Human Papilloma VirusNCT01461408
Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons
A study testing Health Education Session in people with Human Papilloma Virus, run by MEE Productions, Inc. at 1 site in United States.
Trial summary
The investigators propose a non-randomized pilot study to assess the feasibility and effectiveness of using urban beauty salons as settings for culturally-competent health education about HPV vaccination. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Health Education Session
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jul 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother of an 9-18 year old female
- Female who is 18-26 years old
Who cannot join
- Not a mother of an 9-18 year old female
- Not a female who is 18-26 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Pre-selected beauty salons
Philadelphia, Pennsylvania
About this study
Official title: Promoting HPV Vaccination Through African American Beauty Salons: a Pilot Test of a Culturally-Competent Education and Empowerment Strategy
The investigators propose a non-randomized pilot study to assess the feasibility and effectiveness of using urban beauty salons as settings for culturally-competent health education about HPV vaccination. The educational messages will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about. The investigators believe that it is only after women who are opinion leaders among their peers begin positively supporting HPV prevention that it will gain wider acceptance.
The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during "down times" in each of the salons, on a rotating basis.
- The investigators hypothesize the ability to successfully recruit eight (8) beauty salons for participation
- The investigators hypothesize the ability to successfully train multiple stylists per site to talk to their clients about HPV and its impact on women of color
- The investigators hypothesize that knowledge and awareness of HPV, as well as intentions to vaccinate will significantly improve among women who attend a salon-based health education session
- Conditions
- Human Papilloma Virus
- Being tested
- Health Education Session
- Keywords
- HPV Vaccination, Beauty Salons, Health Education, Sexual Health
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education SessionBehavioural
The educational messages during the education session will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about.
The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during "down times" in each of the salons, on a rotating basis. There will be two types of sessions offered, one for mothers of females ages 9-18 and one for females ages 18-26.
| Study group | Role | What they receive |
|---|---|---|
| Beauty Salon #1b | Experimental | Females ages 18-26 Receives: Behavioral: Health Education Session |
| Beauty Salon #1a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #2b | Experimental | Females ages 18-26 Receives: Behavioral: Health Education Session |
| Beauty Salon #3a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #3b | Experimental | Females ages 18-26 Receives: Behavioral: Health Education Session |
| Beauty Salon #4a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #4b | Experimental | Females ages 18-26 Receives: Behavioral: Health Education Session |
| Beauty Salon #2a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #5a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #5b | Experimental | Females ages 9-26 Receives: Behavioral: Health Education Session |
| Beauty Salon #6a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #6b | Experimental | Females ages 18-26 Receives: Behavioral: Health Education Session |
| Beauty Salon #7a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #7b | Experimental | Females ages 18-26 Receives: Behavioral: Health Education Session |
| Beauty Salon #8a | Experimental | Mothers of 9-18 year old females Receives: Behavioral: Health Education Session |
| Beauty Salon #8b | Experimental | Females ages 9-18 Receives: Behavioral: Health Education Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of 8 beauty salons
To recruit 8 beauty salons from Philadelphia PA that would be willing to have their stylists trained to be part of the study, as well as have their salon serve as a host site for education sessions for their female customers.
Measured: 6 months
Secondary outcomes (1)
Intentions to Vaccinate Against HPV
To increase knowledge and awareness about HPV, as well as intentions to vaccinate among beauty salon clients. Intentions to vaccinate will be measured with a single item using the following wording "How likely are you (or your daughter) to start the HPV vaccine series in the next 6 months?". Response options range from "very likely" to "very unlikely" using a 5-point Likert scale.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEE Productions, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, Ivan Juzang, MEE Productions, Inc.
- Investigators
- Ivan Juzang, MBA, Principal investigator, MEE Productions, Inc.Amy Leader, DrPH, MPH, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461408
- Sponsor's protocol ID
- Merck-IISP-39187
- Status last verified
- Oct 2013
- First submitted
- 13 Oct 2011
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting HPV Vaccination Through African American Beauty Salons: a Pilot Test of a Culturally-Competent Education and Empowerment Strategy
- ClinicalTrials.gov ID
- NCT01461408
- Acronym / sponsor ID
- Merck-IISP-39187
- Conditions
- Human Papilloma Virus
- Keywords
- HPV Vaccination, Beauty Salons, Health Education, Sexual Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- MEE Productions, Inc.University, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Oct 2011 (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 investigators propose a non-randomized pilot study to assess the feasibility and effectiveness of using urban beauty salons as settings for culturally-competent health education about HPV vaccination. The educational messages will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about. The investigators believe that it is only after women who are opinion leaders among their peers begin positively supporting HPV prevention that it will gain wider acceptance.
The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during "down times" in each of the salons, on a rotating basis.
- The investigators hypothesize the ability to successfully recruit eight (8) beauty salons for participation
- The investigators hypothesize the ability to successfully train multiple stylists per site to talk to their clients about HPV and its impact on women of color
- The investigators hypothesize that knowledge and awareness of HPV, as well as intentions to vaccinate will significantly improve among women who attend a salon-based health education session
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Beauty Salon #1b | Experimental | Behavioral: Health Education SessionFemales ages 18-26 |
| Beauty Salon #1a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #2b | Experimental | Behavioral: Health Education SessionFemales ages 18-26 |
| Beauty Salon #3a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #3b | Experimental | Behavioral: Health Education SessionFemales ages 18-26 |
| Beauty Salon #4a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #4b | Experimental | Behavioral: Health Education SessionFemales ages 18-26 |
| Beauty Salon #2a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #5a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #5b | Experimental | Behavioral: Health Education SessionFemales ages 9-26 |
| Beauty Salon #6a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #6b | Experimental | Behavioral: Health Education SessionFemales ages 18-26 |
| Beauty Salon #7a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #7b | Experimental | Behavioral: Health Education SessionFemales ages 18-26 |
| Beauty Salon #8a | Experimental | Behavioral: Health Education SessionMothers of 9-18 year old females |
| Beauty Salon #8b | Experimental | Behavioral: Health Education SessionFemales ages 9-18 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mother of an 9-18 year old female
- Female who is 18-26 years old
Key exclusion criteria (2 listed)
- Not a mother of an 9-18 year old female
- Not a female who is 18-26 years old
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 |
|---|---|---|
| Health Education SessionThe educational messages during the education session will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about. The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during "down times" in each of the salons, on a rotating basis. There will be two types of sessions offered, one for mothers of females ages 9-18 and one for females ages 18-26. | Behavioural | Beauty Salon #1a, Beauty Salon #1b, Beauty Salon #2a, Beauty Salon #2b, Beauty Salon #3a, Beauty Salon #3b, Beauty Salon #4a, Beauty Salon #4b, Beauty Salon #5a, Beauty Salon #5b, Beauty Salon #6a, Beauty Salon #6b, Beauty Salon #7a, Beauty Salon #7b, Beauty Salon #8a, Beauty Salon #8b |
Primary outcome
Recruitment of 8 beauty salons
Time frame: 6 months
To recruit 8 beauty salons from Philadelphia PA that would be willing to have their stylists trained to be part of the study, as well as have their salon serve as a host site for education sessions for their female customers.
1 secondary outcome
Intentions to Vaccinate Against HPV
Time frame: 18 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 10 Oct 2013.
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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.
Ivan Juzang, MBA principal investigator
MEE Productions, Inc.
Amy Leader, DrPH, MPH principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education Session in people with Human Papilloma Virus, run by MEE Productions, Inc. 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 2 inclusion and 2 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 10 Oct 2013. 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?
Recruitment of 8 beauty salons (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2013.