Status:
COMPLETED
Behavioral, Clinical and Basic Science Studies of Non-occupational Post-exposure Prophylaxis ("PEP-2")
Lead Sponsor:
University of California, San Francisco
Conditions:
HIV Infections
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
This is a randomized trial to compare the effect of standard versus enhanced risk reduction counseling on risk behavior incidence in individuals receiving PEP medications. The study seeks to 1) determ...
Detailed Description
A. SPECIFIC AIMS Our group (including behavioral, epidemiological, basic, and clinical scientists from UCSF, San Francisco General Hospital, The San Francisco Department of Public Health, and the UCSF...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00473018
Last Update
June 2 2015
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