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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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13 June 2023 |
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Main ID: |
NCT03555669 |
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Date of registration:
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01/06/2018 |
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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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Project SOAR-Mental Health Malawi: Depression and HIV Integration
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Scientific title:
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UNCPM 21609 Project SOAR Mental Health: Evaluation of the Impact of a Depression Treatment Program on Mental Health and HIV Care Outcomes in Malawi |
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Date of first enrolment:
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April 24, 2017 |
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Target sample size:
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2082 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03555669 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential 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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Malawi
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Contacts
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Name:
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Brian Pence, PhD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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UNC Gillings School of Global Public Health |
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Name:
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Michael Udedi, MBA MPhil |
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Address:
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Telephone:
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Email:
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Affiliation:
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Malawi Ministry of Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult (=18 years)
- HIV-infected
- Newly initiating antiretroviral treatment at one of the program sites
- Screened for depression
Exclusion Criteria:
• None
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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Depression
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Intervention(s)
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Other: Depression Treatment
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Primary Outcome(s)
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Proportion of participants who are virally suppressed
[Time Frame: 6 months after ART initiation]
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Proportion of participants who are retained in care
[Time Frame: 6 months after ART initiation]
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Secondary Outcome(s)
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Proportion of scheduled ART visits attended
[Time Frame: 6 months after ART initiation]
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Proportion of participants who achieve depression remission (PHQ-9 score less than 5)
[Time Frame: 6 months after ART initiation]
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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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