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 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT01253850
Eligibility Criteria:
Phase I
Inclusion Criteria:
* Age 13 to 24 years
* HIV-infected and aware of HIV-infection status
* Currently taking antiretroviral therapy, has been prescribed antiretroviral therapy in the past 6 months, or a medical provider has recommended antiretroviral medications within the last 6 months
* Willing and able to provide informed consent or assent (if under the age of 18)
Exclusion Criteria:
* Not willing or able to provide informed consent or assent (if under the age of 18)
* Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
* Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
Phase II
Inclusion Criteria:
* Age 13-24 years
* HIV-infected and aware of HIV-infection status
* Currently taking antiretroviral therapy
* Self-reported difficulties adhering to HIV medications in the past 3 months
* Self-identify as heterosexual or LGB
* Willing and able to provide informed consent/consent of parent/guardian if under the age of 18
Exclusion Criteria:
* Not willing or able to provide informed consent or assent (if under the age of 18)
* Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
* Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
24 Years
Study:
NCT01253850
Study Brief:
Protocol Section:
NCT01253850