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

NCT03445416 | Withdrawn

• 1 other identifier: PA18162
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in vaccine awareness

  Participant reports increased awareness of preventative vaccines

  baseline, 3 months

Secondary Outcomes (2)

• Change in vaccine status abstracted from medical record

  baseline, 3 months

• Change in healthcare engagement

  baseline, 3 months

Study Arms (2)

Intervention: POL arm

EXPERIMENTAL

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

Comparison group

ACTIVE COMPARATOR

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

Interventions

POL arm BEHAVIORAL

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

Intervention: POL arm

Comparison arm BEHAVIORAL

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

Comparison group

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: Must identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University: collaborator
• Florida State University: collaborator

MeSH Terms

Conditions

Meningitis; Hepatitis A

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Amy K Johnson, PhD

  Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: February 26, 2018
• Study Start: September 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share