Investigating HPV Vaccination Uptake in Adults Aged 18-35 Seeking Care at a Health Clinic in Rural Mississippi

Human Papillomavirus Vaccination Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05658198
• Other study ID #: 02
• Status: Enrolling by invitation
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: Plan A Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• patients who have been vaccinated against HPV
• patients under 18 and over 35
• patients whose vaccine records cannot be verified

Related Conditions & MeSH terms

• Human Papillomavirus Vaccination

Intervention

Behavioral:
• Counseling
Patients who first decline HPV vaccination receive a 3-5 minute counseling session on HPV and the benefits of the vaccine.

Locations

Country	Name	City	State
United States	Plan A Health, Inc	Louise	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Plan A Health, Inc	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

Fowler, 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.

Hamborsky, J., & Kroger, A. (Eds.). (2015). Epidemiology and prevention of vaccine-preventable diseases, E-Book: The Pink Book. Public Health Foundation.

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. — View Citation

Mississippi State Department of Health (2018). Mississippi State Plan for Comprehensive Cancer Control 2018-2022. Retrieved 25 April, 2022.

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

United States Census Bureau (2022). Health Insurance Coverage Status by Sex and Age, Mississippi. Retrieved 25 April, 2022.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year
Primary	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.	one year
Primary	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.	one year
Primary	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.	one year
Secondary	Vaccine interest	To identify whether adults who are not vaccinated against HPV are interested in receiving the vaccine.	one year