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

Human Papilloma Virus Clinical Trial

Official title:

Promoting HPV Vaccination Through African American Beauty Salons: a Pilot Test of a Culturally-Competent Education and Empowerment Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461408
• Other study ID #: Merck-IISP-39187
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: October 9, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: MEE Productions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papilloma Virus

Intervention

Behavioral:
• Health Education Session
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.

Locations

Country	Name	City	State
United States	Pre-selected beauty salons	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
MEE Productions, Inc.	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	18 months	No