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临床试验/NCT05196009
NCT05196009Unknown不适用

Breaking Systems Barriers for Trans Women of Color Living With HIV

Public Health Foundation Enterprises, Inc.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Substance use services engagement

研究概览

简要总结

The proposed study will test a mHealth peer navigation intervention for trans women living with HIV in a trans public health clinics to increase initiation and engagement in mental health and substance use services. The peer will navigate and provide support in-person and via mobile phone with HIPAA-compliant text messaging. Ecological momentary assessments will be conducted to enhance self-monitoring of mental health stress and coping-related substance use.

详细描述

Trans women carry the largest population burden of HIV in San Francisco and have low utilization of mental health and substance use services. The investigators' goal is to use lessons learned in a prior previously-funded Special Projects of National Significance to conduct a pilot peer delivered mHealth support and navigation intervention for trans women living with HIV. The investigators will work with partners in San Francisco Department of Public Health (SFDPH) clinics. The SFDPH is a HRSA-funded entity with trans-specific clinics and a host of in-house referrals to trans-competent mental health and substance use services. Despite availability of trans-specific services, considerable systems barriers exist. Trans clinics have limited clinic hours, and providers have large patient loads wherein medical gender affirmation and HIV care needs must be attended to in short visits. Visit and clinic time and large patient volume leaves providers with little time to ensure continuity in mental health and substance use referrals. To overcome these issues, a peer navigator will deliver mobile and in-person support and navigation to increase substance use and mental health service initiation and engagement among trans women living with HIV in trans health clinics. The research team has already conducted formative research with community members, key stakeholders and providers in San Francisco to help shape and refine the intervention model during the implementation phase of the research.In the implementation phase, the research team will pilot the mSN intervention to improve initiation and engagement in mental health and substance use (MHSU) services.

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

入选标准

  • Intervention study:
  • Provision of signed and dated informed consent form
  • Declaration of willingness to comply with all study procedures and availability during the study
  • Age 18 years old or older
  • Male sex designated at birth
  • Identify as trans woman, woman or another gender identity not associated with being a man
  • Desire to join the mSN intervention
  • Access to a cell phone compatible with social networks (smartphone) to participate in a technology-based intervention or willing to use a study provided cell phone
  • Speaks English or Spanish
  • Living in San Francisco Bay Area
  • Attend a clinic within the San Francisco Department of Public Health
  • Potential participants living with HIV must meet the following criteria:
  • Documented diagnosis of HIV infection
  • Have missed one recent HIV care appointment or have a detectable viral load
  • Have not initiated or are regularly engaged in mental health and/or substance use services
  • Screen positive for having an alcohol disorder OR drug misuse OR screen positive for psychological distress.

排除标准

  • Participation in another intervention study to promote HIV care in the last year or participation in another study that prevents concomitant inclusion (co-enrollment)
  • Any health condition that, in the investigator's opinion, makes it impossible to participate in the study or impairs the potential participant

结局指标

主要结局

Substance use services engagement

时间窗: 12 months

The proportion of participants who remain enrolled in substance use services throughout the follow-up period.

Mental health services initiation

时间窗: 12 months

The proportion of participants enrolled in the study who initiate mental health services.

Substance use services initiation

时间窗: 12 months

The proportion of participants enrolled in the study who initiate substance use services.

Mental health services engagement

时间窗: 12 months

The proportion of participants who remain enrolled in mental health services throughout the follow-up period.

次要结局

  • Patterns and correlates of mental health and substance use services engagement(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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