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临床试验/NCT05935644
NCT05935644暂停不适用

ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)

University of Miami1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
30
试验地点
1
主要终点
Proportion of Participants who Complete ORCHID

研究概览

简要总结

The purpose of this research is to test ORCHID (Optimizing Resilience & Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care.

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 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Cis-gender women,
  • Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service,
  • Recent history (12-month) of cervical or anal dysplasia or human papilloma virus (HPV) positivity; AND a recent (12-month) history of one or more of the following:
  • i) drug use (alcohol, tobacco products, marijuana, illicit drugs) or ii) depression or iii) psychiatric condition (anxiety, post-traumatic stress disorder (PTSD)) or iv) unsuppressed HIV viral load d. All life stages - pregnant, non-pregnant, pre/post-menopausal

排除标准

  • Not able to read/write English at the 6th grade level
  • Cognitively impaired adults (as documented in medical records)
  • Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders)

研究组 & 干预措施

ORCHID Group

Experimental

Participants in the ORCHID group will receive an online intervention that improves depressive symptoms and positive affect (emotions) for clinic-based persons living with HIV, for up to 6 months.

干预措施: ORCHID (Behavioral)

结局指标

主要结局

Proportion of Participants who Complete ORCHID

时间窗: Up to 6 months

Average across all participants of the proportion of participants who login to all 8 ORCHID intervention sessions, calculated as total number of sessions opened (0-8) divided by 8.

次要结局

  • Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)(Up to 6 months)
  • Depression as measured by Patient Health Questionnaire (PHQ-9)(Up to 6 months)

研究者

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

Lunthita M. Duthely

Research Associate Professor

University of Miami

研究点 (1)

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