- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05781204
Stigma, Social Support and Quality of Life (4826)
"Perceived Stigma and Social Support: Relationship and Influence on Mental Health and Quality of Life in HIV+ Patients"
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Roma, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived stigma in HIV+ patients
Time Frame: 1 year
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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.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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").
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1 year
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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.
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1 year
|
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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).
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1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SPESS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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