NCT07118683

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

July 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

July 6, 2025

Last Update Submit

August 7, 2025

Conditions

Keywords

Acquired Immunodeficiency SyndromeCardiovascular DiseasesRespiratory Tract DiseasesRenal Insufficiency, ChronicNeoplasmsTreatment Adherence and ComplianceQuality of LifePrevalenceIncidenceBrazilCross-sectional studyProspective cohort

Outcome Measures

Primary Outcomes (2)

  • Prevelance of chronic non-communicable diseases and mental disorders

    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.

    Baseline

  • Incidence of chronic non-communicable diseases and mental disorders

    Cardiovascular diseases, non-infectious respiratory diseases, chronic kidney disease and cancers, and depression.

    1 year

Secondary Outcomes (3)

  • Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases

    Baseline

  • Prevalence of participants with good adherence to antiretroviral therapy.

    Baseline and 1 year after

  • Profile of Quality of life of participants

    Baseline and 1 year after

Other Outcomes (1)

  • Incidence of adverse events potentially associated with antiretroviral therapy

    Baseline and 1 year after

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People living with HIV or Aids.

You may qualify if:

  • Adults aged 18 or over;
  • Any gender identity;
  • Confirmed HIV or AIDS diagnosis;
  • Signature of consent form

You may not qualify if:

  • Indigenous population or those in prison in open or closed regimes;
  • Patients hospitalized at the time of signing the Consent Form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCerebrovascular DisordersRenal Insufficiency, ChronicNeoplasmsCardiovascular DiseasesRespiratory Tract DiseasesTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Officials

  • Victor Sato

    Hospital Alemão Oswaldo Cruz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2025

First Posted

August 12, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08