ClinicalTrials.gg
CompletedNCT03346915Updated Oct 9, 2019

Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention

An interventional study of WoW and BNI in Human Papilloma Virus, Cervical Cancer and Human Papillomavirus Infection, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 9 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by Boston Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
9 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 834 studies in Uterine Cervical Neoplasms with a site in United States — 145 open to participants now, 219 under way, 6 of them phase 3. Uterine Cervical Neoplasms · United States.

Enrollment
362nd of 678
60 · median 71
Started
2018
with 42 others
No phase
246 of 834
51 open now
Registered
455th of 834
by date

Among the 834 studies in Uterine Cervical Neoplasms with a site in United States, this one is the 362nd largest by enrollment of the 678 interventional ones that give a count, is one of 43 that started in 2018, is one of 246 with no phase, and was the 455th registered.

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

Browse Uterine Cervical Neoplasms studies →

Open to participants now

145 of the 834 studies in Uterine Cervical Neoplasms with a site in United States are open now. Recruiting first, the newest first:

140 more — sign in →

All 145 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.

This study: 9 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 834 studies in Uterine Cervical Neoplasms with a site in United States, or all of them as a file.
02

Study summary

The project aims to increase HPV vaccination and cervical cancer screening through a web-based mobile health education program called, Wheel of Wellness (WoW) and a brief negotiated interview (BNI). The in-person BNI and WoW system will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening.

Read the detailed description

WoW will be tailored to the participant and will be based on the participant's cancer screening and HPV vaccine health needs; It will then send custom text messages based their concerns and will remind them to schedule and attend their doctor's appointment. The researchers will conduct a single armed proof of concept where the participants will be actively using WoW. The in-person BNI will empower participants to have positive behavioral changes in regards to their health by giving them appropriate health information as well as answering their questions and concerns about cervical cancer prevention and screening.

03

Conditions studied

  • Human Papilloma Virus
  • Cervical Cancer
  • Human Papillomavirus Infection
  • Oropharyngeal Cancer
  • Vaginal Cancer
  • Vulvar Cancer
  • Anal Cancer
  • Penile Cancer

Keywords

  • HPV vaccinaton
  • Cervical cancer screening
  • Web-based mobile health education
  • brief negotiated interview (BNI
04

Who can participate

Ages eligible
9 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Parent/guardian with a child between the ages of 9 to 17 who receives primary care at one of the participating sites and their male child.
  2. Parent/guardian with a male child who provides consent to have child's HPV vaccination status checked in EMR.
  3. Parent/guardian with a male child who has neither initiated the HPV vaccine nor completed the series
  4. Parent/guardian and male child with the ability to read and write in English.
  5. Parent/guardian and male child have access to a smartphone.

Exclusion criteria

Exclusion Criteria:

  1. Parent/guardian's eligible child is pregnant.
  2. Parent/guardian's has begun or completed the HPV series.
  3. Parent/guardian, in the opinion of the clinical staff, is cognitively impaired and unable to give .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Subjects receiving WoW and BNI

    The behavioral intervention (WoW and BNI) will supplement the subject's standard of care by incorporating interactive messaging, reminders, patient education, and enhanced provider communication.

    Behavioral: WoW and BNI

Interventions

  • BehavioralWoW and BNI

    The Text/web based health information technology system, WoW, will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening. WoW will be tailored to the participant and will be based on the participant's cancer screening and HPV vaccine health needs; It will then send custom text messages based their concerns and will remind them to schedule and attend their doctor's appointment. The brief negotiated interview will encourage and empower participants to have positive behavioral changes in regards to their health.

06

What researchers measure

Primary outcomes

  1. HPV vaccine series start and completion

    The primary outcome of interest is receipt of the first dose and completion of the three-dose or two-dose series of HPV vaccine by participants within six months of intervention by EMR review.

    Time frame: 6 months

Secondary outcomes

  1. HPV and Cervical Cancer awareness and knowledge

    Change in knowledge of HPV vaccination and cervical cancer will be measured using a survey, which is under development, that includes questions about HPV and HPV vaccination. It will be administered before and again after the intervention and changes in responses will be compared.

    Time frame: 6-12 months

  2. Provider-patient communication about HPV vaccine and cervical cancer

    Based on participants' entries onto the WoW website, a list of their concerns and questions about HPV vaccine and cervical cancer will be created and this list will be brought to a clinical visit with their providers. Following the clinical visit, participants will be asked whether providers addressed their questions and concerns about HPV vaccine and cervical cancer using a short questionnaire with a 5 point likert scale where 1=completely addressed and 5= not at all addressed. Lower scores are favorable.

    Time frame: one week after provider visit throughout the duration of the study

  3. Wheel of Wellness (WoW) feasibility

    The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.

    Time frame: 6 months

  4. Wheel of Wellness (WoW) feasibility

    The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.

    Time frame: 12 months

07

Study locations

1 site
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Apr 2019, 8 months.

Of 446 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's 8 months is below that.

Counting every sponsor, half of 462 studies reached it within 33 months; a quarter within 15 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2017
First posted
Nov 20, 2017
StartActual
Aug 14, 2018
Primary completionActual
Apr 19, 2019
CompletionActual
Apr 19, 2019
Last update
Oct 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03346915
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Aug 14, 2018
Primary completion
Apr 19, 2019
Completion
Apr 19, 2019
Last update
Oct 9, 2019

Study contacts

Natalie Joseph, MD, MPH
principal investigator · Boston Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion