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

March 16, 2018 updated by: GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2816

Contacts and Locations

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

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Bhumibol Adulyadej Hospital
      • Bangkok, Thailand
        • Nopparat Rajathanee Hospital
      • Bangkok, Thailand
        • Somdej Prapinklao Hospital
      • Chachoengsao, Thailand
        • Chacheongsao Hospital
      • Chanthaburi, Thailand
        • Prapokklao Hospital
      • Chon Buri, Thailand
        • Chonburi Hospital
      • Kalasin, Thailand
        • Kalasin Hospital
      • Kanchanaburi, Thailand
        • Phaholpolphayuhasena Hospital
      • Khon Kaen, Thailand
        • Khon Kaen Hospital
      • Khon Kaen, Thailand
        • Regional Health Promotion Centre 6, Khon Kaen
      • Lampang, Thailand
        • Lampang Hospital
      • Lamphun, Thailand
        • Lamphun Hospital
      • Nakhon Ratchasima, Thailand
        • Maharaj Nakornratchasrima Hospital
      • Nong Khai, Thailand
        • Nong Khai Hospital
      • Nonthaburi, Thailand
        • Pranangklao Hospital
      • Phayao, Thailand
        • Phayao Provincial Hospital
      • Phitsanulok, Thailand
        • Buddhachinaraj Hospital
      • Ratchaburi, Thailand
        • Ratchaburi Hospital
      • Rayong, Thailand
        • Rayong Hospital
      • Roi-et, Thailand
        • Roi-et Hospital
      • Samut Prakan, Thailand
        • Samutprakarn Hospital
      • Samut Sakhon, Thailand
        • Samutsakon Hospital
    • Chiang Mai
      • Doi Saket, Chiang Mai, Thailand
        • Doi Saket Hospital
      • Mae Rim, Chiang Mai, Thailand
        • Nakornping Hospital
      • Mae on, Chiang Mai, Thailand
        • Mae on Hospital
      • San Kamphaeng, Chiang Mai, Thailand
        • San Kamphaeng Hospital
      • San Pa Tong, Chiang Mai, Thailand, 50120
        • Sanpatong Hospital
      • San Sai, Chiang Mai, Thailand
        • San Sai Hospital
    • Chiang Rai
      • Mae Chan, Chiang Rai, Thailand
        • Mae Chan Hospital
      • Mae Sai, Chiang Rai, Thailand
        • Mae Sai Hospital
      • Phan, Chiang Rai, Thailand
        • Phan Hospital
    • Chiangrai
      • Chiang Rai, Chiangrai, Thailand
        • Chiangrai Prachanukroh Hospital
    • Chonburi
      • Sattahip, Chonburi, Thailand
        • Somdej Pranangchao Sirikit Hospital
    • Khon Kaen
      • Kranuan, Khon Kaen, Thailand
        • Kranuan Crown Prince Hospital
    • Mahasarakam
      • Maha Sarakham, Mahasarakam, Thailand
        • Mahasarakam Hospital
    • Nakhonpathom
      • Nakhon Pathom, Nakhonpathom, Thailand
        • Nakhonpathom Hospital
    • Phayao
      • Chiang Kham, Phayao, Thailand
        • Chiang Kham Hospital
    • Songkla
      • Hat Yai, Songkla, Thailand
        • Hat Yai Hospital

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 Adults and Children

Description

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.

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

Collaborators and Investigators

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

Sponsor

Institut de Recherche pour le Developpement

Collaborators

Ministry of Health, Thailand
Global Fund

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

January 1, 2007

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 8, 2007

First Submitted That Met QC Criteria

February 8, 2007

First Posted (Estimate)

February 9, 2007

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHPT-Cohort

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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