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

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.

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