<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03021005</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00090921</org_study_id>
    <secondary_id>U54EB007958</secondary_id>
    <nct_id>NCT03021005</nct_id>
  </id_info>
  <brief_title>Provision of HIV Self-Test Kit to Emergency Department Patients</brief_title>
  <official_title>Provision of HIV Self-Test Kit to Increase Uptake of HIV Testing Among Emergency Department Patients Who Decline Emergency Department-Based HIV Screening.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed pilot research has three aims: 1) to determine the feasibility and acceptability&#xD;
      of provision of HIV self-testing kit in order to increase uptake and engagement of HIV&#xD;
      testing among emergency department patients who decline conventional emergency department HIV&#xD;
      testing and to increase the engagement of HIV testing at a regular basis for those with an&#xD;
      increased risk for HIV (the index participants); 2) to determine the uptake and engagement of&#xD;
      HIV testing by provision of HIV self-testing kit; and 3) to determine the feasibility and&#xD;
      acceptability of HIV self-testing kit referral among partners or peers of the index&#xD;
      participants.&#xD;
&#xD;
      The investigators will conduct a pilot randomized study at Johns Hopkins Hospital emergency&#xD;
      department on (1) patients who decline routine HIV testing offer and (2) patients who are at&#xD;
      an increased risk for HIV. The consented patient will be randomized to HIV self-testing kit&#xD;
      group which the investigators will provide a free Food and Drug Administration-approved HIV&#xD;
      self-testing home kit for the participant to take it home or to reference group which the&#xD;
      investigators will not provide the self-testing kit. Consented patients in both groups will&#xD;
      fill out a short survey regarding their socio-demographic information as well as their&#xD;
      experience and perceptions regarding HIV testing. For patients who are in the HIV&#xD;
      self-testing kit group, they will be asked if they would like to take a free HIV self-testing&#xD;
      home kit home. Participants in this group will also receive information regarding how to&#xD;
      access &quot;I Want The Kit&quot; website to report the completion of HIV self-testing at home. For&#xD;
      patients who are in the reference group, a standard pamphlet regarding the importance of HIV&#xD;
      testing and HIV testing venues in Baltimore City used by emergency department-based HIV&#xD;
      testing program will be provided to the patients.&#xD;
&#xD;
      Follow-up questionnaires will inquire regarding the patient's experience regarding HIV&#xD;
      testing since their index visit.&#xD;
&#xD;
      When the participants in the HIV self-testing kit group in Aim 1, they will also be provided&#xD;
      5 referral cards for their partners and peers for them to request a free HIV self-testing kit&#xD;
      from the &quot;I Want The Kit&quot; website. At the 1-month phone follow-up, the investigators will ask&#xD;
      participants if they are able to give the referral cards to their partner(s) or friend(s),&#xD;
      how they think if their partner(s) and/or friend(s) will request an HIV self-testing kit from&#xD;
      the &quot;I Want The Kit&quot; website.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Investigators will conduct a pilot randomized study at Johns Hopkins Hospital Emergency&#xD;
      Department on patients who decline routine HIV testing offer by triage nurses. 1. Recruitment&#xD;
&#xD;
      &quot;Refusers&quot; Cohort Study staff will screen the emergency department tracking board (Epic) for&#xD;
      patients who meet study enrollment criteria, which is done routinely as part of the emergency&#xD;
      department HIV testing program. When an eligible patient is identified by the chart review&#xD;
      (please see HIPAA form 4), the study staff will talk to the emergency department clinician&#xD;
      regarding research opportunity for the potentially eligible patients. For all individuals who&#xD;
      are not clinical patients of a study team member, the recruitment procedure will be that the&#xD;
      patient's clinician will request and document in the chart the patient's permission to be&#xD;
      contacted by the research staff.&#xD;
&#xD;
      &quot;High Risk&quot; Cohort &quot;The eligibility of &quot;high-risk cohort&quot; is emergency department patients&#xD;
      who are offered an HIV test as the standard of care in the emergency department, accept the&#xD;
      standard of care (SOC) HIV testing, and who have at increased risk for HIV. Study staff will&#xD;
      screen the emergency department tracking board (Epic) for patients who are offered an HIV&#xD;
      test at triage by the triage nurse, which is done routinely as part of the emergency&#xD;
      department HIV testing program. When an eligible patient is identified by the chart review&#xD;
      (please see HIPAA form 4), the study staff will talk to the emergency department clinician&#xD;
      regarding research opportunity for the potentially eligible patients. For all individuals who&#xD;
