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Vicente Ferrer HIV Cohort Study (VFHCS)

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ClinicalTrials.gov Identifier: NCT02454569
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Gerardo Alvarez-Uria, Rural Development Trust Hospital

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).

Condition or disease
HIV Tuberculosis Cryptococcosis Opportunistic Infections Noncommunicable Diseases

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 [Patient Registry]
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Vicente Ferrer HIV Cohort Study
Study Start Date : September 2009
Estimated Primary Completion Date : September 2039
Estimated Study Completion Date : January 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV infected patients
Criteria

Inclusion Criteria:

  • Positive serology for HIV

Exclusion Criteria:

  • Refuse to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454569


Contacts
Contact: Gerardo Alvarez-Uria hivbtp@gmail.com

Locations
India
RDT Hospital Recruiting
Battalapalli, AP, India, 515661
Contact: Gerardo Alvarez Uria, MD PhD       hivbtp@gmail.com   
Principal Investigator: Gerardo Alvarez-Uria         
Sponsors and Collaborators
Rural Development Trust Hospital
Investigators
Principal Investigator: Gerardo Alvarez-Uria Rural Development Trust

Publications of Results:

Responsible Party: Gerardo Alvarez-Uria, Head of the Department of Infectious Diseases, Rural Development Trust Hospital
ClinicalTrials.gov Identifier: NCT02454569     History of Changes
Other Study ID Numbers: VFHCS
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Tuberculosis
Opportunistic Infections
Cryptococcosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Virus Diseases
Parasitic Diseases
Mycoses