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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
History of Changes
  Purpose

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

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Plasma, CD4, HIV-RNA


Enrollment: 992
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713531

Locations
Thailand
The Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Investigators
Principal Investigator: Nittay - Phanuphak, MD. The Thai Red Cross AIDS Research Centre, Bangkok, Thailand
  More Information

No publications provided

Responsible Party: The Red Cross AIDS Research Centre, Bangkok, Thailand, AFRIMS USA
ClinicalTrials.gov Identifier: NCT00713531     History of Changes
Other Study ID Numbers: SEARCH 008/RV233
Study First Received: July 7, 2008
Last Updated: August 10, 2010
Health Authority: Thailand: Ministry of Public Health

Keywords provided by South East Asia Research Collaboration with Hawaii:
HIV-negative
male and female clients
ages 18-50 years
seeking HIV counseling
testing at TRCARC

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013