Human Papilloma VirusNCT03497936
Marketability of a Technology-based Intervention to Increase HPV Vaccination
A study testing Women's Stories in people with Human Papilloma Virus, run by Real Prevention, LLC at 7 sites in United States.
Trial summary
The overall goal of this SBIR Phase II project is to reduce cancer rates by marketing a brief, easily implemented technology-based intervention that increases human papillomavirus (HPV) vaccination among Planned Parenthood and other clients. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Women's Stories
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2018to 29 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All English-speaking women clients of 4 Planned Parenthood clinics who are between 18 and 26 and have not been vaccinated.
Who cannot join
- Men, women who do not speak English or are not between 18 and 26 years old, anyone not a client of the 4 Planned Parenthood clinics.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Planned Parenthood of Illinois
Chicago, Illinois, 60603
REAL Prevention LLC
Clifton, New Jersey, 07013
University of California, Irvine
Irvine, California, 92697-7700
Public Health Management Corporation
Philadelphia, Pennsylvania, 19102
Planned Parenthood of Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107-6734
Planned Parenthood of the St. Louis Region and Southwest Missouri
St Louis, Missouri, 63108
St. Andrew Development
York, Pennsylvania, 17401-3333
About this study
The overall goal of this SBIR Phase II project is to reduce cancer rates by marketing a brief, easily implemented technology-based intervention that increases human papillomavirus (HPV) vaccination among Planned Parenthood and other clients. The intervention's innovative technology allows for the investigators' narrative videos to be presented along will reminder texts. It will be evaluated for use in waiting rooms and promises to overcome vaccination barriers among high risk but underserved low SES and minority populations.
Read the detailed description
The purpose of this Phase II research project is to evaluate and market an innovative health message intervention to increase uptake of the human papillomavirus (HPV) vaccine and reduce women's cervical cancer risk through partnership with Planned Parenthood. The overall aim is to reach a broad population through Planned Parenthood, the nation's leading sexual and reproductive health care center, especially among low socioeconomic status (SES) and historically underserved populations. Despite an overall increase in vaccination and reduction in HPV-related infections in younger populations targeted by previous health promotion efforts, young adult women who are recommended for vaccination demonstrate much lower vaccination rates and higher rates of infection. In a recent Phase I grant, the investigators developed and demonstrated the usability and feasibility of an innovative, culturally-grounded, technology-based narrative intervention that delivers decision narratives in the form of videos via a health kiosk, an underutilized communication strategy for reaching less involved audiences. This brief, low-cost, easily implementable intervention doubled the uptake of the vaccine in a separate pilot study. The proposed Phase II project will: (1) Complete development of the intervention, (2) Evaluate its effectiveness through a randomized clinical trial, and (3) Prepare the product for the market. To accomplish these aims, the investigators will develop the intervention for implementation in waiting rooms as part of check-in procedures. Development includes programming and installing tablets to accomplish these tasks (Aim 1). The investigators will then conduct the evaluation study in four Planned Parenthood clinics in southeastern Pennsylvania (Aim 2). Eligible women will be consented, complete a pretest, and then randomized to view the brief intervention or attention control messages via the tablet. After viewing the messages, the participants will complete a short posttest. Treatment participants will receive follow up texts/emails as reminders to vaccinate, and all participants will receive texts/emails with links that allow completion of posttest surveys at 3- and 9 months. Finally, the investigators will prepare the intervention for the market that includes not only Planned Parenthood but other clinics that are currently served by the project partners as well as the broader market for HPV vaccination (Aim 3). In summary, the proposed communication strategy has wide reaching implications not only for reducing cancer risk, but more broadly for designing brief and easily implemented prevention messages across many domains of public health. The research will also close the health disparities gap in minority, under-served young adult women's access to preventive health care.
- Conditions
- Human Papilloma Virus
- Being tested
- Women's Stories
- Keywords
- vaccine narratives, HPV prevention, vaccine promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women's StoriesBehavioural
Women's Stories is a brief, HPV vaccination promotion intervention. It presents vaccine information and videos of HPV vaccine decision making. It also includes follow up vaccine reminder text messages.
| Study group | Role | What they receive |
|---|---|---|
| Women's Stories | Experimental | Participants in this group will be randomly assigned to use the Women's Stories intervention. Receives: Behavioral: Women's Stories |
| Programming as usual | No intervention | Participants in this group will be randomly assigned participate in their usual programming. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccination
Uptake of HPV Vaccine as measured by medical records review and self report
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 May 2018
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomly assigned to one of two arms (intervention, no intervention). Intervention participants receive Women's Stories. No intervention participants receive treatment as usual. All participants are administered a pretest and two post tests, and clinical records are examined for vaccination outcomes.
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Prevention, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Michael Hecht, Ph.D., Principal investigator, Real Prevention, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497936
- Sponsor's protocol ID
- R44DP006291
- Status last verified
- Sep 2022
- First submitted
- 10 Apr 2018
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential data cannot be shared.
