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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT02929069
Eligibility Criteria:
Inclusion Criteria:
* self-identification as a gay, bisexual or queer man;
* HIV-negative status confirmed through in-office testing;
* diagnosis of any DSM-5 depressive, anxiety, or trauma-/stress-related disorder;
* risk of HIV transmission through sexual activity (≥ 1 act of past-90-day-condomless anal sex involving a flesh penis with a partner with an unknown HIV status or an HIV-positive status, unless with an HIV-positive primary or main partner with known undetectable viral load or an HIV-negative primary or main partner who is known to be adherent to PrEP);
* not themselves currently adherent to PrEP (defined as taking PrEP on ≥ 4 days/week);
* NYC or Miami residential stability and planned availability for 12 months;
* English-language proficiency; and (9) provision of informed consent.
Exclusion Criteria:
* current active suicidality or homicidality (but not passive suicidality);
* evidence of active untreated mania, psychosis, or gross cognitive impairment;
* current enrollment in another intervention study;
* currently receiving 1 or more mental health treatment sessions/month or 8 or more CBT sessions within the past year;
* HIV-positive status (confirmed through in-office testing).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02929069
Study Brief:
Protocol Section:
NCT02929069