Pilot Study of Immediate HIV Treatment in Guangxi, China

NCT01892228 | Unknown

• 1 other identifier: Treat-All HIV Pilot
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Acquired Immunodeficiency Syndrome

Keywords

antiretroviral therapy; education; mortality

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• mortality

  36 months

• ART treatment coverage

  36 months

Study Arms (1)

Two counties: Zhongshan and Pubei

EXPERIMENTAL

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

Interventions

Immediate post-screening treatment education BEHAVIORAL

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

Two counties: Zhongshan and Pubei

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current residing outside of the borders of the designated study sites

Sponsors & Collaborators

• National Center for AIDS/STD Control and Prevention, China CDC: lead
• Guangxi Center for Disease Control and Prevention: collaborator
• AbbVie: collaborator

Study Sites (2)

Pubei Center for Disease Control

Xiaojiang, Guangxi, China

RECRUITING

Zhongshan Center for Disease Control

Zhongshan, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Zunyou Wu, PhD

  National Center for AIDS/STD Control and Prevention

  STUDY CHAIR

Central Study Contacts

Zunyou Wu, PhD

CONTACT

+86-10-5890-0901; wuzunyou@chinaaids.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2013
• First Posted: July 4, 2013
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2013-06

Locations

CN (2)