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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03445416

Collaborator

Northwestern University (Other), Florida State University (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis HPV - Anogenital Human Papilloma Virus Infection Hepatitis A	Behavioral: POL arm Behavioral: Comparison arm	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention: POL arm 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.	Behavioral: POL arm A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
Active Comparator: Comparison group 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.	Behavioral: Comparison arm A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.

Arm

Intervention/Treatment

Experimental: Intervention: POL arm

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.

Behavioral: POL arm

A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.

Active Comparator: Comparison group

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.

Behavioral: Comparison arm

A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.

Outcome Measures

Primary Outcome Measures

Change in vaccine awareness [baseline, 3 months]
Participant reports increased awareness of preventative vaccines

Secondary Outcome Measures

Change in vaccine status abstracted from medical record [baseline, 3 months]
HPV, meningococcal conjugate and HAV vaccination status of participant
Change in healthcare engagement [baseline, 3 months]
Number of doctor visits; access to primary care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 26 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago
Northwestern University
Florida State University

Investigators

Principal Investigator: Amy K Johnson, PhD, Lurie Children's Hospital of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ann & Robert H Lurie Children's Hospital of Chicago

ClinicalTrials.gov Identifier:

NCT03445416

Other Study ID Numbers:

PA18162

First Posted:

Feb 26, 2018

Last Update Posted:

Jul 23, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis A

Papillomavirus Infections

Papilloma

Meningitis

Study Results

No Results Posted as of Jul 23, 2019