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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find effective ways to increase COVID-19 vaccine acceptance among individuals detained in and working at correctional facilities. Researchers will test various strategies to determine which ones encourage more people to choose vaccination. The trial will compare standard practices with new interventions selected by the ADVANCE Steering Committee, a group focused on improving vaccine acceptance in prisons. Individuals incarcerated in Pennsylvania's Department of Corrections, except those with severe physical or mental illnesses, are eligible to participate. As an unphased trial, this study offers participants an opportunity to contribute to important research that could enhance public health in correctional facilities.

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 prior data suggests that the ADVANCE Steering Committee interventions are safe?

Research shows that the ADVANCE Steering Committee is developing strategies to increase vaccine acceptance in prisons. Although specific safety data from these efforts is unavailable, the study is in the "Not Applicable" phase. This suggests a focus on strategies and education rather than new medical treatments, indicating generally low safety risks.

The interventions aim to improve vaccine uptake by educating individuals and building trust within prison systems. As these efforts center on communication and organization, they should be safe for participants. Similar studies have not reported negative effects from such interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ADVANCE Steering Committee interventions because they offer a fresh approach to increasing vaccine acceptance in prisons. Unlike traditional methods that rely heavily on existing protocols, these interventions are designed to be rapidly deployed at multiple levels, including patient, provider, practice, and prison. This multi-tiered strategy allows for a more comprehensive and adaptable approach, aiming to identify strategies that are both feasible and acceptable for this unique setting. By utilizing a participatory, assets-based framework, the interventions are tailored to the specific needs of the prison environment, which could lead to more effective outcomes compared to the standard interventions.

What evidence suggests that this trial's interventions could be effective for improving vaccine uptake in prisons?

This trial will compare interventions chosen by the ADVANCE Steering Committee with treatment as usual to increase COVID-19 vaccine uptake in prisons. Research has shown that the ADVANCE Steering Committee's efforts aim to boost vaccine acceptance by understanding vaccine hesitancy and developing better strategies. These efforts focus on collaborating with the community to make vaccines more acceptable and accessible. Early results suggest that involving both staff and inmates in the process can lead to higher vaccination rates. Although exact numbers are not yet available, this approach could potentially reduce COVID-19 cases in prisons. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa Puglisi, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05796505

Addressing Vaccine Acceptance in Carceral Settings ... The overall objective is to identify feasible and effective interventions to improve vaccine uptake in correctional facilities and study the effectiveness of ...

2. cic-apps.datascience.columbia.edu cic-apps.datascience.columbia.edu/grants/10632

Addressing Vaccine AcceptaNce in Carceral Settings through ... This proposal, ADdressing Vaccine AcceptaNce in Carceral Settings through Community Engagement (ADVANCE), is to identify feasible and effective interventions ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05796505?tab=table

Addressing Vaccine Acceptance in Carceral Settings ... A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

4. medicine.yale.edu medicine.yale.edu/seiche/research/vaccinations/

Vaccinations < SEICHE Center for Health and Justice ADVANCE's aim is to identify feasible and effective interventions to improve vaccine uptake in prisons.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10151452/

Attitudes towards COVID-19 vaccination among ... These survey findings can inform the design of potential interventions to increase COVID-19 vaccine uptake in these settings.

6. pandemicpact.org pandemicpact.org/grants/P38807

Addressing Vaccine AcceptaNce in Carceral Settings ... ADVANCE represents a substantial departure from previous work on vaccine acceptance by focusing on providing an evidence base for addressing vaccine acceptance ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11209440/

Understanding Vaccine Hesitancy in U.S. Prisons This study examines vaccine hesitancy—and acceptance—among a sample of individuals incarcerated within adult prisons in Pennsylvania ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S221133552200078X

Factors associated with COVID-19 vaccine acceptance and ... Trust in jail health staff was significantly associated with COVID-19 vaccine acceptance (p < 0.001), with 81%, 72%, and 59% acceptance among respondents who ...