NCT05781204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
Last Updated

March 23, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 30, 2023

Last Update Submit

March 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Influence of social support on perceived stigma

    1 year

  • Influence of mental health on perceived stigma

    1 year

  • Influence of quality of life on perceived stigma

    1 year

Interventions

SurveyOTHER

Each participant completed an anonymous 62-item online survey.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We expect the majority of the HIV patient population to be male, between the ages of 40 and 65 and with a high school diploma. We expect a virologically suppressed HIV population with good adherence to antiretroviral therapy. We expect a high level of perceived stigma and low quality of life and high symptoms of depression, anxiety and stress.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 23, 2023

Study Start

April 10, 2022

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

March 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations