Viral Suppression of HIV InfectionNCT03852849
Rapid Build of HIV Related Protective Barriers
A study testing Personal involved intervention strategies and The dosage of 400mg EFV in people with Viral Suppression of HIV Infection, run by National Center for AIDS/STD Control and Prevention, China CDC at 2 sites in China.
Trial summary
The purpose of the study is to screen the optimal intervention strategies to rapid establish the protective barriers against HIV-infection by maximally decreasing the viremia among HIV- infected patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Viral Suppression of HIV Infection
- What is being tested?
- Personal involved intervention strategies and The dosage of 400mg EFV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2019to 1 Mar 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-positive participants who received an newly diagnosed HIV infection within the study period
- Having a current residential address inside of pilot site limits
- Eighteen years old or above
- HIV transmission is heterosexual contact
Who cannot join
- IDU
- Having severe mental disorder
Trial locations and contacts
2 sites in 1 country.
China2 sites
Lincang Center for Disease Control and Prevention
Lincang, Yunnan
Wenshan Center for Disease Control and Prevention
Wenshan, Yunnan
About this study
Official title: Cohort Study on Appropriate Strategies of The Rapid Build of HIV Related Protective Barriers in Yunnan, China
The purpose of the study is to screen the optimal intervention strategies to rapid establish the protective barriers against HIV-infection by maximally decreasing the viremia among HIV- infected patients.
Read the detailed description
Sexual transmission became the primary route of HIV transmission in China and heterosexual transmission also contributed greatly to HIV epidemic which was mostly reported in South-west rural areas. In past years, Yunnan has experienced powerful campaign of scaling-up the HIV identification as well as antrertroviral therapy.
This study will investigate how to reach the last two of HIV'90-90-90 targets': to provide antiretroviral therapy (ART) for 90% of who diagnosed HIV infection and to achieve viral suppression for 90% of those treated.
The study population consists of participants who received an newly diagnosed HIV infection within the study period. All rerolled participants will be randomized into different study group. In intervention group, medical institutions will provide patients personal involved intervention strategies which guided by frequent viral load detection, and providing of the dosage form of 400 mg EFV in their antiviral therapy.
Main assessment measures are viral suppression rate of HIV-infected patients and treatment coverage .
- Conditions
- Viral Suppression of HIV Infection
- Being tested
- Personal involved intervention strategies, The dosage of 400mg EFV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal involved intervention strategiesBehavioural
Medical institutions will provide personal involved intervention strategies for patients which guided by viral load testing monthly until viral load drop below the detection limit.
The dosage of 400mg EFVDrug
The dosage of 400mg EFV will be used in the antiviral therapy.
| Study group | Role | What they receive |
|---|---|---|
| routine care group | No intervention | Medical institutions will provide patients routine care according to the national program standard. |
| medicine intervention group | Experimental | The dosage of 400 mg EFV will be used in the antiviral therapy. Receives: Drug: The dosage of 400mg EFV |
| consolidated intervention group | Experimental | Medical institutions will provide personal involved intervention strategies as well as the providing of dosage form of 400 mgEFV in their antiviral therapy. Receives: Behavioral: Personal involved intervention strategies; Drug: The dosage of 400mg EFV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression of HIV-infected patients
Measured: 12 months
Secondary outcomes (1)
Treatment coverage
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral Suppression of HIV InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- Collaborators
- Yunnan Center for Disease Control and Prevention, Yunnan AIDS Care Center
- Responsible party
- Sponsor
- Investigators
- Zhao Yan, PHD, Principal investigator, National Center for AIDS/STD Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852849
- Sponsor's protocol ID
- 2018ZX10721102-002
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao L, Chang W, Shu Y, Liu Y, Zhang M, Yang Q, Li J, Pai H, Huang L, Chen Y, Yang Z, Lu F, Dong X, Feng Y, Xia X. Emergence of two novel HIV-1 Circulating Recombinant Forms (CRF190_0708 and CRF191_0708): molecular characterization and clinical insights from a five-year study in Yunnan, China. BMC Microbiol. 2026 Jun 23. doi: 10.1186/s12866-026-05323-x. Online ahead of print.
