- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03852849
Rapid Build of HIV Related Protective Barriers
Cohort Study on Appropriate Strategies of The Rapid Build of HIV Related Protective Barriers in Yunnan, China
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 .
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Yunnan
-
Lincang, Yunnan, Kina
- Lincang Center for Disease Control and Prevention
-
Wenshan, Yunnan, Kina
- Wenshan Center for Disease Control and Prevention
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: routine care group
Medical institutions will provide patients routine care according to the national program standard.
|
|
|
Eksperimentel: medicine intervention group
The dosage of 400 mg EFV will be used in the antiviral therapy.
|
The dosage of 400mg EFV will be used in the antiviral therapy.
|
|
Eksperimentel: 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.
|
The dosage of 400mg EFV will be used in the antiviral therapy.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Viral suppression of HIV-infected patients
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Treatment coverage
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Zhao Yan, PHD, National Center for AIDS/STD control and prevention
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018ZX10721102-002
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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