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WithdrawnNCT03445416Updated Jul 23, 2019

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

An interventional study of POL arm and Comparison arm in Meningitis, HPV - Anogenital Human Papilloma Virus Infection and Hepatitis A, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Withdrawn. Open to male participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-23.

Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Health services research

Why this study was withdrawn
Study was not funded and therefore never began.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 26 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Meningitis
  • HPV - Anogenital Human Papilloma Virus Infection
  • Hepatitis A
03

In context

Meningitis

268 studies on the registry are indexed under Meningitis; 28 are open to participants now.

Browse Meningitis studies →

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 180 studies on the registry; 28 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralPOL arm

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

  • BehavioralComparison arm

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

06

What researchers measure

Primary outcomes

  1. Change in vaccine awareness

    Participant reports increased awareness of preventative vaccines

    Time frame: baseline, 3 months

Secondary outcomes

  1. Change in vaccine status abstracted from medical record

    HPV, meningococcal conjugate and HAV vaccination status of participant

    Time frame: baseline, 3 months

  2. Change in healthcare engagement

    Number of doctor visits; access to primary care

    Time frame: baseline, 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03445416
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Sep 2018 (estimated)
Primary completion
Aug 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Jul 23, 2019

Study contacts

Amy K Johnson, PhD
principal investigator · Lurie Children's Hospital of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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