AIDS (Acquired Immunodeficiency Syndrome), Cancer, Cardiovascular and Cerebrovascular Diseases, Chronic Kidney Disease, Respiratory Comorbidities
Conditions
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
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. 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.
Interventions
None listed
Sponsors
Hospital Alemão Oswaldo Cruz
Ministry of Health, Brazil
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevelance of chronic non-communicable diseases and mental disorders | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases | Baseline | 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. |
| Prevalence of participants with good adherence to antiretroviral therapy. | Baseline and 1 year after | 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. |
| Profile of Quality of life of participants | Baseline and 1 year after | 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. |
Countries
Brazil
Contacts
CONTACTVictor Sato
CONTACTRosa Lucchetta
PRINCIPAL_INVESTIGATORVictor Sato
Hospital Alemão Oswaldo Cruz
Outcome results
None listed