HIV Infections Clinical Trial
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)
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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