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:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
NCT ID:
NCT01781806
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Able to understand and provide consent in English or Spanish
* Self identified MSM, MSM/W, or Transfemale
* At least one male sex partner for anal intercourse in the prior 12 months
* HIV negative by enzyme immunoassay (EIA) and viral load (VL)
* CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)
* No signs or symptoms suggestive of primary HIV infection (PHI).
Exclusion Criteria:
* Participants \<18 years of age
* Unable to understand and provide consent in English or Spanish
* Known or found on testing to be HIV positive
* Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing
* Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry
* Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
* Signs or symptoms suspicious for PHI.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01781806
Study Brief:
Protocol Section:
NCT01781806