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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03445416
Other study ID # PA18162
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2018
Est. completion date August 2020

Study information

Verified date July 2019
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 26 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
POL arm
A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
Comparison arm
A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago Florida State University, Northwestern University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in vaccine awareness Participant reports increased awareness of preventative vaccines baseline, 3 months
Secondary Change in vaccine status abstracted from medical record HPV, meningococcal conjugate and HAV vaccination status of participant baseline, 3 months
Secondary Change in healthcare engagement Number of doctor visits; access to primary care baseline, 3 months
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