Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-14 @ 11:15 AM
Study NCT ID:
NCT02454569
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2015-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vicente Ferrer HIV Cohort Study
Sponsor:
Rural Development Trust Hospital
Organization:
Study Overview
Official Title:
Vicente Ferrer HIV Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VFHCS
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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: