MeningitisNCT03445416
Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men
A study testing POL arm and Comparison arm in people with Meningitis and HPV - Anogenital Human Papilloma Virus Infection, run by Ann & Robert H Lurie Children's Hospital of Chicago.
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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Meningitis, HPV - Anogenital Human Papilloma Virus Infection, Hepatitis A
- What is being tested?
- POL arm and Comparison arm
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Being tested
- POL arm, Comparison arm
- Medical subject headings
- Meningitis, Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POL armBehavioural
A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
Comparison armBehavioural
A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Comparison arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vaccine awareness
Participant reports increased awareness of preventative vaccines
Measured: baseline, 3 months
Secondary outcomes (2)
Change in vaccine status abstracted from medical record
HPV, meningococcal conjugate and HAV vaccination status of participant
Measured: baseline, 3 months
Change in healthcare engagement
Number of doctor visits; access to primary care
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study startSep 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: Study was not funded and therefore never began.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Florida State University
- Responsible party
- Sponsor
- Investigators
- Amy K Johnson, PhD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445416
- Sponsor's protocol ID
- PA18162
- Status last verified
- Jul 2019
- First submitted
- 3 Feb 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT03445416
- Acronym / sponsor ID
- PA18162
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded and therefore never began.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University, Florida State University
- Study start
- Sep 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention: POL arm | Experimental | Behavioral: POL armPOL 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. |
| Comparison group | Active comparator | Behavioral: Comparison armPOLs 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POL armA popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men. | Behavioural | Intervention: POL arm |
| Comparison armA popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men. | Behavioural | Comparison group |
Primary outcome
Change in vaccine awareness
Time frame: baseline, 3 months
Participant reports increased awareness of preventative vaccines
2 secondary outcomes
Change in vaccine status abstracted from medical record
Time frame: baseline, 3 months
Change in healthcare engagement
Time frame: baseline, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy K Johnson, PhD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing POL arm and Comparison arm in people with Meningitis and HPV - Anogenital Human Papilloma Virus Infection, run by Ann & Robert H Lurie Children's Hospital of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vaccine awareness (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.