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Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05726903
Enrollment
35
Registered
2023-02-14
Start date
2022-12-06
Completion date
2023-11-17
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Dysphoria, Adolescent

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.

Interventions

DRUGDepo-subQ Provera Injectable Product

SC Injection at Home

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 21 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Satisfied With Self-Administered DMPA at Initiationwithin 6 months of first DMPA administrationPatient satisfaction with DMPA as assessed by thematic analysis of audio-recorded focus groups of each individual participant. 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.
Number of Participants Satisfied With DMPA in an Office Settingwithin 2 months of first DMPA administrationPatient satisfaction with DMPA as assessed by thematic analysis of audio-recorded focus groups of each individual participant. 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.

Countries

United States

Contacts

STUDY_CHAIREva M Dindinger, MPH

University of Colorado, Denver

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
17 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
Age, Continuous17.5 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
29 Participants
Region of Enrollment
United States
35 participants
Sex: Female, Male
Female
35 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 35
other
Total, other adverse events
0 / 35
serious
Total, serious adverse events
0 / 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026