Provision of HIV Self-Test Kit to Increase Uptake of HIV Testing Among Emergency Department Patients Who Decline Emergency Department-Based HIV Screening.

The Investigators will conduct a pilot randomized study at Johns Hopkins Hospital Emergency Department on patients who decline routine HIV testing offer by triage nurses. 1. Recruitment

"Refusers" Cohort Study staff will screen the emergency department tracking board (Epic) for patients who meet study enrollment criteria, which is done routinely as part of the emergency department HIV testing program. When an eligible patient is identified by the chart review (please see HIPAA form 4), the study staff will talk to the emergency department clinician regarding research opportunity for the potentially eligible patients. For all individuals who are not clinical patients of a study team member, the recruitment procedure will be that the patient's clinician will request and document in the chart the patient's permission to be contacted by the research staff.

"High Risk" Cohort "The eligibility of "high-risk cohort" is emergency department patients who are offered an HIV test as the standard of care in the emergency department, accept the standard of care (SOC) HIV testing, and who have at increased risk for HIV. Study staff will screen the emergency department tracking board (Epic) for patients who are offered an HIV test at triage by the triage nurse, which is done routinely as part of the emergency department HIV testing program. When an eligible patient is identified by the chart review (please see HIPAA form 4), the study staff will talk to the emergency department clinician regarding research opportunity for the potentially eligible patients. For all individuals who are not clinical patients of a study team member, the recruitment procedure will be that the patient's clinician will request and document in the chart the patient's permission to be contacted by the research staff. In order to determine if the patient is at increased risk for HIV, the study staff will use of the Screening Question (three screening questions) that is uploaded in the application section 20 (see section 20 for Screening_Question_05312016"). The three questions are as follows: 1) Have you been sexually active in the past 12 months, 2) have you ever used injection drugs in your life, and 3) (for men only), have you ever had sex with a man in your life time. If the patient responds "yes" to the question "Is any of your answer "Yes" (see section 20 for Screening_Question_05312016"), they will be considered eligible and will then go through the consent and enrollment procedures. No identifiers will be collected for this screening step.

2. Enrollment The study staff will obtain verbal informed consent. The process will involve a description of the study as provided in the verbal consent form (OralConsentScript_for_HighRiskPatient_06012016.docx) with a chance to provide answers to any questions about the study. Justification for verbal consent is provided in the e-Institutional Review Board application. Specifically, this study involves no bodily intervention and poses minimal risk to patients. The consent process will take between approximately 5-10 minutes, but as much time as needed will be provided to patients. Consented subjects will be given a copy of the oral

consent document for their information and records. In this consent, the patient will be asked for permission to review their medical charts at Johns Hopkins Hospital for the clinical information of their emergency department visit. Consented patients will be randomized to one of two groups, the Index Group (Group 1) or the Reference Group (Group 2). The index group or the HIV self-testing kit group will be provided a free FDA-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test) and the reference group will not receive the HIV self-testing kit. Consented patients in both groups will fill out a short survey regarding their socio-demographic information as well as their experience, attitudes, and perceptions regarding HIV testing. For patients who are in the HIV self-testing kit group, they will be asked if they would like to take a free FDA-approved HIV self-testing home kit home. If they agree, the research staff will make sure the patients will take the kit home when they are discharged. Participants in this group will also receive information regarding how to access the "I Want The Kit" website to report the completion of HIV self-testing at home. Participants in this group will also be informed of a lottery-based monetary compensation with 1 in 10 chance to win an additional $50 gift card for reporting the test results to the "I Want The Kit" website. Participant who wins the $50 gift card will be notified via text message, followed by a phone call while participant who does not win the gift card will be notified via text message (see section 20 for "Text Message Script for Lottery Incentive). For patients who are in the reference group, a standard pamphlet regarding the importance of HIV testing and HIV testing venues in Baltimore City used by current Johns Hopkins Hospital emergency department-based HIV testing program will be provided to the patients.