POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2010 | ||||
| Last Updated Date | February 22, 2012 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01052415 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Universal precaution [ Time Frame: 6-month and 12-month follow-up ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China | ||||
| Official Title ICMJE | POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China | ||||
| Brief Summary | In this project, UCLA's Center for Community Health (CCH) will develop an efficacious intervention trial integrating both individual and structural components to reduce HIV- related stigma among service providers in China and therefore benefit people living with HIV/AIDS (PLWHA). The purpose of this study is to develop a feasible, practical and low cost intervention strategy that will prevent and/or reduce the negative effects of HIV-related stigma among health service providers in China. This project will be conducted in two provinces and proceed in two phases. In Phase 1, confidential focus groups will take place with small samples of service providers and hospital administrators to finalize the intervention activities, and the investigators will also test and finalize the Audio Computer-Assisted Self-Interview (ACASI) assessment measures and implementation procedures with the same group of service providers. During Phase 1 a small sample of patients will anonymously test the paper-pencil baseline survey. Equal number of samples will be selected from two counties of each province. The findings from Phase 1 will be used to develop intervention, and revise assessment for Phase 2. |
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| Detailed Description | HIV is a serious problem and HIV-related stigma in the medical setting is impeding every step in the battle against HIV in China. The number of annual reported HIV infections in China has increased steadily. The proposed study will be the first randomized controlled intervention trial that specifically targets stigma and access to universal precautions in medical settings, and is implemented at multiple sites in Yunnan and Fujian. Among the two target provinces, Yunnan has the highest number of reported HIV infections in China whereas Fujian is one of the provinces reporting the lowest HIV prevalence rate in China. With the trial implemented in Yunnan and Fujian Provinces simultaneously, we will examine the program's efficacy in two provinces that vary dramatically in HIV prevalence and infection routes. We propose to include two provinces that represent China as a whole, due to the varied HIV rates and infection routes in diverse regions; thus allowing us to disentangle the relations among HIV-related stigma, fear of infection, and HIV prevalence. Specific Aim 1: To examine whether providers in the intervention hospitals, compared to providers in the standard care condition, will demonstrate positive attitudinal outcomes, including an increase in comfort in working with PLH and a decrease in unrealistic fear of infection at work, prejudicial attitudes, and support of coercive policies. Specific Aim 2: To examine whether providers in the intervention hospitals, compared to providers in the standard care condition, will demonstrate more positive behavioral outcomes, including an increase in adherence to universal precaution, routine treatment and referrals, confidentiality protection, diffusion of positive messages with co-workers, and a decrease in critical incidents. Specific Aim 3: To explore whether patients in the intervention hospitals, compared to patients at hospitals in the standard care condition, will report a decreased level of perceived unfair treatment and increased service satisfaction, service utilization, and treatment adherence. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Cognitive behavioral sessions
Behavioral: Cognitive-behavioral, small group format sessions delivered in Chinese to service providers and HIV patients.
Other Name: Intervention, service providers, HIV-related stigma |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5400 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01052415 | ||||
| Other Study ID Numbers ICMJE | R01MH081778 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Li Li, University of California, Los Angeles | ||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||
| Collaborators ICMJE | Centers for Disease Control and Prevention, China | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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