Clinical trial NCT05726903: Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone
Official title: Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gender Dysphoria, Adolescent
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Satisfaction with Self-administered DMPA at initiation
timeFrame: within 6 months of first DMPA administration
measure: Satisfaction with Self-administered DMPA after two injections
timeFrame: between 6 and 12 months of first DMPA administration
measure: Satisfaction with DMPA Administered in an Office Setting
timeFrame: within 2 months of first DMPA administration
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Comprehensive Women's Health Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Eva M Dindinger, MPH
role: STUDY_CHAIR
References: