Pilot Study of Immediate HIV Treatment in Guangxi, China

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by National Center for AIDS/STD Control and Prevention, China CDC
Sponsor:
Collaborators:
Guangxi Center for Disease Control and Prevention
AbbVie
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:
NCT01892228
First received: May 18, 2013
Last updated: June 30, 2013
Last verified: June 2013

May 18, 2013
June 30, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
mortality and treatment coverage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  1. 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.
  2. 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
Same as current
Complete list of historical versions of study NCT01892228 on ClinicalTrials.gov Archive Site
mortality and treatment coverage [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  1. 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.
  2. 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
Same as current
Not Provided
Not Provided
 
Pilot Study of Immediate HIV Treatment in Guangxi, China
Pilot Study of Immediate HIV Treatment by Means of "One-stop Service" in Hospital in Guangxi, China

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.

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.

  1. 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.
  2. 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
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV
  • Acquired Immunodeficiency Syndrome
Behavioral: Immediate post-screening treatment education
immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation
Experimental: Two counties: Zhongshan and Pubei
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: Behavioral: Immediate post-screening treatment education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
July 2015
July 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Zunyou Wu, PhD +86-10-5890-0901 wuzunyou@chinaaids.cn
China
 
NCT01892228
Treat-All HIV Pilot
No
National Center for AIDS/STD Control and Prevention, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
  • Guangxi Center for Disease Control and Prevention
  • AbbVie
Study Chair: Zunyou Wu, PhD National Center for AIDS/STD Control and Prevention
National Center for AIDS/STD Control and Prevention, China CDC
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP