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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT06835751
Eligibility Criteria:
Inclusion Criteria:
* Female sex
* 18 years or older
* Non-reactive or negative HIV test result
* Self-reported drug- or sex-related HIV risk behaviors in the past six months
* Hazardous or harmful opioid use in the past six months
* Meets criteria for at least one of the following co-occurring mental health conditions: symptoms of depression (PHQ-9 \>= 9), anxiety (GAD-7 \>= 10), and/or PTSD (HTQ \>= 40)
Exclusion Criteria:
* Reactive or positive HIV test result
* Currently taking PrEP
* Actively suicidal, homicidal, or psychotic, and needing immediate hospitalization based on safety assessments
* Unable to provide informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06835751
Study Brief:
Protocol Section:
NCT06835751