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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07467018
Eligibility Criteria:
Inclusion Criteria:
* Being reached for mobile health services by a UCLA HHC mobile van
* ≥18 years of age
* Able to provide informed consent
* English or Spanish-speaking
* Willing and able to comply with study procedures
* HIV unknown or negative status and HIV negative based on rapid 4th generation Ag/Ab test on the day of enrollment
* At-risk for HIV, based on clinician assessment (based on CDC guidelines; includes any individual requesting PrEP, regardless of reported risk factors for HIV)
* Pregnant and breastfeeding women/people can be offered LEN with counseling about benefits and risks.
Exclusion Criteria:
* Any clinical or psychosocial condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to take LEN PrEP
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient
* BMI \<35 kg/m2 (77 pounds)
* On oral or other long-acting PrEP and unwilling to discontinue
* Already taking LEN for HIV prevention
* Known HIV diagnosis or positive 4th generation HIV Ab/Ag test (on day of enrollment) or subsequent lab-based confirmatory testing.
* Do not have any active insurance, including Medi-Cal (those without insurance will be referred to an enrollment counselor and may be re-screened for the study once insurance is active)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07467018
Study Brief:
Protocol Section:
NCT07467018