Human Papillomavirus VaccinationNCT05658198
Investigating HPV Vaccination Uptake in Adults Aged 18-35 Seeking Care at a Health Clinic in Rural Mississippi
An observational study of Human Papillomavirus Vaccination, run by Plan A Health, Inc at 1 site in United States.
Trial summary
A study evaluating HPV vaccine uptake among unvaccinated patients between the ages of 18 and 35 of a mobile health clinic serving the Mississippi Delta. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccination
- What is being tested?
- Counseling
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Sep 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients between the ages of 18 and 35 visiting a primarily mobile health clinic in the Mississippi Delta.
Who may be able to join
- between the ages of 18 and 35 and have a verified vaccine record that shows they were not vaccinated with the HPV vaccine or have not had a complete series of the vaccine before their visit.
Who cannot join
- patients who have been vaccinated against HPV
- patients under 18 and over 35
- patients whose vaccine records cannot be verified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-controlled Trial to Determine Whether Counseling Around HPV Increases Vaccine Uptake in Unvaccinated Patients Ages 18-35 Visiting a Rural Health Clinic for Primary or Reproductive Health-related Care in the Mississippi Delta
A study evaluating HPV vaccine uptake among unvaccinated patients between the ages of 18 and 35 of a mobile health clinic serving the Mississippi Delta.
Read the detailed description
This study is intended to serve several purposes. The first is to determine whether patients between the ages of 18 and 35 visiting a mobile health clinic or brick and mortar clinic in the Mississippi Delta who have not received the HPV vaccine or have not completed the vaccine series are receptive to receiving it while seeking care. The second purpose is to determine whether those patients who initially decline the HPV vaccine are interested in receiving it after being counseled about HPV and the potential effects of the virus. The third purpose is to assess whether there is a statistically significant difference between the type of visit people who opt to receive the vaccine are making to the clinics. Finally, the knowledge, attitudes, and perceptions around HPV and the HPV vaccine will be assessed via group interviews with eligible participants at the conclusion of the study.
The study also includes two secondary objectives. The first is to assess whether adults who are not vaccinated against HPV are interested in receiving it. The second is to assess whether adults accurately recall whether they received a specific vaccine during childhood. The implications from these two objectives have the potential to influence policy changes regarding vaccine catch-up among adults and health communication practices as young adults transition out of pediatric care.
Anyone between the ages of 18 and 35 whose vaccination status can be verified is eligible to be enrolled in this study.
- Conditions
- Human Papillomavirus Vaccination
- Being tested
- Counseling
- Keywords
- HPV vaccine, Gardasil, unvaccinated, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Patients who first decline HPV vaccination receive a 3-5 minute counseling session on HPV and the benefits of the vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated patients | Patients who are unvaccinated against HPV when they arrive at Plan A. Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased HPV vaccination rates
Determine whether offering the HPV vaccine free of charge to unvaccinated adults aged 18-35 receiving SRH or primary care services at a primarily mobile health clinic serving mainly low-income patients of color changes vaccination rates in the community.
Measured: one year
Counseling effectiveness
Determine whether a 3-5 minute education session on HPV and HPV-related diseases for people who decline initial vaccination changes their vaccination intentions.
Measured: one year
Visit differences
Determine whether a significant difference exists between the type of visit (SRH versus primary care) patients who decide to become vaccinated made to the clinic.
Measured: one year
Prior information
Examine how access to and prior information given on the HPV vaccine, as well as risk assessment for HPV infection versus vaccination, among unvaccinated adults between 18 and 35, addresses vaccine discordancy and affects the decision to become vaccinated as an adult.
Measured: one year
Secondary outcomes (1)
Vaccine interest
To identify whether adults who are not vaccinated against HPV are interested in receiving the vaccine.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus VaccinationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Plan A Health, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658198
- Sponsor's protocol ID
- 02
- Status last verified
- Nov 2023
- First submitted
- 9 Dec 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
United Health Foundation, America's Health Rankings Annual Report. Accessed 15 March, 2022 at: https://www.americashealthrankings.org/explore/annual/measure/Immunize_HPV/state/ALL
Mississippi State Department of Health (2018). Mississippi State Plan for Comprehensive Cancer Control 2018-2022. Retrieved 25 April, 2022.
United States Census Bureau (2022). Health Insurance Coverage Status by Sex and Age, Mississippi. Retrieved 25 April, 2022.
Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019 Aug 16;68(32):698-702. doi: 10.15585/mmwr.mm6832a3.
PubMed 31415491Fowler, C. I., Gable, J., & Lasater, B. (2021, September). Family Planning Annual Report: 2020 National Summary. Washington, DC: Office of Population Affairs, Office of the Assistant Secretary for Health, Department of Health and Human Services.
Cates JR, Brewer NT, Fazekas KI, Mitchell CE, Smith JS. Racial differences in HPV knowledge, HPV vaccine acceptability, and related beliefs among rural, southern women. J Rural Health. 2009 Winter;25(1):93-7. doi: 10.1111/j.1748-0361.2009.00204.x.
PubMed 19166567Hamborsky, J., & Kroger, A. (Eds.). (2015). Epidemiology and prevention of vaccine-preventable diseases, E-Book: The Pink Book. Public Health Foundation.
Christy K, Kandasamy S, Majid U, Farrah K, Vanstone M. Understanding Black Women's Perspectives and Experiences of Cervical Cancer Screening: A Systematic Review and Qualitative Meta-synthesis. J Health Care Poor Underserved. 2021;32(4):1675-1697. doi: 10.1353/hpu.2021.0159.
