ClinicalTrials.gg
Status unknownNCT01892228Updated May 12, 2015

Pilot Study of Immediate HIV Treatment in Guangxi, China

An interventional study of Immediate post-screening treatment education in HIV and Acquired Immunodeficiency Syndrome, sponsored by National Center for AIDS/STD Control and Prevention, China CDC. Status unknown at 2 sites in China. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by National Center for AIDS/STD Control and Prevention, China CDC · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • HIV
  • Acquired Immunodeficiency Syndrome

Keywords

  • antiretroviral therapy
  • education
  • mortality
03

In context

Acquired Immunodeficiency Syndrome

2,102 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 277 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 104 across 1,593 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

National Center for AIDS/STD Control and Prevention, China CDC is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • Current residing outside of the borders of the designated study sites
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    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

    Behavioral: Immediate post-screening treatment education

Interventions

  • BehavioralImmediate post-screening treatment education

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 36 months

  2. 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

    Time frame: 36 months

07

Study locations

2 of 2 sites recruiting
  • Pubei Center for Disease Control
    Xiaojiang, Guangxi, China
    Recruiting
  • Zhongshan Center for Disease Control
    Zhongshan, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Jul 2013 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2013
First posted
Jul 4, 2013
Start
Jul 2012
Primary completionActual
Jul 2013
CompletionEst.
Jul 2015
Last update
May 12, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01892228
Lead sponsor
National Center for AIDS/STD Control and Prevention, China CDC
Collaborators
Guangxi Center for Disease Control and Prevention, AbbVie
Responsible party
Sponsor
First posted
Jul 4, 2013
Start date
Jul 2012
Primary completion
Jul 2013
Completion
Jul 2015 (estimated)
Last update
May 12, 2015

Study contacts

Zunyou Wu, PhD
Contact
wuzunyou@chinaaids.cn
+86-10-5890-0901
Zunyou Wu, PhD
study chair · National Center for AIDS/STD Control and Prevention

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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