NCT00949234

Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV

A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitted infections.

Detailed description

The Los Angeles County P-QUAD program is a combined effort of County, City, public health, community, academic, and private agencies and individuals in an effort to provide a comprehensive package of HIV prevention services of which PEP can be an integral component. These services are designed to be easily accessible, non-judgmental, culturally, ethnically, and linguistically appropriate to the relevant populations, community-based, and independent of ability to pay or insurance/documentation status. They will also provide vital linkages to associated services, routine HIV testing, and primary health care. In its initial pilot project, 2 community-based sites will serve as facilities at which patients may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases. At the sites, initial eligibility and testing will be performed, and an initial 14-day supply of PEP medications will be provided if appropriate, and referrals will be initiated. All subjects who are provided an initial 14-day supply will be required to return to the site for the remainder of the 28-day course of medication, follow-up testing, adherence counseling, risk-reduction programming, and other appropriate referrals. Follow-up with patients by phone, email, and mobile-phone text message will be used as appropriate to maximize program retention.

Conditions

• HIV Prevention
• HIV Infections

Interventions

Type	Name	Description
DRUG	tenofovir + emtricitabine, lopinavir/ritonavir	The preferred regimen will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min or on hemodialysis, Truvada should not be used. For intolerance to Truvada, Combivir (zidovudine 300mg/lamivudine 150mg)will be available to be taken as 1 PO BID. For highest-risk category exposures (receptive anal intercourse with a known or suspected HIV-positive source patient or in cases of suspected source drug resistance, see Schema, below) one of the following should be added to the above "standard" treatment, creating an "expanded" regimen: Preferred: Lopinavir/ritonavir (200mg/50mg), 2 tablets orally twice daily or 4 tablets once daily

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2011-08-01
• First posted: 2009-07-30
• Last updated: 2017-12-18
• Results posted: 2017-12-18

Locations

2 sites across 1 country: United States