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Pilot Study of Immediate HIV Treatment in Guangxi, China

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01892228
Enrollment
1000
Registered
2013-07-04
Start date
2012-07-31
Completion date
2015-07-31
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome, HIV

Keywords

antiretroviral therapy, education, mortality

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

Interventions

BEHAVIORALImmediate post-screening treatment education

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

Sponsors

Guangxi Center for Disease Control and Prevention
CollaboratorOTHER_GOV
AbbVie
CollaboratorINDUSTRY
National Center for AIDS/STD Control and Prevention, China CDC
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mortality12 monthsHIV-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.
ART treatment coverage12 monthsPercentage 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

MeasureTime frameDescription
mortality36 monthsmortality 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.
ART treatment coverage36 monthsPercentage 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

Countries

China

Contacts

Primary ContactZunyou Wu, PhD
wuzunyou@chinaaids.cn+86-10-5890-0901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026