Prevalence of HIV and Other Sexually Transmitted Infections Among Female Sex Workers and Miners in Honghe Prefecture, Yunnan Province, China

Epidemiology of HIV-1 and Other Sexually Transmitted Infections in Honghe Prefecture, Yunnan Province, China

The purpose of this study is to collect data on the HIV strains currently circulating among female sex workers (FSWs) and their clients. In addition, this study will identify potential participants for future studies.

Study Overview

Detailed Description

The overwhelming majority of HIV/AIDS patients live in the developing world. The rate of HIV infection in China has been consistently and steadily increasing over the past few years. Commercial sex workers and their clients are at highest risk for HIV infection and transmission. Yunnan Province is reported to be home to about half of China's HIV infected population. Honghe Prefecture accounts for 14% of the total reported HIV infections in Yunnan Province. Even though the incidence of HIV is important in tracking the HIV epidemic, there are little data on HIV incidence among FSWs in China. Estimates of HIV incidence are essential for optimally monitoring the HIV epidemic, knowing where to focus prevention efforts, and evaluating the success of vaccines and other prevention strategies. The purpose of this study is to estimate the incidence of and risk factors for HIV infection among FSWs and miners in Honghe Prefecture, Yunnan Province, China. In addition, this study will identify and describe the different HIV clades currently circulating among FSWs and miners. Four cross-sectional surveys will be conducted: three among FSWs and one among miners. In addition, a 12-month cohort study will be conducted among a subgroup of FSWs enrolled in the baseline cross-sectional survey in Kaiyuan City, Honghe Prefecture, Yunnan Province, China.

FSWs will complete cross-sectional surveys at study entry, Month 6, and Month 12. FSWs will complete two study visits: one to complete the survey and another to receive test results and participate in post-test counseling. Physical and gynecologic exams and blood collection will occur at both study visits. Each survey will include general participant information and sexual activity and drug use habits.

Pre-test counseling will be provided to all FSWs; those who elect to donate specimens for laboratory testing will have an additional appointment within 6 weeks of donation to receive test results and post-test counseling. Multiple counseling sessions may be provided to some participants based on their individual needs. FSWs found to be either infected with HIV or another sexually transmitted disease (STD) will be referred for further medical evaluation and treatment.

Every fourth participant enrolled in the FSW cross-sectional survey, all FSWs found to be HIV infected, and all FSWs who are intravenous drug users will participate in a substudy lasting 12 months. Study staff will contact each participant once a month for 12 months and ask them for location information and about their current behaviors.

Participants enrolled as FSW clients (miners) will participate in two study visits. The first visit will include completing a questionnaire and counseling. The second study visit will include post-test counseling to inform participants of their test results and will occur about one month after the first visit. A physical exam and blood and urine collection will occur at both visits.

Study Type

Observational

Enrollment (Anticipated)

3800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yunnan
      • Kunming, Yunnan, China
        • Gejiu CDC, Honghe Prefecture, Yunnan Province
      • Kunming, Yunnan, China
        • Kaiyuan CDC, Honghe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Female sex workers and their clients in Hinghe Prefecture, Yunnan Province, China

Description

Inclusion Criteria for FSWs Completing Cross-sectional Survey:

  • Self-reported to have sold sex for money within the 3 months prior to study entry
  • Works at one of the study sites

Inclusion Criteria for FSW Cohort Study:

  • Participated in the baseline cross-sectional survey in Kaiyuan City, Honghe Prefecture, Yunnan Province, China
  • Willing to provide updated contact information (and a cell phone number, if available)
  • Willing to be contacted by study staff once a month for 12 consecutive months

Inclusion Criteria for FSW Client (Miner) Study:

  • Male
  • Works at one of the selected mine sites

Inclusion Criteria for All Participants:

  • Parent or guardian willing to provide informed consent, if applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Female sex workers
Cross-sectional surveys will occur at study entry, Month 6, and Month 12. Every fourth participant enrolled in the FSW cross-sectional survey, all FSWs found to be HIV infected, and all FSWs who are intravenous drug users will participate in a substudy lasting 12 months.
2
Female sex workers' clients (miners)
An initial questionnaire and counseling will occur once in addition to post-test counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of HIV-1 infection in FSWs and mine workers
Time Frame: Throughout study
Throughout study
Risk factors for HIV-1 infection including, but not limited to injection drug use, STIs, and unprotected sex among FSWs and mine workers separately
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of HIV-1 infection and selected STIs
Time Frame: Throughout study
Throughout study
HIV/STI related knowledge, attitudes, and risk behaviors in FSWs and mine workers separately
Time Frame: Throughout study
Throughout study
HIV-1 viral subtypes in FSWs and mine workers separately
Time Frame: Throughout study
Throughout study
FSW migration patterns in a sub-cohort of FSWs
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ning Wang, MD, PhD, Chinese Center for Disease Control and Prevention, National Center for AIDS/STD Prevention and Control
  • Principal Investigator: Zhongmin Yang, MD, Chinese Center for Disease Control and Prevention, National Center for AIDS/STD Prevention and Control

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 13, 2011

Last Update Submitted That Met QC Criteria

January 12, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • CIPRA CH 005
  • CIPRA Project 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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