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

NCT ID: NCT00433030

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2816 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2018-02-28

Brief Summary

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.

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Global Fund

OTHER

Sponsor Role: collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role: collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role: lead

Responsible Party

GONZAGUE JOURDAIN

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gonzague JOURDAIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Recherche pour le Developpement

Locations

Mae Chan Hospital

Mae Chan, Changwat Chiang Rai, Thailand

Mae Sai Hospital

Mae Sai, Changwat Chiang Rai, Thailand

Phan Hospital

Phan, Changwat Chiang Rai, Thailand

Somdej Pranangchao Sirikit Hospital

Sattahip, Changwat Chon Buri, Thailand

Kranuan Crown Prince Hospital

Kranuan, Changwat Khon Kaen, Thailand

Chiang Kham Hospital

Chiang Kham, Changwat Phayao, Thailand

Hat Yai Hospital

Hat Yai, Changwat Songkhla, Thailand

Doi Saket Hospital

Doi Saket, Chiang Mai, Thailand

Mae on Hospital

Mae On, Chiang Mai, Thailand

Nakornping Hospital

Mae Rim, Chiang Mai, Thailand

San Kamphaeng Hospital

San Kamphaeng, Chiang Mai, Thailand

Sanpatong Hospital

San Pa Tong, Chiang Mai, Thailand

San Sai Hospital

San Sai, Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital

Chiang Rai, Chiangrai, Thailand

Mahasarakam Hospital

Maha Sarakham, Mahasarakam, Thailand

Nakhonpathom Hospital

Nakhon Pathom, Nakhonpathom, Thailand

Bhumibol Adulyadej Hospital

Bangkok, , Thailand

Nopparat Rajathanee Hospital

Bangkok, , Thailand

Somdej Prapinklao Hospital

Bangkok, , Thailand

Chacheongsao Hospital

Chachoengsao, , Thailand

Prapokklao Hospital

Chanthaburi, , Thailand

Chonburi Hospital

Chon Buri, , Thailand

Kalasin Hospital

Kalasin, , Thailand

Phaholpolphayuhasena Hospital

Kanchanaburi, , Thailand

Khon Kaen Hospital

Khon Kaen, , Thailand

Regional Health Promotion Centre 6, Khon Kaen

Khon Kaen, , Thailand

Lampang Hospital

Lampang, , Thailand

Lamphun Hospital

Lamphun, , Thailand

Samutprakarn Hospital

Mueang Samut Prakan, , Thailand

Maharaj Nakornratchasrima Hospital

Nakhon Ratchasima, , Thailand

Nong Khai Hospital

Nong Khai, , Thailand

Pranangklao Hospital

Nonthaburi, , Thailand

Phayao Provincial Hospital

Phayao, , Thailand

Buddhachinaraj Hospital

Phitsanulok, , Thailand

Ratchaburi Hospital

Ratchaburi, , Thailand

Rayong Hospital

Rayong, , Thailand

Roi-et Hospital

Roi Et, , Thailand

Samutsakon Hospital

Samut Sakhon, , Thailand

Countries

Thailand

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Other Identifiers

PHPT-Cohort

Identifier Type: -

Identifier Source: org_study_id