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  • Research & Results
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  • Comparing Clinician-Collected and Sel...

This project has results

Comparing Clinician-Collected and Self-Collected Tests for Detecting High-Risk HPV Infection among Female-to-Male Transgender Adults

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Results Summary and Professional Abstract

Results Summary
Download Summary Español (pdf) Audio Recording (mp3)

Results Summary

What was the research about?

Human papillomavirus, or HPV, is the most common sexually transmitted infection in the United States. Thirteen types of HPV cause almost all cancers of the cervix, or the lower part of the uterus. Testing for high-risk HPV infection can help detect cervical cancer early.

Anyone who has a cervix can get cervical cancer, including transmasculine adults, or transgender people assigned a female sex at birth but who identify as male.

The study looked at two ways to test for high-risk HPV infection in transmasculine adults:

  • The clinician-collected test is like a Pap test. A doctor, nurse practitioner, or other clinician takes a swab of the cervix to collect cells, and a laboratory tests the cells.
  • The self-collected test is a way for people to do the test themselves. They insert a swab a short distance into the vagina to collect cells. Because they don’t need to go to the doctor, more people may be willing to test for high-risk HPV infection this way.

In people who had both tests, the research team compared the accuracy of the self-collected test with the clinician-collected test. The team also asked people their views on the tests.

What were the results?

Accuracy. For 71 percent of people with high-risk HPV, the self-collected test found the same results as the clinician-collected test.

  • The self-collected test worked well to confirm that there was no infection. When the clinician-collected test reported no infection, the self-collected test usually showed the same result.
  • The self-collected test was less accurate for detecting an infection. It detected high-risk HPV in only 15 of 21 people who had an infection, according to the clinician-collected test.

Views of the tests. More than 90 percent of people preferred the self-collected test to the clinician-collected test. They said the self-collected test was easy, private, and gave them a sense of being in control of their health care. However, some weren’t sure if they did the test correctly. Also, some felt physical and emotional discomfort during the self-collected test.

Who was in the study?

The study included 131 transmasculine adults with a cervix who were sexually active in the past three years. All people in the study lived in or near Boston, Massachusetts. Their ages ranged from 21 to 50. The average age was 27, and 74 percent were taking male hormones. Among participants in the study, 76 percent were white, 10 percent were Hispanic, 5 percent were Asian, and 3 percent were African American.

What did the research team do?

The research team obtained two swabs from each person during a clinic visit. One was from the self-collected test. The other was from the clinician-collected test. The team tested the swabs for high-risk HPV and compared the results of both tests.

What were the limits of the study?

Most adults in the study were young and white. The results may be different for people who are older or of other races. People in the study agreed to have cervical exams done by clinicians. They may differ from transmasculine adults who avoid these exams. The study took place at one clinic, which specializes in caring for lesbian, gay, bisexual, and transgender people. The results may not apply to people who live in other areas or receive health care at other places.

Future research could include transmasculine adults who are older, of different races, or live in different regions.

How can people use the results?

Clinicians who provide care for transmasculine adults may consider offering the self-collected test to check for high-risk HPV infection. This test may be a good alternative for those who prefer it, although it doesn’t detect high-risk HPV infection as well as the clinician-collected test.

Professional Abstract

Professional Abstract

Objective

To compare the performance and acceptability of self-collected vaginal wall swabs with provider-collected cervical swabs for detecting high-risk human papillomavirus (hr-HPV) infection among female-to-male transmasculine adults

Study Design

Design Element Description
Design Observational: cross-sectional study
Population 131 transmasculine adults ages 21–50 years with a cervix
Interventions/
Comparators
  • Self-collected vaginal wall hr-HPV DNA swabs
  • Provider-collected cervical hr-HPV DNA swabs
Outcomes

Primary: concordance and performance of self-collected vaginal wall hr-HPV DNA swabs

Secondary: participants’ acceptability of self-collected hr-HPV DNA swabs

Timeframe Not applicable

This cross-sectional observational study compared two collection methods for detecting hr-HPV infection among transmasculine adults: self-collected vaginal wall hr-HPV DNA swabs and provider-collected cervical hr-HPV DNA swabs, which are the gold standard.

The study included 131 adults who identified as a gender different from their female sex assigned at birth, had a cervix, and were sexually active in the past three years. Researchers recruited participants from the general population and clinical care sites around Boston, Massachusetts. Their mean age was 27 years (range 21–50 years), and 74% were taking masculinizing hormones. Of the study participants, 76% were white, 10% were Hispanic, 5% were Asian, and 3% were African American.

Researchers collected both swabs during a single visit to a community health clinic that provides care to the lesbian, gay, bisexual, and transgender community. To minimize ordering effects, researchers randomized participants to undergo the self-collected or provider-collected method first. At the end of the visit, researchers interviewed participants about the two collection methods.

To determine the presence of 13 types of hr-HPV in the swab samples, researchers used DNA hybridization assays. They determined the performance characteristics, including sensitivity and specificity, of the self-collected method using the provider-collected method as a reference.

People who were transmasculine, healthcare providers, and leaders from organizations providing support to the transgender community worked with researchers to develop and conduct the study.

Results

Concordance and performance. Among the 131 transmasculine adults, provider-collected tests detected 21 cases of hr-HPV, a 16% hr-HPV prevalence rate. Of these 21 cases, the self-collected tests accurately detected 15, representing 71% concordance between the two methods (p<0.01). The self-collected method had a sensitivity of 71% (p=0.0495) and specificity of 98% (p<0.0001).

Acceptability. More than 90% of participants preferred the self-collected to the provider-collected test. Participants reported positive aspects of self-collection, including ease of use, privacy, and a sense of self-empowerment. They noted several concerns, including uncertainty about performing the procedure correctly, genital dysphoria or psychological distress during self-collection, and difficulty angling the swab.

Limitations

Most participants in this study were white and relatively young; results may not generalize to transmasculine adults who are older or of other races. The study took place at a single center serving the lesbian, gay, bisexual, and transgender community. Results may be different in other geographic regions or healthcare settings. Participants were willing to undergo cervical swab testing by healthcare providers, and, as a result, they may not be representative of the general transmasculine population, many of whom avoid pelvic examinations because of emotional and physical discomfort.

Conclusions and Relevance

The results of this study suggest that self-collected swabs may be a good, patient-centered alternative to provider-collected swabs for testing for hr-HPV for transmasculine adults who prefer to avoid provider-collected testing.

Future Research Needs

Future studies could enroll transmasculine adults from a variety of age groups, races, geographic locations, and healthcare setting to make study findings generalizable to a wider population.

Final Research Report

View this project's final research report.

Journal Articles

Related Articles

Sexual Medicine

Initial Psychometric Evaluation of a Brief Sexual Functioning Screening Tool for Transmasculine Adults: Transmasculine Sexual Functioning Index

Sexually Transmitted Diseases

Recent Penile Sexual Contact is Associated with an Increased Odds of High-Risk Cervical Human Papillomavirus Infection in Transgender Men

Contraception

The contraceptive and reproductive history and planning goals of trans masculine adults: a mixed methods study

Journal of Interpersonal Violence

Development of a Novel Tool to Assess Intimate Partner Violence Against Transgender Individuals

BMC Psychiatry

Risk and protective factors for mental health morbidity in a community sample of female-to-male trans-masculine adults

BMJ Open

Sexual orientation-related disparities in employment, health insurance, healthcare access and health-related quality of life: a cohort study of US male and female adolescents and young adults

Journal of General Internal Medicine

Gender identity disparities in Pap test use in a sample of binary and non-binary transmasculine adults

PLoS One

Test performance and acceptability of self- versus provider-collected swabs for high-risk HPV DNA testing in female-to-male trans masculine patients

BMC Infectious Diseases

Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol

Qualitative Health Research

Sensitive Health Topics With Underserved Patient Populations: Methodological Considerations for Online Focus Group Discussions

LGBT Health

Sexual Orientation Disparities in Human Papillomavirus Vaccination in a Longitudinal Cohort of U.S. Males and Females

Current Opinion in Endocrinology, Diabetes, and Obesity

Advancing methods for US transgender health research

LGBT Health

Substance Use to Cope with Stigma in Healthcare Among U.S. Female-to-Male Trans Masculine Adults

More on this Project  

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

  • Differentiating HPV testing from cytology and describing the gold standard for diagnosing cervical dysplasia in response to reviewers’ recommendations to make the information more accessible to a general audience
  • Adding limitations to the discussion to point out that this study does not address the evidence gap around sexually transmitted diseases for trans-male individuals who have sex with other men

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator
Sari Reisner, ScD
Project Status
Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted
Project Title
Preventive Sexual Health Screening Among Female-to-Male Transgender Adult Patients
Board Approval Date
September 2014
Project End Date
January 2018
Organization
Fenway Community Health Center
Year Awarded
2014
State
Massachusetts
Year Completed
2018
Project Type
Research Project
Health Conditions  
Cancer
Cervical Cancer
Infectious Diseases
HPV and other Sexually Transmitted Infections
Intervention Strategies
Screening Interventions
Training and Education Interventions
Populations
Racial/Ethnic Minorities
LGBTQ
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options
Project Budget
$956,186
DOI - Digital Object Identifier
10.25302/9.2018.CER.140312625
Study Registration Information
HSRP20152202
NCT02401867
Page Last Updated: 
February 20, 2020

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