      are not clinical patients of a study team member, the recruitment procedure will be that the&#xD;
      patient's clinician will request and document in the chart the patient's permission to be&#xD;
      contacted by the research staff. In order to determine if the patient is at increased risk&#xD;
      for HIV, the study staff will use of the Screening Question (three screening questions) that&#xD;
      is uploaded in the application section 20 (see section 20 for Screening_Question_05312016&quot;).&#xD;
      The three questions are as follows: 1) Have you been sexually active in the past 12 months,&#xD;
      2) have you ever used injection drugs in your life, and 3) (for men only), have you ever had&#xD;
      sex with a man in your life time. If the patient responds &quot;yes&quot; to the question &quot;Is any of&#xD;
      your answer &quot;Yes&quot; (see section 20 for Screening_Question_05312016&quot;), they will be considered&#xD;
      eligible and will then go through the consent and enrollment procedures. No identifiers will&#xD;
      be collected for this screening step.&#xD;
&#xD;
      2. Enrollment The study staff will obtain verbal informed consent. The process will involve a&#xD;
      description of the study as provided in the verbal consent form&#xD;
      (OralConsentScript_for_HighRiskPatient_06012016.docx) with a chance to provide answers to any&#xD;
      questions about the study. Justification for verbal consent is provided in the&#xD;
      e-Institutional Review Board application. Specifically, this study involves no bodily&#xD;
      intervention and poses minimal risk to patients. The consent process will take between&#xD;
      approximately 5-10 minutes, but as much time as needed will be provided to patients.&#xD;
      Consented subjects will be given a copy of the oral&#xD;
&#xD;
      consent document for their information and records. In this consent, the patient will be&#xD;
      asked for permission to review their medical charts at Johns Hopkins Hospital for the&#xD;
      clinical information of their emergency department visit. Consented patients will be&#xD;
      randomized to one of two groups, the Index Group (Group 1) or the Reference Group (Group 2).&#xD;
      The index group or the HIV self-testing kit group will be provided a free FDA-approved HIV&#xD;
      self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test) and the reference group&#xD;
      will not receive the HIV self-testing kit. Consented patients in both groups will fill out a&#xD;
      short survey regarding their socio-demographic information as well as their experience,&#xD;
      attitudes, and perceptions regarding HIV testing. For patients who are in the HIV&#xD;
      self-testing kit group, they will be asked if they would like to take a free FDA-approved HIV&#xD;
      self-testing home kit home. If they agree, the research staff will make sure the patients&#xD;
      will take the kit home when they are discharged. Participants in this group will also receive&#xD;
      information regarding how to access the &quot;I Want The Kit&quot; website to report the completion of&#xD;
      HIV self-testing at home. Participants in this group will also be informed of a lottery-based&#xD;
      monetary compensation with 1 in 10 chance to win an additional $50 gift card for reporting&#xD;
      the test results to the &quot;I Want The Kit&quot; website. Participant who wins the $50 gift card will&#xD;
      be notified via text message, followed by a phone call while participant who does not win the&#xD;
      gift card will be notified via text message (see section 20 for &quot;Text Message Script for&#xD;
      Lottery Incentive). For patients who are in the reference group, a standard pamphlet&#xD;
      regarding the importance of HIV testing and HIV testing venues in Baltimore City used by&#xD;
      current Johns Hopkins Hospital emergency department-based HIV testing program will be&#xD;
      provided to the patients.&#xD;
&#xD;
      3. Survey information:&#xD;
&#xD;
        -  Patients will be consented and enrolled in the study prior to collecting data in the&#xD;
           emergency department.&#xD;
&#xD;
        -  After patient consent and enrollment by the study staff, each study participant will&#xD;
           complete a survey questionnaire (see attached Index_Questionnaire.docx in Supplemental&#xD;
           Study Documents) at the time of enrollment to indicate their social, demographic, and&#xD;
           clinical characteristics. The survey is research (not part of routine care), but would&#xD;
           not add to the patient's length of stay since it can be conducted during waiting time in&#xD;
           a private setting. This survey will be clearly explained by and completed with the&#xD;
           assistance of the study staff.&#xD;
&#xD;
        -  All patients will be informed of intent to contact them for a brief follow-up phone&#xD;
           interview at one month and 3 months from the date of enrollment. This is one of the&#xD;
           exclusion criteria.&#xD;
&#xD;
        -  Following enrollment, a member of the research team will abstract chart data of the&#xD;
           emergency department visits. The abstraction will focus on visit-specific clinical data&#xD;
