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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00433030
• Lead Sponsor: Institut de Recherche pour le Developpement

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-08
• Study First Posted: 2007-02-09
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2816

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (38)

Doi Saket Hospital; 🇹🇭 Doi Saket, Chiang Mai, Thailand

San Sai Hospital; 🇹🇭 San Sai, Chiang Mai, Thailand

Phan Hospital; 🇹🇭 Phan, Chiang Rai, Thailand

San Kamphaeng Hospital; 🇹🇭 San Kamphaeng, Chiang Mai, Thailand

Sanpatong Hospital; 🇹🇭 San Pa Tong, Chiang Mai, Thailand

Somdej Prapinklao Hospital; 🇹🇭 Bangkok, Thailand

Prapokklao Hospital; 🇹🇭 Chanthaburi, Thailand

Lamphun Hospital; 🇹🇭 Lamphun, Thailand

Ratchaburi Hospital; 🇹🇭 Ratchaburi, Thailand

Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

Mae Chan Hospital; 🇹🇭 Mae Chan, Chiang Rai, Thailand

Chacheongsao Hospital; 🇹🇭 Chachoengsao, Thailand

Chonburi Hospital; 🇹🇭 Chon Buri, Thailand

Lampang Hospital; 🇹🇭 Lampang, Thailand

Roi-et Hospital; 🇹🇭 Roi-et, Thailand

Chiangrai Prachanukroh Hospital; 🇹🇭 Chiang Rai, Chiangrai, Thailand

Mae Sai Hospital; 🇹🇭 Mae Sai, Chiang Rai, Thailand

Kranuan Crown Prince Hospital; 🇹🇭 Kranuan, Khon Kaen, Thailand

Khon Kaen Hospital; 🇹🇭 Khon Kaen, Thailand

Mae on Hospital; 🇹🇭 Mae on, Chiang Mai, Thailand

Nakornping Hospital; 🇹🇭 Mae Rim, Chiang Mai, Thailand

Somdej Pranangchao Sirikit Hospital; 🇹🇭 Sattahip, Chonburi, Thailand

Mahasarakam Hospital; 🇹🇭 Maha Sarakham, Mahasarakam, Thailand

Maharaj Nakornratchasrima Hospital; 🇹🇭 Nakhon Ratchasima, Thailand

Pranangklao Hospital; 🇹🇭 Nonthaburi, Thailand

Buddhachinaraj Hospital; 🇹🇭 Phitsanulok, Thailand

Nakhonpathom Hospital; 🇹🇭 Nakhon Pathom, Nakhonpathom, Thailand

Kalasin Hospital; 🇹🇭 Kalasin, Thailand

Phaholpolphayuhasena Hospital; 🇹🇭 Kanchanaburi, Thailand

Regional Health Promotion Centre 6, Khon Kaen; 🇹🇭 Khon Kaen, Thailand

Samutsakon Hospital; 🇹🇭 Samut Sakhon, Thailand

Hat Yai Hospital; 🇹🇭 Hat Yai, Songkla, Thailand

Nopparat Rajathanee Hospital; 🇹🇭 Bangkok, Thailand

Nong Khai Hospital; 🇹🇭 Nong Khai, Thailand

Phayao Provincial Hospital; 🇹🇭 Phayao, Thailand

Rayong Hospital; 🇹🇭 Rayong, Thailand

Chiang Kham Hospital; 🇹🇭 Chiang Kham, Phayao, Thailand

Samutprakarn Hospital; 🇹🇭 Samut Prakan, Thailand