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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Alemão Oswaldo Cruz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 or over;

Confirmed HIV or AIDS diagnosis;

Signature of consent form.

Disqualifiers

Indigenous population or those in prison in open or closed regimes;

Patients hospitalized at the time of signing the Consent Form.

Trial population

People living with HIV or Aids.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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

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.

Time frame
Baseline
2

Prevalence of participants with good adherence to antiretroviral therapy.

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.

Time frame
Baseline and 1 year after
3

Profile of Quality of life of participants

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.

Time frame
Baseline and 1 year after

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Alemão Oswaldo Cruz

Lead sponsor

Ministry of Health, Brazil

Collaborator