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

Study Overview

• Status: Completed
• Conditions: HIV Infections

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.

• Study Type: Observational
• Enrollment (Actual): 992

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of HIV-1 infections per 100 person-years	5 years
Lost to follow-up on an annual basis (10% or better)	5 years
Post-infection viral load and CD4 count	5 years
Willingness to participate in HIV vaccine and prevention trials	5 years
Risk behavior by questionnaire	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
HIV-1 prevalence	5 years
HIV-1 genotype distribution	5 years

Collaborators and Investigators

• Sponsor: South East Asia Research Collaboration with Hawaii
• Investigators: Principal Investigator: Nittay - Phanuphak, MD., The Thai Red Cross AIDS Research Centre, Bangkok, Thailand

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: HIV-negative; male and female clients; ages 18-50 years; seeking HIV counseling; testing at TRCARC
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: SEARCH 008/RV233