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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
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 and questionnaire Behavioral: Community-level stigma reduction program Behavioral: Cross-sectional survey |
Phase I |
| Study Type: | Interventional |
| Study Design: | 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) |
| Estimated Enrollment: | 3830 |
| Estimated Study Completion Date: | June 2007 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
2: Experimental
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
|
|
3: Experimental
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
|
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 |
Inclusion Criteria for All Participants:
Inclusion Criteria for Group 1:
Inclusion Criteria for Group 2:
Inclusion Criteria for Group 3:
Exclusion Criteria for All Study Participants:
Contacts and Locations| China | |
| Chinese Center for Disease Control and Prevention | |
| Beijing, China, 100050 | |
| 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
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | CIPRA Project 2, 1U19-AI51915-01, CIPRA CH 002 |
| Study First Received: | September 12, 2003 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00068991 History of Changes |
| Health Authority: | United States: Federal Government |
|
Behavioral Intervention Study Randomized Prevention Trial China Condom Use |
STDs Sexual Partners HIV Seronegativity |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |