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

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.

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