Clinical trial NCT05658198: Investigating HPV Vaccination Uptake in Adults Aged 18-35 Seeking Care at a Health Clinic in Rural Mississippi
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Human Papillomavirus Vaccination
Keywords: HPV vaccine
Gardasil
unvaccinated
adults
Lead sponsor: Plan A Health, Inc
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increased HPV vaccination rates
timeFrame: one year
measure: Counseling effectiveness
timeFrame: one year
measure: Visit differences
timeFrame: one year
measure: Prior information
timeFrame: one year
Secondary outcomes:
measure: Vaccine interest
timeFrame: one year
Other outcomes:
Locations:
city: Louise
country: United States
facility: Plan A Health, Inc
state: Mississippi
Study officials:
References:
citation: 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
citation: Mississippi State Department of Health (2018). Mississippi State Plan for Comprehensive Cancer Control 2018-2022. Retrieved 25 April, 2022.
citation: United States Census Bureau (2022). Health Insurance Coverage Status by Sex and Age, Mississippi. Retrieved 25 April, 2022.
citation: 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.
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.
citation: 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.
citation: Hamborsky, J., & Kroger, A. (Eds.). (2015). Epidemiology and prevention of vaccine-preventable diseases, E-Book: The Pink Book. Public Health Foundation.
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.