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Withdrawn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
About this trial
This is an interventional health services research trial for Meningitis
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
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
NCT ID
NCT03445416
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
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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Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men
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