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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Prevention, HIV Infections

Intervention / Treatment
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* Drug: tenofovir + emtricitabine, lopinavir/ritonavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open-Label<br>This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP. | Drug: tenofovir + emtricitabine, lopinavir/ritonavir<br>* 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<br>* Other names: Combivir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit |  | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post exposure prophylaxis, biomedical prevention, HIV seronegativity