AIDS (Acquired Immunodeficiency Syndrome)BRAVONCT07118683
BRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS
An observational study of AIDS (Acquired Immunodeficiency Syndrome) and Cardiovascular and Cerebrovascular Diseases, run by Hospital Alemão Oswaldo Cruz at 9 sites in Brazil.
Trial summary
BRAVO proposes the establishment of a comprehensive registry of chronic noncommunicable diseases (NCDs), providing crucial data for the formulation of effective health policies for people living with HIV/AIDS (PLWHA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS (Acquired Immunodeficiency Syndrome), Cardiovascular and Cerebrovascular Diseases, Respiratory Comorbidities
- How many people
- 743 participants
- Where
- 9 sitesBrazil
- Study dates
- 15 Aug 2025to Dec 2026
- How long will I take part?
- 3 Months
- 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: People living with HIV or Aids.
Who may be able to join
- Adults aged 18 or over;
- Confirmed HIV or AIDS diagnosis;
- Signature of consent form.
Who cannot join
- Indigenous population or those in prison in open or closed regimes;
- Patients hospitalized at the time of signing the Consent Form.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rosa Lucchetta contact
9 sites in 1 country
Brazil9 sites, 8 recruiting
- Recruiting
Centro de Pesquisa Clínica Dom Bosco
Araçatuba, São Paulo
Igor Precinoti, PhD, 55, igorprecinoti@gmail.com
- Active, not recruiting
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais
- Not yet recruiting
Faculdade de Medicina de Botucatu da UNESP
Botucatu, São Paulo
Alexandre Barbosa, PhD, 55, barbosa.an@gmail.com
- Recruiting
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná
Monica Gomes, PhD, monica.mgomes@gmail.com
- Recruiting
Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás
Moara Alves, 55, moarasb@ufg.br
- Recruiting
Hospital Federal dos Servidores do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Luiz Passoni, PhD, 5521, lfernandopassoni@gmail.com
- Recruiting
Hospital Federal de Santa Maria
Santa Maria, Rio Grande do Sul
Alexandre V Schwarzbold, PhD, 55, alexvspoa@gmail.com
- Recruiting
Centro Universitário FMABC
Santo André, São Paulo
Olavo Leite, PhD, 55, olavo.leite55@gmail.com
- Recruiting
Instituto de Infectologia Emílio Ribas
São Paulo, São Paulo
Luis C Pereira, PhD, 5511, luiz.junior@emilioribas.sp.gov.br
About this study
BRAVO proposes the establishment of a comprehensive registry of chronic noncommunicable diseases (NCDs), providing crucial data for the formulation of effective health policies for people living with HIV/AIDS (PLWHA). BRAVO is a cross-sectional study, that will collect on the study allocation sociodemographic data, risk factors related to the main NCDs, physical examination data and samples for determination of biochemical and metabolic parameters. To this end, the study will include co-participating research centers from the 5 Brazilian geographic macro-regions.
Read the detailed description
The BRAVO is a multicenter observational study. It includes a cross-sectional baseline assessment to evaluate cardiometabolic health, mental health, and quality of life among people living with HIV/AIDS (PLWHA).
Adults (≥18 years) with a confirmed HIV/AIDS diagnosis from across Brazil will be recruited in 2025 and 2026. Participation requires informed consent. The study captures data on risk factors, diseases, anthropometrics, and biological samples, ART adherence, mental health status, and quality of life (WHOQOL-BREF).
Data are collected using REDCap©, covering: i) Demographics and socioeconomic indicators; ii) Clinical and lab tests (cholesterol, HbA1c, triglycerides); iii) Physical measures (BMI, blood pressure, waist-hip ratio); iv) Respiratory (spirometry), renal, hepatic, and bone assessments (DXA); v) STIs, cancer risk, and CIMT (carotid ultrasound); vi) ART adherence (Morisky-Green), viral load, CD4/CD8 counts; vii) Mental health (depression, anxiety, substance use); and viii) Quality of life via WHOQOL-BREF.
Both validated and project-developed instruments will assess risk factors and outcomes. While validated tools improve reliability, the use of unvalidated questionnaires in certain domains (e.g., interpersonal violence) may introduce bias.
The target sample size is 743 participants, calculated to estimate a 12% prevalence of depression (the condition with the lowest expected prevalence among the non-communicable conditions of interest, derived from a systematic review in low- and middle-income countries) with 20% relative precision and 95% confidence, accounting for 5% refusals or incomplete data.
Statistical Analysis Cross-sectional analysis uses standard tests (Chi-square, t-test, ANOVA, logistic regression) with methods for handling non-normal data and multivariable modeling.
Subgroup analyses are planned for key populations (e.g., transgender, Black individuals, cisgender women).
Challenges No retention strategies are currently outlined, which could affect the study's internal validity due to participant attrition over time. Best practices like reminders and engagement initiatives are recommended.
Ethics The protocol has received approval from the Hospital Alemão Oswaldo Cruz ethics committee (CAAE: 7.003.613). Informed consent and participant confidentiality are ensured.
- Conditions
- AIDS (Acquired Immunodeficiency Syndrome), Cardiovascular and Cerebrovascular Diseases, Respiratory Comorbidities, Chronic Kidney Disease, Cancer
- Keywords
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases, Respiratory Tract Diseases, Renal Insufficiency, Chronic, Neoplasms, Treatment Adherence and Compliance, Quality of Life, Prevalence, Brazil, Cross-sectional study
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cerebrovascular Disorders, Renal Insufficiency, Chronic, Neoplasms, Cardiovascular Diseases, Respiratory Tract Diseases, Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevelance of chronic non-communicable diseases and mental disorders
Prevalence of cardiovascular diseases, non-infectious respiratory diseases, chronic kidney disease and cancers, depression, dependence on alcohol and illicit substances, self-harm and physical violence.
Measured: Baseline
Secondary outcomes (3)
Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases
History of hypertension, diabetes mellitus, dyslipidemia, smoking, physical activity, use of illicit drugs, alcoholism, dietary risk and continuous use medications, measurement of blood pressure, weight, height, abdominal and hip circumference, CD4, CD8, fasting blood glucose, HbA1C, total cholesterol and fractions, triglycerides, apolipoprotein A and B, serum and urinary creatinine, cystatin-C, urine 1, urinary albumin, serum and urinary phosphorus, urinary macroglobulin, urinary retinol-binding protein, AST, AST, Hepatitis A, B and C serologies, bone densitometry parameters, carotid ultrasound and spirometry.
Measured: Baseline
Prevalence of participants with good adherence to antiretroviral therapy.
Adherence to antiretroviral therapy will be assessed using the 8-item Morisky-Green tool adapted for patients with HIV/AIDS.
The instrument consists of eight dichotomous items. The questions were formulated to avoid a 'yes-saying' bias, so one point is assigned to each 'no' answer, except in item 5, which is reversed. At the end, patients are classified according to the score obtained as low adherers (score <6), medium adherers (score 6 to <8) and high adherers (score 8). The original authors also proposed a dichotomous cut-off of low (score <6) vs. high/medium adherence (score ≥6) to facilitate statistical analysis.
Measured: Baseline and 1 year after
Profile of Quality of life of participants
Quality of life will be assessed by WHOQOL-BREF. The WHOQOL-BREF, a shortened version of the WHOQOL-100, is a 26-item questionnaire used to assess an individual's quality of life. It categorizes responses into four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each domain, along with the overall quality of life and general health questions, is scored on a 5-point Likert scale, which is then transformed to a 0-100 scale. A score of 100 represents the best possible quality of life within that domain.
Measured: Baseline and 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS (Acquired Immunodeficiency Syndrome)Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 743 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital Alemão Oswaldo Cruz
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, Victor Augusto Hamamoto Sato, Hospital Alemão Oswaldo Cruz
- Investigators
- Victor Sato, Principal investigator, Hospital Alemão Oswaldo Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118683
- Sponsor's protocol ID
- CAAE: 81912924.9.1001.0070
- Acronym
- BRAVO
- Status last verified
- May 2026
- First submitted
- 6 Jul 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS
- ClinicalTrials.gov ID
- NCT07118683
- Acronym / sponsor ID
- BRAVO / CAAE: 81912924.9.1001.0070
- Conditions
- AIDS (Acquired Immunodeficiency Syndrome), Cardiovascular and Cerebrovascular Diseases, Respiratory Comorbidities, Chronic Kidney Disease, Cancer
- Keywords
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases, Respiratory Tract Diseases, Renal Insufficiency, Chronic, Neoplasms, Treatment Adherence and Compliance, Quality of Life, Prevalence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 743 participants (estimated)
- Lead sponsor
- Hospital Alemão Oswaldo CruzUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Aug 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.
