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Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand

This study has been completed.
Sponsor:
Information provided by:
South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00713531
First received: July 7, 2008
Last updated: August 10, 2010
Last verified: July 2008

July 7, 2008
August 10, 2010
July 2008
December 2009   (final data collection date for primary outcome measure)
  • number of HIV-1 infections per 100 person-years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Lost to follow-up on an annual basis (10% or better) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Post-infection viral load and CD4 count [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Willingness to participate in HIV vaccine and prevention trials [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Risk behavior by questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
number of HIV-1 infections per 100 person-years lost to follow-up on an annual basis (10% or better) Post-infection viral load and CD4 count Willingness to participate in HIV vaccine and prevention trials and risk behavior by questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00713531 on ClinicalTrials.gov Archive Site
  • HIV-1 prevalence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • HIV-1 genotype distribution [ Time Frame: 5 years ] [ Designated as safety issue: No ]
HIV-1 prevalence HIV-1 genotype distribution [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand
Not Provided

The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include:

  1. assess incidence of HIV-1 and volunteer retention
  2. describe early viral load and CD4 counts
  3. assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials
  4. describe volunteer risk behavior

Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma, CD4, HIV-RNA

Non-Probability Sample

Population in Thailand who are seeking HIV counseling and testing at TRCARC

HIV Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
992
June 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Man or woman aged 18-50 years
  • Willing to provide location or contact information and allow contact
  • Thai citizenship as identified by Thai National Identification card
  • Ability and willingness to provide consent
  • Availability for follow-up for the planned study duration

Exclusion Criteria:

  • Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
  • Persons who are known to be HIV-positive
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00713531
SEARCH 008/RV233
No
The Red Cross AIDS Research Centre, Bangkok, Thailand, AFRIMS USA
South East Asia Research Collaboration with Hawaii
Not Provided
Principal Investigator: Nittay - Phanuphak, MD. The Thai Red Cross AIDS Research Centre, Bangkok, Thailand
South East Asia Research Collaboration with Hawaii
July 2008

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