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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT04604743

Collaborator

(none)

Enrollment

Location

Arms

26.3

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Refusal	Behavioral: Intervention, TBN	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2) Cluster randomized controlled trial design (N=4 clinics). This design minimizes risk of contamination between participants in different arms and is ideal when settings are similar in population characteristics. Cluster randomized controlled trials are frequently used when interventions are to be carried out at the level of whole groups (clinic populations).Cluster randomized controlled trial design (N=4 clinics). This design minimizes risk of contamination between participants in different arms and is ideal when settings are similar in population characteristics. Cluster randomized controlled trials are frequently used when interventions are to be carried out at the level of whole groups (clinic populations).

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 20, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham (UAB)	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Henna Budhwani, Assistant Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT04604743

Other Study ID Numbers:

MISP #60590

First Posted:

Oct 27, 2020

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 5, 2022