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

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 2

Conditions: HIV Prevention; HIV Infections

Treatments: Drug: tenofovir + emtricitabine, lopinavir/ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT00949234

PQUAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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267 participants in 1 patient group

Open-Label

Other group

Description:

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

Treatment:

Drug: tenofovir + emtricitabine, lopinavir/ritonavir