           (e.g. chief complaint, diagnosis, acuity level, and disposition (The full variable list&#xD;
           can be found in section 20, Variable List).&#xD;
&#xD;
           4. Patient Follow-up&#xD;
&#xD;
        -  Participants will receive a phone or text message reminder from the study team in order&#xD;
           to remind that they are enrolled in the study within a week after the enrollment. The&#xD;
           study team will make sure that the participant is the one who answers the phone before&#xD;
           reminding the participant of this study. The text message will not contain the words of&#xD;
           HIV or HIV testing. The participant will also receive text message reminder 1 week&#xD;
           before each follow-up time (1 and 3 month time point). The text message will include the&#xD;
           reminder of the phone follow-up as well as the $10 gift card incentive that the&#xD;
           investigators would be providing to the participant upon completing the phone follow up&#xD;
           (see section 20 for &quot;Text reminder version 0.02).&#xD;
&#xD;
        -  Consented patients will be contacted by the study team at one month and 3 months after&#xD;
           enrollment. No more than five separate attempts to contact will be made during this time&#xD;
           until deemed lost to follow up for the particular follow up time point.&#xD;
&#xD;
        -  Follow-up questionnaires will ask the patient about their experience, attitudes, and&#xD;
           perceptions regarding HIV testing since their index visit. Please see attached&#xD;
           Phone_Script.docx&#xD;
&#xD;
        -  A $10.00 gift card will be mailed to the participant once he/she completes the follow-up&#xD;
           survey by phone for each follow up time point.&#xD;
&#xD;
           5. HIV Self-testing at home Instructions for performing the home test, with visual aids,&#xD;
           will be included with the kit. For participants in the HIV self-testing kit group whose&#xD;
           test result by HIV self-testing at home is interpreted as &quot;reactive&quot; or &quot;indeterminate&quot;,&#xD;
           he or she can follow the instruction inside the kit to call a hotline to Johns Hopkins&#xD;
           Hospital emergency department routine rapid HIV screening and linkage to care program&#xD;
           staff that operates 16 hours a day, 7 days a week, OraQuick Consumer Support Center that&#xD;
           operates 24 hours a day, or their primary physician for counseling. Patients with a&#xD;
           reactive test result can either come to Johns Hopkins Hospital emergency department or&#xD;
           the Johns Hopkins HIV Women's Program to receive confirmatory blood testing of the&#xD;
           screening self-test. All participants with a positive or indeterminate screening result&#xD;
           will have blood drawn and sent to the Maryland Department of Health and Mental Hygiene&#xD;
           Laboratories Administration Central Laboratory where free confirmatory testing will be&#xD;
           performed using the HIV-1 Western Blot Assay from Bio-Rad Laboratories. (At Maryland&#xD;
           Department of Health and Mental Hygiene and Central Laboratory, indeterminate and&#xD;
           negative HIV-1 Western Blot specimens are tested using the Multispot HIV-1/HIV-2 Rapid&#xD;
           test as a differentiation assay to rule out HIV-2, and using in-house validated HIV-1&#xD;
           real time polymerase chain reaction assay to detect acute cases of HIV-1).&#xD;
&#xD;
      For participants in the HIV self-testing kit group, they will be asked to report their test&#xD;
      result on to &quot;I Want The Kit&quot; website using the access information provided in the HIV&#xD;
      self-testing kit.&#xD;
&#xD;
      When the participants (the index participants) in the HIV self-testing kit group in Aim 1&#xD;
      receive the self-testing kit, they will also be provided 5 referral cards to give to their&#xD;
      partners and peers in the drug, sex, and social networks for them to request a free HIV&#xD;
      self-testing kit from the &quot;I Want The Kit&quot; website. On the referral card, a unique code&#xD;
      number be used after the subject uses provided website address to land in &quot;I Want The Kit&quot;&#xD;
      website and create an &quot;I Want The Kit&quot; user account. The unique code number will indicate the&#xD;
      &quot;I Want The Kit&quot; user is referred from an emergency department patient who is an index&#xD;
      participant. The index participants would also be informed of a lottery-based monetary&#xD;
      compensation to provide 1 in 10 chance to win an additional $10 gift card for every &quot;I Want&#xD;
      The Kit&quot; user that is referred from an index participant of this study. Participant who wins&#xD;
      the $10 gift card will be notified via text message, followed by a phone call while&#xD;
      participant who does not win the gift card will be notified via text message (see section 20&#xD;
      for &quot;Text Message Script for Lottery Incentive). The confidential code numbers will allow&#xD;
