<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/NCT03768986</url>
  </required_header>
  <id_info>
    <org_study_id>19-018-1</org_study_id>
    <secondary_id>R01MD013550</secondary_id>
    <nct_id>NCT03768986</nct_id>
  </id_info>
  <brief_title>A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women</brief_title>
  <official_title>A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UConn Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>UConn Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      African American and Latina women, as well as women living in poverty, are an identified&#xD;
      health disparities population for HIV. Risks for HIV are compounded in this population when&#xD;
      additional risk factors are present, including other sexually transmitted infections,&#xD;
      intimate partner violence, substance use disorders, and homelessness or housing insecurity.&#xD;
      Knowledge of one's HIV serostatus is key to linkage to care, improving HIV outcomes, and&#xD;
      decreasing the spread of HIV. However, roughly a third of African American women and over&#xD;
      half of Latina women have never been tested (CDC, 2016a). Barriers to testing include&#xD;
      socioeconomical inequality, racial discrimination, low health literacy, and inadequate access&#xD;
      to quality healthcare, among others. Novel methods for increasing HIV testing in this&#xD;
      important health disparities group are greatly needed.&#xD;
&#xD;
      This study aims to test a reinforcement-based intervention to increase HIV testing and repeat&#xD;
      testing among African American, Latina, and women living in poverty who have risk factors for&#xD;
      HIV. We are partnering with multiple community-based organizations, several of which are&#xD;
      non-traditional providers of HIV services (e.g., domestic violence agency, homeless shelter),&#xD;
      to address systemic and structural issues that serve as barriers to testing. A primary aim is&#xD;
      to evaluate the effectiveness of training community-based providers to deliver a&#xD;
      reinforcement-based intervention for promoting HIV testing. In addition, we will compare&#xD;
      standard referral services for HIV testing plus HIV risk reduction education to the same plus&#xD;
      reinforcement for HIV testing (and repeat testing) using a randomized controlled trial with&#xD;
      334 participants. Women in both groups will be encouraged to seek HIV testing; be provided&#xD;
      with the resources to do so (list of testing sites, bus passes if needed); and will receive&#xD;
      basic education about HIV prevention using a widely available web-based resource&#xD;
      (https://wwwn.cdc.gov/hivrisk/). Women in the reinforcement group will also be provided with&#xD;
      $25 for undergoing an HIV test, with a $15 bonus if they have the test in the next 7 days&#xD;
      ($40 total). During the next 12 months, they can receive an additional $25 for undergoing up&#xD;
      to 2 more tests separated by 12 weeks, with $15 bonuses for each test completed within 7 days&#xD;
      (+/- 7 days) of the scheduled date at 6- and 12-months post-initial test. It is hypothesized&#xD;
      that the reinforcement intervention will result in greater proportions of women receiving an&#xD;
      HIV test (and repeat HIV tests) compared to standard services.&#xD;
&#xD;
      In the proposed study, approximately 50 clinicians from our partner sites will be trained on&#xD;
      both the non-reinforcement and reinforcement approaches to increasing HIV testing. Primary&#xD;
      clinician outcomes are clinician knowledge and attitudes about HIV, testing, and&#xD;
      reinforcement interventions. These will be assessed pre- and post-training and at 6-month&#xD;
      intervals thereafter. A secondary outcome is clinician satisfaction with the training. Once&#xD;
      clinicians are trained to competence, 334 women at our partner agencies will be randomized.&#xD;
      Participants will be assessed at baseline and at 3-, 9-, and 15-month follow-ups. The primary&#xD;
      outcome is objective reports of HIV testing, verified by testing centers. Secondary outcomes&#xD;
      are HIV risk behaviors, test results, self-efficacy, client attitudes towards testing, and&#xD;
      HIV knowledge. In addition, this study will include a careful analysis of costs of the&#xD;
      reinforcement intervention to allow for estimates of its cost-effectiveness in increasing HIV&#xD;
      testing.&#xD;
&#xD;
      The overall goal of this study is to determine whether a reinforcement intervention delivered&#xD;
      by community providers is superior to standard referral procedures plus HIV education in&#xD;
      increasing rates of HIV testing among women at the highest risk of HIV infection. A wide&#xD;
      range of community partners that serve some of the highest risk groups of women were chosen&#xD;
      to ensure highly generalizable results. If efficacious, the intervention has the potential&#xD;
      for widespread adoption and implementation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV testing by clients</measure>
    <time_frame>From date of intervention until date of documented HIV test, assessed up to 15 months</time_frame>
    <description>HIV testing completion (i.e. having test completed) will be verified by the testing sites</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinician knowledge</measure>
    <time_frame>Baseline and immediately post-training</time_frame>
    <description>Change in clinician knowledge will be measured through self-reports</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction with training</measure>
    <time_frame>Post-training, up to 1 month</time_frame>
    <description>Satisfaction with training will be measured by self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV risk behaviors</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>Change in self-report measure: Human Immunodeficiency Virus Risk Behavior Scale, total score 0 to 55, higher scores represent worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV Test Results</measure>
    <time_frame>15-month follow-up</time_frame>
    <description>Client self-reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client HIV knowledge</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>Change in knowledge as self-reported on Human Immunodeficiency Virus Knowledge Questionnaire, total score 0 to 18, higher scores represent better outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV Risk Reduction Module Completion</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>Self-reported completion of online HIV risk reduction modules</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">334</enrollment>
  <condition>HIV</condition>
  <condition>HIV Testing</condition>
  <condition>Women</condition>
  <condition>Contingency Management</condition>
  <arm_group>
    <arm_group_label>Treatment Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard referral for HIV testing and online HIV risk reduction training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard referral for HIV testing and online HIV risk reduction training plus reinforcement</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard referral for HIV testing</intervention_name>
    <description>Participants receive standard referral for HIV testing in the community.</description>
    <arm_group_label>Treatment Group A</arm_group_label>
    <arm_group_label>Treatment Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online risk reduction training</intervention_name>
    <description>Participants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them.</description>
    <arm_group_label>Treatment Group A</arm_group_label>
    <arm_group_label>Treatment Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reinforcement</intervention_name>
    <description>Systematic reinforcement of desired behaviors Participants will receive a monetary incentive for getting tested for HIV</description>
    <arm_group_label>Treatment Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Clinician Participants:&#xD;
&#xD;
          -  &gt;6 months experience as a case manager, medical/nursing clinician or mental&#xD;
             health/substance use therapist&#xD;
&#xD;
          -  currently work with women at high risk for contracting HIV&#xD;
&#xD;
          -  able to attend a training and participate in the evaluative components&#xD;
&#xD;
          -  willing to conduct both standard HIV referral for testing and orientation to an online&#xD;
             training and the same with reinforcement, depending on client's random assignment.&#xD;
&#xD;
        Exclusion Criteria for Clinician Participants&#xD;
&#xD;
        - planning to end employment at the agency within the next 3 months&#xD;
&#xD;
        Inclusion Criteria for Client Participants:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  identifies as African American/black or Latina/Hispanic OR is living in poverty based&#xD;
             on the most recent year's federal poverty guidelines&#xD;
&#xD;
          -  18 and older&#xD;
&#xD;
          -  one or more high risk factors for HIV: intravenous drug use; or sexually active with&#xD;
             past year partners with HIV or of unknown HIV status and no or inconsistent use of&#xD;
             condoms&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  passes a quiz related to understanding the informed consent form&#xD;
&#xD;
          -  has an address at which they expect to be able to receive mail and/or a phone to&#xD;
             retrieve messages for the next 15 months&#xD;
&#xD;
        Exclusion Criteria for Client Participants:&#xD;
&#xD;
          -  received a fourth-generation HIV test in the past 6 months&#xD;
&#xD;
          -  HIV positive.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristyn Zajac, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UConn Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruth Fetter</last_name>
    <phone>860-679-4556</phone>
    <email>fetter@uchc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>UConn Health</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruth Fetter</last_name>
      <phone>860-679-4556</phone>
      <email>fetter@uchc.edu</email>
    </contact>
    <investigator>
      <last_name>Kristyn Zajac, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UConn Health</investigator_affiliation>
    <investigator_full_name>Kristyn Zajac</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03768986
org study id: 19-018-1
secondary id: R01MD013550
nct id: NCT03768986
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
African American and Latina women, as well as women living in poverty, are an identified
      health disparities population for HIV. Risks for HIV are compounded in this population when
      additional risk factors are present, including other sexually transmitted infections,
      intimate partner violence, substance use disorders, and homelessness or housing insecurity.
      Knowledge of one's HIV serostatus is key to linkage to care, improving HIV outcomes, and
      decreasing the spread of HIV. However, roughly a third of African American women and over
      half of Latina women have never been tested (CDC, 2016a). Barriers to testing include
      socioeconomical inequality, racial discrimination, low health literacy, and inadequate access
      to quality healthcare, among others. Novel methods for increasing HIV testing in this
      important health disparities group are greatly needed.

