BRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 743
- Locations
- 9
- Primary Endpoint
- Prevelance of chronic non-communicable diseases and mental disorders
Study Overview
Brief 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). 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 or over;
- •Confirmed HIV or AIDS diagnosis;
- •Signature of consent form.
Exclusion Criteria
- •Indigenous population or those in prison in open or closed regimes;
- •Patients hospitalized at the time of signing the Consent Form.
Outcomes
Primary Outcomes
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.
Incidence of chronic non-communicable diseases and mental disorders
Time Frame: 1 year
Cardiovascular diseases, non-infectious respiratory diseases, chronic kidney disease and cancers, and depression.
Secondary Outcomes
- Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases(Baseline)
- Prevalence of participants with good adherence to antiretroviral therapy.(Baseline and 1 year after)
- Profile of Quality of life of participants(Baseline and 1 year after)
Investigators
Victor Augusto Hamamoto Sato
Principal Investigator
Hospital Alemão Oswaldo Cruz