Reminders for HPV Vaccine

Not currently recruiting at 1 trial location

Overseen By Ashley Stephens, MD

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Non-English/Luganda speakers, Previous study participants

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of text message and automated phone reminders in helping people start and complete the HPV vaccine series. The study focuses on parents of girls aged 10-14 in Kampala who have cell phones capable of receiving texts. Participants will either receive reminders or continue with usual care (no reminders). The goal is to determine if reminders can improve vaccination rates.

As an unphased trial, this study provides participants the opportunity to contribute to important research that could enhance public health strategies.

Do I need to stop my current medications for this trial?

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

What prior data suggests that these HPV vaccine reminders are safe?

Research shows that using text messages and automated phone calls to remind people about the HPV vaccine is both safe and effective. Studies have found that these reminders increase vaccination rates without causing harm. Text reminders, in particular, have successfully encouraged people to get their HPV shots. Although automated phone calls (robocalls) are less effective because some do not reach the recipient, they remain safe.

There is no safety concern with receiving these reminders. The goal is to increase vaccination rates, not to test a new medical treatment, so no negative effects are linked to the reminders. In summary, text and phone reminders are safe and help more people complete their HPV vaccinations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach to HPV vaccination, which often relies on patients remembering to schedule their own appointments, this trial is exploring the effectiveness of text message and automated phone reminders. Researchers are excited about this method because these reminders could significantly increase vaccination rates by providing timely prompts. This approach leverages technology to improve public health by making it easier for people to stay on top of their vaccination schedules, potentially reducing HPV-related health issues in the long run.

What evidence suggests that HPV vaccine reminders are effective for increasing vaccination rates?

Research has shown that text messages and automated phone reminders can increase timely HPV vaccination rates. In this trial, participants in one arm will receive text message or automated phone reminders, which previous studies have shown lead to more people starting their HPV vaccines. One study found that text reminders doubled the number of adults who completed the vaccine series. Although automated calls were less effective due to delivery problems, text messages consistently had a positive impact. Overall, these reminders offer a practical way to encourage more people to get vaccinated against HPV. ^{1 2 3 6 7}

Who Is on the Research Team?

Melissa Stockwell, MD MPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for parents of girls aged 10-14 in Kampala or nearby, who speak English or Luganda and have a cell phone that can receive texts. Parents already in the study with another child, or involved in past HPV vaccine reminder studies, can't join.

Inclusion Criteria

I am a parent of a girl aged 10-14.

I can understand and agree to the study's requirements.

Reside in Kampala and/or the surrounding districts

Exclusion Criteria

I speak a language other than English or Luganda.

Parenting adult already enrolled in the study for another child

Participation in previous HPV vaccine reminder study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive text message or automated phone reminders for HPV vaccination

12 months

Follow-up

Participants are monitored for timeliness of HPV vaccination completion

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HPV Vaccine Reminders

Trial Overview

The SEARCH II Study is testing if text messages and automated phone reminders increase the start and completion rates of HPV vaccination among adolescent girls at health centers and schools affiliated with KCCA.

How Is the Trial Designed?

Group I: Text message/automated phone reminders Experimental Treatment 1 Intervention

Text message or automated phone reminders

Group II: Usual Care Active Control 1 Intervention

No reminders

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Makerere University

Collaborator

Trials

297

Recruited

1,862,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Gardasil® and Cervarix® vaccines are highly effective and safe in preventing cervical cancer caused by human papillomaviruses (HPV), which is the third most common cancer in women.

Current research is focused on developing more affordable second-generation HPV vaccines using different formulations, as the high cost of existing vaccines limits their global implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic papillomavirus vaccines. Ribeiro-Müller, L., Müller, M.[2022]

The two-dose HPV vaccine series for pre-adolescent girls (ages 9-15) is effective in providing protection against HPV 16 and other types, with the World Health Organization recommending this schedule since 2015, while older women still require a three-dose series.

Gardasil9 and Cervarix both show strong efficacy in preventing HPV infections, with Cervarix offering a potentially more cost-effective option due to its sustained high antibody levels and the possibility of effective protection with just one dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV vaccines - A review of the first decade. Harper, DM., DeMars, LR.[2022]

A study involving 215,965 individuals who received the nine-valent HPV vaccine (HPV9) found no new safety concerns, confirming its established safety profile from previous research.

While some elevated event categories were noted, such as skin disorders and ill-defined conditions, most were either previously known or had other causes, and no deaths were linked to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. Hansen, J., Yee, A., Lewis, N., et al.[2023]

HPV-related cancers, including cervical and head and neck cancers, account for a significant portion of global cancer cases, highlighting the urgent need for effective vaccination strategies, especially since over 80% of people are exposed to HPV by age 50.

