NCT03852849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

February 22, 2019

Last Update Submit

February 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Viral suppression of HIV-infected patients

    12 months

Secondary Outcomes (1)

  • Treatment coverage

    12 months

Study Arms (3)

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.

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.

Behavioral: Personal involved intervention strategiesDrug: The dosage of 400mg EFV

Interventions

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.

consolidated intervention group

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

consolidated intervention groupmedicine intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • IDU
  • Having severe mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lincang Center for Disease Control and Prevention

Lincang, Yunnan, China

Location

Wenshan Center for Disease Control and Prevention

Wenshan, Yunnan, China

Location

MeSH Terms

Interventions

efavirenz

Study Officials

  • Zhao Yan, PHD

    National Center for AIDS/STD Control and Prevention

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 25, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2020

Study Completion

March 1, 2021

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations