Behavioral, Clinical and Basic Science Studies of Non-occupational Post-exposure Prophylaxis ("PEP-2")
PEP-2
1 other identifier
interventional
N/A
0 countries
N/A
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) determine if there are equivalent changes in the incidence of self-reported risk behaviors, STD incidence, and adherence to medications in individuals who receive enhanced risk reduction and adherence counseling and those who received standard risk reduction and adherence counseling; 2) evaluate viral and host biological factors involved in sexual transmission that may either influence PEP efficacy, or themselves be negatively or positively affected by the administration of PEP medications; and 3) contribute to the CDC registry in an attempt to provide crucial data for a case control analysis to establish the efficacy of PEP for sexual and injection drug use exposures. The principal outcome will be the change in participants' number of unprotected sexual acts following administration of PEP. This is defined as the number of prior 3-month acts of high risk unprotected sex, assessed at 12 months following a course of PEP, minus the number of unprotected acts the participant reported in the 3 and 6 months prior to beginning PEP (assessed at baseline). Methods to be used consist of interview data collection, questionnaires, risk reduction and adherence counseling and source recruitment counseling (index subject).
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2007
CompletedFirst Posted
Study publicly available on registry
May 14, 2007
CompletedJune 2, 2015
May 1, 2007
May 9, 2007
June 1, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle E Roland
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 9, 2007
First Posted
May 14, 2007
Last Updated
June 2, 2015
Record last verified: 2007-05