Pilot Study of Immediate HIV Treatment in Guangxi, China
Primary Purpose
HIV, Acquired Immunodeficiency Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Immediate post-screening treatment education
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring antiretroviral therapy, education, mortality
Eligibility Criteria
Inclusion Criteria:
- New diagnosis of HIV infection as defined by having positive HIV antibody screening results between July 1, 2012 and July 1, 2015 OR
- Having a current residential address inside of pilot site limits
Exclusion criteria:
- Current residing outside of the borders of the designated study sites
Sites / Locations
- Pubei Center for Disease ControlRecruiting
- Zhongshan Center for Disease ControlRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Two counties: Zhongshan and Pubei
Arm Description
Immediate post-screening treatment education for HIV-positive participants residing in the Zhongshan and Pubei pilot sites in the "Treat-All" HIV Pilot Program
Outcomes
Primary Outcome Measures
mortality
HIV-related mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.
ART treatment coverage
Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period
Secondary Outcome Measures
mortality
mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.
ART treatment coverage
Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period
Full Information
NCT ID
NCT01892228
First Posted
May 18, 2013
Last Updated
May 11, 2015
Sponsor
National Center for AIDS/STD Control and Prevention, China CDC
Collaborators
Guangxi Center for Disease Control and Prevention, AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT01892228
Brief Title
Pilot Study of Immediate HIV Treatment in Guangxi, China
Official Title
Pilot Study of Immediate HIV Treatment by Means of "One-stop Service" in Hospital in Guangxi, China
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for AIDS/STD Control and Prevention, China CDC
Collaborators
Guangxi Center for Disease Control and Prevention, AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to decrease mortality related to HIV.
The study's proposed mechanism of decreasing mortality rates is to shorten the time between initial HIV screening and ART implementation to within two weeks.
The study population consists of participants who received an initial HIV infection diagnosis within the study period. Medical institutions will provide "one-stop services" by following detailed guidelines regarding reporting of positive HIV antibody screenings, further testing procedures, and treatment referrals in accordance with a pre-determined timetable. In addition, additional strategies focusing on policy development, medical personnel training, and a broad general public education campaign will be implemented.
Main assessment measures are HIV-related mortality rates, treatment coverage, or other health outcomes.
Detailed Description
The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to decrease mortality related to HIV/AIDS. In past years, Guangxi has experienced a relatively high rate of late HIV diagnoses, which has contributed to a significant proportion of HIV-related deaths occurring in the same year of initial diagnosis. The study's proposed mechanism of decreasing mortality rates is to shorten the time between initial HIV screening and ART implementation to within two weeks.
Two pilot sites were selected based on past core assessment indicators. The study population consists of participants who received an initial HIV infection diagnosis within the study period. Medical institutions will provide "one-stop services" by following detailed guidelines regarding reporting of positive HIV antibody screenings, further testing procedures, and treatment referrals in accordance with a pre-determined timetable. In addition, additional strategies focusing on policy development, medical personnel training, and a broad general public education campaign will be implemented.
The study will be performed from July,2012 to July,2015. Main assessment measures are HIV-related mortality rates, treatment coverage, or other health outcomes.
HIV-related mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.
Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Acquired Immunodeficiency Syndrome
Keywords
antiretroviral therapy, education, mortality
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Two counties: Zhongshan and Pubei
Arm Type
Experimental
Arm Description
Immediate post-screening treatment education for HIV-positive participants residing in the Zhongshan and Pubei pilot sites in the "Treat-All" HIV Pilot Program
Intervention Type
Behavioral
Intervention Name(s)
Immediate post-screening treatment education
Intervention Description
immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation
Primary Outcome Measure Information:
Title
mortality
Description
HIV-related mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.
Time Frame
12 months
Title
ART treatment coverage
Description
Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
mortality
Description
mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.
Time Frame
36 months
Title
ART treatment coverage
Description
Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period
Time Frame
36 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New diagnosis of HIV infection as defined by having positive HIV antibody screening results between July 1, 2012 and July 1, 2015 OR
Having a current residential address inside of pilot site limits
Exclusion criteria:
Current residing outside of the borders of the designated study sites
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zunyou Wu, PhD
Phone
+86-10-5890-0901
Email
wuzunyou@chinaaids.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zunyou Wu, PhD
Organizational Affiliation
National Center for AIDS/STD Control and Prevention
Official's Role
Study Chair
Facility Information:
Facility Name
Pubei Center for Disease Control
City
Pubei
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Center for Disease Control
City
Zhongshan
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Immediate HIV Treatment in Guangxi, China
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