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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Comprehensive International Program of Research on AIDS
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00068991
First received: September 12, 2003
Last updated: February 17, 2009
Last verified: September 2008
  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 and questionnaire
Behavioral: Community-level stigma reduction program
Behavioral: Cross-sectional survey
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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)

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, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Self-efficacy score in HIV-infected participants [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Knowledge of correct condom use score among HIV-infected participants [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 3830
Estimated Study Completion Date: June 2007
Arms Assigned Interventions
Experimental: 1
Participants will be HIV-infected villagers and will will take part in 2-hour skills training sessions every week from study entry to Week 8. Participants will bring a family member to each training session. After training, participants complete a post-training evaluation of the training sessions. Participants will also complete questionnaires at study entry and 6 and 12 months after completion of training.
Behavioral: HIV skills training program and questionnaire
Two-hour weekly skills training sessions followed by evaluation questionnaire
Experimental: 2
Participants will be villagers considered influential members of their community. In the first 2 months of the study, Participants will take part in four 2-hour training sessions focusing on anti-stigma and anti-discrimination messages. Participants will also attend additional support meetings monthly, from Months 2 to 15. They will be evaluated before and after their training sessions to determine the improvements in knowledge and attitudes about HIV among group participants.
Behavioral: Community-level stigma reduction program
Two-hour training sessions focusing on anti-stigma and anti-discrimination
Experimental: 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.
Behavioral: Cross-sectional survey
Survey evaluation of community attitudes towards HIV

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
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: NCT00068991

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

No publications provided

Responsible Party: Rona Siskind, DAIDS
ClinicalTrials.gov Identifier: NCT00068991     History of Changes
Other Study ID Numbers: CIPRA Project 2, 1U19-AI51915-01, CIPRA CH 002
Study First Received: September 12, 2003
Last Updated: February 17, 2009
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

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

ClinicalTrials.gov processed this record on July 20, 2014