CClinicalTrials.gg
Status unknownNCT04154358Updated Mar 23, 2020

Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men

An interventional study of HPV testing in Transgenderism, Cervical Cancer and Human Papilloma Virus, sponsored by Augusta University. Status unknown. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-23.

Sponsored by Augusta University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
21 Years and older
Sex
Female
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Study summary

Transgender men are individuals born genetically female that have a gender identity that is incongruent with their biological sex. For those who have begun or completed transition, they may present as males but still have a uterus and cervix. Thus far, no distinction has been made between routine cervical cancer screening guidelines in non-transgender women and those for transgender men, despite wide variations in sexual practices, including lifelong vaginal abstinence. The purpose of this study is to offer transgender men seen at clinic visits self-collected HPV testing to evaluate for improved cervical cancer screening rates, as well as a survey to further investigate sexual practices, rates of appropriate screening prior to being offered self-collection, and barriers to obtaining appropriate care.

02

Conditions studied

  • Transgenderism
  • Cervical Cancer
  • Human Papilloma Virus
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age >21 for survey and age> 25 for HPV testing
  • Transgender male or gender non-conforming identity
  • Female sex at birth
  • Consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • impaired decision making capacity
  • Absence of cervix
  • Non-English speaking
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    HPV Testing

    Will perform HPV testing with self-collected specimen

    Diagnostic Test: HPV testing

Interventions

  • Diagnostic testHPV testing

    will perform HPV testing with self-collected specimen

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What researchers measure

Primary outcomes

  1. Rate of cervical cancer screening

    Evaluate whether implementation of HPV DNA self swabs will increase rates of cervical cancer screening among transgender men by percentage of trans men who obtain screening through the study

    Time frame: 1 year

Secondary outcomes

  1. incidence of barriers to care

    Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.

    Time frame: 1 year

  2. incidence of high risk sexual practices

    Evaluate for the presence of high risk behaviors to determine whether transgender men in our population are at higher or lower risk for HPV-related cervical dysplasia. Measured via survey.

    Time frame: 1 year

  3. rate of HPV vaccination

    Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04154358
Lead sponsor
Augusta University
Collaborators
The Equality Clinic of Augusta
Responsible party
Sponsor
First posted
Nov 6, 2019
Start date
May 1, 2020 (estimated)
Primary completion
Jun 30, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Mar 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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