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

NCT04604743 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-04-06

No results posted yet for this study

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.

Conditions

  • Vaccine Refusal

Interventions

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2022-08-07
Completion
2022-08-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04604743 on ClinicalTrials.gov