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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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12 December 2020 |
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Main ID: |
NCT03288246 |
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Date of registration:
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13/09/2017 |
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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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Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti
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Scientific title:
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Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti |
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Date of first enrolment:
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May 3, 2018 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03288246 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Haiti
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Contacts
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Name:
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Daniel Fitzgerald, 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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Weill Cornell Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 10-24 years
- HIV-infected
- On ART for > 6 months
- Permanent residence in Port-au-Prince
- Able to provide informed consent/assent
Exclusion Criteria:
- Requires urgent VL test the day of enrollment/randomization
- Requires ART regimen change
- Currently pregnant
- Co-infected with tuberculosis
- Severe co-morbidities including cognitive impairment, bipolar disorder, psychosis, or
current need for inpatient psychiatric hospitalization
Age minimum:
10 Years
Age maximum:
24 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Diagnostic Test: point-of-care viral load test
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Primary Outcome(s)
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The number of steps in the HIV care cascade involved with viral load testing.
[Time Frame: 1 day of clinic visit]
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Secondary Outcome(s)
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The proportion of participants who achieve or sustain a viral level <1000 cells/ml
[Time Frame: 6 months]
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The proportion of participants who demonstrate comprehension of the correlation between ART adherence and viral level
[Time Frame: 1 month]
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Secondary ID(s)
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1708018474
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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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