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

NCT05658198 | Unknown

• 1 other identifier: 02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Papillomavirus Vaccination

Keywords

HPV vaccine; Gardasil; unvaccinated; adults

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Vaccine interest

  one year

Study Arms (1)

Unvaccinated patients

Patients who are unvaccinated against HPV when they arrive at Plan A.

Behavioral: Counseling

Interventions

Counseling BEHAVIORAL

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

Unvaccinated patients

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 18 and 35 visiting a primarily mobile health clinic in the Mississippi Delta.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Plan A Health, Inc: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Plan A Health, Inc

Louise, Mississippi, 39097, United States

Location

Related Publications (8)

• 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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31415491 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19166567 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 34803036 BACKGROUND

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 20, 2022
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)