Provision of HIV Self-Test Kit to Emergency Department Patients
Condition: HIV Infections
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The proposed pilot research has three aims: 1) to determine the feasibility and acceptability
      of provision of HIV self-testing kit in order to increase uptake and engagement of HIV
      testing among emergency department patients who decline conventional emergency department HIV
      testing and to increase the engagement of HIV testing at a regular basis for those with an
      increased risk for HIV (the index participants); 2) to determine the uptake and engagement of
      HIV testing by provision of HIV self-testing kit; and 3) to determine the feasibility and
      acceptability of HIV self-testing kit referral among partners or peers of the index
      participants.

      The investigators will conduct a pilot randomized study at Johns Hopkins Hospital emergency
      department on (1) patients who decline routine HIV testing offer and (2) patients who are at
      an increased risk for HIV. The consented patient will be randomized to HIV self-testing kit
      group which the investigators will provide a free Food and Drug Administration-approved HIV
      self-testing home kit for the participant to take it home or to reference group which the
      investigators will not provide the self-testing kit. Consented patients in both groups will
      fill out a short survey regarding their socio-demographic information as well as their
      experience 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 HIV self-testing
      home kit home. Participants in this group will also receive information regarding how to
      access "I Want The Kit" website to report the completion of HIV self-testing at home. 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 emergency department-based HIV
      testing program will be provided to the patients.

      Follow-up questionnaires will inquire regarding the patient's experience regarding HIV
      testing since their index visit.

      When the participants in the HIV self-testing kit group in Aim 1, they will also be provided
      5 referral cards for their partners and peers for them to request a free HIV self-testing kit
      from the "I Want The Kit" website. At the 1-month phone follow-up, the investigators will ask
      participants if they are able to give the referral cards to their partner(s) or friend(s),
      how they think if their partner(s) and/or friend(s) will request an HIV self-testing kit from
      the "I Want The Kit" website.
    

Detailed description: 
      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.

      3. Survey information:

        -  Patients will be consented and enrolled in the study prior to collecting data in the
           emergency department.

        -  After patient consent and enrollment by the study staff, each study participant will
           complete a survey questionnaire (see attached Index_Questionnaire.docx in Supplemental
           Study Documents) at the time of enrollment to indicate their social, demographic, and
           clinical characteristics. The survey is research (not part of routine care), but would
           not add to the patient's length of stay since it can be conducted during waiting time in
           a private setting. This survey will be clearly explained by and completed with the
           assistance of the study staff.

        -  All patients will be informed of intent to contact them for a brief follow-up phone
           interview at one month and 3 months from the date of enrollment. This is one of the
           exclusion criteria.

        -  Following enrollment, a member of the research team will abstract chart data of the
           emergency department visits. The abstraction will focus on visit-specific clinical data
           (e.g. chief complaint, diagnosis, acuity level, and disposition (The full variable list
           can be found in section 20, Variable List).

           4. Patient Follow-up

        -  Participants will receive a phone or text message reminder from the study team in order
           to remind that they are enrolled in the study within a week after the enrollment. The
           study team will make sure that the participant is the one who answers the phone before
           reminding the participant of this study. The text message will not contain the words of
           HIV or HIV testing. The participant will also receive text message reminder 1 week
           before each follow-up time (1 and 3 month time point). The text message will include the
           reminder of the phone follow-up as well as the $10 gift card incentive that the
           investigators would be providing to the participant upon completing the phone follow up
           (see section 20 for "Text reminder version 0.02).

        -  Consented patients will be contacted by the study team at one month and 3 months after
           enrollment. No more than five separate attempts to contact will be made during this time
           until deemed lost to follow up for the particular follow up time point.

        -  Follow-up questionnaires will ask the patient about their experience, attitudes, and
           perceptions regarding HIV testing since their index visit. Please see attached
           Phone_Script.docx

        -  A $10.00 gift card will be mailed to the participant once he/she completes the follow-up
           survey by phone for each follow up time point.

           5. HIV Self-testing at home Instructions for performing the home test, with visual aids,
           will be included with the kit. For participants in the HIV self-testing kit group whose
           test result by HIV self-testing at home is interpreted as "reactive" or "indeterminate",
           he or she can follow the instruction inside the kit to call a hotline to Johns Hopkins
           Hospital emergency department routine rapid HIV screening and linkage to care program
           staff that operates 16 hours a day, 7 days a week, OraQuick Consumer Support Center that
           operates 24 hours a day, or their primary physician for counseling. Patients with a
           reactive test result can either come to Johns Hopkins Hospital emergency department or
           the Johns Hopkins HIV Women's Program to receive confirmatory blood testing of the
           screening self-test. All participants with a positive or indeterminate screening result
           will have blood drawn and sent to the Maryland Department of Health and Mental Hygiene
           Laboratories Administration Central Laboratory where free confirmatory testing will be
           performed using the HIV-1 Western Blot Assay from Bio-Rad Laboratories. (At Maryland
           Department of Health and Mental Hygiene and Central Laboratory, indeterminate and
           negative HIV-1 Western Blot specimens are tested using the Multispot HIV-1/HIV-2 Rapid
           test as a differentiation assay to rule out HIV-2, and using in-house validated HIV-1
           real time polymerase chain reaction assay to detect acute cases of HIV-1).

      For participants in the HIV self-testing kit group, they will be asked to report their test
      result on to "I Want The Kit" website using the access information provided in the HIV
      self-testing kit.

      When the participants (the index participants) in the HIV self-testing kit group in Aim 1
      receive the self-testing kit, they will also be provided 5 referral cards to give to their
      partners and peers in the drug, sex, and social networks for them to request a free HIV
      self-testing kit from the "I Want The Kit" website. On the referral card, a unique code
      number be used after the subject uses provided website address to land in "I Want The Kit"
      website and create an "I Want The Kit" user account. The unique code number will indicate the
      "I Want The Kit" user is referred from an emergency department patient who is an index
      participant. The index participants would also be informed of a lottery-based monetary
      compensation to provide 1 in 10 chance to win an additional $10 gift card for every "I Want
      The Kit" user that is referred from an index participant of this study. Participant who wins
      the $10 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). The confidential code numbers will allow
      determination of whether emergency department subjects and/or their referrals use the "I Want
      The Kit" website but will not allow research team access to identity-linked test results
      (Please see data management section below regarding de-identification before data analysis).
      At the 1-month and 3-month phone follow-up, the investigators will ask participants if they
      are able to give the referral cards to their partner(s) or friend(s), how many cards they are
      able to give out, how many cards they are able to give to their partner(s), how many cards
      they are able to give to their friend(s), and how likely it is that their partner(s) and/or
      friend(s) will request an HIV self-testing kit from the "I Want The Kit" website. Finally,
      the investigators will ask them how the investigators can increase the likelihood of their
      partner(s) and/or friend(s) accessing the "I Want The Kit" website and requesting an HIV
      self-testing kit.
    

Intervention name(s): HIV Self-testing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening