BRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS

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.

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.