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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Open-Label	tenofovir + emtricitabine, lopinavir/ritonavir	This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.

Primary Outcome Measures