Clinical trial NCT06812910: Urban and Insular Study on Treatment Experiences and Stigma in People Living with HIV
Official title: Clinical Characterization and Cross-Sectional Comparison of Stigma, Mental Health, and Treatment Experience Among People Living with HIV in Urban and Insular Settings in Portugal
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV
Stigma
Depression/Anxiety
Keywords: HIV
HIV related stigma
mental health
pill burden
treatment experience
Lead sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Sponsor class: NETWORK
First posted: 2025-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of individuals living with HIV (PLWH) who are receiving care in urban and island settings in Portugal. Participants must be 18 years of age or older, diagnosed with HIV, and on antiretroviral therapy (ART) for at least six months. They must also be on a daily oral treatment regimen (single or multiple pills) and able to provide informed consent.

Brief summary: Study Title: SUNRISE Study: Urban and Island Experiences of HIV Treatment and Stigma

What is this study about? This study aims to understand how living in urban areas versus islands affects the experiences of people living with HIV (PLWH) in Portugal. Specifically, the investigators want to explore how stigma and mental health (such as depression and anxiety) differ between these two settings. The investigators are also interested in understanding how the number of pills a person takes daily (called "pill burden") impacts their mental health and satisfaction with treatment.

Why is this study important? Stigma related to HIV can make it harder for people to stick to their treatment and can negatively affect their mental health and overall well-being. By comparing urban and island settings, the investigators hope to identify unique challenges faced by PLWH in different environments. This information will help the investigators to develop better strategies to support people living with HIV, no matter where they live.

Who can participate? Adults (18 years or older) who have been diagnosed with HIV. People who have been on antiretroviral therapy (HIV treatment) for at least six months.

Individuals living in urban areas or island region.

What will happen during the study?

Participants will complete a one-time interview during their regular HIV care visit. The interview will include questions about:

Their experiences with HIV-related stigma. Their mental health (including depression and anxiety). Their satisfaction with their current HIV treatment. The number of pills they take daily and how this affects their daily life. All information will be kept confidential, and participation is voluntary.

What are the potential benefits of participating? This study will help to understand the challenges faced by people living with HIV in different parts of Portugal. This knowledge can lead to improved support services and treatment options for PLWH in the future.

What are the risks of participating? There are no physical risks associated with this study. However, some questions may touch on sensitive topics, such as stigma or mental health.

How will the results be used? The results of this study will be shared with the scientific community, healthcare providers, and organizations that support people living with HIV. The goal is to use this information to improve care and reduce stigma for PLWH in Portugal and beyond.

Who is conducting this study? This study is led by researchers from the Faculty of Medicine of Lisbon, in collaboration with hospitals in Portugal mainland, the Azores, and Madeira.


Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with HIV
* Aged 18 years or older.
* On antiretroviral therapy (ART) for at least six months.
* On a daily oral treatment regimen (single or multiple pills).
* Able to provide informed consent.

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals who have switched antiretroviral regimen in the previous six months.
* Individuals unable to provide informed consent (e.g., due to cognitive impairment or lack of capacity).
* Individuals with limited understanding of the study procedures or questionnaires (e.g., language barriers or cognitive limitations).
* Individuals who are incarcerated or deprived of liberty.
* Pregnant individuals.

Primary outcomes:
measure: Levels of HIV-Related Stigma in Urban versus Island Settings
timeFrame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Secondary outcomes:
measure: Prevalence of Depression and Anxiety in Urban versus Island PLWH
timeFrame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
measure: Association Between Stigma and Mental Health Indicators (Depression and Anxiety)
timeFrame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
measure: Association Between Pill Burden and Mental Health Impact in People Living With HIV
timeFrame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
measure: Association Between HIV Treatment Satisfaction and Stigma/Mental Health Indicators
timeFrame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
measure: Assessment and comparison of HIV-Related Knowledge between Urban versus Island Settings
timeFrame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Unidade Local de Saúde de Santa Maria
Study officials:
References: