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