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 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT03116932
Eligibility Criteria:
INCLUSION CRITERIA;
Study subjects who meet the following inclusion criteria will be considered for enrollment for Part A:
1. age 21 years or older
2. understand and sign the informed consent form and willing to participate in the study
3. male or transgender female
4. has one of the following risk factors:
* a high risk MSM as defined by:
* having unprotected sexual intercourse with at least two male partners in the past 6 months, or
* diagnosed with an STI in the past 6 months.
PART A - EXCLUSION CRITERIA:
Subjects with any of the following will not be considered for enrollment in Part A:
1. Age younger than 21 years old
2. Unable or unwilling to provide an informed consent
3. Female gender at birth
4. Do not meet the high risk criteria
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT03116932
Study Brief:
Protocol Section:
NCT03116932