Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
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.
Uterine Cervical Neoplasms
Sexually Transmitted Diseases
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients|
- Concordance between vaginal self-swab and provider-collected cervical swab for HPV DNA among sexually active FTM adults [ Time Frame: 1 day ] [ Designated as safety issue: No ]Quantitatively assess 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. Specimens will be analyzed using a 13 strain qualitative high-risk HPV assay (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68).
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02401867
|Contact: Sari Reisner, ScDfirstname.lastname@example.org|
|Contact: Dana Pardeeemail@example.com|
|United States, Massachusetts|
|Fenway Community Health||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Sari Reisner, ScD 617-927-6017 firstname.lastname@example.org|
|Contact: Dana Pardee 617-927-6371 email@example.com|
|Principal Investigator: Sari Reisner, ScD|
|Principal Investigator:||Sari Reisner, ScD||Fenway Community Health|