal ideation, as confirmed by its developers. Such individuals will be referred to a licensed psychologist following the study's established referral plan, thereby ensuring they receive the appropriate care and support.
Inclusion criteria for a support person:
The PRISM intervention requires a caretaker or parent to be invited by the study participant to join the third session.
• Parent or caretaker should be ≥ 18 years of age and consent to participation.
Exclusion criteria for a support person:
• A parent or caretaker who refuses to participate.
Eligibility Criteria for Participation in Semi-Structured Interviews Post Intervention
Inclusion criteria for participants:
* Adolescents who have been in the treatment arm of the PRISM intervention pilot clinical trial.
* Adolescents who completed all sessions of the PRISM intervention.
* Adolescents who are willing to be audio taped.
Exclusion criteria for participants:
• Participants who meet the inclusion criteria but are unwilling to provide informed consent or assent and/or parental consent.
Inclusion criteria for implementers:
• PRISM coaches who offered all sessions of the PRISM intervention and who will be willing to be audio-taped.
Exclusion criteria for implementers:
• PRISM coaches who meet the inclusion criteria but are unwilling to provide informed consent to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
19 Years
Study:
NCT07101458
Study Brief:
Protocol Section:
NCT07101458