Clinical Trial: Vicente Ferrer HIV Cohort Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Vicente Ferrer HIV Cohort Study
Brief 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).
Detailed Summary:
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:
- Epidemiology: trends in HIV incidence, transmission mechanisms, socioeconomic risk factors associated with HIV.
- Incidence and prevalence of opportunistic infections, especially tuberculosis and c
Sponsor: Rural Development Trust Hospital
Current Primary Outcome: Mortality [ Time Frame: Time to event methods will be used. Participants will be followed from HIV diagnosis until death, assessed up to 30 years ]
Original Primary Outcome: Mortality [ Time Frame: Participants will be followed from HIV diagnosis until death, assessed up to 30 years ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Rural Development Trust Hospital
Dates:
Date Received: May 15, 2015
Date Started: September 2009
Date Completion: January 2040
Last Updated: December 30, 2016
Last Verified: December 2016
