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临床试验/NCT07571044
NCT07571044已完成不适用

Project to Enhance Patient-Health Engagement in HIV Infection: Optimizing Quality of Life and Psychological Well-being Through Involvement (HIV-IN-ACTION)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年11月8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
75
试验地点
1
主要终点
score of PLWH

研究概览

简要总结

The importance of patient involvement in their care is emerging as a crucial element in the active management of chronic conditions, including HIV infection. For people living with HIV (PLWH), a proactive role in managing their health promotes improved quality of life and greater adherence to treatment. However, data on enhancing patient engagement among PLWH are currently lacking.

This project aims to offer, for the first time, training to enhance patient engagement specifically for PLWH, delivered by psychologists at the Infectious Diseases Outpatient Clinic of the Gemelli Hospital in Rome. The program aims to strengthen emotional, cognitive, and behavioral involvement in the treatment process, promoting greater adherence to treatment, improved management of comorbidities, and increased healthy behaviors. Furthermore, the project aims to adapt the training to the specific needs of PLWH and evaluate its actual impact on quality of life and psychological well-being.

Scientific Rationale Over 38 million people are living with HIV worldwide, with approximately 1.5 million new infections in 2021. In Italy, 1,770 new HIV diagnoses were recorded in 2021, with a higher incidence in men between the ages of 30 and 39. Thanks to antiretroviral therapy (ART), AIDS mortality has decreased significantly, and the U=U (Undetectable=Untransmittable) principle has confirmed the importance of virological suppression in reducing virus transmission.

Despite the success of ART, one of the current challenges is ensuring a good quality of life for PLWH. HIV management is a chronic process that requires continuity of care, treatment adherence, and a multidisciplinary approach to address emerging comorbidities, including cardiovascular, bone, renal, metabolic, oncological, and neuropsychiatric conditions. In this context, active patient involvement becomes essential to improve adherence to therapy and overall health management.

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

入选标准

  • Consent to participate in the study
  • HIV diagnosis
  • Current antiretroviral therapy
  • - Age >18
  • Be able to write, speak, and understand Italian
  • Be able to participate in 3 in-person meetings

排除标准

  • Refusal to participate in the study
  • No HIV diagnosis
  • Not currently receiving antiretroviral therapy
  • Not being treated at the Infectious Diseases Outpatient Clinic at the Gemelli Hospital in Rome
  • Age <18 years
  • Non-native Italian speaker
  • Unable to attend three in-person meetings

结局指标

主要结局

score of PLWH

时间窗: 10 months

to evaluate whether the score of PLWH obtained in the scale measuring engagement increases significantly after the training

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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