Publications
Hopfer S, Ray AE, Hecht ML, Miller-Day M, Belue R, Zimet G, Evans WD, McKee FX. Taking an HPV vaccine research-tested intervention to scale in a clinical setting. Transl Behav Med. 2018 Sep 8;8(5):745-752. doi: 10.1093/tbm/ibx066.
PubMed 29425333
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marketability of a Technology-based Intervention to Increase HPV Vaccination
- ClinicalTrials.gov ID
- NCT03497936
- Acronym / sponsor ID
- R44DP006291
- Conditions
- Human Papilloma Virus
- Keywords
- vaccine narratives, HPV prevention, vaccine promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Real Prevention, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Study start
- 1 May 2018 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this SBIR Phase II project is to reduce cancer rates by marketing a brief, easily implemented technology-based intervention that increases human papillomavirus (HPV) vaccination among Planned Parenthood and other clients. The intervention's innovative technology allows for the investigators' narrative videos to be presented along will reminder texts. It will be evaluated for use in waiting rooms and promises to overcome vaccination barriers among high risk but underserved low SES and minority populations.
Detailed description
The purpose of this Phase II research project is to evaluate and market an innovative health message intervention to increase uptake of the human papillomavirus (HPV) vaccine and reduce women's cervical cancer risk through partnership with Planned Parenthood. The overall aim is to reach a broad population through Planned Parenthood, the nation's leading sexual and reproductive health care center, especially among low socioeconomic status (SES) and historically underserved populations. Despite an overall increase in vaccination and reduction in HPV-related infections in younger populations targeted by previous health promotion efforts, young adult women who are recommended for vaccination demonstrate much lower vaccination rates and higher rates of infection. In a recent Phase I grant, the investigators developed and demonstrated the usability and feasibility of an innovative, culturally-grounded, technology-based narrative intervention that delivers decision narratives in the form of videos via a health kiosk, an underutilized communication strategy for reaching less involved audiences. This brief, low-cost, easily implementable intervention doubled the uptake of the vaccine in a separate pilot study. The proposed Phase II project will: (1) Complete development of the intervention, (2) Evaluate its effectiveness through a randomized clinical trial, and (3) Prepare the product for the market. To accomplish these aims, the investigators will develop the intervention for implementation in waiting rooms as part of check-in procedures. Development includes programming and installing tablets to accomplish these tasks (Aim 1). The investigators will then conduct the evaluation study in four Planned Parenthood clinics in southeastern Pennsylvania (Aim 2). Eligible women will be consented, complete a pretest, and then randomized to view the brief intervention or attention control messages via the tablet. After viewing the messages, the participants will complete a short posttest. Treatment participants will receive follow up texts/emails as reminders to vaccinate, and all participants will receive texts/emails with links that allow completion of posttest surveys at 3- and 9 months. Finally, the investigators will prepare the intervention for the market that includes not only Planned Parenthood but other clinics that are currently served by the project partners as well as the broader market for HPV vaccination (Aim 3). In summary, the proposed communication strategy has wide reaching implications not only for reducing cancer risk, but more broadly for designing brief and easily implemented prevention messages across many domains of public health. The research will also close the health disparities gap in minority, under-served young adult women's access to preventive health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomly assigned to one of two arms (intervention, no intervention). Intervention participants receive Women's Stories. No intervention participants receive treatment as usual. All participants are administered a pretest and two post tests, and clinical records are examined for vaccination outcomes.
| Arm | Type | Receives |
|---|---|---|
| Women's Stories | Experimental | Behavioral: Women's StoriesParticipants in this group will be randomly assigned to use the Women's Stories intervention. |
| Programming as usual | No intervention | –Participants in this group will be randomly assigned participate in their usual programming. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All English-speaking women clients of 4 Planned Parenthood clinics who are between 18 and 26 and have not been vaccinated.
Key exclusion criteria (1 listed)
- Men, women who do not speak English or are not between 18 and 26 years old, anyone not a client of the 4 Planned Parenthood clinics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women's StoriesWomen's Stories is a brief, HPV vaccination promotion intervention. It presents vaccine information and videos of HPV vaccine decision making. It also includes follow up vaccine reminder text messages. | Behavioural | Women's Stories |
Primary outcome
HPV Vaccination
Time frame: 9 months
Uptake of HPV Vaccine as measured by medical records review and self report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 29425333Hopfer S, Ray AE, Hecht ML, Miller-Day M, Belue R, Zimet G, Evans WD, McKee FX. Taking an HPV vaccine research-tested intervention to scale in a clinical setting. Transl Behav Med. 2018 Sep 8;8(5):745-752. doi: 10.1093/tbm/ibx066.
- Individual participant dataSharing planned: No. Confidential data cannot be shared.
Related trials for Human Papilloma Virus
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hecht, Ph.D. principal investigator
Real Prevention, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women's Stories in people with Human Papilloma Virus, run by Real Prevention, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV Vaccination (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.