- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01052415
POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- UCLA Semel Institute-Center for Community Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Service providers: 18 years and older, who work at the county hospital that is participating in the study, including doctors, nurses and lab technicians, and who provide informed consent.
- Hospital administrators: 18 years and older, who work at the county hospital that is participating in the study as administrators, and who provide informed consent.
- Patients: Age 18 and older, who receive treatment from STD, obstetrics/gynecology or HIV care department at the participating hospital, and who provide informed consent.
Exclusion Criteria:
- Those who cannot give informed consent (e.g., intoxicated)
- Those who have a permanent disability (e.g., deaf, serious mental illness, mental retardation).
- Anyone who does not meet the inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
Service providers and HIV patients, offered intervention at the end of study
|
|
Experimental: Intervention
Behavioral: Cognitive-behavioral, small group format sessions delivered in Chinese to service providers and HIV patients.
|
Behavioral: Cognitive-behavioral, small group format sessions delivered in Chinese to service providers and HIV patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV related stigma
Time Frame: 6-month and 12-month follow-up
|
6-month and 12-month follow-up
|
Patient satisfaction
Time Frame: 6-mont and 12-month follow-up
|
6-mont and 12-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Universal precaution
Time Frame: 6-month and 12-month follow-up
|
6-month and 12-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Li Li, PhD, UCLA Semel Institute, Center for Community Health
Publications and helpful links
General Publications
- Li L, Liang LJ, Wu Z, Lin C, Guan J. Assessing outcomes of a stigma-reduction intervention with venue-based analysis. Soc Psychiatry Psychiatr Epidemiol. 2014 Jun;49(6):991-9. doi: 10.1007/s00127-013-0808-6. Epub 2013 Dec 28.
- Li L, Wu Z, Liang LJ, Lin C, Guan J, Jia M, Rou K, Yan Z. Reducing HIV-related stigma in health care settings: a randomized controlled trial in China. Am J Public Health. 2013 Feb;103(2):286-92. doi: 10.2105/AJPH.2012.300854. Epub 2012 Dec 13.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01MH081778 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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