Skip to main content
OpenTrials
Completed

NCT Number: NCT07376239

Quality of Life, Depression and Sexual Function in Men Living With HIV

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Male sex
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Quality of life score (EUROHIS-QOL-8)

    Time frame: Baseline (at study enrollment; single assessment)

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

Secondary outcomes

  1. Depression severity (Beck Depression Inventory)

    Time frame: Baseline (at study enrollment; single assessment)

    Depressive symptoms measured using the Beck Depression Inventory (BDI). Higher scores indicate more severe depression.

  2. Sexual function (Arizona Sexual Experience Scale)

    Time frame: Baseline (at study enrollment; single assessment)

    Sexual function measured using the Arizona Sexual Experience Scale (ASEX). Higher scores indicate greater sexual dysfunction.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.