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临床试验/NCT04305977
NCT04305977撤回不适用

Writing to Alleviate Violence Exposure for Transgender Women

University of Miami2 个研究点 分布在 1 个国家开始时间: 2020年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Percentage of participant satisfaction

研究概览

简要总结

WAVE - TW (Writing to Alleviate Violence Exposure for Transgender women living with HIV) is an intervention development study which aims to assess the feasibility and acceptability of a proposed trauma writing and adherence intervention that addresses Post-Traumatic Stress Disorder (PTSD) and depressive symptoms, antiretroviral therapy (ART) adherence and viral suppression among transgender women.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Living with HIV
  • Age 18 or older
  • Detectable viral load within the past year
  • Transgender female
  • English speaking
  • Capable of completing and fully understanding the informed consent process and the study procedures
  • History of trauma/abuse

排除标准

  • Unable to completely and fully understand the consent process and the study procedures.
  • Significant interfering mental health symptoms (e.g., untreated active psychosis, active suicidality with a plan).
  • Engaged in an intervention to address trauma symptoms and adherence within the past year

结局指标

主要结局

Percentage of participant satisfaction

时间窗: Up to 11 months

Perceptions about the participants' satisfaction with the proposed trauma writing and integrated adherence training intervention. The percentage of participants who report being either satisfied or very satisfied as captured by the Client Satisfaction Survey.

Number of Completed visits

时间窗: Up to 11 months

Mean number of visits attended by participants with an attendance rate of 70% or above as an indicator of good attendance.

次要结局

  • Number of Participants with Viral load suppression(Up to 6 months)
  • Change in PTSD symptoms as assessed by the PTSD Checklist for DSM-5(Baseline, 9 months)
  • Change in Depressive symptoms as assessed by the CES-D Scale(Baseline, 9 months)
  • Change in HIV viral load levels(Baseline, Up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sannisha K Dale

Associate Professor

University of Miami

研究点 (2)

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