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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03512418
Eligibility Criteria:
Inclusion Criteria:
* Cisgender MSM
* Moderate to severe non-alcohol substance use disorder
* Self-reported missed PrEP doses (\> or equal to 2 doses in 1 week over past 3 months)
* HIV negative
* On PrEP or initiating PrEP
* Has qualifying laboratory testing: Cr clearance, HBV, liver function tests
* Owns a smartphone with Android or iOS
* Age 18 or older
Exclusion Criteria:
* Non-English speaker
* HIV positive
* History of Crohn's disease or ulcerative colitis
* History of gastric bypass, bowel stricture
* History of GI malignancy or radiation to abdomen
* Unable/unwilling to ingest a digital pill
* Allergy to gelatin, silver or zinc (components of the digital pill)
* Does not qualify for PrEP (abnormal liver function, or Cr Clearance \<60)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03512418
Study Brief:
Protocol Section:
NCT03512418