      determination of whether emergency department subjects and/or their referrals use the &quot;I Want&#xD;
      The Kit&quot; website but will not allow research team access to identity-linked test results&#xD;
      (Please see data management section below regarding de-identification before data analysis).&#xD;
      At the 1-month and 3-month phone follow-up, the investigators will ask participants if they&#xD;
      are able to give the referral cards to their partner(s) or friend(s), how many cards they are&#xD;
      able to give out, how many cards they are able to give to their partner(s), how many cards&#xD;
      they are able to give to their friend(s), and how likely it is that their partner(s) and/or&#xD;
      friend(s) will request an HIV self-testing kit from the &quot;I Want The Kit&quot; website. Finally,&#xD;
      the investigators will ask them how the investigators can increase the likelihood of their&#xD;
      partner(s) and/or friend(s) accessing the &quot;I Want The Kit&quot; website and requesting an HIV&#xD;
      self-testing kit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Did HIV Testing</measure>
    <time_frame>At 1 month post enrollment</time_frame>
    <description>Number of participants who did the HIV testing (HIV testing rate) will be determined by a telephone follow-up at 1 month after the index emergency department visit (enrollment).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Self Testing Kit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group 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 &quot;I Want The Kit&quot; website.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Self Testing Kit</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the &quot;I Want The Kit&quot; website.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HIV Self-testing</intervention_name>
    <arm_group_label>Self Testing Kit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Johns Hopkins Hospital emergency department patients who decline routine HIV testing&#xD;
             offer (&quot;Decliners&quot;) or patients who are offered an HIV test as the standard of care in&#xD;
             the emergency department , accept the standard of care (SOC) HIV testing, and who have&#xD;
             at increased risk for HIV &quot;High Risk&quot;).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any person who is already known to be HIV positive. Patients with a chief complaint of&#xD;
             sexual assault, patients with chief complaint of occupational exposure and patients&#xD;
             who are otherwise ineligible to consent to an HIV test due to medical condition (e.g.,&#xD;
             severe illness, altered mental status). Any person who has previously enrolled in this&#xD;
             study. Any person less than 18 years of age. Any person who is not able to provide&#xD;
             contact information for follow-up survey. Any person who reports they are unable to&#xD;
             access the internet.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Hsiang Hsieh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <reference>
    <citation>Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, Clark JE; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4.</citation>
    <PMID>16988643</PMID>
  </reference>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.</citation>
    <PMID>17136020</PMID>
  </reference>
  <reference>
    <citation>Czarnogorski M, Brown J, Lee V, Oben J, Kuo I, Stern R, Simon G. The Prevalence of Undiagnosed HIV Infection in Those Who Decline HIV Screening in an Urban Emergency Department. AIDS Res Treat. 2011;2011:879065. doi: 10.1155/2011/879065. Epub 2011 May 9.</citation>
    <PMID>21738860</PMID>
  </reference>
  <reference>
    <citation>Johnson C, Baggaley R, Forsythe S, van Rooyen H, Ford N, Napierala Mavedzenge S, Corbett E, Natarajan P, Taegtmeyer M. Realizing the potential for HIV self-testing. AIDS Behav. 2014 Jul;18 Suppl 4:S391-5. doi: 10.1007/s10461-014-0832-x.</citation>
    <PMID>24986599</PMID>
  </reference>
  <reference>
    <citation>Vargo S, Agronick G, O'Donnell L, Stueve A. Using peer recruitment and OraSure to increase HIV testing. Am J Public Health. 2004 Jan;94(1):29-31. doi: 10.2105/ajph.94.1.29.</citation>
    <PMID>14713690</PMID>
  </reference>
  <reference>
    <citation>Gaydos CA, Hsieh YH, Harvey L, Burah A, Won H, Jett-Goheen M, Barnes M, Agreda P, Arora N, Rothman RE. Will patients &quot;opt in&quot; to perform their own rapid HIV test in the emergency department? Ann Emerg Med. 2011 Jul;58(1 Suppl 1):S74-8. doi: 10.1016/j.annemergmed.2011.03.029.</citation>
    <PMID>21684413</PMID>
  </reference>
  <reference>
    <citation>Nour S, Hsieh YH, Rothman RE, Jett-Goheen M, Langhorne O, Wu L, Peterson S, Gaydos CA. Patients Can Accurately Perform Their Own Rapid HIV Point-of-Care Test in the Emergency Department. Point Care. 2012 Dec 1;11(4):176-179. doi: 10.1097/POC.0b013e3182666eb7.</citation>
    <PMID>24031999</PMID>
  </reference>
  <reference>
    <citation>Chai SJ, Aumakhan B, Barnes M, Jett-Goheen M, Quinn N, Agreda P, Whittle P, Hogan T, Jenkins WD, Rietmeijer CA, Gaydos CA. Internet-based screening for sexually transmitted infections to reach nonclinic populations in the community: risk factors for infection in men. Sex Transm Dis. 2010 Dec;37(12):756-63. doi: 10.1097/OLQ.0b013e3181e3d771.</citation>
