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

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ClinicalTrials.gov Identifier: NCT00068991
Recruitment Status : Withdrawn
First Posted : September 16, 2003
Last Update Posted : June 1, 2015
Sponsor:
Collaborator:
Comprehensive International Program of Research on AIDS
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Behavioral: HIV skills training program and questionnaire Behavioral: Community-level stigma reduction program Behavioral: Cross-sectional survey Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported [ Time Frame: Throughout study ]
  2. Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores [ Time Frame: Throughout study ]
  3. Self-efficacy score in HIV-infected participants [ Time Frame: Throughout study ]
  4. Knowledge of correct condom use score among HIV-infected participants [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068991


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 Centers for Disease Control and Prevention, China
Principal Investigator: Jie Xu, MD, MS Centers for Disease Control and Prevention, China
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Rona Siskind, DAIDS
ClinicalTrials.gov Identifier: NCT00068991     History of Changes
Other Study ID Numbers: CIPRA Project 2
1U19AI051915-01 ( U.S. NIH Grant/Contract )
CIPRA CH 002
First Posted: September 16, 2003    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: September 2008

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases