Pilot Study of Immediate HIV Treatment in Guangxi, China

NCT ID: NCT01892228

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

Conditions

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HIV Acquired Immunodeficiency Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Immediate post-screening treatment education

Intervention Type BEHAVIORAL

immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation

Interventions

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Immediate post-screening treatment education

immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangxi Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role collaborator

National Center for AIDS/STD Control and Prevention, China CDC

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zunyou Wu, PhD

Role: STUDY_CHAIR

National Center for AIDS/STD Control and Prevention

Locations

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Pubei Center for Disease Control

Xiaojiang, Guangxi, China

Site Status RECRUITING

Zhongshan Center for Disease Control

Zhongshan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zunyou Wu, PhD

Role: CONTACT

+86-10-5890-0901

Other Identifiers

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Treat-All HIV Pilot

Identifier Type: -

Identifier Source: org_study_id

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