Clinical trial NCT00949234: Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Prevention
HIV Infections
Keywords: post exposure prophylaxis
biomedical prevention
HIV seronegativity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Public Health
name: AIDS Project Los Angeles
name: Los Angeles LGBT Center
name: The OASIS Clinic
First posted: 2009-07-30
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: L.A. Gay & Lesbian Center
state: California
city: Los Angeles
country: United States
facility: OASIS Clinic
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Raphael J. Landovitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: