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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: |
NCT03397420 |
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Date of registration:
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02/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Family-centered HIV Care, Viral Suppression and Retention in HIV-positive Children, Swaziland
FAM-CARE |
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Scientific title:
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Effect of Family-centered Model of HIV Care (FAM-CARE) on Viral Suppression and Retention in Care of HIV-positive Children in Swaziland |
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Date of first enrolment:
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September 13, 2017 |
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Target sample size:
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742 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03397420 |
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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: Treatment. 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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Swaziland
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Contacts
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Name:
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Caspian Chouraya, 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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Elizabeth Glaser Pediatric AIDS Foundation |
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Name:
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Lynne Mofenson, 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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Elizabeth Glaser Pediatric AIDS Foundation |
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Name:
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Nobuble Mthethwa, 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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Ministry of Health, Swaziland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV-positive child aged <15 years receiving HIV care at the study facility.
Exclusion Criteria:
- At least one family member residing in the household is also HIV-positive and is
receiving services at the study facility
Age minimum:
N/A
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Other: FAM-CARE
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Primary Outcome(s)
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Proportion of HIV-positive children on ART virally suppressed
[Time Frame: 18 months after study enrollment.]
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Proportion of HIV-positive on ART virally unsuppressed
[Time Frame: 18 months after study enrollment.]
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Secondary Outcome(s)
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Factors associated with HIV viral suppression
[Time Frame: 18 months after study enrollment]
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Proportion HIV-positive children on ART virally suppressed (<1,000 copies/mL of HIV RNA) at 6 and 12 months after study enrollment
[Time Frame: 6 and 12 months after study enrollment]
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Acceptability of the FAM-CARE program based on individual interview responses
[Time Frame: 18 months after study enrollment]
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ART initiation
[Time Frame: 18 months after study enrollment]
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Loss to follow-up
[Time Frame: 18 months after study enrollment]
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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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