Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria, Adolescent
• Intervention / Treatment: Drug: Depo-subQ Provera Injectable Product

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nancy Z Fang, MD; Phone Number: 3037248482; Email: NANCY.FANG@CUANSCHUTZ.EDU
• Study Contact Backup: Name: Eva M Dindinger, MPH; Phone Number: 303-724-8482; Email: Eva.Dindinger@CUAnschutz.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80230
      • Recruiting
      • Comprehensive Women's Health Center
      • Contact: Nancy Fang, MD; Phone Number: 303-724-8576; Email: nancy.fang@cuanschtuz.edu
      • Contact: Eva Dindinger, MPH; Phone Number: 303-501-4157; Email: eva.dinidnger@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Depo SC Home; Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.	Drug: Depo-subQ Provera Injectable Product; SC Injection at Home; Other Names: Depo, DMPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 6 months of first DMPA administration
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.	between 6 and 12 months of first DMPA administration
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.	within 2 months of first DMPA administration

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Study Chair: Eva M Dindinger, MPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: 22-1037

Drug and device information, study documents

• 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