Skip to content

Vicente Ferrer HIV Cohort Study

Vicente Ferrer HIV Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02454569
Acronym
VFHCS
Enrollment
30000
Registered
2015-05-27
Start date
2009-09-30
Completion date
2040-01-31
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptococcosis, HIV, Noncommunicable Diseases, Opportunistic Infections, Tuberculosis

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.

Interventions

None listed

Sponsors

Rural Development Trust Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Positive serology for HIV

Exclusion criteria

* Refuse to consent

Design outcomes

Primary

MeasureTime frameDescription
MortalityTime to event methods will be used. Participants will be followed from HIV diagnosis until death, assessed up to 30 yearsSurvival since diagnosis of HIV infection

Countries

India

Contacts

Primary ContactGerardo Alvarez-Uria
hivbtp@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026