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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT01751594
Eligibility Criteria:
To be considered eligible for enrollment into Trial 1 and Trial 2, an individual must meet the criteria listed below:
* Receives services at one of the selected AMTU sites or one of their community partners;
* Biological male at birth and self identifies as male gender at the time of consent;
* Self identifies as "Black" (including Black/African-American, Black Latino, Black/Afro-Caribbean, Black/African immigrant, or any self-identified member of the African Diaspora);
* HIV-infected as documented by medical record review or verification with referring medical professional;
* Between the ages of 16-24 years, inclusive, at the time of consent;
* HIV-infected through sexual behavior;
* At least one sexual encounter involving oral or anal sex with a male partner in the past year;
* Ability to understand both written and spoken English;
* Willingness to participate in a group-based intervention with other HIV-positive B-YMSM and agree to respect the privacy of other group members;
* Willingness and ability to attend the first group session on any of the date chosen by the site staff and;
* Willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable.
To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
* Active psychiatric condition that in the opinion of the site personnel would interfere with the ability to give true informed consent and to adhere to the study requirements;
* Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior);
* Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
* Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.
* Previous participation in ATN 090, "Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who have Sex with Men." (NOTE: YAB members from ATN090 cannot participate in ATN 104)
* Previous participation in Trial 1 of ATN104 and;
* Current enrollment in any other behavioral intervention study or program. Any cases that are uncertain require Protocol Team approval.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT01751594
Study Brief:
Protocol Section:
NCT01751594