Stigma, Social Support and Quality of Life

HIV Infections Clinical Trial

— 4826  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05781204
• Other study ID #: SPESS
• Status: Completed
• Start date: April 10, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: January 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Survey
Each participant completed an anonymous 62-item online survey.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived stigma in HIV+ patients	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.	1 year
Secondary	Influence of social support on perceived stigma	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").	1 year
Secondary	Influence of mental health on perceived stigma	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.	1 year
Secondary	Influence of quality of life on perceived stigma	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).	1 year