Clinical trial NCT00433030: Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand
Official title: Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Highly Active Antiretroviral Therapy
HIV Viral load
HIV drug Resistance
Thailand
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Global Fund
name: Ministry of Health, Thailand
First posted: 2007-02-09
Enrollment: 2816
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected Adults and Children

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Doi Saket
country: Thailand
facility: Doi Saket Hospital
state: Chiang Mai
city: Mae on
country: Thailand
facility: Mae on Hospital
state: Chiang Mai
city: Mae Rim
country: Thailand
facility: Nakornping Hospital
state: Chiang Mai
city: San Kamphaeng
country: Thailand
facility: San Kamphaeng Hospital
state: Chiang Mai
city: San Pa Tong
country: Thailand
facility: Sanpatong Hospital
state: Chiang Mai
city: San Sai
country: Thailand
facility: San Sai Hospital
state: Chiang Mai
city: Mae Chan
country: Thailand
facility: Mae Chan Hospital
state: Chiang Rai
city: Mae Sai
country: Thailand
facility: Mae Sai Hospital
state: Chiang Rai
city: Phan
country: Thailand
facility: Phan Hospital
state: Chiang Rai
city: Chiang Rai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
state: Chiangrai
city: Sattahip
country: Thailand
facility: Somdej Pranangchao Sirikit Hospital
state: Chonburi
city: Kranuan
country: Thailand
facility: Kranuan Crown Prince Hospital
state: Khon Kaen
city: Maha Sarakham
country: Thailand
facility: Mahasarakam Hospital
state: Mahasarakam
city: Nakhon Pathom
country: Thailand
facility: Nakhonpathom Hospital
state: Nakhonpathom
city: Chiang Kham
country: Thailand
facility: Chiang Kham Hospital
state: Phayao
city: Hat Yai
country: Thailand
facility: Hat Yai Hospital
state: Songkla
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Bangkok
country: Thailand
facility: Nopparat Rajathanee Hospital
city: Bangkok
country: Thailand
facility: Somdej Prapinklao Hospital
city: Chachoengsao
country: Thailand
facility: Chacheongsao Hospital
city: Chanthaburi
country: Thailand
facility: Prapokklao Hospital
city: Chon Buri
country: Thailand
facility: Chonburi Hospital
city: Kalasin
country: Thailand
facility: Kalasin Hospital
city: Kanchanaburi
country: Thailand
facility: Phaholpolphayuhasena Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
city: Khon Kaen
country: Thailand
facility: Regional Health Promotion Centre 6, Khon Kaen
city: Lampang
country: Thailand
facility: Lampang Hospital
city: Lamphun
country: Thailand
facility: Lamphun Hospital
city: Nakhon Ratchasima
country: Thailand
facility: Maharaj Nakornratchasrima Hospital
city: Nong Khai
country: Thailand
facility: Nong Khai Hospital
city: Nonthaburi
country: Thailand
facility: Pranangklao Hospital
city: Phayao
country: Thailand
facility: Phayao Provincial Hospital
city: Phitsanulok
country: Thailand
facility: Buddhachinaraj Hospital
city: Ratchaburi
country: Thailand
facility: Ratchaburi Hospital
city: Rayong
country: Thailand
facility: Rayong Hospital
city: Roi-et
country: Thailand
facility: Roi-et Hospital
city: Samut Prakan
country: Thailand
facility: Samutprakarn Hospital
city: Samut Sakhon
country: Thailand
facility: Samutsakon Hospital
Study officials:
affiliation: Institut de Recherche pour le Developpement
name: Gonzague JOURDAIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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