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Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

Primary Purpose

Gender Dysphoria, Adolescent

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depo-subQ Provera Injectable Product
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gender Dysphoria, Adolescent

Eligibility Criteria

15 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: between the ages of 15-21, 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. Exclusion Criteria: Any contraindications to DMPA (based on any category 3 or 4 recommendations from the CDC MEC guidelines)

Sites / Locations

  • Comprehensive Women's Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Depo SC Home

Arm Description

Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.

Outcomes

Primary Outcome Measures

Satisfaction with Self-administered DMPA at initiation
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.
Satisfaction with Self-administered DMPA after two injections
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.
Satisfaction with DMPA Administered in an Office Setting
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. Patients who elect for DMPA administration in an office setting will not undergo individual interviews.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2023
Last Updated
February 13, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05726903
Brief Title
Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone
Official Title
Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. The 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.
Detailed Description
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. The 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria, Adolescent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depo SC Home
Arm Type
Experimental
Arm Description
Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.
Intervention Type
Drug
Intervention Name(s)
Depo-subQ Provera Injectable Product
Other Intervention Name(s)
Depo, DMPA
Intervention Description
SC Injection at Home
Primary Outcome Measure Information:
Title
Satisfaction with Self-administered DMPA at initiation
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.
Time Frame
within 6 months of first DMPA administration
Title
Satisfaction with Self-administered DMPA after two injections
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.
Time Frame
between 6 and 12 months of first DMPA administration
Title
Satisfaction with DMPA Administered in an Office Setting
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. Patients who elect for DMPA administration in an office setting will not undergo individual interviews.
Time Frame
within 2 months of first DMPA administration

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: between the ages of 15-21, 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. Exclusion Criteria: Any contraindications to DMPA (based on any category 3 or 4 recommendations from the CDC MEC guidelines)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Z Fang, MD
Phone
3037248482
Email
NANCY.FANG@CUANSCHUTZ.EDU
First Name & Middle Initial & Last Name or Official Title & Degree
Eva M Dindinger, MPH
Phone
303-724-8482
Email
Eva.Dindinger@CUAnschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Dindinger, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Women's Health Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Fang, MD
Phone
303-724-8576
Email
nancy.fang@cuanschtuz.edu
First Name & Middle Initial & Last Name & Degree
Eva Dindinger, MPH
Phone
303-501-4157
Email
eva.dinidnger@cuanschutz.edu

12. IPD Sharing Statement

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Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

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