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

NCT ID: NCT03445416

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningitis HPV - Anogenital Human Papilloma Virus Infection Hepatitis A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

POL arm

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Comparison arm

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

POL arm

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

Intervention Type BEHAVIORAL

Comparison arm

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy K Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Lurie Children's Hospital of Chicago

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PA18162

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.