Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand

This study is currently recruiting participants.
Verified February 2013 by Institut de Recherche pour le Developpement
Sponsor:
Collaborators:
Global Fund
Ministry of Health, Thailand
Information provided by (Responsible Party):
Gonzague Jourdain, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT00433030
First received: February 8, 2007
Last updated: February 19, 2013
Last verified: February 2013

February 8, 2007
February 19, 2013
January 2007
November 2016   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00433030 on ClinicalTrials.gov Archive Site
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Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand
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Since 2004, the Thai Ministry of Public Health has massively scaled up antiretroviral treatment programs to provide therapy to more than 80,000 patients with partial support of the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM).

As access to HIV care continues to expand under the universal health coverage system, it is important to document and analyze the efficacy, tolerance, toxicity and acceptability of antiretroviral therapy within pilot treatment programs, to provide evidence based feedback and recommendations to the national program and policy makers.

As Thailand is rapidly expanding access to antiretroviral treatments under the universal health coverage system, it is crucial to document and learn from pilot antiretroviral treatment programs, in particular the medical outcomes and logistical, and organizational issues faced by hospital teams and patients in order to adapt the ARV delivery and monitoring system to various local settings.

Specific objectives

  1. Analyze data collected in patients participating in the PHPT antiretroviral treatment program, in accordance to national and international guidelines, with no experimental interventions.
  2. To determine factors associated with treatment outcome including immune status, virologic factors and antiretroviral drugs levels
  3. To study the operational aspects of integrating comprehensive HIV care into the existing care system with regards to new activities generated at the hospital level (counseling, referral systems, biological monitoring), the impact on other health activities, mobilization of human and financial resources, affordability and sustainability.

The population of the study consists of approximately 2,000 consenting HIV-infected patients, including one-third of children, receiving HIV care as part of the GF-ATM or OXFAM Access to Antiretroviral programs, presenting at any of the PHPT network hospitals.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

HIV-infected Adults and Children

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
November 2016
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults and children (children are defined as less than 18 years old) patients are eligible for the inclusion in the cohort if they meet all the following inclusion criteria:

    • Participation in the GFATM or Oxfam Access to Antiretroviral Programs
    • For adults, consent to have their clinical or biological data used for this research study, and willingness to be followed at one of the PHPT network hospitals. For children, caregiver's consent to participate, willingness to bring the child to the scheduled visits for the duration of the treatment, and to have the child's clinical or biological data used for this research study.

Exclusion Criteria:

  • This is an observational study of an access to treatment program, therefore all patients who require treatment and are willing to be followed by the medical team and have their data collected can be enrolled in the study. The only exclusion criteria would be refusal to participate and the discontinuation criteria would be withdrawal of consent.
Both
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Contact: Marc Lallemant, MD +66 53819125 ext 0 marc@phpt.org
Contact: Gonzague Jourdain, MD, PhD +66 53819125 ext 0 gonzague.jourdain@ird.fr
Thailand
 
NCT00433030
PHPT-Cohort
No
Gonzague Jourdain, Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement
  • Global Fund
  • Ministry of Health, Thailand
Principal Investigator: Marc Lallemant, MD Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP