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

November 14, 2023 updated by: Plan A Health, Inc

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Louise, Mississippi, United States, 39097
        • Plan A Health, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unvaccinated patients
Patients who are unvaccinated against HPV when they arrive at Plan A.
Behavioral: Counseling
Patients who first decline HPV vaccination receive a 3-5 minute counseling session on HPV and the benefits of the vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year
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.
one year
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.
one year
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine interest
Time Frame: one year
To identify whether adults who are not vaccinated against HPV are interested in receiving the vaccine.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plan A Health, Inc

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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