interventions for hiv negative men and women who have high-risk suspected exposure to hiv

Conditions: HIV Prevention; HIV Infections

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.

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

Keywords: post exposure prophylaxis biomedical prevention hiv seronegativity