Vaccine Acceptance Interventions for Coronavirus in Prisons

Overseen By Cerella Craig, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Severe physical or mental illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

37122 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to reduce morbidity and mortality from COVID-19 amongst people who are detained in and work in correctional facilities. The overall objective is to identify feasible and effective interventions to improve vaccine uptake in correctional facilities and study the effectiveness of these interventions through rapid cycle, cluster randomized trials in the Pennsylvania prison system.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment ADVANCE Steering Committee interventions for increasing vaccine acceptance in prisons?

Research shows that educational interventions and community engagement can increase vaccine uptake in prisons. For example, a study in Canadian federal prisons found that education improved vaccine acceptance, and another initiative for justice-involved youth used community-based approaches to successfully increase vaccination rates. ^{1 2 3 4 5}

Is the COVID-19 vaccine safe for people in prisons?

The COVID-19 vaccine has been administered to people in prisons, and while there are concerns about side effects and mistrust, no specific safety issues have been reported in these settings. Education and counseling have been shown to increase vaccine uptake and confidence among incarcerated individuals. ^{1 2 3 4 5}

How is the ADVANCE Steering Committee treatment different from other COVID-19 vaccine acceptance treatments in prisons?

The ADVANCE Steering Committee treatment is unique because it focuses on increasing COVID-19 vaccine acceptance in prisons through community engagement, addressing mistrust, and using community-driven ideas, rather than just providing the vaccine itself. This approach involves understanding and addressing the specific concerns and cultural values of incarcerated individuals to improve vaccine uptake. ^{1 4 5 6 7}

Research Team

Lisa Puglisi, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for people detained in Pennsylvania correctional facilities, aiming to improve COVID-19 vaccine uptake. Those with severe physical or mental illness and those in special units like medical units are excluded.

Inclusion Criteria

All incarcerated people in the Pennsylvania DOC are included in the study population for these low-risk interventions. In each individual intervention, inclusion criteria will be based on where incarcerated people are housed and therefore what intervention they will be exposed to.

Exclusion Criteria

Exclusion criteria will likely include severe physical or mental illness as these individuals are often incarcerated in special units which will not be included in the study (i.e. medical units).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

1 month of preparation by the ADVANCE Steering Committee to select and plan interventions

4 weeks

Intervention

Interventions are deployed at patient, provider, practice, and prison levels to improve vaccine acceptance

12 weeks

Analysis and Dissemination

2 months for analysis and rapid dissemination of results

8 weeks

Follow-up

Participants are monitored for vaccine acceptance and health outcomes post intervention

12 weeks

Treatment Details

Interventions

• ADVANCE Steering Committee interventions

Trial Overview The study tests the effectiveness of community engagement strategies developed by the ADVANCE Steering Committee to increase COVID-19 vaccination rates among incarcerated individuals and staff.

Participant Groups

Group I: ADVANCE Steering Committee chosen interventions Experimental Treatment 1 Intervention

Interventions will be selected by the ADVANCE Steering Committee and will be rapidly deployed without additional effort on the part of front-line staff at four distinct levels: patient, provider, practice and prison level. Interventions will be tested one at a time in an iterative process. A participatory, assets-based framework will be used to identify acceptable and feasible strategies to improve vaccine acceptance. Each round of testing will include 1 month of preparation by the steering committee,12-week intervention period, and 2 months for analysis and rapid dissemination.

Group II: Treatment as usual Active Control 1 Intervention

Participants receive standard interventions currently in use (treatment as usual).

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Out of 2,564 jail residents offered a COVID-19 vaccine, only 56.2% accepted at least one dose, indicating significantly lower vaccine acceptance compared to the general population.

