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Completed

NCT Number: NCT00713531

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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

SEARCH Research Foundation

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jul 11, 2008
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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