Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05726903
Collaborator
(none)
40
1
1
17.8
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Depo-subQ Provera Injectable Product
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone
Actual Study Start Date :
Dec 6, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Satisfaction with Self-administered DMPA at initiation [within 6 months of first DMPA administration]

      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.

    2. Satisfaction with Self-administered DMPA after two injections [between 6 and 12 months of first DMPA administration]

      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.

    3. Satisfaction with DMPA Administered in an Office Setting [within 2 months of first DMPA administration]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 21 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Women's Health Center Denver Colorado United States 80230

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05726903
    Other Study ID Numbers:
    • 22-1037
    First Posted:
    Feb 14, 2023
    Last Update Posted:
    Feb 14, 2023
    Last Verified:
    Feb 1, 2023
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2023