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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how to encourage people who inject drugs to get vaccinated against COVID-19. It will explore their reasons for hesitancy and test various messaging strategies to boost vaccination rates. Participants will receive either regular text messages or text messages with links to videos, both designed to promote vaccination. Ideal participants are those who have used injection drugs in the past 90 days and have not yet received a COVID-19 vaccine. As an unphased trial, this study provides a unique opportunity to contribute to public health by enhancing vaccination strategies.

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 prior data suggests that this messaging technique is safe for increasing COVID-19 vaccine uptake among PWID?

In a previous study, video messages increased interest in the COVID-19 vaccine by addressing specific concerns. Another study found that after watching a targeted COVID-19 vaccine education video, 32% of people were more likely to consider vaccination. These findings suggest that using videos to promote vaccination is generally safe. The videos aim to provide information, not to administer medication or perform procedures. Therefore, no direct risks or negative effects have been reported from watching these videos. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to increase COVID-19 vaccine uptake using technology-based messaging. Unlike traditional public health campaigns, this method leverages personalized text messages and engaging videos to reach individuals directly on their mobile devices. This approach aims to provide targeted information and encouragement, potentially making it more effective than general public service announcements or static information. By directly interacting with individuals, this strategy hopes to enhance understanding and trust in the vaccine, ultimately increasing vaccination rates.

What evidence suggests that this trial's treatments could be effective for increasing COVID-19 vaccination among PWID?

This trial will compare the effectiveness of text messages alone versus text messages combined with videos in increasing COVID-19 vaccination rates. Studies have shown that both text and video messages can effectively raise vaccination rates. Specifically, research indicates that text messages with particular wording, like those in this trial, have boosted vaccine uptake in Israel. Additionally, videos addressing specific vaccine concerns have increased people's willingness to get vaccinated. One study found that short videos promoting community responsibility improved vaccine acceptance by encouraging consideration of others' well-being. These findings suggest that both text and video messages could effectively encourage vaccination among people who inject drugs. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

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]

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]

Citations

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