Sexually Transmitted Diseases, Uterine Cervical Neoplasms
Conditions
Keywords
transgender, female-to-male, cervical cancer, HPV, sexual health
Brief summary
The purpose of this study is to assess the acceptability and effectiveness of utilizing vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections (STIs) among sexually active female-to-male (FTM) transgender adults.
Detailed description
This observational study will examine sexual health in a bio-behavioral cross-sectional mixed-methods design among 150 FTM patients in Boston, Massachusetts, and will determine the acceptability as well as collect epidemiologic data on the comparative performance characteristics of several biological screening modalities in this patient population. Patients and stakeholders are key partners throughout the project and are involved in all phases of study development, implementation, and plans for dissemination. Eligible participants will participate in a one-time clinical visit. Following written consent, the one-time clinical visit will include: 1) Quantitative assessment; 2) Collection of biological specimens/biomarkers (HPV DNA vaginal self-swab, HPV DNA cervical swab collected by provider, Pap test with cytology, STI testing self- and provider-collected); 3) Qualitative Interview. A series of national, online focus groups with FTMs, providers, and key stakeholders will occur to gather information on the sexual health needs of FTM individuals outside the Boston area and to ensure that the dissemination of study findings take differing demographic concerns into consideration.
Interventions
None listed
Sponsors
Patient-Centered Outcomes Research Institute
Fenway Community Health
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-64 * Assigned a female sex at birth and now self-identifies as a man, trans masculine, trans man, FTM, transgender, genderqueer/non-binary, transsexual, male, and/or another diverse transgender identity or expression * Have a cervix * Sexually active in the past 36 months (with sexual partner(s) of any gender) * Able to speak and understand English * Willing and able to provide informed consent
Exclusion criteria
* Unable to provide informed consent due to severe mental or physical illness * Substance intoxication at the time of interview
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults | 1 day | Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Sample Descriptive characteristics for the full sample (n=150). | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Analysis | Cervical assay could not be conducted | 9 |
| Specimen Collection | Didn't receive 1 or more tests | 10 |
Baseline characteristics
| Characteristic | Full Sample |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants |
| Age, Continuous | 27.49 years STANDARD_DEVIATION 5.74 |
| Diagnosed with Chlamydia - Lifetime No | 142 Participants |
| Diagnosed with Chlamydia - Lifetime Yes | 8 Participants |
| Diagnosed with Genital Herpes - Lifetime No | 145 Participants |
| Diagnosed with Genital Herpes - Lifetime Yes | 5 Participants |
| Diagnosed with Genital Warts - Lifetime No | 146 Participants |
| Diagnosed with Genital Warts - Lifetime Yes | 4 Participants |
| Diagnosed with Gonorrhea - Lifetime No | 145 Participants |
| Diagnosed with Gonorrhea - Lifetime Yes | 5 Participants |
| Diagnosed with Hepatitis C - Lifetime No | 149 Participants |
| Diagnosed with Hepatitis C - Lifetime Yes | 1 Participants |
| Diagnosed with HPV - Lifetime Don't Know | 3 Participants |
| Diagnosed with HPV - Lifetime No | 135 Participants |
| Diagnosed with HPV - Lifetime Prefer Not to Answer | 1 Participants |
| Diagnosed with HPV - Lifetime Yes | 11 Participants |
| Diagnosed with Syphilis - Lifetime No | 149 Participants |
| Diagnosed with Syphilis - Lifetime Yes | 1 Participants |
| Diagnosed with Trichomoniasis - Lifetime No | 144 Participants |
| Diagnosed with Trichomoniasis - Lifetime Yes | 6 Participants |
| HIV Status - Lifetime Don't Know | 28 Participants |
| HIV Status - Lifetime Negative | 120 Participants |
| HIV Status - Lifetime Positive | 1 Participants |
| HIV Status - Lifetime Prefer Not to Answer | 1 Participants |
| Provider-Collected Cervical Cytology (Current) Abnormal | 9 Participants |
| Provider-Collected Cervical Cytology (Current) Assay could not be tested | 27 Participants |
| Provider-Collected Cervical Cytology (Current) Assay not collected | 3 Participants |
| Provider-Collected Cervical Cytology (Current) Normal | 111 Participants |
| Provider-Collected Cervical HPV DNA (Current) Assay could not be tested | 9 Participants |
| Provider-Collected Cervical HPV DNA (Current) Assay not collected | 9 Participants |
| Provider-Collected Cervical HPV DNA (Current) Negative | 111 Participants |
| Provider-Collected Cervical HPV DNA (Current) Positive | 21 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 133 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants |
| Race/Ethnicity, Customized Yes, Hispanic/Latino | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 112 Participants |
| Region of Enrollment United States | 150 participants |
| Self-Collected Vaginal HPV DNA (Current) Assay not collected | 3 Participants |
| Self-Collected Vaginal HPV DNA (Current) Negative | 126 Participants |
| Self-Collected Vaginal HPV DNA (Current) Positive | 21 Participants |
| Sex/Gender, Customized Trans Masculine/ Male to Female | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
Primary
Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults
Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data.
Time frame: 1 day
Population: Analytic sample =131: 10 participants did not receive both the vaginal self-swab HPV DNA test and the provider cervical test (reference); 7 received the self, but not the provider; 1 received the provider, but not the self; 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Positive Cervical HPV DNA Test Result | Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults | Positive vaginal self-swab HPV DNA test | 15 Participants |
| Participants With Positive Cervical HPV DNA Test Result | Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults | Negative vaginal self-swab HPV DNA test | 6 Participants |
| Participants With a Negative Cervical HPV DNA Test Result | Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults | Positive vaginal self-swab HPV DNA test | 2 Participants |
| Participants With a Negative Cervical HPV DNA Test Result | Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults | Negative vaginal self-swab HPV DNA test | 108 Participants |
Comparison: Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal \[ H0 : p1 = p2 \]p-value: 0.29McNemar
Comparison: Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.p-value: <0.00195% CI: [0.58, 0.92]Kappa
Comparison: Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).95% CI: [47.82, 88.72]
95% CI: [93.59, 99.78]
Comparison: Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).95% CI: [63.56, 98.54]
Comparison: Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).95% CI: [88.9, 98.04]