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临床试验/NCT05726903
NCT05726903已完成4 期

Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年12月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
35
试验地点
1
主要终点
Number of Participants Satisfied With Self-Administered DMPA at Initiation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Any contraindications to DMPA (based on any category 3 or 4 recommendations from the CDC MEC guidelines)

研究组 & 干预措施

Depo SC Home

Experimental

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

干预措施: Depo-subQ Provera Injectable Product (Drug)

结局指标

主要结局

Number of Participants Satisfied With Self-Administered DMPA at Initiation

时间窗: 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. 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 Setting

时间窗: 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. 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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