NCT04604743

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

Withdrawn NA Last updated 6 April 2023

What this trial tests

NA trial testing Intervention, TBN in Vaccine Refusal. Withdrawn.

Timeline

20 April 2021

Primary endpoint
7 August 2022

7 August 2022

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Start date	20 April 2021
Primary completion	7 August 2022
Estimated completion	7 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Intervention, TBN

Conditions studied

• Vaccine Refusal — all drugs for Vaccine Refusal →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 15 to 26, any sex, with Vaccine Refusal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to increase COVID-19 vaccine uptake: a scoping review.
   Andreas M, Iannizzi C, Bohndorf E, Monsef I, et al · · 2022 · cited 24× · PMID 35920693 · DOI 10.1002/14651858.cd015270
2. COVID-19 Vaccine Sentiments Among African American or Black Adolescents in Rural Alabama.
   Budhwani H, Maycock T, Murrell W, Simpson T. · · 2021 · cited 23× · PMID 34666953 · DOI 10.1016/j.jadohealth.2021.09.010
3. Developing a Clinic-Based, Vaccine-Promoting Intervention for African American Youth in Rural Alabama: Protocol for a Pilot Cluster-Randomized Controlled Implementation Science Trial.
   Budhwani H, Sharma V, Long D, Simpson T. · · 2022 · cited 2× · PMID 35212640 · DOI 10.2196/33982