Validation of a Multidimensional Scale for the Detection of Health Needs in People With HIV
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Evaluation of the diagnostic performance of multidimensional screening test in identifying alterations in considered domains in patients with hiv
研究概览
简要总结
The primary objective is to evaluate the diagnostic performance of the multidimensional screening test in identifying alterations in the domains considered in people with HIV, in order to improve the predictivity of disorders, ensure better care and consequently improve the quality of life of people with HIV
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Age 18 years and older
- •Confirmed HIV infection
- •Good understanding of the Italian language
- •Signature of informed consent
- •Inclusion of at least 33% women and at least 33% people older than 50 years of age
排除标准
- •Acute ongoing diseases that, in the opinion of the investigators, may affect the performance of the tests (bacterial or viral infections, neoplasms under active chemotherapy treatment)
- •Dementia or other severe neurodegenerative/neurocognitive disorders.
- •Individuals unable to express consent independently and/or supported by protective legal figures
结局指标
主要结局
Evaluation of the diagnostic performance of multidimensional screening test in identifying alterations in considered domains in patients with hiv
时间窗: At enrollment
Composite endpolint for each domani: 1. Cognitive impairment (using the Brief Neurocognitive Screening Test) 2. Depressive symptoms (using the Patient Health Questionnaire-9) 3. anxiety symptoms (using the General Anxiety Disorder-7 test) 4. sleep quality (using the Pittsburgh Sleep Quality Index) 5. quality of life (using the EQ-5D-5L) 6. functional test (using the Advanced Instrumental Activities of Daily Living Scale) 7. nutritional (using the Mini Nutritional Assessment (MNA) - short form) 8. socio-economic (using detailed questions) 9. stigma (using HIV Stigma Scale - 12 item version, Karolinska Institute) 10. comorbidities (checking in the medical records) 11. polytherapy (checking in the medical records) 12. alcool or drug use (using Audit-C and Brief Substance Craving Scale)
次要结局
未报告次要终点
研究者
Giovanni Di Perri
Prof.
University of Turin, Italy