Rapid Build of HIV Related Protective Barriers

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.

Study Overview

• Status: Unknown
• Conditions: Viral Suppression of HIV Infection
• Intervention / Treatment: Drug: The dosage of 400mg EFV; Behavioral: Personal involved intervention strategies

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao Yan, PHD; Phone Number: +86-10-5338-0980; Email: zhaoyan@chinaaids.cn

Study Locations

• China
  • Yunnan
    • Lincang, Yunnan, China
      • Lincang Center for Disease Control and Prevention
    • Wenshan, Yunnan, China
      • Wenshan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: routine care group; Medical institutions will provide patients routine care according to the national program standard.
Experimental: medicine intervention group; The dosage of 400 mg EFV will be used in the antiviral therapy.	Drug: The dosage of 400mg EFV; The dosage of 400mg EFV will be used in the antiviral therapy.
Experimental: 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.	Drug: The dosage of 400mg EFV; The dosage of 400mg EFV will be used in the antiviral therapy.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Viral suppression of HIV-infected patients	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment coverage	12 months

Collaborators and Investigators

• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Collaborators: Yunnan Center for Disease Control and Prevention; Yunnan AIDS Care Center
• Investigators: Principal Investigator: Zhao Yan, PHD, National Center for AIDS/STD control and prevention

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 2018ZX10721102-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No