PubMed 34803036
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-controlled Trial to Determine Whether Counseling Around HPV Increases Vaccine Uptake in Unvaccinated Patients Ages 18-35 Visiting a Rural Health Clinic for Primary or Reproductive Health-related Care in the Mississippi Delta
- ClinicalTrials.gov ID
- NCT05658198
- Acronym / sponsor ID
- 02
- Conditions
- Human Papillomavirus Vaccination
- Keywords
- HPV vaccine, Gardasil, unvaccinated, adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Plan A Health, IncUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 20 Dec 2022 (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.
A study evaluating HPV vaccine uptake among unvaccinated patients between the ages of 18 and 35 of a mobile health clinic serving the Mississippi Delta.
Detailed description
This study is intended to serve several purposes. The first is to determine whether patients between the ages of 18 and 35 visiting a mobile health clinic or brick and mortar clinic in the Mississippi Delta who have not received the HPV vaccine or have not completed the vaccine series are receptive to receiving it while seeking care. The second purpose is to determine whether those patients who initially decline the HPV vaccine are interested in receiving it after being counseled about HPV and the potential effects of the virus. The third purpose is to assess whether there is a statistically significant difference between the type of visit people who opt to receive the vaccine are making to the clinics. Finally, the knowledge, attitudes, and perceptions around HPV and the HPV vaccine will be assessed via group interviews with eligible participants at the conclusion of the study.
The study also includes two secondary objectives. The first is to assess whether adults who are not vaccinated against HPV are interested in receiving it. The second is to assess whether adults accurately recall whether they received a specific vaccine during childhood. The implications from these two objectives have the potential to influence policy changes regarding vaccine catch-up among adults and health communication practices as young adults transition out of pediatric care.
Anyone between the ages of 18 and 35 whose vaccination status can be verified is eligible to be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated patients | – | Behavioral: CounselingPatients who are unvaccinated against HPV when they arrive at Plan A. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients between the ages of 18 and 35 visiting a primarily mobile health clinic in the Mississippi Delta.
Key inclusion criteria (1 listed)
- between the ages of 18 and 35 and have a verified vaccine record that shows they were not vaccinated with the HPV vaccine or have not had a complete series of the vaccine before their visit.
Key exclusion criteria (3 listed)
- patients who have been vaccinated against HPV
- patients under 18 and over 35
- patients whose vaccine records cannot be verified
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 |
|---|---|---|
| CounselingPatients who first decline HPV vaccination receive a 3-5 minute counseling session on HPV and the benefits of the vaccine. | Behavioural | Unvaccinated patients |
Primary outcome
Increased HPV vaccination rates
Time frame: one year
Determine whether offering the HPV vaccine free of charge to unvaccinated adults aged 18-35 receiving SRH or primary care services at a primarily mobile health clinic serving mainly low-income patients of color changes vaccination rates in the community.
Counseling effectiveness
Time frame: one year
Determine whether a 3-5 minute education session on HPV and HPV-related diseases for people who decline initial vaccination changes their vaccination intentions.
Visit differences
Time frame: one year
Determine whether a significant difference exists between the type of visit (SRH versus primary care) patients who decide to become vaccinated made to the clinic.
Prior information
Time frame: one year
Examine how access to and prior information given on the HPV vaccine, as well as risk assessment for HPV infection versus vaccination, among unvaccinated adults between 18 and 35, addresses vaccine discordancy and affects the decision to become vaccinated as an adult.
1 secondary outcome
Vaccine interest
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- BackgroundUnited Health Foundation, America's Health Rankings Annual Report. Accessed 15 March, 2022 at: https://www.americashealthrankings.org/explore/annual/measure/Immunize_HPV/state/ALL
- BackgroundMississippi State Department of Health (2018). Mississippi State Plan for Comprehensive Cancer Control 2018-2022. Retrieved 25 April, 2022.
- BackgroundUnited States Census Bureau (2022). Health Insurance Coverage Status by Sex and Age, Mississippi. Retrieved 25 April, 2022.
- Background: PubMed 31415491Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019 Aug 16;68(32):698-702. doi: 10.15585/mmwr.mm6832a3.
- BackgroundFowler, C. I., Gable, J., & Lasater, B. (2021, September). Family Planning Annual Report: 2020 National Summary. Washington, DC: Office of Population Affairs, Office of the Assistant Secretary for Health, Department of Health and Human Services.
- Background: PubMed 19166567Cates JR, Brewer NT, Fazekas KI, Mitchell CE, Smith JS. Racial differences in HPV knowledge, HPV vaccine acceptability, and related beliefs among rural, southern women. J Rural Health. 2009 Winter;25(1):93-7. doi: 10.1111/j.1748-0361.2009.00204.x.
- BackgroundHamborsky, J., & Kroger, A. (Eds.). (2015). Epidemiology and prevention of vaccine-preventable diseases, E-Book: The Pink Book. Public Health Foundation.
- Background: PubMed 34803036Christy K, Kandasamy S, Majid U, Farrah K, Vanstone M. Understanding Black Women's Perspectives and Experiences of Cervical Cancer Screening: A Systematic Review and Qualitative Meta-synthesis. J Health Care Poor Underserved. 2021;32(4):1675-1697. doi: 10.1353/hpu.2021.0159.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Vaccination, run by Plan A Health, Inc at 1 site in United States.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Increased HPV vaccination rates (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658198, which also lists 8 linked publications.
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 15 Nov 2023.