Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

NCT ID: NCT05726903

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2027-06-01

Brief Summary

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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

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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.

Conditions

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Gender Dysphoria, Adolescent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Depo SC Home

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

Group Type EXPERIMENTAL

Depo-subQ Provera Injectable Product

Intervention Type DRUG

SC Injection at Home

Interventions

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Depo-subQ Provera Injectable Product

SC Injection at Home

Intervention Type DRUG

Other Intervention Names

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Depo, DMPA

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva M Dindinger, MPH

Role: STUDY_CHAIR

University of Colorado, Denver

Locations

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Comprehensive Women's Health Center

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nancy Z Fang, MD

Role: CONTACT

3037248482

Eva M Dindinger, MPH

Role: CONTACT

303-724-8482

Facility Contacts

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Nancy Fang, MD

Role: primary

303-724-8576

Eva Dindinger, MPH

Role: backup

303-501-4157

Other Identifiers

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22-1037

Identifier Type: -

Identifier Source: org_study_id

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