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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2022 |
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Main ID: |
NCT03249493 |
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Date of registration:
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07/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Monitoring Of Viral Load In Decentralised Area in Vietnam
MOVIDA-2 |
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Scientific title:
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Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART |
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Date of first enrolment:
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August 15, 2017 |
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Target sample size:
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584 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03249493 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Fabien TAIEB, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Pasteur |
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Name:
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Yoann Madec, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Pasteur |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- confirmed HIV-1 infection,
- age at enrolment =18 years,
- ART naïve (women exposed through PMTCT are eligible),
- consent to participate.
Exclusion Criteria:
- negative for HIV,
- age at enrolment <18 years,
- ART experienced (excepted PMTCT),
- not consenting to participate.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Viral Load
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Dried Blood Spot
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HIV/AIDS
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Intervention(s)
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Other: Blood sample on DBS
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Primary Outcome(s)
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Virological success at 24 months of ART
[Time Frame: 24 months (+/- 1 month) after ART initiation]
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Secondary Outcome(s)
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Virological failure at 6, 12 and 24 months of ART
[Time Frame: At 6, 12 and 24 months of ART]
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virological success at 6 and at 12 months of ART
[Time Frame: At 6 and 12 months of ART]
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Outcomes related to ability of DBS to provide viral load result
[Time Frame: through study completion, an average of 2 years]
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Impact of viral load result on second-line ART initiation
[Time Frame: through study completion, an average of 2 years]
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Description of HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
[Time Frame: At 6, 12 and 24 months of ART]
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Baseline HIV drug resistance in case of virological failure
[Time Frame: ART initiation]
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HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
[Time Frame: At 6, 12 and 24 months of ART]
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Outcomes related to delay concerning the return of viral load result
[Time Frame: through study completion, an average of 2 years]
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Impact of viral load result on second-line ART initiation in term of delay
[Time Frame: through study completion, an average of 2 years]
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Outcomes related to quality of DBS samples
[Time Frame: through study completion, an average of 2 years]
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Outcomes related to ability of DBS to provide HIV drug resistance result
[Time Frame: through study completion, an average of 2 years]
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Mortality
[Time Frame: through study completion, an average of 2 years]
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Attrition
[Time Frame: through study completion, an average of 2 years]
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Baseline HIV drug resistance
[Time Frame: ART initiation]
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Outcomes related to DBS transfer
[Time Frame: through study completion, an average of 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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