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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adults aged 18 or over; - Any gender identity; - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07118683
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital Alemão Oswaldo Cruz
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Victor Sato
Principal Investigator Affiliation Hospital Alemão Oswaldo Cruz
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

AIDS (Acquired Immunodeficiency Syndrome), Cardiovascular and Cerebrovascular Diseases, Respiratory Comorbidities, Chronic Kidney Disease, Cancer
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Victor Sato

[email protected]

+551135490515

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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