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Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons

Primary Purpose

Human Papilloma Virus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education Session
Sponsored by
MEE Productions, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus focused on measuring HPV Vaccination, Beauty Salons, Health Education, Sexual Health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Mother of an 9-18 year old female
  • Female who is 18-26 years old

Exclusion Criteria:

  • Not a mother of an 9-18 year old female
  • Not a female who is 18-26 years old

Sites / Locations

  • Pre-selected beauty salons

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Beauty Salon #1b

Beauty Salon #1a

Beauty Salon #2b

Beauty Salon #3a

Beauty Salon #3b

Beauty Salon #4a

Beauty Salon #4b

Beauty Salon #2a

Beauty Salon #5a

Beauty Salon #5b

Beauty Salon #6a

Beauty Salon #6b

Beauty Salon #7a

Beauty Salon #7b

Beauty Salon #8a

Beauty Salon #8b

Arm Description

Females ages 18-26

Mothers of 9-18 year old females

Females ages 18-26

Mothers of 9-18 year old females

Females ages 18-26

Mothers of 9-18 year old females

Females ages 18-26

Mothers of 9-18 year old females

Mothers of 9-18 year old females

Females ages 9-26

Mothers of 9-18 year old females

Females ages 18-26

Mothers of 9-18 year old females

Females ages 18-26

Mothers of 9-18 year old females

Females ages 9-18

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 13, 2011
Last Updated
October 9, 2013
Sponsor
MEE Productions, Inc.
Collaborators
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT01461408
Brief Title
Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons
Official Title
Promoting HPV Vaccination Through African American Beauty Salons: a Pilot Test of a Culturally-Competent Education and Empowerment Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MEE Productions, Inc.
Collaborators
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
HPV Vaccination, Beauty Salons, Health Education, Sexual Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beauty Salon #1b
Arm Type
Experimental
Arm Description
Females ages 18-26
Arm Title
Beauty Salon #1a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #2b
Arm Type
Experimental
Arm Description
Females ages 18-26
Arm Title
Beauty Salon #3a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #3b
Arm Type
Experimental
Arm Description
Females ages 18-26
Arm Title
Beauty Salon #4a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #4b
Arm Type
Experimental
Arm Description
Females ages 18-26
Arm Title
Beauty Salon #2a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #5a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #5b
Arm Type
Experimental
Arm Description
Females ages 9-26
Arm Title
Beauty Salon #6a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #6b
Arm Type
Experimental
Arm Description
Females ages 18-26
Arm Title
Beauty Salon #7a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #7b
Arm Type
Experimental
Arm Description
Females ages 18-26
Arm Title
Beauty Salon #8a
Arm Type
Experimental
Arm Description
Mothers of 9-18 year old females
Arm Title
Beauty Salon #8b
Arm Type
Experimental
Arm Description
Females ages 9-18
Intervention Type
Behavioral
Intervention Name(s)
Health Education Session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment of 8 beauty salons
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Intentions to Vaccinate Against HPV
Description
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.
Time Frame
18 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mother of an 9-18 year old female Female who is 18-26 years old Exclusion Criteria: Not a mother of an 9-18 year old female Not a female who is 18-26 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Juzang, MBA
Organizational Affiliation
MEE Productions, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Leader, DrPH, MPH
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pre-selected beauty salons
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

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Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons

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