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Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men

Primary Purpose

Meningitis, HPV - Anogenital Human Papilloma Virus Infection, Hepatitis A

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
POL arm
Comparison arm
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Meningitis

Eligibility Criteria

18 Years - 26 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years or older
  • report a social or sexual connection to at least 15 YBMSM
  • be willing to diffuse information through their networks
  • score at least 25 on the opinion leadership scale
  • live in the Chicago area
  • be available for the POL training

Exclusion criteria:

  • Younger than age 18
  • Less than 15 YBMSM in network
  • Score lower than 25 on leadership scale
  • Live outside the Chicago area
  • Not available for the POL training

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention: POL arm

    Comparison group

    Arm Description

    POL intervention. Enrolled POLs will be randomized at their intake visit; those randomized to the intervention arm will attend the popular opinion leader training (developed in Aim 1) and will be asked to diffuse the intervention messages to their network recruits.

    POLs who are randomized to the comparison arm will receive an abbreviated version of the POL training that includes general health messaging, but does not incorporate medical mistrust, stigma or specific vaccination messaging.

    Outcomes

    Primary Outcome Measures

    Change in vaccine awareness
    Participant reports increased awareness of preventative vaccines

    Secondary Outcome Measures

    Change in vaccine status abstracted from medical record
    HPV, meningococcal conjugate and HAV vaccination status of participant
    Change in healthcare engagement
    Number of doctor visits; access to primary care

    Full Information

    First Posted
    February 3, 2018
    Last Updated
    July 22, 2019
    Sponsor
    Ann & Robert H Lurie Children's Hospital of Chicago
    Collaborators
    Northwestern University, Florida State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03445416
    Brief Title
    Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men
    Official Title
    Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was not funded and therefore never began.
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ann & Robert H Lurie Children's Hospital of Chicago
    Collaborators
    Northwestern University, Florida State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Vaccine-preventable diseases such as hepatitis A and meningitis, as well as cancers caused by human papillomavirus (HPV) disproportionately impact young Black men who have sex with men (YBMSM). Traditional techniques of vaccination promotion have been unable to address the racial disparities in vaccination rates. One promising method for influencing behavior change within YBMSM networks is diffusion of information through Popular Opinion Leaders (POLs). The POL model engages persons who are leaders within their own networks/communities to promote behavior change. The objective of this project is to develop and pilot test a POL intervention to increase routine HAV, HPV and meningococcal conjugate vaccination among YBMSM, ages 18-26. research (PAR) framework to facilitate community support and ensure intervention strategies are salient. PAR includes community members as equal collaborators in the research process. Outcomes from these aims are expected to have an impact on health outcomes by identifying effective strategies for increasing vaccination and routine healthcare engagement among YBMSM.
    Detailed Description
    For young black men who have sex with men (YBMSM), being at the intersection of racial and sexual minority status negatively impacts their access to healthcare and health seeking behavior, both of which fuel health disparities-particularly in infectious diseases. Prominent illustrations of these health disparities can be seen in reduced healthcare engagement and receipt of recommended vaccinations. Vaccine-preventable diseases such as hepatitis A and meningitis, as well as cancers caused by human papillomavirus (HPV) disproportionately impact MSM. As such, MSM are considered to be at high risk and are recommended to receive routine vaccination for hepatitis A (HAV), human papillomavirus (HPV) and meningitis. However, very little is known about how to promote uptake of routine vaccination among YBMSM. Traditional techniques of vaccination promotion (e.g., leveraging healthcare providers, school entry requirements) have been unable to address the racial disparities in vaccination rates. One promising method for influencing behavior change within YBMSM networks is diffusion of information through Popular Opinion Leaders (POLs). Trusted POLs may be successful in mitigating barriers in which traditional approaches have failed. The POL model engages persons who are leaders within their own networks/communities to promote behavior change. In response to PA-18-162 ("Health Promotion among Racial and Ethnic Minority Males"), the objective of this project is to develop and pilot test a POL intervention to increase routine HAV, HPV and meningococcal conjugate vaccination among YBMSM, ages 18-26. The long-term goal of our research is to reduce health disparities by identifying effective strategies to engage YBMSM in preventive healthcare. YBMSM will be included in all phases of research via a participatory action research (PAR) framework to facilitate community support and ensure intervention strategies are salient. PAR includes community members as equal collaborators in the research process. Outcomes from these aims are expected to have an impact on health outcomes by identifying effective strategies for increasing vaccination and routine healthcare engagement among YBMSM.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meningitis, HPV - Anogenital Human Papilloma Virus Infection, Hepatitis A

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    We will employ an experimental design with pre/posttest measures to determine changes in vaccination awareness, intention and status, as well as engagement in health care. A total of 20 POLs will be identified and randomized to either the intervention or comparison arm. Regardless of assignment, POLs will be asked to diffuse information to at least 5 YBMSM network recruits; either the intervention (comprised of vaccination messaging developed in partnership with YBMSM) or comparison group health messaging. The comparison group content will be developed by the investigative team and consist of general, non-tailored health-related messaging (e.g., no vaccination messaging, will not address stigma or medical mistrust). Outcome analysis will compare the 50 intervention recruits to the 50 SOC recruits at 3 months post intervention.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention: POL arm
    Arm Type
    Experimental
    Arm Description
    POL intervention. Enrolled POLs will be randomized at their intake visit; those randomized to the intervention arm will attend the popular opinion leader training (developed in Aim 1) and will be asked to diffuse the intervention messages to their network recruits.
    Arm Title
    Comparison group
    Arm Type
    Active Comparator
    Arm Description
    POLs who are randomized to the comparison arm will receive an abbreviated version of the POL training that includes general health messaging, but does not incorporate medical mistrust, stigma or specific vaccination messaging.
    Intervention Type
    Behavioral
    Intervention Name(s)
    POL arm
    Intervention Description
    A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Comparison arm
    Intervention Description
    A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
    Primary Outcome Measure Information:
    Title
    Change in vaccine awareness
    Description
    Participant reports increased awareness of preventative vaccines
    Time Frame
    baseline, 3 months
    Secondary Outcome Measure Information:
    Title
    Change in vaccine status abstracted from medical record
    Description
    HPV, meningococcal conjugate and HAV vaccination status of participant
    Time Frame
    baseline, 3 months
    Title
    Change in healthcare engagement
    Description
    Number of doctor visits; access to primary care
    Time Frame
    baseline, 3 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Must identify as male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years or older report a social or sexual connection to at least 15 YBMSM be willing to diffuse information through their networks score at least 25 on the opinion leadership scale live in the Chicago area be available for the POL training Exclusion criteria: Younger than age 18 Less than 15 YBMSM in network Score lower than 25 on leadership scale Live outside the Chicago area Not available for the POL training
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy K Johnson, PhD
    Organizational Affiliation
    Lurie Children's Hospital of Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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