HIVSUNRISENCT06812910
Urban and Insular Study on Treatment Experiences and Stigma in People Living with HIV
An observational study of HIV and Stigma, run by Fábio Cota Medeiros at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Stigma, Depression/Anxiety
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2025to 27 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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 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.
Read more
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.
- Conditions
- HIV, Stigma, Depression/Anxiety
- Keywords
- HIV, HIV related stigma, mental health, pill burden, treatment experience
- Medical subject headings
- Social Stigma, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urban Cohort | People living with HIV (PLWH) who receive care in urban centers. | |
| Island Cohort | People living with HIV (PLWH) who receive care in island regions (Azores and Madeira). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of HIV-Related Stigma in Urban versus Island Settings
This outcome measures the levels of HIV-related stigma experienced by individuals living with HIV (PLWH) in urban and island settings in Portugal. Stigma is assessed using a validated HIV Stigma Scale, which evaluates perceived and internalized stigma (range: 0-48, where higher scores indicate greater perceived stigma). The results will be compared between the two geographic cohorts to identify differences in stigma experiences.
Measured: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Secondary outcomes (5)
Prevalence of Depression and Anxiety in Urban versus Island PLWH
This outcome measures the prevalence of depression and anxiety among individuals living with HIV in urban and island settings. Depression is assessed using the Patient Health Questionnaire-9 (PHQ-9 ; range: 0-27, where higher scores indicate more severe depression), and anxiety is assessed using the Generalized Anxiety Disorder-7 scale (GAD-7; range: 0-21, where higher scores indicate more severe anxiety). Results will be compared between the two cohorts to identify differences in mental health outcomes.
Measured: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Association Between Stigma and Mental Health Indicators (Depression and Anxiety)
This outcome evaluates the association between HIV-related stigma (measured using the HIV Stigma Scale; range: 0-48, where higher scores indicate greater stigma) and mental health indicators (depression measured using the Patient Health Questionnaire-9, PHQ-9; range: 0-27, where higher scores indicate more severe depression; and anxiety measured using the Generalized Anxiety Disorder-7, GAD-7; range: 0-21, where higher scores indicate more severe anxiety). The goal is to determine whether higher levels of stigma are associated with worse mental health outcomes, adjusting for potential confounding variables such as age, gender, and duration of HIV treatment. Statistical analysis will include multiple linear regression models to assess these associations. The regression models will estimate the strength and direction of the associations, controlling for covariates.
Measured: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Association Between Pill Burden and Mental Health Impact in People Living With HIV
This outcome evaluates the association between the number of daily pills (pill burden) for HIV treatment and its impact on mental health (depression measured using the Patient Health Questionnaire-9, PHQ-9; range: 0-27, where higher scores indicate more severe depression; and anxiety measured using the Generalized Anxiety Disorder-7, GAD-7; range: 0-21, where higher scores indicate more severe anxiety). The goal is to determine whether a higher pill burden is associated with worse mental health outcomes, adjusting for potential confounding variables such as age, gender, and duration of HIV treatment. Statistical analysis will include multiple linear regression models to assess these associations. The regression models will estimate the strength and direction of the associations, controlling for covariates.
Measured: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Association Between HIV Treatment Satisfaction and Stigma/Mental Health Indicators
This outcome evaluates the association between satisfaction with HIV treatment (measured using the HIV Treatment Satisfaction Questionnaire, HIVTSQ; range: 0-60, where higher scores indicate greater satisfaction) and indicators of stigma (HIV Stigma Scale; range: 0-48, where higher scores indicate greater stigma) and mental health (depression measured using the Patient Health Questionnaire-9, PHQ-9; range: 0-27, where higher scores indicate more severe depression; and anxiety measured using the Generalized Anxiety Disorder-7, GAD-7; range: 0-21, where higher scores indicate more severe anxiety). The goal is to determine whether higher treatment satisfaction is associated with lower levels of stigma and better mental health outcomes, adjusting for potential confounding variables such as age, gender, and duration of HIV treatment. Statistical analysis will include multiple linear regression models to assess these associations.
Measured: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Assessment and comparison of HIV-Related Knowledge between Urban versus Island Settings
This outcome evaluates the level of knowledge about HIV using the HIV Knowledge Questionnaire-18 (HIV-KQ-18; range: 0-18, where higher scores indicate greater knowledge). The objective is to compare HIV knowledge levels between two regions and identify potential gaps. The analysis will consider key sociodemographic factors such as age, gender and education level. Statistical methods will include independent t-tests or Mann-Whitney U tests for regional comparisons, and multiple linear regression models to examine the association between knowledge scores and sociodemographic variables, adjusting for potential confounders.
Measured: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fábio Cota Medeiros
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Fábio Cota Medeiros, Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812910
- Sponsor's protocol ID
- SUNRISE
- Acronym
- SUNRISE
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06812910
- Acronym / sponsor ID
- SUNRISE / SUNRISE
- Conditions
- HIV, Stigma, Depression/Anxiety
- Keywords
- HIV, HIV related stigma, mental health, pill burden, treatment experience
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fábio Cota MedeirosResearch network
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urban Cohort | – | –People living with HIV (PLWH) who receive care in urban centers. |
| Island Cohort | – | –People living with HIV (PLWH) who receive care in island regions (Azores and Madeira). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of HIV-Related Stigma in Urban versus Island Settings
Time frame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
This outcome measures the levels of HIV-related stigma experienced by individuals living with HIV (PLWH) in urban and island settings in Portugal. Stigma is assessed using a validated HIV Stigma Scale, which evaluates perceived and internalized stigma (range: 0-48, where higher scores indicate greater perceived stigma). The results will be compared between the two geographic cohorts to identify differences in stigma experiences.
5 secondary outcomes
Prevalence of Depression and Anxiety in Urban versus Island PLWH
Time frame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Association Between Stigma and Mental Health Indicators (Depression and Anxiety)
Time frame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Association Between Pill Burden and Mental Health Impact in People Living With HIV
Time frame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Association Between HIV Treatment Satisfaction and Stigma/Mental Health Indicators
Time frame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Assessment and comparison of HIV-Related Knowledge between Urban versus Island Settings
Time frame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Stigma, run by Fábio Cota Medeiros at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fábio Cota Medeiros, MD (+35121 780 5000, fmedeiros@medicina.ulisboa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of HIV-Related Stigma in Urban versus Island Settings (time frame: Cross-sectional assessment at baseline (one-time measurement during study enrollment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.