Trials / Not Yet Recruiting

Not Yet RecruitingNCT07118683

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

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 2,100 (estimated)

Sponsor: Hospital Alemão Oswaldo Cruz · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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). The study will comprise a cross-sectional and longitudinal assessment: the cross-sectional study, 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; the longitudinal study, lasting 1 year and with the possibility of extension, will follow the participants to identify new diagnoses in the broad spectrum of NCDs. 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 and a longitudinal cohort with annual follow-ups to evaluate cardiometabolic health, mental health, and quality of life among people living with HIV/AIDS (PLWHA). BRAVO combines cross-sectional and prospective designs. Adults (≥18 years) with a confirmed HIV/AIDS diagnosis from across Brazil will be recruited in 2025, with follow-up starting in 2026. Participation requires informed consent. The cross-sectional phase captures data on risk factors, anthropometrics, and biological samples, while the longitudinal phase includes annual updates on clinical and mental health status, ART adherence, 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. Regarding the sample size, the cross-sectional should include 79-310 participants (to detect diabetes prevalence); and the longitudinal should include 1,613-1,893 participants (to detect associations with risk factors), with a target of 2,100 participants considering dropouts. 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. Longitudinal data will be analyzed with paired tests (e.g., McNemar, paired t-test), GEE models, and ANCOVA. Missing data \>5% will be imputed using machine learning (Orange software). 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

Timeline

Start date: 2025-08-15
Primary completion: 2026-11-01
Completion: 2026-12-01
First posted: 2025-08-12
Last updated: 2025-08-12

Source: ClinicalTrials.gov record NCT07118683. Inclusion in this directory is not an endorsement.