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临床试验/NCT07376239
NCT07376239已完成不适用

Quality of Life, Depression and Sexual Function in Men Living With HIV Under Effective Antiretroviral Therapy Compared With Healthy Controls

Kocaeli University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2026年2月3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
99
试验地点
1
主要终点
Quality of life score (EUROHIS-QOL-8)

研究概览

简要总结

This observational case-control study evaluates quality of life, depressive symptoms, and sexual function in heterosexual men living with HIV who are receiving effective combination antiretroviral therapy and have achieved virologic suppression, compared with healthy male controls. Participants complete validated questionnaires assessing quality of life (EUROHIS-QOL-8), depression (Beck Depression Inventory), and sexual function (Arizona Sexual Experience Scale). The study aims to identify psychosocial and sexual health challenges that may persist despite effective HIV treatment.

详细描述

Combination antiretroviral therapy (cART) has markedly improved survival and virologic outcomes in people living with HIV; however, impairments in quality of life, mental health, and sexual function may persist even under long-term effective treatment. These outcomes are clinically important because they influence treatment adherence, overall wellbeing, and long-term health.

This is a comparative, observational, case-control study conducted at the outpatient clinic of the Department of Infectious Diseases and Clinical Microbiology at Kocaeli University Hospital. The study includes heterosexual men living with HIV who are receiving regular cART and have achieved virologic suppression confirmed at two consecutive visits. A control group of healthy male volunteers matched for age and key sociodemographic characteristics is recruited from companions of patients attending the same clinic.

During a three-week recruitment period, all eligible participants are invited to complete a set of validated self-report questionnaires in a quiet environment without researcher interference. Sociodemographic data are collected, including age, educational status, marital status, physical activity, living conditions, smoking, and alcohol use.

Quality of life is assessed using the EUROHIS-QOL-8 (WHOQOL-8), depressive symptoms are measured using the Beck Depression Inventory (BDI), and sexual function is evaluated using the Arizona Sexual Experience Scale (ASEX), all of which have validated Turkish versions. These instruments provide continuous measures of wellbeing, depression severity, and sexual dysfunction.

The primary objective is to compare quality of life, depression, and sexual function between men living with HIV and healthy controls. Secondary objectives include evaluating correlations between depression, sexual function, quality of life, and age within each group. The results are intended to clarify the psychosocial and sexual health burden among virologically suppressed men living with HIV and to inform routine screening and supportive care strategies in HIV clinics.

研究设计

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

入排标准

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

入选标准

  • Age ≥ 18 years
  • Heterosexual orientation
  • Confirmed diagnosis of HIV infection
  • Receiving combination antiretroviral therapy (cART)
  • Virologic suppression confirmed at two consecutive visits
  • Ability to understand and complete the questionnaires

排除标准

  • Female sex
  • Age < 18 years
  • Advanced HIV disease
  • Presence of significant comorbid medical conditions
  • Cognitive impairment or communication difficulties that could interfere with completion of the survey

研究组 & 干预措施

Men living with HIV

Heterosexual adult men with HIV receiving combination antiretroviral therapy and with confirmed virologic suppression who complete quality-of-life, depression, and sexual-function questionnaires.

Healthy controls

HIV-negative adult men without major medical conditions who complete the same quality-of-life, depression, and sexual-function questionnaires for comparison.

结局指标

主要结局

Quality of life score (EUROHIS-QOL-8)

时间窗: Baseline (at study enrollment; single assessment)

Quality of life measured using the EUROHIS-QOL-8 questionnaire. Higher scores indicate better quality of life.

次要结局

  • Depression severity (Beck Depression Inventory)(Baseline (at study enrollment; single assessment))
  • Sexual function (Arizona Sexual Experience Scale)(Baseline (at study enrollment; single assessment))

研究者

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

Özlem Güler

Assistant Professor M.D.

Kocaeli University

研究点 (1)

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