A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China
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|ClinicalTrials.gov Identifier: NCT00479141|
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : March 27, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: HIV skills training Behavioral: Popular Opinion Leaders training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||December 2008|
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
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.
- Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants [ Time Frame: Throughout study ]
- Level of stigma among community members, including HIV knowledge [ Time Frame: Throughout study ]
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): NCT00479141
|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|