HIVNCT01892228
Pilot Study of Immediate HIV Treatment in Guangxi, China
A study testing Immediate post-screening treatment education in people with HIV and Acquired Immunodeficiency Syndrome, run by National Center for AIDS/STD Control and Prevention, China CDC at 2 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV, Acquired Immunodeficiency Syndrome
- What is being tested?
- Immediate post-screening treatment education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current residing outside of the borders of the designated study sites
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Pubei Center for Disease Control
Xiaojiang, Guangxi
- Recruiting
Zhongshan Center for Disease Control
Zhongshan
About this study
Official title: Pilot Study of Immediate HIV Treatment by Means of "One-stop Service" in Hospital in Guangxi, China
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.
Read more
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.
- 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.
- 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
- HIV, Acquired Immunodeficiency Syndrome
- Being tested
- Immediate post-screening treatment education
- Keywords
- antiretroviral therapy, education, mortality
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate post-screening treatment educationBehavioural
immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Immediate post-screening treatment education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 36 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- Collaborators
- Guangxi Center for Disease Control and Prevention, AbbVie
- Responsible party
- Sponsor
- Investigators
- Zunyou Wu, PhD, Study chair, National Center for AIDS/STD Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892228
- Sponsor's protocol ID
- Treat-All HIV Pilot
- Status last verified
- Jun 2013
- First submitted
- 18 May 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Immediate HIV Treatment by Means of "One-stop Service" in Hospital in Guangxi, China
- ClinicalTrials.gov ID
- NCT01892228
- Acronym / sponsor ID
- Treat-All HIV Pilot
- Conditions
- HIV, Acquired Immunodeficiency Syndrome
- Keywords
- antiretroviral therapy, education, mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- Collaborators
- Guangxi Center for Disease Control and Prevention, AbbVie
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two counties: Zhongshan and Pubei | Experimental | Behavioral: Immediate post-screening treatment educationImmediate post-screening treatment education for HIV-positive participants residing in the Zhongshan and Pubei pilot sites in the "Treat-All" HIV Pilot Program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Current residing outside of the borders of the designated study sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate post-screening treatment educationimmediate treatment education after screening to decrease time from initial HIV screening to treatment implementation | Behavioural | Two counties: Zhongshan and Pubei |
Primary outcome
mortality
Time frame: 12 months
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.
ART treatment coverage
Time frame: 12 months
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
2 secondary outcomes
mortality
Time frame: 36 months
ART treatment coverage
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zunyou Wu, PhD study chair
National Center for AIDS/STD Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate post-screening treatment education in people with HIV and Acquired Immunodeficiency Syndrome, run by National Center for AIDS/STD Control and Prevention, China CDC at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zunyou Wu, PhD (+86-10-5890-0901, wuzunyou@chinaaids.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.