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

NCT ID: NCT07118683

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-12-31

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). 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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Hospital Alemão Oswaldo Cruz

OTHER

Sponsor Role: lead

Responsible Party

Victor Augusto Hamamoto Sato

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor Sato

Role: PRINCIPAL_INVESTIGATOR

Hospital Alemão Oswaldo Cruz

Central Contacts

Victor Sato

Role: CONTACT

victorhsato@gmail.com

+551135490515

Rosa Lucchetta

Role: CONTACT

rosa.lucchetta@haoc.com.br

+551135490515

Other Identifiers

CAAE: 81912924.9.1001.0070

Identifier Type: -

Identifier Source: org_study_id