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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT03086057
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Biological male at birth and current male gender identity
* Exchanged sex for money or drugs with another man in the past 3 months
* Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
* HIV uninfected by antibody test\* Stage 2
* Able to understand and speak English (for consent and counseling)
* Mental competency to provide voluntary informed consent
* Lives in the New England area
* Willing to initiate PrEP
Exclusion Criteria:
* Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
* HIV Positive at baseline
* Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate \< 50) \*Stage 2
* History of or current medical conditions that would preclude taking Truvada for PrEP \*Stage 2
* Currently taking Truvada for PrEP
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03086057
Study Brief:
Protocol Section:
NCT03086057