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Sponsor: Icahn School of Medicine at Mount Sinai
Conditions: HIV/AIDS, PrEP
Interventions: PrEP screening program, PrEP starter pack
Countries: United States
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new infections. Since approval, the promise of PrEP as a transformative intervention has yet to be realized. Despite the implementation of systems for clinical evaluation for and initiation of PrEP by primary care providers, HIV specialists, and STI clinics, numerous barriers to PrEP expansion have been identified, including: 1) patient and provider lack of knowledge, 2) lack of access to medical care among high-risk individuals, 3) provider discomfort and inexperience with screening for risk behaviors, and 4) insurance and affordability. This proposal seeks to expand access to and engagement in PrEP among high risk individuals though an innovative delivery approach in the Emergency Department (ED) while addressing these four barriers.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: PrEP screen group: * Patients 18 years of age and above * Medically stable as determined by their provider * Able to speak English * Willing and able to consent to study participation. * Not requiring hospital admission for ongoing care. iPrep group: * ED patients 18 years of age and above * HIV negative determined by 4th generation rapid testing with no evidence of acute HIV infection as determined by their ED provider * Medically stable as determined by their primary provider * Able to speak English * Able to consent to participation * Contact information available for linkage * Not requiring hospital admission for ongoing care. * Eligible for PrEP based on CDC risk behavior and clinical criteria. Exclusion Criteria: PrEP screen group: * ED patients younger than 18 years of age * Medically or psychiatrically unstable as determined by the ED provider * Unable to speak or understand English * Unable to provide consent for study participation. * Being admitted to the hospital for ongoing care iPrEP group: * ED patients younger than 18 years of age * Known HIV positive or positive rapid HIV test in ED * Medically or psychiatrically unstable as determined by the ED provider * Unable to speak or understand English * Unable to provide consent for study participation * No means of re-contact upon ED discharge * No behavioral risk factors indicating need for PrEP * Medical contraindications to PrEP * Pregnant or breastfeeding
- New York, New York, United States