Pilot Study of Immediate HIV Treatment in Guangxi, China

HIV Clinical Trial

Official title:

Pilot Study of Immediate HIV Treatment by Means of "One-stop Service" in Hospital in Guangxi, China

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01892228
• Other study ID #: Treat-All HIV Pilot
• Status: Unknown status
• Phase: N/A
• First received: May 18, 2013
• Last updated: May 11, 2015
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: June 2013
• Source: National Center for AIDS/STD Control and Prevention, China CDC
• Contact: Zunyou Wu, PhD
• Phone: +86-10-5890-0901
• Email: wuzunyou[@]chinaaids.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 1000
• Est. completion date: July 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• Immediate post-screening treatment education
immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation

Locations

Country	Name	City	State
China	Pubei Center for Disease Control	Pubei	Guangxi
China	Zhongshan Center for Disease Control	Zhongshan

Sponsors (3)

Lead Sponsor	Collaborator
National Center for AIDS/STD Control and Prevention, China CDC	AbbVie, Guangxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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	12 months
Secondary	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.	36 months
Secondary	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	36 months