    <PMID>20644498</PMID>
  </reference>
  <reference>
    <citation>Gaydos CA, Barnes M, Aumakhan B, Quinn N, Agreda P, Whittle P, Hogan T. Can e-technology through the Internet be used as a new tool to address the Chlamydia trachomatis epidemic by home sampling and vaginal swabs? Sex Transm Dis. 2009 Sep;36(9):577-80. doi: 10.1097/OLQ.0b013e3181a7482f. No abstract available.</citation>
    <PMID>19543145</PMID>
  </reference>
  <reference>
    <citation>Gaydos CA, Dwyer K, Barnes M, Rizzo-Price PA, Wood BJ, Flemming T, Hogan MT. Internet-based screening for Chlamydia trachomatis to reach non-clinic populations with mailed self-administered vaginal swabs. Sex Transm Dis. 2006 Jul;33(7):451-7. doi: 10.1097/01.olq.0000200497.14326.fb. Erratum In: Sex Transm Dis. 2007 Aug;34(8):625.</citation>
    <PMID>16652069</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>March 4, 2020</results_first_submitted>
  <results_first_submitted_qc>March 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2020</results_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03021005/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03021005/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental: Self Testing Kit</title>
          <description>This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group 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 &quot;I Want The Kit&quot; website.</description>
        </group>
        <group group_id="P2">
          <title>No Intervention: No Self Testing Kit</title>
          <description>This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the &quot;I Want The Kit&quot; website.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental: Self Testing Kit</title>
          <description>This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group 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 &quot;I Want The Kit&quot; website.</description>
        </group>
        <group group_id="B2">
          <title>No Intervention: No Self Testing Kit</title>
          <description>This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the &quot;I Want The Kit&quot; website.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
            <count group_id="B2" value="98"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31" lower_limit="24" upper_limit="42"/>
                    <measurement group_id="B2" value="38" lower_limit="28" upper_limit="48"/>
                    <measurement group_id="B3" value="35" lower_limit="25" upper_limit="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Transgender</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Did HIV Testing</title>
        <description>Number of participants who did the HIV testing (HIV testing rate) will be determined by a telephone follow-up at 1 month after the index emergency department visit (enrollment).</description>
        <time_frame>At 1 month post enrollment</time_frame>
        <population>39 participants in Self Testing Kit group and 26 participants in No Self Testing Kit group were lost to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Self Testing Kit</title>
            <description>This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group 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 &quot;I Want The Kit&quot; website.&#xD;
HIV Self-testing</description>
          </group>
          <group group_id="O2">
            <title>No Self Testing Kit</title>
            <description>This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the &quot;I Want The Kit&quot; website.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Did HIV Testing</title>
          <description>Number of participants who did the HIV testing (HIV testing rate) will be determined by a telephone follow-up at 1 month after the index emergency department visit (enrollment).</description>
          <population>39 participants in Self Testing Kit group and 26 participants in No Self Testing Kit group were lost to follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental: Self Testing Kit</title>
          <description>This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group 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 &quot;I Want The Kit&quot; website.</description>
        </group>
        <group group_id="E2">
          <title>No Intervention: No Self Testing Kit</title>
          <description>This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the &quot;I Want The Kit&quot; website.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.01</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Yu-Hsiang Hsieh</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410-735-6413</phone>
      <email>yhsieh1@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021005
org study id: IRB00090921
secondary id: U54EB007958
nct id: NCT03021005
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of Participants Who Did HIV Testing
time frame: At 1 month post enrollment
description: Number of participants who did the HIV testing (HIV testing rate) will be determined by a telephone follow-up at 1 month after the index emergency department visit (enrollment).
