HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women

Cervical Cancer Screening Clinical Trial

Official title:

HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012932
• Other study ID #: 20161052
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: March 24, 2018

Study information

• Verified date: September 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study will examine the implementation of a Human Papilloma Virus (HPV) self-sampling intervention for under screened LBQ women living in South Florida. The study will enroll participants to receive the self-sampling intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 24, 2018
• Est. primary completion date: March 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Self-identify as lesbian, bisexual, or queer woman

• Assigned female sex at birth

• English speaking

• ages 25-65 years

• report not having had a pap smear in the last three years (per USPSTF guidelines)

• if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years (per USPSTF guidelines)

Exclusion Criteria:

• report having had a hysterectomy

• report having history of cervical cancer

• unable to consent

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• HPV self-sampling
All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV Self-sampling uptake	Percentage of eligible women who complete HPV self-sampling	through study completion, up to 1 year