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OpenTrials
Completed

NCT Number: NCT05781204

Stigma, Social Support and Quality of Life

The primary goal of this observational study is to investigate the relationship between perceived stigma and social support in HIV+ patients. The secondary objective is to measure mental health indicators (depression, anxiety, and stress) and quality of life to assess whether they are affected by the relationship between perceived stigma and social support.

The main questions it aims to answer are:

* Measuring perceived stigma and social support to understand the health status and behaviour of people living with HIV. * Monitor the mental state of people living with HIV in order to be able to implement, there where necessary, a psychological support strategy in order to promote proper adherence to treatment and care services.

Participants will fill out an online cross-sectional survey. The online questionnairesurvey will collect:

* sociodemographic and clinical data related to HIV infection, * perceived stigma, * social support, * mental health, * quality of life.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV diagnosis.
  • Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
  • Ongoing antiretroviral therapy.
  • Age > 18 years.
  • Native Italian speaker.
  • Informed consent to participate in the study.

Exclusion criteria

  • Absence of an HIV diagnosis.
  • Not being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
  • Absence of ongoing antiretroviral therapy.
  • Age > 18 years.
  • Not being a native Italian speaker.
  • Refusal to sign informed consent

Treatment and study plan

Survey

Other

Each participant completed an anonymous 62-item online survey.

Primary outcomes

  1. Perceived stigma in HIV+ patients

    Time frame: 1 year

    Perceived stigma in HIV+ patients will be assess through the following test: the 12-item short version of the HIV stigma scale. The test consists of four subscales: personalized stigma, concerns about disclosure of one's HIV status, concerns about the attitudes of others and negative self-image.

Secondary outcomes

  1. Influence of social support on perceived stigma

    Time frame: 1 year

    HIV+ patients' perceived social support will be examined through the use of 6 statements (1. "If you are sick, you have someone to rely on physically for example as help with household chores or as company during doctor's visits"; 2. "You have someone who can look after your home if you are away"; 3. "If you wanted to go on a trip, you would have someone to share the experience with"; 4. "You have someone who accepts you with your strengths and faults"; 4. "You have someone who loves you and gives you affection"; 6. "If you have emotional difficulties, you have someone who listens to you and gives you support and advice").

  2. Influence of mental health on perceived stigma

    Time frame: 1 year

    Mental health will be investigated using the Depression Anxiety Stress Scale (DASS) 21, a self-assessment instrument containing 21 useful items to investigate three constructs: depression, anxiety and stress. Each construct constitutes a specific subscale, consisting of 7 items. Each item corresponds to a statement, referring to the past week.

  3. Influence of quality of life on perceived stigma

    Time frame: 1 year

    Quality of life will be investigated using the 12-item Short-Form Health Survey (SF-12). The SF-12 investigates quality of life with 12 items: 6 items are concerned with physical health (physical functioning, physical plane limitations, physical pain, general health) and 6 items are concerned with mental health (emotional plane limitations, fatigue or lack of energy, social functioning, emotional well-being).

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

"Perceived Stigma and Social Support: Relationship and Influence on Mental Health and Quality of Life in HIV+ Patients"

Acronym: 4826

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2023
Registry last updated
Mar 23, 2023

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.

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