Vicente Ferrer HIV Cohort Study

Status Recruiting

Clinical Trial Summary

The VFHCS is a long-term prospective cohort study of HIV infected patients from a resource-poor rural setting in India. The aim of the study is to use data collected from routine clinical care in order to describe the epidemiology of HIV and its related conditions in the investigators area, and to study the effectiveness of health interventions in a "real-world" setting (implementation and operational research).

Clinical Trial Description

Andhra Pradesh is the state with highest burden of HIV in India. Anantapur is a district situated in the South border of Andhra Pradesh with 72% rural population and adult literacy rate of 74.1% in men and 54.3% in women. In Anantapur, the HIV epidemic is largely driven by heterosexual transmission and it is characterized by poor socioeconomic conditions and high levels of illiteracy. Rural Development Trust (RDT) is a nongovernmental organization, which provides medical care to people living with HIV free of charge, including medicines, consultation and admission charges. In Bathalapalli Hospital, outpatient clinics and 71 beds are allocated exclusively for HIV or tuberculosis infected patients. The Vicente Ferrer HIV Cohort Study (VFHCS) is a prospective open cohort study of all HIV infected patients who have attended Bathalapalli RDT Hospital. Routine clinical data from patients are collected prospectively since September 2009 and entered in a SQL-server database using C# as front end. Details of route of transmission, HIV associated risk factors and socio-demographic data are collected at enrolment. Data collected include medical treatment (antiretroviral treatment and other medications), laboratory investigations (haemogram, renal function tests, liver function tests, CD4 lymphocyte count, bacterial infections), and standardized diagnoses. The objective of the VFHCS is to describe social and medical aspects related to HIV in the investigators setting, including: 1. Epidemiology: trends in HIV incidence, transmission mechanisms, socioeconomic risk factors associated with HIV. 2. Incidence and prevalence of opportunistic infections, especially tuberculosis and cryptococcosis. 3. Life expectancy and factors associated with mortality 4. Describe the retention across the continuum of care and investigate factors associated with loss to follow-up. 5. Toxicity and effectiveness of antiretroviral therapy. 6. Effectiveness of programmes to prevent mother to child transmission. 7. Incidence and prevalence of non-communicable diseases such as cancer or cardiovascular diseases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02454569
Study type	Observational [Patient Registry]
Source	Rural Development Trust Hospital
Contact	Gerardo Alvarez-Uria
Email	hivbtp@gmail.com
Status	Recruiting
Phase
Start date	September 2009
Completion date	January 2040

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Vicente Ferrer HIV Cohort Study — VFHCS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms