Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 5:39 AM
Study NCT ID:
NCT05726903
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-15', 'mcpReleaseN': 2, 'releaseDate': '2025-05-05'}, {'resetDate': '2025-06-16', 'mcpReleaseN': 3, 'releaseDate': '2025-05-30'}], 'estimatedResultsFirstSubmitDate': '2025-05-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000068116', 'term': 'Gender Dysphoria'}], 'ancestors': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020884', 'term': 'DEPO'}, {'id': 'C050795', 'term': 'N,N-dimethyl-4-anisidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction with Self-administered DMPA at initiation', 'timeFrame': 'within 6 months of first DMPA administration', 'description': 'Patient satisfaction with DMPA as assessed by thematic analysis of audio-recorded focus groups of each individual participant using NVivo. Satisfaction will be measured through thematic analysis as the transcripts for the focus groups are coded, identifying phrases and words relating to satisfaction or dissatisfaction with their injection experience. Focus groups will be led by a member of the trans-masculine young adult community who will be trained on focus group procedures. Guides will be developed from a collaboration between experts in gender-affirming care.'}, {'measure': 'Satisfaction with Self-administered DMPA after two injections', 'timeFrame': 'between 6 and 12 months of first DMPA administration', 'description': 'Patient satisfaction with DMPA as assessed by thematic analysis of audio-recorded interviews of each individual participant using NVivo. Satisfaction will be measured through thematic analysis as the transcripts for the interviews are coded, identifying phrases and words relating to satisfaction or dissatisfaction with their injection experience. Interviews will be led by a member of the trans-masculine young adult community who will be trained on interview procedures. Guides will be developed from a collaboration between experts in gender-affirming care.'}, {'measure': 'Satisfaction with DMPA Administered in an Office Setting', 'timeFrame': 'within 2 months of first DMPA administration', 'description': 'Patient satisfaction with DMPA as assessed by thematic analysis of audio-recorded focus groups of each individual participant using NVivo. Satisfaction will be measured through thematic analysis as the transcripts for the focus groups are coded, identifying phrases and words relating to satisfaction or dissatisfaction with their injection experience. Focus groups will be led by a member of the trans-masculine young adult community who will be trained on focus group procedures. Guides will be developed from a collaboration between experts in gender-affirming care.\n\nPatients who elect for DMPA administration in an office setting will not undergo individual interviews.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gender Dysphoria, Adolescent']}, 'descriptionModule': {'briefSummary': "Recommendations regarding contraceptive counseling and reproductive health differ amongst transgender and gender diverse (TGD) youth compared to cis-gender youth. Limited existing literature demonstrates the need for contraceptive counseling that moves beyond cis- and heteronormative assumptions that start with pregnancy prevention and address concerns at the intersection of gender identity.\n\nThe Investigator's qualitative study will focus on creating best practices regarding equitable contraceptive counseling for TGD youth. The Investigator will recruit transgender youth who are assigned female at birth, and currently or interested in using depo medroxyprogesterone (DMPA). Through focus groups and semi-structured interviews, the investigator hopes to guide providers in creating best practices and more equitable contraceptive counseling for TGD youth and measure satisfaction of DMPA in TGD youth.", 'detailedDescription': "Recommendations regarding contraceptive counseling and reproductive health differ amongst transgender and gender diverse (TGD) youth compared to cis-gender youth. TGD youth face unique health disparities including increased risk of sexually transmitted infections, sexual abuse and violence, and unwanted pregnancies. TGD youth also face inequities within the healthcare system including lack of access to providers and delay or avoidance of care. Both patients and providers also have misconceptions around pregnancy risk in transgender individuals assigned female at birth (AFAB) who are sexually active with people assigned male at birth. Limited existing literature demonstrates the need for contraceptive counseling that moves beyond cis- and heteronormative assumptions that start with pregnancy prevention and address concerns at the intersection of gender identity.\n\nThe Investigator's qualitative study will focus on creating best practices regarding equitable contraceptive counseling for TGD youth. The Investigator will recruit transgender youth who are AFAB, and currently or interested in using depo medroxyprogesterone (DMPA). Through focus groups and semi-structured interviews, the investigator hopes to gain the perspectives of and experiences of TGD youth with self-and clinic- administered DMPA. The investigator hopes the results of this study can guide providers in creating best practices and more equitable contraceptive counseling and measure to satisfaction of DMPA for TGD youth."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Assigned female at birth. Gender identity, transgender or gender diverse. Our qualitative study will focus on creating best practices regarding equitable contraceptive counseling for transgender and gender diverse youth.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 15-21,\n* currently receiving care at one of the clinic sites, assigned female at birth, identify as transgender or gender diverse , and are currently using or are interested in using DMPA.\n\nExclusion Criteria:\n\n* Any contraindications to DMPA (based on any category 3 or 4 recommendations from the CDC MEC guidelines)'}, 'identificationModule': {'nctId': 'NCT05726903', 'briefTitle': 'Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone', 'orgStudyIdInfo': {'id': '22-1037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Depo SC Home', 'description': 'Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.', 'interventionNames': ['Drug: Depo-subQ Provera Injectable Product']}], 'interventions': [{'name': 'Depo-subQ Provera Injectable Product', 'type': 'DRUG', 'otherNames': ['Depo, DMPA'], 'description': 'SC Injection at Home', 'armGroupLabels': ['Depo SC Home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Fang, MD', 'role': 'CONTACT', 'email': 'nancy.fang@cuanschtuz.edu', 'phone': '303-724-8576'}, {'name': 'Eva Dindinger, MPH', 'role': 'CONTACT', 'email': 'eva.dinidnger@cuanschutz.edu', 'phone': '303-501-4157'}], 'facility': "Comprehensive Women's Health Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Nancy Z Fang, MD', 'role': 'CONTACT', 'email': 'NANCY.FANG@CUANSCHUTZ.EDU', 'phone': '3037248482'}, {'name': 'Eva M Dindinger, MPH', 'role': 'CONTACT', 'email': 'Eva.Dindinger@CUAnschutz.edu', 'phone': '303-724-8482'}], 'overallOfficials': [{'name': 'Eva M Dindinger, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}