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

April 15, 2026 updated by: Özlem Güler, Kocaeli University

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Izmit
      • Kocaeli, Izmit, Turkey (Türkiye), 41380
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study group consisted of heterosexual men living with HIV (MLWH) who were receiving cART and had achieved virological suppression, confirmed at least at two separate visits. The control group comprised volunteers among the companions of patients attending the same clinic for other medical reasons, who were matched for age and basic demographic characteristics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (at study enrollment; single assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (at study enrollment; single assessment)
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.
Baseline (at study enrollment; single assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Özlem Güler, MD, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2026

Primary Completion (Actual)

April 16, 2026

Study Completion (Actual)

April 16, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOKAEK-2025/19/06 2025/450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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