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

Vaccine Refusal Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04604743
• Other study ID #: MISP #60590
• Status: Withdrawn
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: August 7, 2022

Study information

• Verified date: April 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 7, 2022
• Est. primary completion date: August 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaccine Refusal

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham (UAB)	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV Vaccination	Initial dose of HPV vaccine within 6 months from intervention	Within 6 months from intervention
Primary	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