Clinical trial NCT01892228: 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
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Acquired Immunodeficiency Syndrome
Keywords: antiretroviral therapy
education
mortality
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
Collaborators: name: Guangxi Center for Disease Control and Prevention
name: AbbVie
First posted: 2013-07-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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

Primary outcomes:
measure: mortality
timeFrame: 12 months
measure: ART treatment coverage
timeFrame: 12 months
Secondary outcomes:
measure: mortality
timeFrame: 36 months
measure: ART treatment coverage
timeFrame: 36 months
Other outcomes:
Locations:
city: Pubei
country: China
facility: Pubei Center for Disease Control
state: Guangxi
city: Zhongshan
country: China
facility: Zhongshan Center for Disease Control
Study officials:
affiliation: National Center for AIDS/STD Control and Prevention
name: Zunyou Wu, PhD
role: STUDY_CHAIR
References: