Clinic-based HPV and COVID-19 Vaccine Promoting Intervention for AfAm Adolescents in Alabama

Exploratory Sequential Mixed Methods Cluster Randomized Controlled Implementation Science Trial to Develop a Clinic-based HPV and COVID-19 Vaccine Promoting Intervention for African American Older Adolescents in Rural Alabama

In this 30-month study, the investigators propose to develop a culturally appropriate vaccine confidence intervention, targeting positive change related to HPV vaccine uptake behavior and reducing sentiments of hesitancy towards a COVID-19 vaccine, that can be seamlessly integrated into the existing environment of pediatric and family practice clinics in rural Alabama. To do so, the investigators will first assess stakeholders' knowledge, sentiments, and beliefs related to vaccination in general, a COVID-19 vaccination, and the HPV vaccination. The investigators will also assess stakeholders' perceptions of barriers to vaccination that exist in rural Alabama. This will occur in Aim 1. Then, in Aim 2, the investigators will use these data to inform the development of a non-invasive, modular synchronous counseling intervention targeting 15-17 year old adolescents (rationale for this age range presented later in this proposal). After the intervention has been finalized, in our final aim, Aim 3, we will conduct a hybrid type 1 effectiveness-implementation cluster randomized control trial to assess intervention acceptability and feasibility (N=4 clinics; N=120 adolescents), while also assessing for a "clinical signal" of effectiveness. To support dissemination and scale up, also during Aim 3, we will document implementation contexts to provide real-world insight. To do this, the investigators will conduct in-depth interviews with the same groups of stakeholders that we interviewed in Aim 1.

Study Overview

• Status: Withdrawn
• Conditions: Vaccine Refusal
• Intervention / Treatment: Behavioral: Intervention, TBN

Detailed Description

In this 30-month study, the investigators propose to develop a culturally appropriate vaccine confidence intervention, targeting positive change related to HPV vaccine uptake behavior and reducing sentiments of hesitancy towards a COVID-19 vaccine, that can be seamlessly integrated into the existing environment of pediatric and family practice clinics in rural Alabama. To do so, the investigators will first assess stakeholders' knowledge, sentiments, and beliefs related to vaccination in general, a COVID-19 vaccination, and the HPV vaccination. The investigators will also assess stakeholders' perceptions of barriers to vaccination that exist in rural Alabama. This will occur in Aim 1. Then, in Aim 2, the investigators will use these data to inform the development of a non-invasive, modular synchronous counseling intervention targeting 15-17 year old adolescents (rationale for this age range presented later in this proposal). After the intervention has been finalized, in our final aim, Aim 3, we will conduct a hybrid type 1 effectiveness-implementation cluster randomized control trial to assess intervention acceptability and feasibility (N=4 clinics; N=120 adolescents), while also assessing for a "clinical signal" of effectiveness. To support dissemination and scale up, also during Aim 3, we will document implementation contexts to provide real-world insight. To do this, the investigators will conduct in-depth interviews with the same groups of stakeholders that we interviewed in Aim 1.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham (UAB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 15-26 years
• Have not completed HPV vaccination schedule
• Located in a rural, non-urban setting
• Able to provide informed consent

Exclusion Criteria:

• Doe not meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 2 Clinics	Behavioral: Intervention, TBN; The intervention will target adolescents aged 15-17 years who have not received at least one dose of the HPV vaccine. The intervention has yet to be named; this will occur through the conduct of Aim 1. Our intervention, when developed, will improve knowledge of HPV, COVID-19, the HPV vaccine, and the COVID-19 vaccine (Information), reduce stigma and distrust improving motivation (Motivation), leading to improved vaccine confidence and higher vaccination rates and lower vaccine hesitancy (Behavioral Skills). Each one of these three change objectives will be encapsulated in its own Zoom-based session with the near peer interventionist. We anticipate that each modular session will be no longer than seven minutes; thus, the entire three module intervention will be no longer than twenty-one minutes long.
No Intervention: Control; 2 Clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Vaccination	Initial dose of HPV vaccine within 6 months from intervention	Within 6 months from intervention
Reduction in Vaccine Hesitancy	Reduction in hesitancy measured by change in knowledge and motivation via surveys; survey tools to be developed based on qualitative data	Within 6 months from intervention

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• Budhwani H, Sharma V, Long D, Simpson T. Developing a Clinic-Based, Vaccine-Promoting Intervention for African American Youth in Rural Alabama: Protocol for a Pilot Cluster-Randomized Controlled Implementation Science Trial. JMIR Res Protoc. 2022 Apr 8;11(4):e33982. doi: 10.2196/33982.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): August 7, 2022
• Study Completion (Actual): August 7, 2022

Study Registration Dates

• First Submitted: October 25, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MISP #60590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing with occur in compliance with Merck's data sharing policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No