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HIV Educational Programs for Villagers of Funan County or Yingzhou District, Anhui Province, China

This study is not yet open for participant recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), July 2006

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Comprehensive International Program of Research on AIDS
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00068991
  Purpose

The purpose of this study is to determine whether two educational programs about HIV will improve the quality of life of HIV infected people living in the rural villages of China. The study will enroll HIV infected adult residents, influential community members, and other community members of selected villages of Funan County or Yingzhou District, Anhui Province, China.


Condition Intervention Phase
HIV Infections
Behavioral: HIV skills training program
Biological: Community-level stigma reduction program
Phase I

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   A Cluster-Randomized Trial to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for HIV-Positive Villagers in Rural China (China CIPRA Project 2)

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

Secondary Outcome Measures:
  • level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported
  • emotional well-being of HIV infected participants, as determined by perceived support scale and stigma scale scores
  • self-efficacy score in HIV infected participants
  • knowledge of correct condom use score among HIV infected participants

Estimated Enrollment:   3830
Estimated Study Completion Date:   June 2007

Detailed Description:

A previous study found that HIV infected villagers in Anhui Province, China describe their quality of life as poor. While poverty, poor health, stigma, and discrimination contribute to this poor quality of life, all these issues are interrelated and deserve further investigation. The quality of life for HIV infected people may be made better through education, either for HIV infected people to learn more about HIV, the treatments they are receiving, and how to deal with their disease, or for HIV uninfected people to understand HIV infection and to reduce stigma and discrimination associated with HIV infection. This study will provide skills training to HIV infected adults and anti-stigma and anti-discrimination training to influential community members. The purpose of this study is to evaluate the changes in quality of life in HIV infected villagers living in Anhui Province, China that result after these two training programs are administered.

There will be 3 groups in this study. Group 1 participants will be HIV infected villagers. Group 1 participants will take part in 2-hour skills training sessions every week from study entry to Week 8. Participants will also be asked to bring a family member to each training session. After completing training, participants will be asked to complete a post-training evaluation of the training sessions. Group 1 participants will be asked to complete questionnaires at study entry and 6 and 12 months after completion of training.

Group 2 participants will be villagers considered influential members of their community. In the first 2 months of the study, Group 2 participants will take part in four, 2-hour training sessions focusing on anti-stigma and anti-discrimination messages. Group 2 participants will also attend additional support meetings monthly, from Months 2 to 15. Group 2 participants will be evaluated before and after their training sessions to determine the improvements in knowledge and attitudes about HIV among group participants.

Group 3 participants will be randomly selected community members and will complete a cross-sectional survey at study entry and 6 and 12 months after Group 2's completion of training, to determine changing community attitudes about HIV as a result of Group 2's training. There will be no additional study visits or training for Group 3 participants.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria for All Participants:

  • Live in one of the fourteen administrative villages in Funan County or Yingzhou District, Anhui Province, China

Inclusion Criteria for Group 1:

  • HIV infected
  • Willing and able to take part in all study visits
  • Willing and able to provide contact information for locator purposes
  • Willing and able to bring a family member to training sessions

Inclusion Criteria for Group 2:

  • Considered an influential member of their community
  • Willing and able to take part in all training and follow-up support meetings

Inclusion Criteria for Group 3:

  • Willing to complete the cross-sectional survey

Exclusion Criteria for All Study Participants:

  • Spent more than 6 months outside of the community in the year prior to study entry
  • Permanent disability (e.g., deafness, serious mental illness, mental retardation) that would interfere with the study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068991

Contacts
Contact: Monica S. Ruiz, MD, MPH     mruiz@niaid.nih.gov    

Locations
China
Chinese Center for Disease Control and Prevention    
      Beijing, China, 100050

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Comprehensive International Program of Research on AIDS

Investigators
Principal Investigator:     Zunyou Wu, MD, PhD     Chinese Center for Disease Control and Prevention    
Principal Investigator:     Jie Xu, MD, MS     Chinese Center for Disease Control and Prevention    
  More Information


Study ID Numbers:   CIPRA Project 2, 1U19-AI51915-01, CIPRA CH 002
First Received:   September 12, 2003
Last Updated:   July 21, 2006
ClinicalTrials.gov Identifier:   NCT00068991
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Behavioral Intervention Study  
Randomized Prevention Trial  
China  
Condom Use  
STDs
Sexual Partners
HIV Seronegativity

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Quality of Life
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on November 30, 2008




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