NCT01461408

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

October 13, 2011

Last Update Submit

October 9, 2013

Conditions

Keywords

HPV VaccinationBeauty SalonsHealth EducationSexual Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Intentions to Vaccinate Against HPV

    18 months

Study Arms (16)

Beauty Salon #1b

EXPERIMENTAL

Females ages 18-26

Behavioral: Health Education Session

Beauty Salon #1a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #2b

EXPERIMENTAL

Females ages 18-26

Behavioral: Health Education Session

Beauty Salon #3a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #3b

EXPERIMENTAL

Females ages 18-26

Behavioral: Health Education Session

Beauty Salon #4a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #4b

EXPERIMENTAL

Females ages 18-26

Behavioral: Health Education Session

Beauty Salon #2a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #5a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #5b

EXPERIMENTAL

Females ages 9-26

Behavioral: Health Education Session

Beauty Salon #6a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #6b

EXPERIMENTAL

Females ages 18-26

Behavioral: Health Education Session

Beauty Salon #7a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #7b

EXPERIMENTAL

Females ages 18-26

Behavioral: Health Education Session

Beauty Salon #8a

EXPERIMENTAL

Mothers of 9-18 year old females

Behavioral: Health Education Session

Beauty Salon #8b

EXPERIMENTAL

Females ages 9-18

Behavioral: Health Education Session

Interventions

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.

Beauty Salon #1aBeauty Salon #1bBeauty Salon #2aBeauty Salon #2bBeauty Salon #3aBeauty Salon #3bBeauty Salon #4aBeauty Salon #4bBeauty Salon #5aBeauty Salon #5bBeauty Salon #6aBeauty Salon #6bBeauty Salon #7aBeauty Salon #7bBeauty Salon #8aBeauty Salon #8b

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pre-selected beauty salons

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ivan Juzang, MBA

    MEE Productions, Inc.

    PRINCIPAL INVESTIGATOR
  • Amy Leader, DrPH, MPH

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 28, 2011

Study Start

May 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations