NCT03012932

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

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

January 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

January 3, 2017

Last Update Submit

September 24, 2018

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • HPV Self-sampling uptake

    Percentage of eligible women who complete HPV self-sampling

    through study completion, up to 1 year

Study Arms (1)

HPV Self-sampling

OTHER

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.

Behavioral: HPV self-sampling

Interventions

HPV self-samplingBEHAVIORAL

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.

HPV Self-sampling

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • report having had a hysterectomy
  • report having history of cervical cancer
  • unable to consent
  • Pregnant women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

Study Officials

  • Julia Seay, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 6, 2017

Study Start

February 2, 2017

Primary Completion

March 24, 2018

Study Completion

March 24, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)