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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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16 December 2017 |
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Main ID: |
NCT02128087 |
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Date of registration:
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15/04/2014 |
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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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Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
RATA |
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Scientific title:
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Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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330 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02128087 |
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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: Factorial 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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Uganda
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United States
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Contacts
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Name:
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Sebastian Linnemayr, 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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RAND |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 15-24
- have been in HIV care at the clinic for at least three months
- are currently taking HIV-related medication (ART or co-trimoxazole)
- have demonstrated adherence problems (defined as having missed at least one medication
dose per week on average)
- either own a phone or have regular access to one
- intend to stay at the clinic for the study period
- are not in boarding school (where phones are forbidden)
Exclusion Criteria:
- does not speak or understand either English or Luganda
Age minimum:
15 Years
Age maximum:
24 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus
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Intervention(s)
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Behavioral: One-way SMS intervention group
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Behavioral: Two-way SMS intervention
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Primary Outcome(s)
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Medication adherence rates using electronically monitored adherence (MEMS cap) data
[Time Frame: 6 months after enrollment]
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Medication adherence rates using electronically monitored adherence (MEMS cap) data
[Time Frame: 12 months after enrollment]
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Medication adherence rates using electronically monitored adherence (MEMS cap) data
[Time Frame: 24 months after enrollment]
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Secondary Outcome(s)
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Clinic Attendance
[Time Frame: Continuous over 24 months]
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Fraction of clients displaying adherence of 90% or more
[Time Frame: At 6, 12, 18 and 24 months]
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Pharmacy Refill Adherence
[Time Frame: Months 6, 12, 18 and 24]
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Indicator for treatment interruptions of more than 48 hours
[Time Frame: At 6, 12, 18 and 24 months]
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Cluster of differentiation 4 (CD4) count
[Time Frame: Occasionally over 24 months]
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Self-reported adherence
[Time Frame: At baseline, 6, 12, 18 and 24 months]
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Viral load assays
[Time Frame: At month 12]
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Secondary ID(s)
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1R01HD074925-01
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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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