NCT00278499

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 13, 2011

Status Verified

January 1, 2011

Enrollment Period

4.8 years

First QC Date

January 16, 2006

Last Update Submit

January 12, 2011

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of HIV-1 infection in FSWs and mine workers

    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

    Throughout study

Secondary Outcomes (4)

  • Prevalence of HIV-1 infection and selected STIs

    Throughout study

  • HIV/STI related knowledge, attitudes, and risk behaviors in FSWs and mine workers separately

    Throughout study

  • HIV-1 viral subtypes in FSWs and mine workers separately

    Throughout study

  • FSW migration patterns in a sub-cohort of FSWs

    Throughout study

Study Arms (2)

1

Female sex workers

Behavioral: Cross-sectional surveys

2

Female sex workers' clients (miners)

Behavioral: Questionnaire/counseling

Interventions

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.

1

An initial questionnaire and counseling will occur once in addition to post-test counseling.

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gejiu CDC, Honghe Prefecture, Yunnan Province

Kunming, Yunnan, China

Location

Kaiyuan CDC, Honghe

Kunming, Yunnan, China

Location

Related Publications (5)

  • 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.

    PMID: 12856339BACKGROUND
  • Chen 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.

    PMID: 16375618BACKGROUND
  • Ding 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.

    PMID: 15735451BACKGROUND
  • Tucker 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.

    PMID: 15802971BACKGROUND
  • Zhao 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.

    PMID: 16375617BACKGROUND

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Interventions

Cross-Sectional StudiesSurveys and QuestionnairesCounseling

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthData CollectionMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

March 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 13, 2011

Record last verified: 2011-01

Locations