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CompletedNCT00713531Updated May 28, 2015

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

An observational study in HIV Infections, sponsored by SEARCH Research Foundation. Completed at 1 site in Thailand. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by SEARCH Research Foundation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
992
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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
Read the 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV-negative
  • male and female clients
  • ages 18-50 years
  • seeking HIV counseling
  • testing at TRCARC
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 992 is above the median of 200 across 713 observational studies indexed under HIV Infections.

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Lead sponsor

SEARCH Research Foundation is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
992 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. number of HIV-1 infections per 100 person-years

    Time frame: 5 years

  2. Lost to follow-up on an annual basis (10% or better)

    Time frame: 5 years

  3. Post-infection viral load and CD4 count

    Time frame: 5 years

  4. Willingness to participate in HIV vaccine and prevention trials

    Time frame: 5 years

  5. Risk behavior by questionnaire

    Time frame: 5 years

Secondary outcomes

  1. HIV-1 prevalence

    Time frame: 5 years

  2. HIV-1 genotype distribution

    Time frame: 5 years

07

Study locations

1 site
  • The Thai Red Cross AIDS Research Centre
    Bangkok, 10330, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00713531
Lead sponsor
SEARCH Research Foundation
Responsible party
Assoc.Prof.Jintanat Ananworanich, M.D. (Jintanat Ananworanich, SEARCH Research Foundation) — Principal investigator
First posted
Jul 11, 2008
Start date
Jul 2008
Primary completion
Dec 2009
Completion
Jun 2010
Last update
May 28, 2015

Study contacts

Nittay - Phanuphak, MD.
principal investigator · The Thai Red Cross AIDS Research Centre, Bangkok, Thailand

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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