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 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT01508559
Eligibility Criteria:
Inclusion Criteria:
All subjects
* 18-49 years inclusive
* Identifying as MSM
* Willing and able to provide written informed consent
* Able to complete screening tools.
* Fluent in spoken and written English
* Patients who have given written and dated informed consent to participate in this study and to use the data.
* Patients co-infected with chronic hepatitis B/C (diagnosed serologically at least 6 months prior to study to exclude seroconversion/recent infection) and/or currently using recreational substances including alcohol will be included in this study ("real world" data)
HIV-infected subjects • Known HIV of at least 6 months duration (in order to exclude symptoms associated with primary HIV infection)
HIV-uninfected controls
* HIV-negative by rapid point of care test (POCT) or standard laboratory testing
* No unprotected anal intercourse (UPAI) in last 3 months
Exclusion Criteria:
All subjects
* HIV or hepatitis B/C infection thought to have occurred in the last 6 months
* Current/active central nervous system (CNS) opportunistic infections or CNS malignancies.
* Previous cerebrovascular accidents (CVA/stroke) or history of transient ischemic attacks (TIAs).
* Neuromuscular disease that will limit ability to perform the screening tests.
* Patients receiving current therapy with ribavirin or interferon for hepatitis co-infection or expected to start such therapy in the coming 12 months
* Current medical or psychiatric/psychological condition deemed significant by the investigator o (e.g. psychosis, bipolar disorder, dementia, eating disorders, severe head injury (loss of consciousness for at least an hour), current CNS opportunistic infection)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT01508559
Study Brief:
Protocol Section:
NCT01508559