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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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17 May 2021 |
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Main ID: |
NCT04884867 |
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Date of registration:
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07/05/2021 |
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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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A Psychosocial Tele-health Stigma Intervention for Youth Living With HIV in Vietnam
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Scientific title:
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"S?ng Vui, Live Happily": A Psychosocial Tele-health Intervention to Address Multi-level Stigma Among Youth Living With HIV in Vietnam |
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Date of first enrolment:
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April 14, 2021 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04884867 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. 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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Vietnam
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Contacts
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Name:
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Nhu Tran, 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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Name:
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Mary DeSilva, ScD, SM, MSFS |
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Address:
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Telephone:
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2072214567 |
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Email:
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mdesilva1@une.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- are between 18 and 24 years old
- are a patient at the OPC
- are expected to remain in care at the OPC for 3 months minimum(?)
- are currently on ART
- have primary responsibility for taking their own medications,
- self-report intrapersonal stigma via a brief screening questionnaire,
- are able to complete a short phone call from the location where they intend to be when
participating in coaching sessions,
- agree to follow all study procedures, AND
- provide informed consent.
Exclusion Criteria:
- are below the age of 18 years or above the age of 24,
- are not currently on ART,
- live outside the clinic catchment area,
- are identified as having severe mental health issues as identified through screening,
OR
- are not willing to provide informed consent.
Age minimum:
18 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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Stigma, Social
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Intervention(s)
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Behavioral: CBT-based supportive skills delivered by phone by lay coaches
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Primary Outcome(s)
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Adherence
[Time Frame: Week 12 (endline)]
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Anxiety
[Time Frame: change between Week 1 and Week 12]
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Depression
[Time Frame: change between Week 1 and Week 12]
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Interpersonal Stigma
[Time Frame: change between Week 1 and Week 12]
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Intrapersonal Stigma
[Time Frame: change between Week 1-Week 12]
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Secondary ID(s)
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R21TW011085-01
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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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