4826: Stigma, Social Support and Quality of Life

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT05781204
Collaborator
(none)
96
1
2.2
44.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey

Study Design

Study Type:
Observational
Actual Enrollment :
96 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
"Perceived Stigma and Social Support: Relationship and Influence on Mental Health and Quality of Life in HIV+ Patients"
Actual Study Start Date :
Apr 10, 2022
Actual Primary Completion Date :
Jun 15, 2022
Actual Study Completion Date :
Jun 15, 2022

Outcome Measures

Primary Outcome Measures

  1. Perceived stigma in HIV+ patients [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 Outcome Measures

  1. Influence of social support on perceived stigma [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05781204
Other Study ID Numbers:
  • SPESS
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 23, 2023