While prophylactic vaccines like Gardasil® and Cervarix® have successfully reduced HPV infections in young populations, there are currently no FDA-approved therapeutic vaccines for those already infected, indicating a critical gap in treatment options for HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Vaccines for HPV-Associated Malignancies. Smalley Rumfield, C., Roller, N., Pellom, ST., et al.[2020]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

The 9-valent HPV vaccine (Gardasil 9®) significantly increases protection against cervical cancer by covering 9 oncogenic HPV types, raising potential protection from about 70% to 90%, based on clinical trials involving young women.

Clinical trials demonstrated that the 9vHPV vaccine has a comparable safety profile and immunogenicity to the original 4-valent vaccine, with a 2-dose regimen showing similar effectiveness in younger boys and girls compared to the standard 3-dose regimen for older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. Zhang, Z., Zhang, J., Xia, N., et al.[2019]

Both Gardasil and Cervarix HPV vaccines have shown outstanding efficacy in preventing infections and related conditions in young women, with excellent safety profiles and only mild to moderate side effects reported.

Neither vaccine is effective in treating existing HPV infections or lesions, but they provide strong protection against specific HPV types for at least four years, with Gardasil also preventing genital warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. Schiller, JT., Castellsagué, X., Villa, LL., et al.[2022]

Over 4 years of post-licensure safety surveillance of the HPV-16/18 vaccine (Cervarix) showed that the most commonly reported adverse events were consistent with those expected in the general population, indicating a favorable safety profile.

No significant patterns of serious immune-mediated diseases were found, and the incidences of conditions like Bell's palsy and Guillain-Barré syndrome were within expected ranges, reinforcing the vaccine's acceptable benefit-risk profile for adolescent girls and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Angelo, MG., Zima, J., Tavares Da Silva, F., et al.[2021]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

The HPV vaccines Gardasil and Cervarix are effective in preventing infection from the most harmful HPV types and are generally considered safe based on data from the U.S. Vaccine Adverse Event Reporting System (VAERS).

While the vaccines are effective, some studies have reported autoimmune side effects, indicating a need for further research to explore the potential link between HPV vaccination and autoimmunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of human papilloma virus-blockers and the risk of triggering autoimmune diseases. Baker, B., Eça Guimarães, L., Tomljenovic, L., et al.[2015]

Gardasil is a newly available vaccine in the U.S. for girls and women aged 9 to 26 that protects against human papillomavirus (HPV), a major cause of cervical cancer.

These HPV vaccines, including the under-development Cervarix, could potentially lower the incidence of cervical cancer by up to 70%, marking a significant advancement in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the new HPV vaccines in clinical practice. Widdice, LE., Kahn, JA.[2019]

Cervarix, an HPV vaccine, has shown a 70.2% reduction in cervical precancerous lesions in HPV-naïve young girls, indicating its strong efficacy in preventing cervical cancer caused by HPV types 16, 18, 31, 33, and 45.

Cervarix induces significantly higher levels of neutralizing antibodies and memory immune cells compared to Gardasil, with sustained protection lasting over 7 years, demonstrating its long-term effectiveness and safety in preventing HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical update of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine, Cervarix. Schwarz, TF.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

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Text Messages and Automated Phone Reminders for HPV ...

In this novel trial, SMS text message and automated phone reminders were effective in promoting more timely HPV vaccination in this population.

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Effectiveness of Centralized Text Message Reminders on ...

MCO-based text reminders are feasible and have a modest effect on HPV dose 1 vaccination rates for those parents able to receive text messages with valid phone ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0091743523000282

Effectiveness and feasibility of three types of parent ...

Text message reminders were effective in increasing HPV vaccine receipt. Robocalls were least feasible reminder type with one third of reminders undelivered.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S221133551500087X

Parental education and text messaging reminders as ...

69 parents received HPV education onsite, 45 of whom also received a series of text message vaccination reminders. We measured HPV vaccination completion of the ...

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valueinhealthjournal.com/article/S1098-3015(12)01402-7/fulltext

PIN62 Effectiveness of Text Message Reminders for ...

Among adult patients who initiated the HPV series alone, text messages doubled the rate of vaccine completion (37.5% vs. 18.5%; RR = 2.03). Text messaging was ...

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pmc.ncbi.nlm.nih.gov/articles/PMC10145812/

Using Electronic Reminders to Improve Human ...

At the time of our intervention development, past studies demonstrated text messaging as an effective reminder system for HPV vaccination [27,28 ...

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pmc.ncbi.nlm.nih.gov

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Text Message Reminder–Recall to Increase HPV ...

We found that text message reminder-recall improved HPV immunization uptake in a young, primarily black and un- or underinsured HIV-1 infected patients.