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 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT00473018
Eligibility Criteria:
Inclusion Criteria:
To be included in the study the subject must be:
* \>/= 14 years of age
* Able to give informed consent
* English- or Spanish-speaking
* Able to report risk of HIV exposure during the previous 72 hours defined as:
* unprotected sex defined as:
* unprotected receptive or insertive anal or vaginal sex without a condom (with or without ejaculation); or
* protected receptive or insertive anal or vaginal intercourse with a condom which breaks or falls off during intercourse (with or without ejaculation); or
* sharing of potentially contaminated injection drug use equipment; or
* unprotected receptive oral sex with ejaculation; and this exposure was with a
* high risk partner defined as:
* known to be HIV-infected; or
* is a man who has sex with men; or
* is or has been an injection drug user; or
* is a sex worker, or
* the partner is anonymous, or
* the partner is known to the subject but their sexual or injection drug use history is unknown.
* Additional exposures will be considered if they involve potentially HIV-infected body fluids in contact with a mucous membrane or non-intact skin, at the discretion of the study clinician. The subject must report that he/she has never received antiretroviral medications for the treatment of established HIV infection nor been diagnosed with HIV infection. The subject must elect to initiate PEP medications.
* Index subjects will be allowed to enroll in the study up to four times in one year (re-PEP). They will be encouraged to participate in referrals for enhanced prevention services at the direction of the counseling supervisor. Subjects who enroll more than once will be given 2 additional counseling sessions for each re-enrollment episode designed to address issues related to on-going exposure.
* All women will be tested for pregnancy; if pregnant, they will still be offered enrollment in the study, with additional counseling provided by the Bay Area Perinatal Aids Center (BAPAC) at San Francisco General Hospital.
Exclusion Criteria:
Subjects will be excluded if they are:
* Unable to give informed consent
* Known to be infected with HIV by their report
* Unable to commit to or make follow-up visits.
Cases of sexual assault will be referred to rape counseling services. PEP may be offered as a non-study service in collaboration with the rape counseling services.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00473018
Study Brief:
Protocol Section:
NCT00473018