Key reasons for vaccine hesitancy included concerns about side effects and efficacy, along with a notable mistrust of medical personnel, highlighting the need for targeted interventions that address these issues and utilize trusted information sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with COVID-19 vaccine acceptance and hesitancy among residents of Northern California jails. Liu, YE., Oto, J., Will, J., et al.[2023]

An educational intervention significantly increased COVID-19 vaccine uptake among incarcerated individuals, with 5% of those receiving the intervention agreeing to get vaccinated compared to only 1% in the control group.

The intervention also improved participants' knowledge, attitudes, and beliefs about the COVID-19 vaccine, highlighting the importance of education in enhancing vaccine confidence in correctional settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education increases COVID-19 vaccine uptake among people in Canadian federal prisons in a prospective randomized controlled trial: The EDUCATE study. Zolotarova, T., Dussault, C., Park, H., et al.[2023]

A COVID-19 vaccination initiative successfully provided access to the vaccine for 31 justice-involved youth in Allegheny County, addressing barriers such as limited parental involvement and transportation issues.

The initiative highlighted the importance of individualized education and counseling to combat vaccine hesitancy, emphasizing trust-building with communities historically affected by medical mistreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccination for Justice-Involved Youth. Goldman, PN., Szoko, N., Lynch, L., et al.[2023]

A study involving 21 recently released individuals from the Federal Bureau of Prisons revealed that only 3 out of 7 who had access to the COVID-19 vaccine while incarcerated chose to get vaccinated, highlighting significant vaccine hesitancy due to distrust in the prison system and concerns about safety.

In contrast, 12 participants got vaccinated after their release, indicating that trust in community healthcare and better access to information played crucial roles in their decision to accept the vaccine post-incarceration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 vaccination hesitancy and uptake: Perspectives from people released from the Federal Bureau of Prisons. Kramer, C., Song, M., Sufrin, CB., et al.[2023]

Justice-involved populations are at higher risk for infectious diseases, and the COVID-19 pandemic has worsened this situation, making vaccination crucial in carceral settings.

Stakeholders, including sheriffs and corrections officers, identified significant barriers to vaccine distribution, primarily vaccine hesitancy and communication issues, but also noted that there are opportunities to improve distribution practices through community engagement and better planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corrections Officers' and Sheriffs' Perceptions of COVID-19 Vaccine Operationalization. Kraus, C., Guardado, R., Wurcel, AG.[2023]

In a study involving 1016 prisoners and 288 prison staff in Alicante, Spain, 88.72% of respondents expressed willingness to receive the COVID-19 vaccine, indicating a strong acceptance rate among this population.

The high acceptance of vaccination is crucial for public health efforts, as 89% of participants believed the benefits of vaccination outweigh the risks, supporting the idea that vaccination should be mandatory for certain activities in prisons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of the COVID-19 Vaccine by Prisoners and Staff in Spanish Prisons. Vicente-Alcalde, N., Sferle, SM., Franco-Paredes, C., et al.[2023]

Community participation is essential for promoting COVID-19 vaccine acceptance, as it helps address misconceptions and tailor sensitization activities to specific community values and cultures.

Mapping community resources and engaging local organizations can empower grassroots initiatives, making vaccination efforts more effective and relevant to the population's needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing COVID-19 vaccine hesitancy: Lessons from the role of community participation in previous vaccination programs. Afolabi, AA., Ilesanmi, OS.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors associated with COVID-19 vaccine acceptance and hesitancy among residents of Northern California jails. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Education increases COVID-19 vaccine uptake among people in Canadian federal prisons in a prospective randomized controlled trial: The EDUCATE study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Vaccination for Justice-Involved Youth. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

COVID-19 vaccination hesitancy and uptake: Perspectives from people released from the Federal Bureau of Prisons. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Corrections Officers' and Sheriffs' Perceptions of COVID-19 Vaccine Operationalization. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptance of the COVID-19 Vaccine by Prisoners and Staff in Spanish Prisons. [2023]

7. Iran pubmed.ncbi.nlm.nih.gov

Addressing COVID-19 vaccine hesitancy: Lessons from the role of community participation in previous vaccination programs. [2022]