NCT03222817

Brief Summary

The proposed study will examine the implementation of a Human Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. The study will enroll participants to receive this cervical cancer screening 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 May 2018

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

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

May 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

July 17, 2017

Last Update Submit

May 1, 2019

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • Acceptability of HPV self-sampling Questionnaire

    This questionnaire, designed with substantial input from community partners, will gauge how acceptable the participants find HPV self-sampling through both closed and open-ended questions regarding ease of use, preference of self-sampler vs. physician-collected Pap smear, as well as open-ended inquiries regarding the self-sampling process.

    This questionnaire will be administered immediately after participants self-sample

Study Arms (1)

HPV Self-sampling

EXPERIMENTAL

All participants will receive HPV self-sampling. HPV self-sampling allows an individual to screen themselves for cervical cancer in private, using a device that is similar to a tampon.

Behavioral: HPV self-sampling

Interventions

HPV self-samplingBEHAVIORAL

Participants will be provided with education regarding cervical cancer screening, as well as instructions regarding how to use the HPV self-sampler. Participants will also receive referrals to trans-competent healthcare providers for follow-up screening and care.

HPV Self-sampling

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be assigned female sex at birth and identify as transgender male or transmasculine.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as transgender male or as transmasculine
  • Assigned female sex at birth
  • English speaking
  • ages 25-65 years
  • report not having had a pap smear in the last three years
  • if age 30 and over, report not having a Pap smear/HPV co-test in the past 5 years

You may not qualify if:

  • Those who report having had a hysterectomy
  • Those who report having history of cervical cancer
  • Adults unable to consent
  • Those who are pregnant
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

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

July 17, 2017

First Posted

July 19, 2017

Study Start

May 12, 2018

Primary Completion

October 17, 2018

Study Completion

October 17, 2018

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)