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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201608001738234 |
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Date of registration:
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08/08/2016 |
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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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Social, Emotional and Economic empowerment thru Knowledge of Group Support Psychotherapy content (SEEK-GSP) Trial
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Scientific title:
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Effectiveness of group support psychotherapy delivered by trained lay health workers to persons with HIV and depression in primary care in Uganda: a cluster randomized trial. |
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Date of first enrolment:
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15/08/2016 |
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Target sample size:
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1200 |
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Recruitment status: |
Other |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1738 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Eligible health centers(clusters) were stratified by district, then randomly assigned (1:1) to experimental and control arms. Randomisation was done by urn randomisation picked by the head of the health center.,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Paul
Kutyabami |
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Address:
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Makerere University, Pharmacy Building, P.O.BOX 7072
256
Kampala
Uganda |
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Telephone:
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+256772404970 |
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Email:
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pkutyabami@med.mak.ac.ug |
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Affiliation:
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Chairperson, School of Health Sciences Research and Ethics Committee |
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Name:
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Hellen
Opolot |
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Address:
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Plot 6, Kimera Road, Ntinda, P.O.BOX 6884
256
Kampala
Uganda |
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Telephone:
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+256414705500 |
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Email:
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info@uncst.go.ug |
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Affiliation:
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Adminstrative Assistant to Executive Secretary of the UNCST |
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Key inclusion & exclusion criteria
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Inclusion criteria:
HIV positive
Aged 19 years or older
Met Mini International Neuropsychiatric Interview (MINI) criteria for major depression
Live or work in the villages served by participating lay health worker
Be antidepressant naive.
Exclusion criteria: Individuals with the following conditions will be excluded from the study:
High suicide risk
A severe medical disorder such as pneumonia or active tuberculosis
Psychotic symptoms
Hearing or visual impairment
Age minimum:
19 Year(s)
Age maximum:
80 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mental and Behavioural Disorders
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Mental and Behavioural Disorders
Depression
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Depression
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Intervention(s)
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Group support psychotherapy
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Group HIV education
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Primary Outcome(s)
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Major depressive disorder (MDD)
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Functioning
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Secondary Outcome(s)
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Process evaluation outcomes: Acceptability, Contextual influences & Causal mechanisms
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Cost-effectiveness
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HIV treatment outcomes:Adherence to anti-retroviral therapy(ART) and Viral load
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Process evaluation outcomes: Feasibility& Fidelity
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Emotional outcomes: Depression,PTSD symptoms,self-esteem
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Economic outcomes: Poverty index scores & Disability days
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Social outcomes:Alcohol Use & Perceived social support,Coping skills, HIV related stigma, enacted stigma(discrimination)
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Secondary ID(s)
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SS 5006
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TASOREC/17/16-UG-REC-009
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SHSREC REF: 2016-019
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Source(s) of Monetary Support
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Grand Challenges Canada
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MQ Transforming Mental Health
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Ethics review
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Status: Approved
Approval date: 15/06/2016
Contact:
Makerere College of Health Sciences School of Health Sciences Research Ethics Committee
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Status: Approved
Approval date: 27/06/2016
Contact:
Uganda National Council of Science and Technology
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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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