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
  Purpose

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.


Condition Intervention
HIV
Acquired Immunodeficiency Syndrome
Behavioral: Immediate post-screening treatment education

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study of Immediate HIV Treatment by Means of "One-stop Service" in Hospital in Guangxi, China

Resource links provided by NLM:


Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Immediate post-screening treatment education
immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation

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.

  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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892228

Contacts
Contact: Zunyou Wu, PhD +86-10-5890-0901 wuzunyou@chinaaids.cn

Locations
China, Guangxi
Pubei Center for Disease Control Recruiting
Pubei, Guangxi, China
China
Zhongshan Center for Disease Control Recruiting
Zhongshan, China
Sponsors and Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
Guangxi Center for Disease Control and Prevention
AbbVie
Investigators
Study Chair: Zunyou Wu, PhD National Center for AIDS/STD Control and Prevention
  More Information

No publications provided

Responsible Party: National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier: NCT01892228     History of Changes
Other Study ID Numbers: Treat-All HIV Pilot
Study First Received: May 18, 2013
Last Updated: June 30, 2013
Health Authority: China: Ministry of Health

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
antiretroviral therapy
education
mortality

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 15, 2014