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临床试验/NCT00949234
NCT00949234已完成2 期

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

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
267
试验地点
2
主要终点
Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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).

排除标准

  • 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

研究组 & 干预措施

Open-Label

Other

This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.

干预措施: tenofovir + emtricitabine, lopinavir/ritonavir (Drug)

结局指标

主要结局

Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit

时间窗: 24 Weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Raphael Landovitz

Associate Director, UCLA Center for Clinical AIDS Research & Education (CARE)

University of California, Los Angeles

研究点 (2)

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