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Rapid Build of HIV Related Protective Barriers

Primary Purpose

Viral Suppression of HIV Infection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Personal involved intervention strategies
The dosage of 400mg EFV
Sponsored by
National Center for AIDS/STD Control and Prevention, China CDC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Suppression of HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lincang Center for Disease Control and Prevention
  • Wenshan Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

routine care group

medicine intervention group

consolidated intervention group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Viral suppression of HIV-infected patients

Secondary Outcome Measures

Treatment coverage

Full Information

First Posted
February 22, 2019
Last Updated
February 22, 2019
Sponsor
National Center for AIDS/STD Control and Prevention, China CDC
Collaborators
Yunnan Center for Disease Control and Prevention, Yunnan AIDS Care Center
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1. Study Identification

Unique Protocol Identification Number
NCT03852849
Brief Title
Rapid Build of HIV Related Protective Barriers
Official Title
Cohort Study on Appropriate Strategies of The Rapid Build of HIV Related Protective Barriers in Yunnan, China
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for AIDS/STD Control and Prevention, China CDC
Collaborators
Yunnan Center for Disease Control and Prevention, Yunnan AIDS Care Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Suppression of HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
routine care group
Arm Type
No Intervention
Arm Description
Medical institutions will provide patients routine care according to the national program standard.
Arm Title
medicine intervention group
Arm Type
Experimental
Arm Description
The dosage of 400 mg EFV will be used in the antiviral therapy.
Arm Title
consolidated intervention group
Arm Type
Experimental
Arm Description
Medical institutions will provide personal involved intervention strategies as well as the providing of dosage form of 400 mgEFV in their antiviral therapy.
Intervention Type
Behavioral
Intervention Name(s)
Personal involved intervention strategies
Intervention Description
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
Drug
Intervention Name(s)
The dosage of 400mg EFV
Intervention Description
The dosage of 400mg EFV will be used in the antiviral therapy.
Primary Outcome Measure Information:
Title
Viral suppression of HIV-infected patients
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Treatment coverage
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Yan, PHD
Phone
+86-10-5338-0980
Email
zhaoyan@chinaaids.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Yan, PHD
Organizational Affiliation
National Center for AIDS/STD Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lincang Center for Disease Control and Prevention
City
Lincang
State/Province
Yunnan
Country
China
Facility Name
Wenshan Center for Disease Control and Prevention
City
Wenshan
State/Province
Yunnan
Country
China

12. IPD Sharing Statement

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Rapid Build of HIV Related Protective Barriers

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