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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03852849
Other study ID # 2018ZX10721102-002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date March 1, 2021

Study information

Verified date February 2019
Source National Center for AIDS/STD Control and Prevention, China CDC
Contact Zhao Yan, PHD
Phone +86-10-5338-0980
Email zhaoyan@chinaaids.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date March 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Lincang Center for Disease Control and Prevention Lincang Yunnan
China Wenshan Center for Disease Control and Prevention Wenshan Yunnan

Sponsors (3)

Lead Sponsor Collaborator
National Center for AIDS/STD Control and Prevention, China CDC Yunnan AIDS Care Center, Yunnan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Viral suppression of HIV-infected patients 12 months
Secondary Treatment coverage 12 months