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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00479141 |
Purpose
The HIV epidemic in China has reached a phase of exponential growth; the number of new infections has been steadily increasing over the past decade. The purpose of this study is to evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for HIV-Positive Villagers and decrease HIV related stigma in Rural China.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Behavioral: HIV skills training Behavioral: Popular Opinion Leaders training |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | A Cluster-Randomized Trail to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life (QOL) For HIV-Positive Villagers in Rural China |
| Enrollment: | 3199 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
HIV infected participants and their families
|
Behavioral: HIV skills training
Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15
|
|
2: Experimental
Popular Opinion Leaders (POL) participants
|
Behavioral: Popular Opinion Leaders training
Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.
|
Over the past decade, the rates of HIV infection and death due to HIV/AIDS have been steadily increasing in China. The China Comprehensive AIDS Response (China CARES) program was developed in 2003 in order to help poor counties and those with severe epidemic problems increase public awareness and improve knowledge about epidemic diseases such as HIV. Currently, behavioral interventions focusing on individual skills training and self-efficacy building for HIV infected individuals are not included in China CARES. Fuyang, Anhui Province, China has a high rate of HIV infected individuals, many of whom were former plasma donors (FPDs) and would benefit from HIV skills training.
In 2004, CIPRA conducted a study (CIPRA CH 002A), entitled "A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China," which provided insight into HIV infected individuals in Fuyang, Anhui Province, China.
According to the results of CIRPA CH 002A, most HIV infected individuals described their QOL as poor. The factors affecting their poor QOL include poverty, poor health, stigma and discrimination. Participants in the CIPRA CH 002A study showed interest in learning more about HIV/AIDS disease and treatment. This study will last 18 months. HIV infected participants and their families will attend eight 2-hour group skills training sessions during Weeks 1 through 8, and booster sessions every two months during Months 3 through 15. Popular Opinion Leaders (POL) participants will attend 4 weeks of 2-hour training sessions about anti-stigma and anti-discrimination, followed by support meetings every 2 months during Months 2 through 13. Some participants will complete cross-sectional surveys evaluating the levels of stigma and discrimination in the community at study entry and at Months 6 and 12 following completion of POL training. All participants will complete follow-up visits at Months 6 and 12.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for HIV Infected Individuals:
Inclusion Criteria for Family members of HIV Infected Individuals:
Inclusion Criteria for POLs:
Inclusion Criteria for Cross-Sectional Survey Participants:
Exclusion Criteria for HIV Infected Individuals:
Exclusion Criteria for Family Members of HIV Infected Individuals:
Exclusion Criteria for POLs:
Exclusion Criteria for Cross-Sectional Survey Participants:
Contacts and Locations| China | |
| Fuyang CDC Office | |
| Beijing, China, 100050 | |
| Study Chair: | Zunyou Wu, MD, PhD | Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention |
| Study Chair: | Jie Xu, MD, MS, MPH | Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | CIPRA CH 002B |
| Study First Received: | May 25, 2007 |
| Last Updated: | March 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00479141 History of Changes |
| Health Authority: | United States: Federal Government |
|
Treatment Naive Treatment Experienced Complementary Therapies |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Quality of Life Retroviridae Infections Immunologic Deficiency Syndromes |
|
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 |
