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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00949234
Eligibility Criteria:
Inclusion Criteria:
* Patients must be at least 18 years of age
* Able to understand and provide consent
* High-Risk Exposure Characteristic
* (one or more of the below, unprotected or with failed condom use)
* Receptive Anal Intercourse
* Insertive Anal Intercourse
* Receptive Vaginal Intercourse
* Insertive Vaginal Intercourse
* Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source (supersedes all "high-risk source" criteria below)
* Sharing injection drug works which have been intravascular
* High-Risk Source (one or more of the below)
* Known HIV positive
* MSM
* MSM/W
* IDU
* CSW
* Sexual perpetrator
* From an endemic country (prevalence \>1%)
* Partner of one of the above
* Exposure within 72 hours of presentation
* Not known to be HIV positive
* No countermanding concomitant medications or allergies
* HIV-negative on presentation and without symptoms of PHI (do not withhold first dose pending these laboratory assessments).
Exclusion Criteria:
* Patients \<18 years of age
* Unable to understand and provide consent
* Exposure \>72 hours of presentation
* Known to be HIV positive
* Currently in-progress of a course of PEP initiated via non-P-QUAD mechanisms
* Any condition, which in the opinion of the intake provider, will seriously compromise the patient's ability to comply with the protocol, including
* adherence to PEP medication dosing
* Demonstrated HIV-positive on rapid testing
* Unwillingness to commit to barrier-method (male and/or female condom) use until HIV-negative-status is confirmed 6 months after exposure
* Unwillingness of breast-feeding women to transition to formula feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00949234
Study Brief:
Protocol Section:
NCT00949234