HIV InfectionsNCT00278499
Prevalence of HIV and Other Sexually Transmitted Infections Among Female Sex Workers and Miners in Honghe Prefecture, Yunnan Province, China
An observational study of HIV Infections and Sexually Transmitted Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Cross-sectional surveys and Questionnaire/counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 3,800 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2006to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female sex workers and their clients in Hinghe Prefecture, Yunnan Province, China
Who may be able to join
- 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
- Male
- Works at one of the selected mine sites
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Gejiu CDC, Honghe Prefecture, Yunnan Province
Kunming, Yunnan
Kaiyuan CDC, Honghe
Kunming, Yunnan
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Cross-sectional surveys, Questionnaire/counseling
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional surveysBehavioural
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.
Questionnaire/counselingBehavioural
An initial questionnaire and counseling will occur once in addition to post-test counseling.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Female sex workers Receives: Behavioral: Cross-sectional surveys | |
| 2 | Female sex workers' clients (miners) Receives: Behavioral: Questionnaire/counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HIV-1 infection in FSWs and mine workers
Measured: 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
Measured: Throughout study
Secondary outcomes (4)
Prevalence of HIV-1 infection and selected STIs
Measured: Throughout study
HIV/STI related knowledge, attitudes, and risk behaviors in FSWs and mine workers separately
Measured: Throughout study
HIV-1 viral subtypes in FSWs and mine workers separately
Measured: Throughout study
FSW migration patterns in a sub-cohort of FSWs
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,800 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Ning Wang, MD, PhD, Principal investigator, Chinese Center for Disease Control and Prevention, National Center for AIDS/STD Prevention and ControlZhongmin Yang, MD, Principal investigator, Chinese Center for Disease Control and Prevention, National Center for AIDS/STD Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278499
- Sponsor's protocol ID
- CIPRA CH 005
- Other IDs
- CIPRA Project 1
- Status last verified
- Jan 2011
- First submitted
- 16 Jan 2006
- Last updated
- 13 Jan 2011
- Results posted
- No
Publications
Anderson AF, Qingsi Z, Hua X, Jianfeng B. China's floating population and the potential for HIV transmission: a social-behavioural perspective. AIDS Care. 2003 Apr;15(2):177-85. doi: 10.1080/0954012031000068326.
PubMed 12856339Chen XS, Yin YP, Liang GJ, Gong XD, Li HS, Poumerol G, Thuy N, Shi MQ, Yu YH. Sexually transmitted infections among female sex workers in Yunnan, China. AIDS Patient Care STDS. 2005 Dec;19(12):853-60. doi: 10.1089/apc.2005.19.853.
PubMed 16375618Ding Y, Detels R, Zhao Z, Zhu Y, Zhu G, Zhang B, Shen T, Xue X. HIV infection and sexually transmitted diseases in female commercial sex workers in China. J Acquir Immune Defic Syndr. 2005 Mar 1;38(3):314-9.
PubMed 15735451Tucker JD, Henderson GE, Wang TF, Huang YY, Parish W, Pan SM, Chen XS, Cohen MS. Surplus men, sex work, and the spread of HIV in China. AIDS. 2005 Mar 24;19(6):539-47. doi: 10.1097/01.aids.0000163929.84154.87.
PubMed 15802971Zhao R, Gao H, Shi X, Tucker JD, Yang Z, Min X, Qian H, Duan Q, Wang N. Sexually transmitted disease/HIV and heterosexual risk among miners in townships of Yunnan Province, China. AIDS Patient Care STDS. 2005 Dec;19(12):848-52. doi: 10.1089/apc.2005.19.848.
PubMed 16375617
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of HIV-1 and Other Sexually Transmitted Infections in Honghe Prefecture, Yunnan Province, China
- ClinicalTrials.gov ID
- NCT00278499
- Acronym / sponsor ID
- CIPRA CH 005
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,800 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Cross-sectional surveysFemale sex workers |
| 2 | – | Behavioral: Questionnaire/counselingFemale sex workers' clients (miners) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female sex workers and their clients in Hinghe Prefecture, Yunnan Province, China
Key inclusion criteria (6 listed)
- 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
- Male
- Works at one of the selected mine sites
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-sectional surveysCross-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. | Behavioural | 1 |
| Questionnaire/counselingAn initial questionnaire and counseling will occur once in addition to post-test counseling. | Behavioural | 2 |
Primary outcome
Incidence of HIV-1 infection in FSWs and mine workers
Time frame: 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
4 secondary outcomes
Prevalence of HIV-1 infection and selected STIs
Time frame: Throughout study
HIV/STI related knowledge, attitudes, and risk behaviors in FSWs and mine workers separately
Time frame: Throughout study
HIV-1 viral subtypes in FSWs and mine workers separately
Time frame: Throughout study
FSW migration patterns in a sub-cohort of FSWs
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
- Background: PubMed 12856339Anderson AF, Qingsi Z, Hua X, Jianfeng B. China's floating population and the potential for HIV transmission: a social-behavioural perspective. AIDS Care. 2003 Apr;15(2):177-85. doi: 10.1080/0954012031000068326.
- Background: PubMed 16375618Chen XS, Yin YP, Liang GJ, Gong XD, Li HS, Poumerol G, Thuy N, Shi MQ, Yu YH. Sexually transmitted infections among female sex workers in Yunnan, China. AIDS Patient Care STDS. 2005 Dec;19(12):853-60. doi: 10.1089/apc.2005.19.853.
- Background: PubMed 15735451Ding Y, Detels R, Zhao Z, Zhu Y, Zhu G, Zhang B, Shen T, Xue X. HIV infection and sexually transmitted diseases in female commercial sex workers in China. J Acquir Immune Defic Syndr. 2005 Mar 1;38(3):314-9.
- Background: PubMed 15802971Tucker JD, Henderson GE, Wang TF, Huang YY, Parish W, Pan SM, Chen XS, Cohen MS. Surplus men, sex work, and the spread of HIV in China. AIDS. 2005 Mar 24;19(6):539-47. doi: 10.1097/01.aids.0000163929.84154.87.
- Background: PubMed 16375617Zhao R, Gao H, Shi X, Tucker JD, Yang Z, Min X, Qian H, Duan Q, Wang N. Sexually transmitted disease/HIV and heterosexual risk among miners in townships of Yunnan Province, China. AIDS Patient Care STDS. 2005 Dec;19(12):848-52. doi: 10.1089/apc.2005.19.848.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Wang, MD, PhD principal investigator
Chinese Center for Disease Control and Prevention, National Center for AIDS/STD Prevention and Control
Zhongmin Yang, MD principal investigator
Chinese Center for Disease Control and Prevention, National Center for AIDS/STD Prevention and Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sexually Transmitted Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HIV-1 infection in FSWs and mine workers (time frame: Throughout study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00278499, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2011.