A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00479141
First received: May 25, 2007
Last updated: March 26, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: HIV skills training
Behavioral: Popular Opinion Leaders training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Cluster-Randomized Trail to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life (QOL) For HIV-Positive Villagers in Rural China

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of stigma among community members, including HIV knowledge [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 3199
Study Start Date: March 2006
Study Completion Date: December 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HIV infected participants and their families
Behavioral: HIV skills training
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
Experimental: 2
Popular Opinion Leaders (POL) participants
Behavioral: Popular Opinion Leaders training
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.

Detailed Description:

Over the past decade, the rates of HIV infection and death due to HIV/AIDS have been steadily increasing in China. The China Comprehensive AIDS Response (China CARES) program was developed in 2003 in order to help poor counties and those with severe epidemic problems increase public awareness and improve knowledge about epidemic diseases such as HIV. Currently, behavioral interventions focusing on individual skills training and self-efficacy building for HIV infected individuals are not included in China CARES. Fuyang, Anhui Province, China has a high rate of HIV infected individuals, many of whom were former plasma donors (FPDs) and would benefit from HIV skills training.

In 2004, CIPRA conducted a study (CIPRA CH 002A), entitled "A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China," which provided insight into HIV infected individuals in Fuyang, Anhui Province, China. According to the results of CIRPA CH 002A, most HIV infected individuals described their QOL as poor. The factors affecting their poor QOL include poverty, poor health, stigma and discrimination. Participants in the CIPRA CH 002A study showed interest in learning more about HIV/AIDS disease and treatment. This study will last 18 months. HIV infected participants and their families will attend eight 2-hour group skills training sessions during Weeks 1 through 8, and booster sessions every two months during Months 3 through 15. Popular Opinion Leaders (POL) participants will attend 4 weeks of 2-hour training sessions about anti-stigma and anti-discrimination, followed by support meetings every 2 months during Months 2 through 13. Some participants will complete cross-sectional surveys evaluating the levels of stigma and discrimination in the community at study entry and at Months 6 and 12 following completion of POL training. All participants will complete follow-up visits at Months 6 and 12.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for HIV Infected Individuals:

  • HIV infected
  • Resident of Funan County or Yingzhou District, Anhui Province, China
  • Willing to provide location information

Inclusion Criteria for Family members of HIV Infected Individuals:

  • Resident of Funan County or Yingzhou District, Anhui Province, China
  • Family member of HIV infected participant

Inclusion Criteria for POLs:

  • 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

Inclusion Criteria for Cross-Sectional Survey Participants:

  • Resident of Funan County or Yingzhou District, Anhui Province, China
  • Randomly selected and invited to participate in study

Exclusion Criteria for HIV Infected Individuals:

  • 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

Exclusion Criteria for Family Members of HIV Infected Individuals:

  • Permanent disability (e.g., deafness, serious mental illness, mental retardation)

Exclusion Criteria for POLs:

  • 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)

Exclusion Criteria for Cross-Sectional Survey Participants:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479141

Locations
China
Fuyang CDC Office
Beijing, China, 100050
Sponsors and Collaborators
Investigators
Study Chair: 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
  More Information

Additional Information:
Publications:
Responsible Party: Rona Siskind, DAIDS
ClinicalTrials.gov Identifier: NCT00479141     History of Changes
Other Study ID Numbers: CIPRA CH 002B
Study First Received: May 25, 2007
Last Updated: March 26, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Naive
Treatment Experienced
Complementary Therapies

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014