Vaccine Refusal
Conditions
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.
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.
Interventions
BEHAVIORALIntervention, 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
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
15 Years to 26 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| HPV Vaccination | Within 6 months from intervention | Initial dose of HPV vaccine within 6 months from intervention |
Countries
United States
Outcome results
None listed