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Clinical Trials/NCT00068991
NCT00068991
Withdrawn
Phase 1

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)

ConditionsHIV Infections

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
HIV Infections
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
1
Primary Endpoint
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants
Status
Withdrawn
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2003
End Date
June 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Throughout study

Secondary Outcomes

  • Knowledge of correct condom use score among HIV-infected participants(Throughout study)
  • Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores(Throughout study)
  • Self-efficacy score in HIV-infected participants(Throughout study)
  • Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported(Throughout study)

Study Sites (1)

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