Recruiting

Health Communication

Sponsor:

Meharry Medical College

Code:

NCT04380623

Conditions

Human Papilloma Virus

HPV-Related Carcinoma

Vaccine Refusal

Parents

Program, Communication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mobile Phone-Based Web-Page: HPV vaccine

Study Details

Brief summary:

The human papillomavirus (HPV) causes 90% of cervical cancers and is implicated in multiple other cancers. The HPV vaccine can prevent the vast majority of these cancers, but it is underused in adolescents, especially among those within vaccine hesitant (VH) parents. The proposed research is to develop and pilot test a tailored, health communication intervention aimed to increase HPV vaccination among VH parents. The proposed research is innovative because no evidence-based health communication interventions target HPV VH parents, and we will use stakeholder engagement throughout this study. The research will add knowledge on how tailored education provided before a doctor's visit can play a role in improving HPV vaccination rates among underserved, VH parents.

Conditions

Human Papilloma Virus

HPV-Related Carcinoma

Vaccine Refusal

Parents

Program, Communication

Study ID

NCT04380623

Start date

Feb 15, 2021

Status verified date

Sep, 2021

Completion date

May 30, 2024

Anticipated

Primary completion date

May 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Aims 1 and 2 Only

Inclusion Criteria

Parents

1. Parents of patients of MMC Pediatrics aged 11-18
2. Refused HPV vaccination in the past two years
3. Have not received any doses of HPV vaccine
4. Own smartphone
5. Speak English
6. Have a clinic appointment scheduled within the coming month (AIM 1 Stage 2 \& AIM 2 only)
7. Did not participate in Aim 1 Stage 1 (AIM 1 Stage 2 only)
8. Did not participate in Aim 1 Stage 1 or Aim 1 Stage 2 (Aim 2 only)

Providers

1. Physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18 (Aim 1 Stage 1)
2. Physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18 and the intervention at Meharry Medical College. (Aim 1 Stage 2, Aim 2)

Exclusion Criteria:

Parents

1. Parents with vaccinated patients or never been offered the vaccine in MMC pediatrics aged 11-18
2. Unvaccinated yet never refused the vaccine
3. Do not speak English
4. Do not own a smart phone
5. Does not have an upcoming clinic visit (Aim 1 Stage 2 and Aim 2)

Providers

1. Providers: Physicians, nurse practitioners, and physician assistants who do not deliver primary care to pediatric patients aged 11-18 at Meharry and other clinics
2. Providers who do not provide the HPV vaccine.
3. Providers who do not participate in Aim 1 stage 1 (Aim 1 Stage 2 only)
4. Did not pilot study (Aim 2)

Study Design

Enrollment

244 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mobile Phone-Based Web-Page: HPV vaccine

Parents who have already declined the HPV vaccine for their adolescent will receive pre-visit, tailored education information on the HPV vaccine via a text message with a website link.

active comparator: Mobile Phone-Based Web-Page: Healthy Lifestyles

Parents who have already declined the HPV vaccine for their adolescent will receive pre-visit education information on an unrelated topic (e.g., healthy eating and physical activity) via a text message with a website link.

Interventions

Mobile Phone-Based Web-Page: HPV vaccine

Website to be accessed via mobile phone to deliver tailored educational material

Primary outcome measure

  • Recruitment Rates [ Time Frame: 6 months ]
  • Retention Rates [ Time Frame: 6 months ]
  • Data collection processes [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Meharry Medical College

Recruiting

Nashville, Tennessee, United States, 37208

Contacts

Jennifer C Erves, PhD

6153275692jerves@mmc.edu

Kimberly Thomas, RN, CCRP, LNC

615-327-6735kthomas@mmc.edu

More Information

Sponsor

Meharry Medical College

Last update posted

Sep 8, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Meharry Medical College on 2021-09-08.