PubMed 42332571
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Appropriate Strategies of The Rapid Build of HIV Related Protective Barriers in Yunnan, China
- ClinicalTrials.gov ID
- NCT03852849
- Acronym / sponsor ID
- 2018ZX10721102-002
- Conditions
- Viral Suppression of HIV Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- Collaborators
- Yunnan Center for Disease Control and Prevention, Yunnan AIDS Care Center
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 25 Feb 2019 (actual)
- 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 purpose of the study is to screen the optimal intervention strategies to rapid establish the protective barriers against HIV-infection by maximally decreasing the viremia among HIV- infected patients.
Detailed description
Sexual transmission became the primary route of HIV transmission in China and heterosexual transmission also contributed greatly to HIV epidemic which was mostly reported in South-west rural areas. In past years, Yunnan has experienced powerful campaign of scaling-up the HIV identification as well as antrertroviral therapy.
This study will investigate how to reach the last two of HIV'90-90-90 targets': to provide antiretroviral therapy (ART) for 90% of who diagnosed HIV infection and to achieve viral suppression for 90% of those treated.
The study population consists of participants who received an newly diagnosed HIV infection within the study period. All rerolled participants will be randomized into different study group. In intervention group, medical institutions will provide patients personal involved intervention strategies which guided by frequent viral load detection, and providing of the dosage form of 400 mg EFV in their antiviral therapy.
Main assessment measures are viral suppression rate of HIV-infected patients and treatment coverage .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| routine care group | No intervention | –Medical institutions will provide patients routine care according to the national program standard. |
| medicine intervention group | Experimental | Drug: The dosage of 400mg EFVThe dosage of 400 mg EFV will be used in the antiviral therapy. |
| consolidated intervention group | Experimental | Behavioral: Personal involved intervention strategies, Drug: The dosage of 400mg EFVMedical institutions will provide personal involved intervention strategies as well as the providing of dosage form of 400 mgEFV in their antiviral therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-positive participants who received an newly diagnosed HIV infection within the study period
- Having a current residential address inside of pilot site limits
- Eighteen years old or above
- HIV transmission is heterosexual contact
Key exclusion criteria (2 listed)
- IDU
- Having severe mental disorder
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 |
|---|---|---|
| Personal involved intervention strategiesMedical institutions will provide personal involved intervention strategies for patients which guided by viral load testing monthly until viral load drop below the detection limit. | Behavioural | consolidated intervention group |
| The dosage of 400mg EFVThe dosage of 400mg EFV will be used in the antiviral therapy. | Drug | consolidated intervention group, medicine intervention group |
Primary outcome
Viral suppression of HIV-infected patients
Time frame: 12 months
1 secondary outcome
Treatment coverage
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 42332571Gao L, Chang W, Shu Y, Liu Y, Zhang M, Yang Q, Li J, Pai H, Huang L, Chen Y, Yang Z, Lu F, Dong X, Feng Y, Xia X. Emergence of two novel HIV-1 Circulating Recombinant Forms (CRF190_0708 and CRF191_0708): molecular characterization and clinical insights from a five-year study in Yunnan, China. BMC Microbiol. 2026 Jun 23. doi: 10.1186/s12866-026-05323-x. Online ahead of print.
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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.
Zhao Yan, PHD principal investigator
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 Personal involved intervention strategies and The dosage of 400mg EFV in people with Viral Suppression of HIV Infection, 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 4 inclusion and 2 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 25 Feb 2019. 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 Zhao Yan, PHD (+86-10-5338-0980, zhaoyan@chinaaids.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression of HIV-infected patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852849, which also lists 1 linked publication.
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 25 Feb 2019.