arm group label: Self Testing Kit
arm group type: Experimental
description: This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group 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.
arm group label: No Self Testing Kit
arm group type: No Intervention
description: This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the "I Want The Kit" website.
intervention type: Behavioral
intervention name: HIV Self-testing
arm group label: Self Testing Kit
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Yu-Hsiang Hsieh, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
citation: Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, Clark JE; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4.
PMID: 16988643
citation: Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.
PMID: 17136020
citation: Czarnogorski M, Brown J, Lee V, Oben J, Kuo I, Stern R, Simon G. The Prevalence of Undiagnosed HIV Infection in Those Who Decline HIV Screening in an Urban Emergency Department. AIDS Res Treat. 2011;2011:879065. doi: 10.1155/2011/879065. Epub 2011 May 9.
PMID: 21738860
citation: Johnson C, Baggaley R, Forsythe S, van Rooyen H, Ford N, Napierala Mavedzenge S, Corbett E, Natarajan P, Taegtmeyer M. Realizing the potential for HIV self-testing. AIDS Behav. 2014 Jul;18 Suppl 4:S391-5. doi: 10.1007/s10461-014-0832-x.
PMID: 24986599
citation: Vargo S, Agronick G, O'Donnell L, Stueve A. Using peer recruitment and OraSure to increase HIV testing. Am J Public Health. 2004 Jan;94(1):29-31. doi: 10.2105/ajph.94.1.29.
PMID: 14713690
citation: Gaydos CA, Hsieh YH, Harvey L, Burah A, Won H, Jett-Goheen M, Barnes M, Agreda P, Arora N, Rothman RE. Will patients "opt in" to perform their own rapid HIV test in the emergency department? Ann Emerg Med. 2011 Jul;58(1 Suppl 1):S74-8. doi: 10.1016/j.annemergmed.2011.03.029.
PMID: 21684413
citation: Nour S, Hsieh YH, Rothman RE, Jett-Goheen M, Langhorne O, Wu L, Peterson S, Gaydos CA. Patients Can Accurately Perform Their Own Rapid HIV Point-of-Care Test in the Emergency Department. Point Care. 2012 Dec 1;11(4):176-179. doi: 10.1097/POC.0b013e3182666eb7.
PMID: 24031999
citation: Chai SJ, Aumakhan B, Barnes M, Jett-Goheen M, Quinn N, Agreda P, Whittle P, Hogan T, Jenkins WD, Rietmeijer CA, Gaydos CA. Internet-based screening for sexually transmitted infections to reach nonclinic populations in the community: risk factors for infection in men. Sex Transm Dis. 2010 Dec;37(12):756-63. doi: 10.1097/OLQ.0b013e3181e3d771.
PMID: 20644498
citation: Gaydos CA, Barnes M, Aumakhan B, Quinn N, Agreda P, Whittle P, Hogan T. Can e-technology through the Internet be used as a new tool to address the Chlamydia trachomatis epidemic by home sampling and vaginal swabs? Sex Transm Dis. 2009 Sep;36(9):577-80. doi: 10.1097/OLQ.0b013e3181a7482f. No abstract available.
PMID: 19543145
citation: Gaydos CA, Dwyer K, Barnes M, Rizzo-Price PA, Wood BJ, Flemming T, Hogan MT. Internet-based screening for Chlamydia trachomatis to reach non-clinic populations with mailed self-administered vaginal swabs. Sex Transm Dis. 2006 Jul;33(7):451-7. doi: 10.1097/01.olq.0000200497.14326.fb. Erratum In: Sex Transm Dis. 2007 Aug;34(8):625.
PMID: 16652069
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No
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