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临床试验/NCT05208541
NCT05208541招募中不适用

Advancing Dignity, Health, and Optimism in Connection With Long Acting Injectables

Mazonson & Santas Inc.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Loneliness

研究概览

简要总结

ADHOC-LA is an observational study of people living with HIV who either are taking, or have taken, a long-acting injectable therapy to manage their HIV. Data from this study will be used to research the ways in which HIV impacts the lives of these patients.

详细描述

ADHOC-LA is an observational study that uses an online questionnaire to collect data on adults living with HIV who are currently taking, or have previously taken, long-acting injectable therapy to manage their HIV. The questionnaire includes information on sociodemographic factors, activities and interests, HIV diagnosis and status, health care use and satisfaction, antiretroviral therapy, comorbid medical conditions, health and well-being, substance use, and sexual practices.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Loneliness

时间窗: Through study completion, an average of 12 months

Measured using the Three-Item Loneliness Scale. This scale is comprised of 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation. The scale range of each response item is 1-3. The total score ranges from 3-9 with higher total scores indicating a higher level of perceived loneliness.

Quality of life measurement

时间窗: Through study completion, an average of 12 months

Measured using the PozQoL. PozQoL is a short 13-question scale assessing quality of life among people living with HIV. The scale includes four subscales: health concerns, psychological, social and functional. The scale range of each response item is 1-5. The total score is the average of all response items ranges from 1-5 with higher total scores indicating higher quality of life.

Cognitive function

时间窗: Through study completion, an average of 12 months

Measured using the Functional Assessment of HIV Infection (FAHI Cognition). The FAHI Cognition subscale is used to create a standardized score to assess outcome. The scale range of each response is 0-4. The total score has a range of 0-12 with higher total scores indicating a higher cognitive functioning.

Social well-being

时间窗: Through study completion, an average of 12 months

Measured using the Functional Assessment of HIV Infection (FAHI). The FAHI Social Well-being subscale will be used to create a standardized score to assess outcome. The scale range of each response is 0-4. The total score has a range of 0-32 with higher total scores indicating better social well-being.

Depression

时间窗: Through study completion, an average of 12 months

Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). The scale range of each response item is 0-3. The total score for depression has a range from 0-6 with higher scores indicating positive for depression.

Anxiety

时间窗: Through study completion, an average of 12 months

Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). The scale range of each response item is 0-3. The total score for anxiety has a range from 0-6 with higher scores indicating positive for generalized anxiety.

Sleep quality

时间窗: Through study completion, an average of 12 months

Measured using The Medical Outcomes Study Sleep Scale (MOS-SS). MOS-SS includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. The scale range of each response item is 0-100. The total score is the average of all response items and has a range of 0-100 with higher scores indicating poorer sleep quality.

Alcohol use

时间窗: Through study completion, an average of 12 months

Measured using the Alcohol Use Disorder Identification Test (AUDIT-C). The AUDIT-C is a 3-item screening survey that can help identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The scale range of each response item is 0-4. The total score has a range of 0-12 with a higher score indicating more hazardous drinking behavior.

Internalized stigma

时间窗: Through study completion, an average of 12 months

Measured using the Internalized AIDS-Related Stigma scale (IAS). IAS is a six-item scale designed to measure the construct of internalized stigma. The scale range of each response item is 0-1. The total score has a range of 0-6 with higher scores indicating more internalized stigma.

Resilience

时间窗: Through study completion, an average of 12 months

Measured using the Connor-Davidson Resilience Scale (CD-RISC 2). The CD-RISC contains two items and was developed as a measure of "bounce-back" and adaptability. The scale range of each response item is 0-8. The total score range is 0-16 with higher scores indicating higher resilience.

Interpersonal support

时间窗: Through study completion, an average of 12 months

Measured using the Interpersonal Support Evaluation Checklist - 6 (ISEL-6). ISEL-6 is derived from the long form of the ISEL and contains 6 items that assess the perceived availability of social support. The scale range of each response item is 1-4. The total score range is 6-48 with higher scores indicating higher social support.

Anti-HIV medication adherence

时间窗: Through study completion, an average of 12 months

Measured using the brief adherence self-report questionnaire. This questionnaire asks participants how much of their anti-HIV medications they have taken over the past month (0 to 100%). Higher score indicates greater adherence to anti-HIV medication(s).

Frailty

时间窗: Through study completion, an average of 12 months

Measured using the Frailty Index Elders (FIFE). FIFE is a 10-item instrument with scores ranging from 0-10. A score of 0 indicates no frailty; a score of 1-3 indicates frailty risk; and a score of 4 or greater indicates frailty.

次要结局

未报告次要终点

研究者

发起方
Mazonson & Santas Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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