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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT02891720
Eligibility Criteria:
Inclusion Criteria
Young men who meet all of the following criteria are eligible for inclusion:
* PrEP-eligible YMSM
* Ages 18-24
* Biologically born male
* Report interest in PrEP
* Intend to use PrEP for a full 6 month period
* Eligible to be a PrEP patient at the CORE Center PrEP Clinic
* Meet one the following sexual risk criteria:
* Have an HIV-positive sexual partner
* Had recent bacterial STI
* Report high numbers of sexual partners
* Report history of inconsistent or no condom use
* Report exchange/transactional sex.
Exclusion Criteria
Young men who meet any of the following criteria will be excluded:
* HIV+
* Creatinine clearance \<60 cc/min)
* Allergy to topical adhesive
* Acute gastrointestinal symptoms
* History of major GI surgery
* Presence of an implanted electronic medical device.
* Subjects who are receiving any of the following medications:Nephrotoxic drugs (e.g., cidofovir, amphotericin, aminoglycosides, dapsone, tacrolimus, foscarnet, ACE inhibitors), all diuretics, drugs that may interfere with TFV excretion (e.g., (Val)ganciclovir, Cyclosporin A, Sirolimus, Antineoplastics), drugs (not including mineral and vitamin supplements) used for treatment of osteoporosis (e.g., alendronate and other bisphosphonates, teriparatide, denosumab, and calcitonin), chronic use of oral or systemic steroids (i.e., daily use for two weeks or more is not allowed), experimental medications that are not Food and Drug Administration (FDA)-approved, and FTC/TDF (Truvada®) received outside of the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
24 Years
Study:
NCT02891720
Study Brief:
Protocol Section:
NCT02891720