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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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