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

NCT07376239 | Completed

• 1 other identifier: GOKAEK-2025/19/06 2025/450
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

HAART; Sustained virologic response; Health surveys; Psychological wellbeing; Sexual health

Outcome Measures

Primary Outcomes (1)

• Quality of life score (EUROHIS-QOL-8)

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

  Baseline (at study enrollment; single assessment)

Secondary Outcomes (2)

• Depression severity (Beck Depression Inventory)

  Baseline (at study enrollment; single assessment)

• Sexual function (Arizona Sexual Experience Scale)

  Baseline (at study enrollment; single assessment)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Izmit, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Özlem Güler, MD

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor M.D.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 3, 2026
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

TU (1)