Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
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|ClinicalTrials.gov Identifier: NCT02401867|
Recruitment Status : Completed
First Posted : March 30, 2015
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
|Condition or disease|
|Uterine Cervical Neoplasms Sexually Transmitted Diseases|
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.
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
- Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401867
|United States, Massachusetts|
|Fenway Community Health|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sari Reisner, ScD||Fenway Community Health|