Vicente Ferrer HIV Cohort Study (VFHCS)

March 28, 2023 updated by: Gerardo Alvarez-Uria, Rural Development Trust Hospital
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).

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • AP
      • Battalapalli, AP, India, 515661
        • Recruiting
        • RDT Hospital
        • Contact:
        • Principal Investigator:
          • Gerardo Alvarez-Uria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV infected patients

Description

Inclusion Criteria:

  • Positive serology for HIV

Exclusion Criteria:

  • Refuse to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time to event methods will be used. Participants will be followed from HIV diagnosis until death, assessed up to 30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rural Development Trust Hospital

Investigators

  • Principal Investigator: Gerardo Alvarez-Uria, Rural Development Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

September 1, 2039

Study Completion (Anticipated)

January 1, 2040

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VFHCS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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