Technology-Based Messaging for Increasing COVID-19 Vaccine Uptake

Overseen By Ian D Aronson, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NDRI-USA, Inc.

Disqualifiers: Pregnancy, Minors, Prisoners, others

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

Compensation: Varies

Number of Visits: 1

545 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the COVID-19 vaccines used in the treatment?

Research shows that both the Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) vaccines are effective in preventing COVID-19 infection and reducing the severity of the disease in real-world conditions. These vaccines have been authorized for use based on their demonstrated efficacy in clinical trials and post-marketing studies. ^{1 2 3 4 5}

Is the COVID-19 vaccine safe for humans?

The Pfizer-BioNTech (Comirnaty) and Moderna (mRNA-1273) COVID-19 vaccines have been shown to have a reassuring safety profile, with most adverse reactions being mild, such as local injection-site reactions. Studies have found the risk of serious adverse events to be low. ^{1 4 6 7 8}

How does the technology-based messaging treatment for increasing COVID-19 vaccine uptake differ from other treatments?

This treatment is unique because it uses technology-based messaging to encourage people to get vaccinated, rather than directly administering a vaccine or medication. It focuses on communication strategies to increase vaccine uptake, which is different from traditional medical treatments that involve physical interventions. ^{5 9 10 11 12}

What is the purpose of this trial?

People who inject drugs (PWID) experience disproportionate risk of being infected with SARS-CoV-2, the virus that causes COVID-19, yet due to stigma, fear of mistreatment, and other factors, PWID are far less likely to be vaccinated compared to other populations. In response, we propose to continue our collaboration with a prominent community based organization serving African American and Latino PWID. Our project will explore baseline hesitancy to vaccinate among PWID, identify barriers to vaccination, and then develop and evaluate messaging designed to increase COVID-19 vaccination among our target population of PWID through a clinical trial.

Eligibility Criteria

This trial is for adults over 18 who use injection drugs and haven't been vaccinated against COVID-19. They must understand English or Spanish, be able to consent, and not have been vaccinated before. Pregnant women, those unable to consent, minors, and prisoners are excluded.

Inclusion Criteria

You have used injected drugs in the last 90 days.

You have not received a COVID-19 vaccine before.

I am 18 or older, can consent to treatment, and understand English or Spanish.

Exclusion Criteria

Prisoners

I am unable to give consent for medical procedures.

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants are enrolled and assessed for baseline attitudes and knowledge about vaccination

Baseline

1 visit (in-person)

Intervention

Participants receive weekly text messages, with or without video links, to increase vaccination uptake

6 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for vaccination uptake and SARS-CoV-2 literacy

6 weeks

Treatment Details

Interventions

• No video
• Video Text

Trial Overview The study tests whether technology-based messaging with a video can increase COVID-19 vaccine uptake among people who inject drugs compared to messaging without a video.

Participant Groups

Group I: Video text condition Experimental Treatment 1 Intervention

Participants in the video text condition will receive the text messages designed to increase vaccination among our sample, along with links to iteratively developed intervention videos

Group II: No video condition Experimental Treatment 1 Intervention

Participants in the no video condition will receive weekly text messages designed to increase vaccination among our sample.

Who Is Running the Clinical Trial?

NDRI-USA, Inc.

Lead Sponsor

Trials

3

Recruited

1,400+

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

New York Harm Reduction Educators

Collaborator

Trials

1

Recruited

550+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study of 2030 healthcare workers, those previously infected with COVID-19 reported a higher incidence of side effects after the first dose of the Comirnaty vaccine compared to those who had not been infected, with 46.76% experiencing side effects versus 29.15%.

After the second dose, the side effect rate for previously infected individuals was lower (63.23%) compared to those not previously infected (70.79%), suggesting that prior infection may influence the vaccine's side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. Ossato, A., Tessari, R., Trabucchi, C., et al.[2023]

In a study of 3975 health care and frontline workers, the two-dose mRNA vaccines (Pfizer-BioNTech and Moderna) showed a 91% effectiveness in preventing SARS-CoV-2 infection among fully vaccinated individuals and 81% effectiveness for those partially vaccinated.

Vaccinated individuals who did contract SARS-CoV-2 had a 40% lower viral RNA load, experienced 58% fewer febrile symptoms, and spent an average of 2.3 fewer days sick in bed compared to unvaccinated individuals, indicating that the vaccines not only prevent infection but also reduce the severity of illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and Attenuation of Covid-19 with the BNT162b2 and mRNA-1273 Vaccines. Thompson, MG., Burgess, JL., Naleway, AL., et al.[2023]

The review highlights the clinical efficacy of the Janssen, Pfizer-BioNTech, and Moderna COVID-19 vaccines, based on data from major clinical trials and postmarketing surveillance, emphasizing their effectiveness in preventing COVID-19.

It provides a comprehensive comparison of the safety profiles of these vaccines, focusing on their authorization for general use in the US market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccines. Hahn, WO., Wiley, Z.[2023]

In a study of 433,672 US veterans, both the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines showed low risks of adverse events over 38 weeks, with only small differences in risk observed shortly after vaccination.

Recipients of the mRNA-1273 vaccine experienced lower risks of ischemic stroke, myocardial infarction, and kidney injury compared to those who received the BNT162b2 vaccine, suggesting that mRNA-1273 may have a better safety profile in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety of BNT162b2 and mRNA-1273 Vaccines in a Nationwide Cohort of US Veterans. Dickerman, BA., Madenci, AL., Gerlovin, H., et al.[2023]

In a study of over 1.8 million U.S. Veterans, mRNA-1273 (Moderna) showed a significantly lower risk of SARS-CoV-2 infection and related hospitalizations compared to BNT162b2 (Pfizer-BioNTech), with adjusted hazard ratios indicating a 26% and 37% reduced risk, respectively.

The differences in effectiveness were more pronounced during the Delta variant surge, suggesting that mRNA-1273 may offer better protection over time and against more transmissible variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Moderna versus Pfizer-BioNTech COVID-19 vaccine outcomes: A target trial emulation study in the U.S. Veterans Affairs healthcare system. Ioannou, GN., Locke, ER., Green, PK., et al.[2022]

Two cases of erythema multiforme (EM) were reported following the Pfizer/BioNTech COVID-19 vaccine, indicating a potential but rare cutaneous reaction to the vaccine.

Both patients experienced positive rechallenges, confirming that the vaccine likely induced the EM, which is significant as it provides evidence of a causal relationship between the vaccine and the skin reaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erythema multiforme reactions following Pfizer/BioNTech (tozinameran) vaccination: two case-reports with positive rechallenge and review of the literature. Charfi, O., Lakhoua, G., Berrim, K., et al.[2023]

In a survey of 2,659 healthcare workers in Italy, common adverse events following the Comirnaty® COVID-19 vaccine included injection site pain, fatigue, and headache, with severe reactions being more frequent after the second dose and in women.

Despite the frequent occurrence of adverse events, severe reactions were uncommon, supporting the safety of the vaccine and aiding in risk profiling for future vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital. Vigezzi, GP., Lume, A., Minerva, M., et al.[2022]

In a study of 9700 individuals after the first dose and 8321 after the second dose of the BNT162b2 (Pfizer BioNTech) vaccine, adverse events were significantly more common after the second dose, indicating a potential increase in side effects with the second vaccination.

The study found that female sex and younger age were associated with a higher likelihood of experiencing adverse events after both vaccine doses, while the level of SARS-CoV-2 IgG antibodies did not correlate with adverse events after the first dose but was associated with them after the second dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between IgG antibody levels and adverse events after first and second Bnt162b2 mRNA vaccine doses. Braun, E., Horowitz, NA., Leiba, R., et al.[2023]

The mRNA vaccines developed by Pfizer-BioNTech and Moderna have shown high efficacy against COVID-19, particularly in preventing severe cases, with real-world studies confirming their effectiveness even against variants like alpha and beta.

While vaccine protection wanes over time, a third booster shot has been shown to restore efficacy, especially in older populations, and the overall safety profile is good, with only minor adverse reactions and a lower risk of myocarditis compared to the risks associated with COVID-19 itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mRNA vaccines against COVID-19: a showcase for the importance of microbial biotechnology. Brüssow, H.[2023]

Reconstituted Pfizer-BioNTech and Moderna COVID-19 vaccines maintain mRNA integrity for at least 3 hours during continuous moderate movement at room temperature, which is crucial for effective transportation to vaccination sites.

However, the integrity of these vaccines is significantly compromised when subjected to repeated Vortex shaking, indicating that careful handling during transport is essential to preserve vaccine efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconstituted mRNA COVID-19 vaccines may maintain stability after continuous movement. Grau, S., Ferrández, O., Martín-García, E., et al.[2023]

The Pfizer-BioNTech mRNA COVID-19 vaccine (BNT162b2) was developed in just nine months through unprecedented global collaboration, addressing challenges in vaccine formulation and distribution while maintaining high safety and efficacy standards.

The decision to use an mRNA-based approach was foundational, allowing for rapid adaptation to changing health priorities and facilitating the manufacturing and delivery of vast quantities of vaccine doses worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective. Lewis, LM., Badkar, AV., Cirelli, D., et al.[2023]

In a study of 19 internal medicine residents, the Pfizer-BioNTech COVID-19 vaccine was associated with a decrease in heart rate variability (HRV) after both doses, indicating a physiological response to vaccination.

Participants experienced an initial decrease in sleep duration following vaccination, which then increased over the following days, suggesting that sleep patterns may influence the body's response to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic Response to the Pfizer-BioNTech COVID-19 Vaccine Measured Using Wearable Devices: Prospective Observational Study. Hajduczok, AG., DiJoseph, KM., Bent, B., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. [2023]

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

Prevention and Attenuation of Covid-19 with the BNT162b2 and mRNA-1273 Vaccines. [2023]

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

COVID-19 Vaccines. [2023]

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

Comparative Safety of BNT162b2 and mRNA-1273 Vaccines in a Nationwide Cohort of US Veterans. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of Moderna versus Pfizer-BioNTech COVID-19 vaccine outcomes: A target trial emulation study in the U.S. Veterans Affairs healthcare system. [2022]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Erythema multiforme reactions following Pfizer/BioNTech (tozinameran) vaccination: two case-reports with positive rechallenge and review of the literature. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Association between IgG antibody levels and adverse events after first and second Bnt162b2 mRNA vaccine doses. [2023]

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

mRNA vaccines against COVID-19: a showcase for the importance of microbial biotechnology. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Reconstituted mRNA COVID-19 vaccines may maintain stability after continuous movement. [2023]

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

The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

Physiologic Response to the Pfizer-BioNTech COVID-19 Vaccine Measured Using Wearable Devices: Prospective Observational Study. [2021]