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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT03058835
Eligibility Criteria:
Inclusion Criteria:
* 18 - 64 years old
* Able to give consent
* "At risk" for HIV as defined by any of the following:
1. unprotected sex (in past 6 months) with 1 or more men of unknown HIV status
2. evaluated for an STI within 6 months prior to screening
3. sex in last 6 months with an HIV-infected partner
4. IDU with report of using previously used or shared needles in past 6 months or has been in a methadone, buprenorphine, or suboxone treatment program in past 6 months or engaging in high-risk sexual behaviors
5. individuals engaging in transactional sex (i.e sex for money, drugs, or housing)
6. Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner)
* CrCl ≥ 60 ml/min
* HIV- uninfected women desiring PrEP
Exclusion Criteria:
* Active alcohol or drug use or dependence which may interfere with adherence to study requirements
* HIV-infected at screening or enrollment
* Estimated CrCl \< 60 mL/min
* Past participation in an HIV vaccine study
* Positive Hepatitis B surface antigen test
* Underlying medical condition with survival unlikely during follow-up period
* Any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives
* Pregnant or breast feeding
* Actively trying to achieve pregnancy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03058835
Study Brief:
Protocol Section:
NCT03058835