BRAVO proposes the establishment of a comprehensive registry of chronic noncommunicable diseases (NCDs), providing crucial data for the formulation of effective health policies for people living with HIV/AIDS (PLWHA). BRAVO is a cross-sectional study, that will collect on the study allocation sociodemographic data, risk factors related to the main NCDs, physical examination data and samples for determination of biochemical and metabolic parameters. To this end, the study will include co-participating research centers from the 5 Brazilian geographic macro-regions.
Detailed description
The BRAVO is a multicenter observational study. It includes a cross-sectional baseline assessment to evaluate cardiometabolic health, mental health, and quality of life among people living with HIV/AIDS (PLWHA).
Adults (≥18 years) with a confirmed HIV/AIDS diagnosis from across Brazil will be recruited in 2025 and 2026. Participation requires informed consent. The study captures data on risk factors, diseases, anthropometrics, and biological samples, ART adherence, mental health status, and quality of life (WHOQOL-BREF).
Data are collected using REDCap©, covering: i) Demographics and socioeconomic indicators; ii) Clinical and lab tests (cholesterol, HbA1c, triglycerides); iii) Physical measures (BMI, blood pressure, waist-hip ratio); iv) Respiratory (spirometry), renal, hepatic, and bone assessments (DXA); v) STIs, cancer risk, and CIMT (carotid ultrasound); vi) ART adherence (Morisky-Green), viral load, CD4/CD8 counts; vii) Mental health (depression, anxiety, substance use); and viii) Quality of life via WHOQOL-BREF.
Both validated and project-developed instruments will assess risk factors and outcomes. While validated tools improve reliability, the use of unvalidated questionnaires in certain domains (e.g., interpersonal violence) may introduce bias.
The target sample size is 743 participants, calculated to estimate a 12% prevalence of depression (the condition with the lowest expected prevalence among the non-communicable conditions of interest, derived from a systematic review in low- and middle-income countries) with 20% relative precision and 95% confidence, accounting for 5% refusals or incomplete data.
Statistical Analysis Cross-sectional analysis uses standard tests (Chi-square, t-test, ANOVA, logistic regression) with methods for handling non-normal data and multivariable modeling.
Subgroup analyses are planned for key populations (e.g., transgender, Black individuals, cisgender women).
Challenges No retention strategies are currently outlined, which could affect the study's internal validity due to participant attrition over time. Best practices like reminders and engagement initiatives are recommended.
Ethics The protocol has received approval from the Hospital Alemão Oswaldo Cruz ethics committee (CAAE: 7.003.613). Informed consent and participant confidentiality are ensured.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV or Aids.
Key inclusion criteria (3 listed)
- Adults aged 18 or over;
- Confirmed HIV or AIDS diagnosis;
- Signature of consent form.
Key exclusion criteria (2 listed)
- Indigenous population or those in prison in open or closed regimes;
- Patients hospitalized at the time of signing the Consent Form.
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
Prevelance of chronic non-communicable diseases and mental disorders
Time frame: Baseline
Prevalence of cardiovascular diseases, non-infectious respiratory diseases, chronic kidney disease and cancers, depression, dependence on alcohol and illicit substances, self-harm and physical violence.
3 secondary outcomes
Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases
Time frame: Baseline
Prevalence of participants with good adherence to antiretroviral therapy.
Time frame: Baseline and 1 year after
Profile of Quality of life of participants
Time frame: Baseline and 1 year after
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 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rosa Lucchetta contact
Victor Sato principal investigator
Hospital Alemão Oswaldo Cruz
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS (Acquired Immunodeficiency Syndrome) and Cardiovascular and Cerebrovascular Diseases, run by Hospital Alemão Oswaldo Cruz at 9 sites in Brazil.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. 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 Victor Sato (5511, victorhsato@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevelance of chronic non-communicable diseases and mental disorders (time frame: Baseline). 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 22 May 2026.