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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT06444360
Eligibility Criteria:
Inclusion Criteria:
* Age 16-24 years, inclusive, at enrollment
* Male or female
* Self-reports condomless anal or vaginal sex while using stimulants (5 hour prior to, or during sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and MDMA (e.g., ecstasy, molly)
* Willing and able to provide written informed consent for study participation
* Access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)
* Provide a mailing address where they can receive a package
* Access to stable internet that they can use for more than 2 hours at a time
* Have a private place (where no one else can see or hear) where they can complete visits online
* Reside within the continental U.S.
Exclusion Criteria:
* Unable to provide informed consent due to severe mental or physical illness
* Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable)
* Randomized to IMPACT arm prior to March 2025 study stop
* Non-English-speaking
* Is currently incarcerated or pending incarceration
* Is currently pregnant or planning to become pregnant
* Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT06444360
Study Brief:
Protocol Section:
NCT06444360