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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: |
NCT02909218 |
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Date of registration:
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10/07/2016 |
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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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MaxART: Early Access to ART for All in Swaziland
MaxART |
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Scientific title:
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MaxART: Early Access to ART for All in Swaziland |
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Date of first enrolment:
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September 1, 2014 |
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Target sample size:
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3485 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02909218 |
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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: Triple (Participant, Care Provider, Investigator).
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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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Velephi Okello, 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:
- All ART-naive HIV-positive individuals who are 18 years of age or older - excluding
pregnant or breastfeeding women - who attend the health facilities included in the
study will be asked for their consent to enroll in the study.
Exclusion Criteria:
- All HIV-positive individuals who < 18 years of age or older and pregnant or
breastfeeding women.
- All HIV-positive individuals who did not consent to participate or who have already
been initiated on ART.
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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HIV/AIDS
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Intervention(s)
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Other: Early Access to ART for All
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Primary Outcome(s)
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Viral suppression
[Time Frame: 6 months]
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Retention
[Time Frame: 12 months]
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Secondary Outcome(s)
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12-month mortality rate
[Time Frame: 12 months]
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Drug resistance
[Time Frame: 36 months]
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ART uptake among those who are eligible
[Time Frame: 3 months]
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Cost per patient per year
[Time Frame: 12 months]
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HIV infection
[Time Frame: 36 months]
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Visit adherence among those initiated on ART
[Time Frame: 36 months]
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Tuberculosis
[Time Frame: 36 months]
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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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