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临床试验/NCT05376397
NCT05376397已完成不适用

Addressing Intersectional Stigma: Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Depressive Symptoms

研究概览

简要总结

The primary goal of this study is to test a minority stress model of psychological health outcomes for Black sexual minority men (BSMM) while using and not using a novel intervention named THRIVE 365. THRIVE 365 combines mHealth and institutional support elements to provide four areas of support for BSMM: 1) Promote HIV and psychological health knowledge and motivation; 2) Foster a sense of community and positive social connections among BSMM; 3) Connect clients to BSMM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. To examine the effects of the intervention, we will utilize a 14-day daily diary study to capture daily intervention engagement, HIV and psychological health outcomes, coping, and experiences of racial and sexual minority stressors. We will first examine main associations between intervention engagement and HIV (antiretroviral treatment use) and psychological health (depressive symptoms, anxiety symptoms, emotion regulation difficulties outcomes) outcomes, then consider how intervention engagement affects coping and attenuates the impacts of racial and sexual minority stressors during the 14 day period.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 16 years old or older ;
  • Identifying as masculine
  • Identifying as Black/African American
  • Reporting being attracted to and/or sexually active with men;
  • Able to complete all procedures in English.
  • Mobile access to the internet in order to complete the once-daily survey procedures.

排除标准

  • evidence of unstable, unmanaged, or serious psychiatric symptoms that could be made worse by participation;
  • evidence of gross cognitive impairment that would interfere with successful completion of study procedures.

结局指标

主要结局

Depressive Symptoms

时间窗: 24 Hours

The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which they had been experiencing each item the past day (e.g., "In the past 24 hours, I've been feeling down, depressed, or hopeless") on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point.

Anxiety Symptoms

时间窗: 24 Hours

The Patient Health Questionnaire-4 assesses anxiety and depressive symptoms. Participants rate the extent to which they had been experiencing each item the past day (e.g., "In the past 24 hours, I've been feeling nervous, anxious, or on edge") on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point.

Emotion Regulation

时间窗: 24 Hours

A validated four-item version of the Difficulties with Emotion Regulation Scale assesses emotion regulation. Participants rated the extent to which they had been experiencing each item (e.g., "In the past 24 hours, I've been experiencing my emotions as overwhelming") in the past day on a scale from 0 (not at all) to 3 (completely). We used an average across all items for each time point.

Antiretroviral (ART) Medication Use

时间窗: 24 Hours

A single dichotomous no(0)/yes(1) item assesses ART use over the past 24 hours: "In the past 24 hours, did you take ART medication?"

次要结局

  • Coping(24 Hours)

研究者

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

Devin English, PhD

Assistant Professor

Rutgers, The State University of New Jersey

研究点 (2)

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