Human PapillomavirusNCT02808832
An HPV Vaccine Provider Intervention in Safety Net Clinics
A study testing Educational materials in people with Human Papillomavirus and Uterine Cervical Neoplasms, run by Meharry Medical College at 1 site in United States.
Trial summary
The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus, Uterine Cervical Neoplasms
- What is being tested?
- Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2016
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being seen as a pediatric patient at a study clinic on the day of enrollment
- Self-identified African American or Hispanic
- Aged 9-18 years (mother accompanying child to clinic visit had no age limit)
- Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit
Who cannot join
- Already having received two or more doses of HPV vaccine
- Mother or female guardian (referred to as "mother" henceforth) not accompanying the child
- Plans to move away from the clinic catchment area within the next 12 months
- Not completing the baseline assessment prior to entering the exam room
- Mother not providing or unable to give consent
- Child not giving assent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention
The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.
Read the detailed description
In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.
- Conditions
- Human Papillomavirus, Uterine Cervical Neoplasms
- Being tested
- Educational materials
- Keywords
- Human papillomavirus (HPV) vaccine, Cervical cancer screening, Provider intervention
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materialsBehavioural
5-minute video and information sheet with a list of suggested questions to ask the provider
| Study group | Role | What they receive |
|---|---|---|
| Educational materials | Experimental | 5-minute video and information sheet with a list of suggested questions to ask the provider Receives: Behavioral: Educational materials |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children participants who completed the 3-dose HPV vaccine series
Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.
Measured: 12 months
Secondary outcomes (1)
Number of mother participants who received appropriate cervical cancer screening
Cervical cancer screening is no longer recommended annually so the investigators measured receipt of a Pap smear as needed within a 12 month period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startSep 2010
- Primary completionMar 2016
- Study completionAug 2016
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 PapillomavirusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, Matthew Walker Comprehensive Health Center, Memphis Health Center, Southside/Dodson Avenue Community Health Centers
- Responsible party
- Sponsor
- Investigators
- Maureen Sanderson, PhD, Principal investigator, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808832
- Sponsor's protocol ID
- U54CA153708
- Status last verified
- Sep 2016
- First submitted
- 16 Jun 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sanderson M, Canedo JR, Khabele D, Fadden MK, Harris C, Beard K, Burress M, Pinkerton H, Jackson C, Mayo-Gamble T, Hargreaves MK, Hull PC. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics. BMC Public Health. 2017 Feb 2;17(1):158. doi: 10.1186/s12889-017-4094-1.
PubMed 28153042
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention
- ClinicalTrials.gov ID
- NCT02808832
- Acronym / sponsor ID
- U54CA153708
- Conditions
- Human Papillomavirus, Uterine Cervical Neoplasms
- Keywords
- Human papillomavirus (HPV) vaccine, Cervical cancer screening, Provider intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- Vanderbilt University, Matthew Walker Comprehensive Health Center, Memphis Health Center, Southside/Dodson Avenue Community Health Centers
- Study start
- Sep 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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 purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.
Detailed description
In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational materials | Experimental | Behavioral: Educational materials5-minute video and information sheet with a list of suggested questions to ask the provider |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being seen as a pediatric patient at a study clinic on the day of enrollment
- Self-identified African American or Hispanic
- Aged 9-18 years (mother accompanying child to clinic visit had no age limit)
- Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit
Key exclusion criteria (6 listed)
- Already having received two or more doses of HPV vaccine
- Mother or female guardian (referred to as "mother" henceforth) not accompanying the child
- Plans to move away from the clinic catchment area within the next 12 months
- Not completing the baseline assessment prior to entering the exam room
- Mother not providing or unable to give consent
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 |
|---|---|---|
| Educational materials5-minute video and information sheet with a list of suggested questions to ask the provider | Behavioural | Educational materials |
Primary outcome
Number of children participants who completed the 3-dose HPV vaccine series
Time frame: 12 months
Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.
1 secondary outcome
Number of mother participants who received appropriate cervical cancer screening
Time frame: 12 months
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 14 Sep 2016.
- Derived from this study: PubMed 28153042Sanderson M, Canedo JR, Khabele D, Fadden MK, Harris C, Beard K, Burress M, Pinkerton H, Jackson C, Mayo-Gamble T, Hargreaves MK, Hull PC. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics. BMC Public Health. 2017 Feb 2;17(1):158. doi: 10.1186/s12889-017-4094-1.
- Individual participant dataSharing planned: No
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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.
Maureen Sanderson, PhD principal investigator
Meharry Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational materials in people with Human Papillomavirus and Uterine Cervical Neoplasms, run by Meharry Medical College at 1 site 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 4 inclusion and 6 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of children participants who completed the 3-dose HPV vaccine series (time frame: 12 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 NCT02808832, 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 14 Sep 2016.