Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
This study aims to enroll 150 female-to-male (FTM) individuals, ages 21-64. Participants will be recruited from the existing FTM patient population at Fenway Health, as well as via community outreach in the greater Boston area. A diverse sample is anticipated; the aim is to recruit 40% racial/ethnic minority FTMs.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sari Reisner, ScD | Fenway Community Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Community Health | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34146966 | Derived | Suarez NA, Peitzmeier SM, Potter J, Samandur A, Reisner SL. Preliminary findings for adverse childhood experiences and associations with negative physical and mental health and victimization in transmasculine adults. Child Abuse Negl. 2021 Aug;118:105161. doi: 10.1016/j.chiabu.2021.105161. Epub 2021 Jun 16. | |
| 32396475 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Sample | Overall sample reported as all participants received both the self and the provider swab. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled |
| |||||||||||||
| Specimen Collection |
| |||||||||||||
| Analysis |
|
Enrolled =150, analytic sample =131: 10 participants did not receive the vaginal HPV DNA self-swab and provider cervical swab; 7 received the self-swab, but not the provider; 1 received the provider-swab, but not the self; and 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Full Sample | Descriptive characteristics for the full sample (n=150). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | No | 1 day |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Full Sample | Descriptive characteristics for the full sample (n=150). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sari Reisner, ScD | Fenway Community Health | 617-927-6017 | sari.reisner@childrens.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
| Pletta DR, White Hughto JM, Peitzmeier S, Deutsch MB, Pardee D, Potter J, Reisner SL. Individual- and Partnership-Level Correlates of Protective Barrier Use in a Sample of Transmasculine Adults with Diverse Sexual Partnerships. AIDS Patient Care STDS. 2020 May;34(5):237-246. doi: 10.1089/apc.2019.0296. |
| 30626372 | Derived | McDowell MJ, Hughto JMW, Reisner SL. Risk and protective factors for mental health morbidity in a community sample of female-to-male trans-masculine adults. BMC Psychiatry. 2019 Jan 9;19(1):16. doi: 10.1186/s12888-018-2008-0. |
| 29654599 | Derived | Agenor M, White Hughto JM, Peitzmeier SM, Potter J, Deutsch MB, Pardee DJ, Reisner SL. Gender identity disparities in Pap test use in a sample of binary and non-binary transmasculine adults. J Gen Intern Med. 2018 Jul;33(7):1015-1017. doi: 10.1007/s11606-018-4400-3. No abstract available. |
| 28645254 | Derived | Reisner SL, Deutsch MB, Peitzmeier SM, White Hughto JM, Cavanaugh T, Pardee DJ, McLean S, Marrow EJ, Mimiaga MJ, Panther L, Gelman M, Green J, Potter J. Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol. BMC Infect Dis. 2017 Jun 23;17(1):444. doi: 10.1186/s12879-017-2539-x. |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosed with Chlamydia - Lifetime | Count of Participants | Participants |
|
| Diagnosed with Gonorrhea - Lifetime | Count of Participants | Participants |
|
| Diagnosed with Syphilis - Lifetime | Count of Participants | Participants |
|
| Diagnosed with Trichomoniasis - Lifetime | Count of Participants | Participants |
|
| Diagnosed with Hepatitis C - Lifetime | Count of Participants | Participants |
|
| Diagnosed with Genital Herpes - Lifetime | Count of Participants | Participants |
|
| Diagnosed with Genital Warts - Lifetime | Count of Participants | Participants |
|
| Diagnosed with HPV - Lifetime | Count of Participants | Participants |
|
| HIV Status - Lifetime | Count of Participants | Participants |
|
| Provider-Collected Cervical Cytology (Current) | Count of Participants | Participants |
|
| Provider-Collected Cervical HPV DNA (Current) | Count of Participants | Participants |
|
| Self-Collected Vaginal HPV DNA (Current) | Count of Participants | Participants |
|
Positive result determined by reference test: provider cervical HPV DNA Hybridization assay |
| OG001 | Participants With a Negative Cervical HPV DNA Test Result | Negative result determined by reference test: provider cervical HPV DNA Hybridization assay |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
Not provided
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |