Vicente Ferrer HIV Cohort Study

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).

Recruiting

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Key information

Conditions

HIV Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Cryptococcosis Disease Attributes Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycoses Noncommunicable Diseases Opportunistic Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Tuberculosis

Sex eligibility

All sexes

Study type

Observational

Primary location

RDT Hospital

Battalapalli, Andhra Pradesh, 515661, India

Location status: Recruiting

Location contact

Gerardo Alvarez Uria, MD PhD

CONTACT

[email protected]

Gerardo Alvarez-Uria

PRINCIPAL_INVESTIGATOR

About this study

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 cryptococcosis.
Life expectancy and factors associated with mortality
Describe the retention across the continuum of care and investigate factors associated with loss to follow-up.
Toxicity and effectiveness of antiretroviral therapy.
Effectiveness of programmes to prevent mother to child transmission.
Incidence and prevalence of non-communicable diseases such as cancer or cardiovascular diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Positive serology for HIV

Exclusion criteria

Refuse to consent

Treatment and study plan

Primary outcomes

Mortality

Time frame: Time to event methods will be used. Participants will be followed from HIV diagnosis until death, assessed up to 30 years

Survival since diagnosis of HIV infection

Study contacts

Contact information is provided by the study sponsor or research team.

Gerardo Alvarez-Uria

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rural Development Trust Hospital

Other

Registry information

Acronym: VFHCS

Important dates

Study start: 2009
Primary completion: 2039
Study completion: 2040
First posted: May 27, 2015
Registry last updated: Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting