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Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status and phase

Enrolling
Phase 4

Conditions

Gender Dysphoria, Adolescent

Treatments

Drug: Depo-subQ Provera Injectable Product

Study type

Interventional

Funder types

Other

Identifiers

NCT05726903
22-1037

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

15 to 21 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Depo SC Home
Experimental group
Description:
Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.
Treatment:
Drug: Depo-subQ Provera Injectable Product

Trial contacts and locations

1

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Central trial contact

Eva M Dindinger, MPH; Nancy Z Fang, MD

Data sourced from clinicaltrials.gov

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