Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-17 @ 7:37 PM
Study NCT ID:
NCT02401867
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2015-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sari.reisner@childrens.harvard.edu', 'phone': '617-927-6017', 'title': 'Sari Reisner, ScD', 'organization': 'Fenway Community Health'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Full Sample', 'description': 'Descriptive characteristics for the full sample (n=150).', 'otherNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Positive Cervical HPV DNA Test Result', 'description': 'Positive result determined by reference test: provider cervical HPV DNA Hybridization assay'}, {'id': 'OG001', 'title': 'Participants With a Negative Cervical HPV DNA Test Result', 'description': 'Negative result determined by reference test: provider cervical HPV DNA Hybridization assay'}], 'classes': [{'title': 'Positive vaginal self-swab HPV DNA test', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Negative vaginal self-swab HPV DNA test', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.29', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistical significance was determined at an a priori threshold of p \\<0.05', 'groupDescription': "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 \\]", 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Degrees of freedom = 1', 'nonInferiorityComment': "We selected our initial sample size of 150 participants to detect a clinically meaningful % discordance between the two sampling approaches and achieve 90% power at the 0.05 alpha-level using McNemar's test adjusted for analysis of clustered matched-pair data."}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Kappa', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.75', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.92', 'pValueComment': 'A priori threshold: p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'estimateComment': 'Using the asymptotic standard error assuming the null hypothesis.', 'groupDescription': '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.', 'statisticalMethod': 'Kappa', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.43', 'ciLowerLimit': '47.82', 'ciUpperLimit': '88.72', 'estimateComment': 'Used exact confidence intervals.', 'groupDescription': 'Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.18', 'ciLowerLimit': '93.59', 'ciUpperLimit': '99.78', 'estimateComment': 'Used exact confidence intervals.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Assessed specificity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).'}, {'groupIds': ['OG000'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '88.24', 'ciLowerLimit': '63.56', 'ciUpperLimit': '98.54', 'estimateComment': 'Used exact confidence intervals.', 'groupDescription': 'Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Negative predictive value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '94.74', 'ciLowerLimit': '88.90', 'ciUpperLimit': '98.04', 'estimateComment': 'Used exact confidence intervals', 'groupDescription': 'Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': "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.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Sample', 'description': 'Overall sample reported as all participants received both the self and the provider swab.'}], 'periods': [{'title': 'Enrolled', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Specimen Collection', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed both vaginal self-swab and provider-collected cervical swab', 'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': "Didn't receive 1 or more tests", 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}, {'title': 'Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Comparative analysis of vaginal HPV DNA results and cervical HPV DNA results', 'groupId': 'FG000', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Cervical assay could not be conducted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Full Sample', 'description': 'Descriptive characteristics for the full sample (n=150).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.49', 'spread': '5.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Trans Masculine/ Male to Female', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Yes, Hispanic/Latino', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic/Latino', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosed with Chlamydia - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosed with Gonorrhea - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosed with Syphilis - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosed with Trichomoniasis - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosed with Hepatitis C - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosed with Genital Herpes - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosed with Genital Warts - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosed with HPV - Lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}]}]}, {'title': "Don't Know", 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Prefer Not to Answer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV Status - Lifetime', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}, {'title': "Don't Know", 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Prefer Not to Answer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Provider-Collected Cervical Cytology (Current)', 'classes': [{'title': 'Abnormal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Normal', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': 'Assay could not be tested', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Assay not collected', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Provider-Collected Cervical HPV DNA (Current)', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': 'Assay could not be tested', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Assay not collected', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Self-Collected Vaginal HPV DNA (Current)', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}, {'title': 'Assay not collected', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '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.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2015-01-30', 'resultsFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-11', 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults', 'timeFrame': '1 day', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transgender', 'female-to-male', 'cervical cancer', 'HPV', 'sexual health'], 'conditions': ['Uterine Cervical Neoplasms', 'Sexually Transmitted Diseases']}, 'referencesModule': {'references': [{'pmid': '34146966', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32396475', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30626372', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29654599', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '28645254', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEligible 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-64\n* 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\n* Have a cervix\n* Sexually active in the past 36 months (with sexual partner(s) of any gender)\n* Able to speak and understand English\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to provide informed consent due to severe mental or physical illness\n* Substance intoxication at the time of interview'}, 'identificationModule': {'nctId': 'NCT02401867', 'briefTitle': 'Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fenway Community Health'}, 'officialTitle': 'Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients', 'orgStudyIdInfo': {'id': 'CER-1403-12625'}}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fenway Community Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sari Reisner, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fenway Community Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fenway Community Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Sari Reisner, ScD', 'investigatorAffiliation': 'Fenway Community Health'}}}}