<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/NCT03033888</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00060938</org_study_id>
    <secondary_id>P30AI094189</secondary_id>
    <nct_id>NCT03033888</nct_id>
  </id_info>
  <brief_title>Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV</brief_title>
  <acronym>CHECC-uP</acronym>
  <official_title>Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <brief_summary>
    <textblock>
      The long-term goal is to build a sustainable, community-based outreach program to promote&#xD;
      cervical cancer screening among women living with HIV (WLH), thereby reducing related&#xD;
      morbidity and mortality. The strategy for achieving this goal is to develop an intervention&#xD;
      incorporating health literacy approaches and principles of community-based participatory&#xD;
      research. Health literacy is a relatively new concept that has been applied mainly toward&#xD;
      identifying high-risk individuals rather than toward changing health behaviors and outcomes.&#xD;
      The proposed intervention is the first to integrate health literacy into educating WLH to&#xD;
      promote cervical cancer screening. Community Health Workers (CHW) support has also rarely&#xD;
      been incorporated into cancer screening interventions targeting WLH, making the proposed&#xD;
      intervention a uniquely comprehensive approach. Building on recent successful testing by the&#xD;
      investigators of a health literacy-focused intervention to promote cervical cancer screening&#xD;
      in recent immigrant women, the investigators will test whether health literacy-focused&#xD;
      interventions delivered by trained CHWs will be effective in promoting health literacy and&#xD;
      increasing Pap test rates in a new population, WLH. The investigators hypothesize that,&#xD;
      compared to WLH in the control group, WLH who receive the health literacy-focused CHW&#xD;
      intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health&#xD;
      literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion of Pap test (medical records)</measure>
    <time_frame>6 months</time_frame>
    <description>Participants medical records will be audited to verify completion of a Pap test within 6 months of completing baseline survey. The measure of completion of Pap testing by 6 months after baseline visit will be tested using a one-sided, two-group test of proportions set at an alpha of 0.05. Known covariates of Pap test screening (e.g., age, education, insurance, and provider recommendation) will be controlled in the analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change scores for health literacy</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Health Literacy scores will be measured using Assessment of Health Literacy-Cancer, a cervical cancer specific instrument with 52 items. Scores on the scale range from 0-52 with a score &gt; 26 signifying a high health literacy score and scores &lt;26 signifying low health literacy score. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores for cervical cancer knowledge</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Cervical cancer knowledge will be measured with the Cervical Cancer Knowledge Test, a 22- item which measures knowledge of cervical cancer using a binary (true/false) scale. Higher scores indicate higher cervical cancer knowledge. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores for self-efficacy</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Self-efficacy will be measured with the Self Efficacy Scale, a 4- item instrument which measures how confident a woman is in carrying out tasks in relation to Pap testing. Higher scores indicate higher self-efficacy. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention includes: Trained community health workers will deliver 1) 1.5-2 hour health literacy training offered in a group format at an approved community site that is most convenient to the majority of participants ; and 2) monthly phone follow-up and navigation assistance for 6 months. We will offer a Human Papilloma Virus (HPV) mobile app for participant's adolescent/young adult child (11-26 yrs), as an option rather than part of the standardized protocol. The app will be introduced at the end of the health literacy group training session for the intervention group; those who choose to download the app will be given a link with study specific password. They will be encouraged to go through the key HPV related contents with their children at home at a time that is most convenient for them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health-Literacy Focused Education Session</intervention_name>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV infection Able to read and write English 12+ months since Pap test Willing to&#xD;
             provide written consent to allow the team to audit medical records for Pap test use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had undergone a hysterectomy Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hae-Ra Han, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University School of Nursing</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</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>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03033888
org study id: IRB00060938
secondary id: P30AI094189
nct id: NCT03033888
lead sponsor: 
collaborator: 
The long-term goal is to build a sustainable, community-based outreach program to promote
      cervical cancer screening among women living with HIV (WLH), thereby reducing related
      morbidity and mortality. The strategy for achieving this goal is to develop an intervention
      incorporating health literacy approaches and principles of community-based participatory
      research. Health literacy is a relatively new concept that has been applied mainly toward
      identifying high-risk individuals rather than toward changing health behaviors and outcomes.
      The proposed intervention is the first to integrate health literacy into educating WLH to
      promote cervical cancer screening. Community Health Workers (CHW) support has also rarely
      been incorporated into cancer screening interventions targeting WLH, making the proposed
      intervention a uniquely comprehensive approach. Building on recent successful testing by the
      investigators of a health literacy-focused intervention to promote cervical cancer screening
      in recent immigrant women, the investigators will test whether health literacy-focused
      interventions delivered by trained CHWs will be effective in promoting health literacy and
      increasing Pap test rates in a new population, WLH. The investigators hypothesize that,
      compared to WLH in the control group, WLH who receive the health literacy-focused CHW
      intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health
      literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Completion of Pap test (medical records)
time frame: 6 months
description: Participants medical records will be audited to verify completion of a Pap test within 6 months of completing baseline survey. The measure of completion of Pap testing by 6 months after baseline visit will be tested using a one-sided, two-group test of proportions set at an alpha of 0.05. Known covariates of Pap test screening (e.g., age, education, insurance, and provider recommendation) will be controlled in the analyses.
measure: Change scores for health literacy
time frame: Baseline and 6 months
description: Health Literacy scores will be measured using Assessment of Health Literacy-Cancer, a cervical cancer specific instrument with 52 items. Scores on the scale range from 0-52 with a score > 26 signifying a high health literacy score and scores <26 signifying low health literacy score. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
measure: Change scores for cervical cancer knowledge
time frame: Baseline and 6 months
description: Cervical cancer knowledge will be measured with the Cervical Cancer Knowledge Test, a 22- item which measures knowledge of cervical cancer using a binary (true/false) scale. Higher scores indicate higher cervical cancer knowledge. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
measure: Change scores for self-efficacy
time frame: Baseline and 6 months
description: Self-efficacy will be measured with the Self Efficacy Scale, a 4- item instrument which measures how confident a woman is in carrying out tasks in relation to Pap testing. Higher scores indicate higher self-efficacy. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
arm group label: Intervention Group
arm group type: Other
description: Intervention includes: Trained community health workers will deliver 1) 1.5-2 hour health literacy training offered in a group format at an approved community site that is most convenient to the majority of participants ; and 2) monthly phone follow-up and navigation assistance for 6 months. We will offer a Human Papilloma Virus (HPV) mobile app for participant's adolescent/young adult child (11-26 yrs), as an option rather than part of the standardized protocol. The app will be introduced at the end of the health literacy group training session for the intervention group; those who choose to download the app will be given a link with study specific password. They will be encouraged to go through the key HPV related contents with their children at home at a time that is most convenient for them.
arm group label: Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Health-Literacy Focused Education Session
arm group label: Intervention Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hae-Ra Han, PhD
role: Principal Investigator
affiliation: Johns Hopkins University School of Nursing
facility: 
country: United States
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No