      This study aims to test a reinforcement-based intervention to increase HIV testing and repeat
      testing among African American, Latina, and women living in poverty who have risk factors for
      HIV. We are partnering with multiple community-based organizations, several of which are
      non-traditional providers of HIV services (e.g., domestic violence agency, homeless shelter),
      to address systemic and structural issues that serve as barriers to testing. A primary aim is
      to evaluate the effectiveness of training community-based providers to deliver a
      reinforcement-based intervention for promoting HIV testing. In addition, we will compare
      standard referral services for HIV testing plus HIV risk reduction education to the same plus
      reinforcement for HIV testing (and repeat testing) using a randomized controlled trial with
      334 participants. Women in both groups will be encouraged to seek HIV testing; be provided
      with the resources to do so (list of testing sites, bus passes if needed); and will receive
      basic education about HIV prevention using a widely available web-based resource
      (https://wwwn.cdc.gov/hivrisk/). Women in the reinforcement group will also be provided with
      $25 for undergoing an HIV test, with a $15 bonus if they have the test in the next 7 days
      ($40 total). During the next 12 months, they can receive an additional $25 for undergoing up
      to 2 more tests separated by 12 weeks, with $15 bonuses for each test completed within 7 days
      (+/- 7 days) of the scheduled date at 6- and 12-months post-initial test. It is hypothesized
      that the reinforcement intervention will result in greater proportions of women receiving an
      HIV test (and repeat HIV tests) compared to standard services.

      In the proposed study, approximately 50 clinicians from our partner sites will be trained on
      both the non-reinforcement and reinforcement approaches to increasing HIV testing. Primary
      clinician outcomes are clinician knowledge and attitudes about HIV, testing, and
      reinforcement interventions. These will be assessed pre- and post-training and at 6-month
      intervals thereafter. A secondary outcome is clinician satisfaction with the training. Once
      clinicians are trained to competence, 334 women at our partner agencies will be randomized.
      Participants will be assessed at baseline and at 3-, 9-, and 15-month follow-ups. The primary
      outcome is objective reports of HIV testing, verified by testing centers. Secondary outcomes
      are HIV risk behaviors, test results, self-efficacy, client attitudes towards testing, and
      HIV knowledge. In addition, this study will include a careful analysis of costs of the
      reinforcement intervention to allow for estimates of its cost-effectiveness in increasing HIV
      testing.

      The overall goal of this study is to determine whether a reinforcement intervention delivered
      by community providers is superior to standard referral procedures plus HIV education in
      increasing rates of HIV testing among women at the highest risk of HIV infection. A wide
      range of community partners that serve some of the highest risk groups of women were chosen
      to ensure highly generalizable results. If efficacious, the intervention has the potential
      for widespread adoption and implementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HIV testing by clients
time frame: From date of intervention until date of documented HIV test, assessed up to 15 months
description: HIV testing completion (i.e. having test completed) will be verified by the testing sites
measure: Clinician knowledge
time frame: Baseline and immediately post-training
description: Change in clinician knowledge will be measured through self-reports
measure: Clinician satisfaction with training
time frame: Post-training, up to 1 month
description: Satisfaction with training will be measured by self-report
measure: HIV risk behaviors
time frame: Baseline and 3-month follow-up
description: Change in self-report measure: Human Immunodeficiency Virus Risk Behavior Scale, total score 0 to 55, higher scores represent worse outcomes
measure: HIV Test Results
time frame: 15-month follow-up
description: Client self-reports
measure: Client HIV knowledge
time frame: Baseline and 3-month follow-up
description: Change in knowledge as self-reported on Human Immunodeficiency Virus Knowledge Questionnaire, total score 0 to 18, higher scores represent better outcomes
measure: HIV Risk Reduction Module Completion
time frame: 3-month follow-up
description: Self-reported completion of online HIV risk reduction modules
arm group label: Treatment Group A
arm group type: Active Comparator
description: Standard referral for HIV testing and online HIV risk reduction training
arm group label: Treatment Group B
arm group type: Experimental
description: Standard referral for HIV testing and online HIV risk reduction training plus reinforcement
intervention type: Behavioral
intervention name: Standard referral for HIV testing
description: Participants receive standard referral for HIV testing in the community.
arm group label: Treatment Group A
arm group label: Treatment Group B
intervention type: Behavioral
intervention name: Online risk reduction training
description: Participants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them.
arm group label: Treatment Group A
arm group label: Treatment Group B
intervention type: Behavioral
intervention name: Reinforcement
description: Systematic reinforcement of desired behaviors Participants will receive a monetary incentive for getting tested for HIV
arm group label: Treatment Group B
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristyn Zajac, Ph.D.
role: Principal Investigator
affiliation: UConn Health
last name: Ruth Fetter
phone: 860-679-4556
email: fetter@uchc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: UConn Health
investigator full name: Kristyn Zajac
investigator title: Professor