Rapid Build of HIV Related Protective Barriers

NCT ID: NCT03852849

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-03-01

Brief Summary

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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

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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

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Viral Suppression of HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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routine care group

Medical institutions will provide patients routine care according to the national program standard.

Group Type NO_INTERVENTION

No interventions assigned to this group

medicine intervention group

The dosage of 400 mg EFV will be used in the antiviral therapy.

Group Type EXPERIMENTAL

The dosage of 400mg EFV

Intervention Type DRUG

The dosage of 400mg EFV will be used in the antiviral therapy.

consolidated intervention group

Medical institutions will provide personal involved intervention strategies as well as the providing of dosage form of 400 mgEFV in their antiviral therapy.

Group Type EXPERIMENTAL

Personal involved intervention strategies

Intervention Type BEHAVIORAL

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 EFV

Intervention Type DRUG

The dosage of 400mg EFV will be used in the antiviral therapy.

Interventions

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Personal involved intervention strategies

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.

Intervention Type BEHAVIORAL

The dosage of 400mg EFV

The dosage of 400mg EFV will be used in the antiviral therapy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* IDU
* Having severe mental disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yunnan Center for Disease Control and Prevention

OTHER

Sponsor Role collaborator

Yunnan AIDS Care Center

OTHER

Sponsor Role collaborator

National Center for AIDS/STD Control and Prevention, China CDC

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhao Yan, PHD

Role: PRINCIPAL_INVESTIGATOR

National Center for AIDS/STD Control and Prevention

Locations

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Lincang Center for Disease Control and Prevention

Lincang, Yunnan, China

Site Status

Wenshan Center for Disease Control and Prevention

Wenshan, Yunnan, China

Site Status

Countries

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China

Central Contacts

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Zhao Yan, PHD

Role: CONTACT

+86-10-5338-0980

Other Identifiers

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2018ZX10721102-002

Identifier Type: -

Identifier Source: org_study_id

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