NCT00479141

Brief Summary

The HIV epidemic in China has reached a phase of exponential growth; the number of new infections has been steadily increasing over the past decade. The purpose of this study is to evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for HIV-Positive Villagers and decrease HIV related stigma in Rural China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,199

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 27, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

May 25, 2007

Last Update Submit

March 26, 2009

Conditions

HIV Infections

Keywords

Treatment NaiveTreatment ExperiencedComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants

    Throughout study

Secondary Outcomes (1)

  • Level of stigma among community members, including HIV knowledge

    Throughout study

Study Arms (2)

1

EXPERIMENTAL

HIV infected participants and their families

Behavioral: HIV skills training

2

EXPERIMENTAL

Popular Opinion Leaders (POL) participants

Behavioral: Popular Opinion Leaders training

Interventions

HIV skills trainingBEHAVIORAL

Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15

1
Popular Opinion Leaders trainingBEHAVIORAL

Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • Resident of Funan County or Yingzhou District, Anhui Province, China
  • Willing to provide location information
  • Resident of Funan County or Yingzhou District, Anhui Province, China
  • Family member of HIV infected participant
  • Identified as an influential member of the community
  • Resident of Funan County or Yingzhou District, Anhui Province, China
  • Willing to attend training and follow-up meetings Note: Both HIV infected and non HIV infected individuals may participate as POLs
  • Resident of Funan County or Yingzhou District, Anhui Province, China
  • Randomly selected and invited to participate in study

You may not qualify if:

  • Spent more than 6 months outside the community within the year prior to study entry
  • Permanent disability (e.g., deafness, serious mental illness, mental retardation)
  • Has not made contact with study staff after three attempts
  • Permanent disability (e.g., deafness, serious mental illness, mental retardation)
  • Spent more than 6 months outside the community within the year prior to study entry
  • Permanent disability (e.g., deafness, serious mental illness, mental retardation)
  • Spent more than 6 months outside the community within the year prior to study entry
  • Permanent disability (e.g., deafness, serious mental illness, mental retardation)
  • Has not made contact with study staff after three attempts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuyang CDC Office

Beijing, 100050, China

Location

Related Publications (1)

  • Wu Z, Sullivan SG, Wang Y, Rotheram-Borus MJ, Detels R. Evolution of China's response to HIV/AIDS. Lancet. 2007 Feb 24;369(9562):679-90. doi: 10.1016/S0140-6736(07)60315-8.

    PMID: 17321313BACKGROUND

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Zunyou Wu, MD, PhD

    Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention

    STUDY CHAIR

  • Jie Xu, MD, MS, MPH

    Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

March 1, 2006

Primary Completion

July 1, 2007

Study Completion

December 1, 2008

Last Updated

March 27, 2009

Record last verified: 2009-01

Locations

CN(1)