Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201608001738234 Date of Approval: 08/08/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Social, Emotional and Economic empowerment thru Knowledge of Group Support Psychotherapy content (SEEK-GSP) Trial
Official scientific title 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.
Brief summary describing the background and objectives of the trial Background: The shifting of mental health related tasks from health professionals to para-professionals or non-health professionals (lay health workers) has been documented in non-HIV populations. However, little is known about the effectiveness of task shifting of mental health related services in HIV populations. Aims Primary aim: The primary aim of the study is to compare the effects of group support psychotherapy and group HIV education delivered by trained lay health workers to persons living with HIV(PLWH) presenting with depression in primary care on depression and function outcomes 6 months after the end of treatment. Secondary aims: 1) To compare the effects of group support psychotherapy and group HIV education delivered by trained lay health workers to PLWH presenting with depression in primary care on social outcomes: social support, coping skills and HIV related stigma; HIV treatment outcomes: adherence to anti-retroviral therapy (ART) and viral load; economic outcomes: reduction in number of disability days, asset possession scores and poverty index scores at 6,12 and 24 months after the end of treatment. 2) To compare the cost-effectiveness of group support psychotherapy and group HIV education delivered by trained lay health workers to PLWH presenting with depression in primary care. 3)To compare changes in knowledge and perceptions of depression between lay health workers trained in delivery of group support psychotherapy and those trained in delivery of group HIV education. 4To conduct a process evaluation of trial activities to determine indicators of feasibility including Reach, Dose delivered and received, as well as Attrition; indicators of acceptability including satisfaction with intervention content, delivery agents and effects; Fidelity (whether the intervention is delivered as planned). Further, potential causal mechanisms and the impact of contextual influences on intervention delivery and outcomes will be explored.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SEEK GSP
Disease(s) or condition(s) being studied Depression,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 15/08/2016
Actual trial start date 13/09/2016
Anticipated date of last follow up 01/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants) 1140
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
SHSREC REF: 2016-019 Makerere College of Health Sciences School of Health Sciences Research Ethics Committee
SS 5006 Uganda National Council of Science and Technology
TASOREC/17/16-UG-REC-009 The AIDS Support Organization
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group support psychotherapy 8 weekly sessions 2-3 hours Group support psychotherapy (GSP) is a culturally sensitive intervention that aims to treat depression by enhancing social support, teaching coping skills, and income-generating skills 578
Control Group Group HIV education 8 weekly sessions 2 hours Consists of eight Health education talks on pertinent HIV topics 562
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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 19 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2016 Makerere College of Health Sciences School of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O.BOX 7072 Kampala 256 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/06/2016 Uganda National Council of Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road, Ntinda. P.O.BOX 6884 Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Major depressive disorder (MDD) baseline, at end of treatment(2 months), 6 ,12,18 and 24 months after treatment
Primary Outcome Functioning baseline, at end of treatment(2 months), 6 ,12,18 and 24 months after treatment
Secondary Outcome Emotional outcomes: Depression,PTSD symptoms,self-esteem baseline, at end of treatment(2 months), 6 ,12,18 and 24 months after treatment
Secondary Outcome Social outcomes:Alcohol Use & Perceived social support,Coping skills, HIV related stigma, enacted stigma(discrimination) baseline, at end of treatment(2 months), 6 ,12,18 and 24 months after treatment
Secondary Outcome Economic outcomes: Poverty index scores & Disability days baseline, at end of treatment(2 months), 6 ,12,18 and 24 months after treatment
Secondary Outcome HIV treatment outcomes:Adherence to anti-retroviral therapy(ART) and Viral load baseline, at end of treatment(2 months), 6 ,12,18 and 24 months after treatment
Secondary Outcome Cost-effectiveness 6 and 24 months after treatment
Secondary Outcome Process evaluation outcomes: Feasibility& Fidelity at the end(2 months) after treatment
Secondary Outcome Process evaluation outcomes: Acceptability, Contextual influences & Causal mechanisms 6 months after the end of the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pader district Pader 256 Uganda
Gulu District Gulu 256 Uganda
Kitgum District Kitgum 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada MaRS Centre, South Tower, 101 College street, Suite 406 Toronto M5G1L7 Canada
MQ Transforming Mental Health 4th Floor West, 1-5 Clerkenwell Road, London EC1M5PA United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Grand Challenges Canada MaRS Centre, South Tower, 101 College street, Suite 406 Toronto M5G 1L7 Canada Funding Agency
Secondary Sponsor Makerere University Makerere Hill Road, P.O.BOX 7062 Kampala 256 Uganda University
COLLABORATORS
Name Street address City Postal code Country
James Okello Gulu University, Department of Mental Health P.O.BOX 16 Gulu 256 Uganda
Josephine Birungi The AIDS Support Organization (TASO) Mulago Hospital Complex. P.O BOX 10443 Kampala 256 Uganda
Steve Kanters Precision Global Health,1505 West 2nd Avenue Suite 302 Vancouver V6H 3Y4 Canada
Jean Nachega Faculty of Medicine, University of Stellenbosch P O Box 19063 Tygerberg 7505 South Africa
Seggane Musisi Makerere University College of Health Sciences Department of Psychiatry. Mulago Hill road P.O.BOX 7072 Kampala 256 Uganda
Ramin Mojtabai fJohns Hopkins School of Public Health, Department of Mental Health,624 North Broadway, Room 797 Baltimore 21205 United States of America
Josephine Birungi The AIDS Support Organization (TASO) Mulago Hospital Complex. P.O BOX 10443 Kampala 256 Uganda
Jean Nachega Faculty of Medicine, University of Stellenbosch P O Box 19063 Tygerberg 7505 South Africa
Ramin Mojtabai fJohns Hopkins School of Public Health, Department of Mental Health,624 North Broadway, Room 797 Baltimore 21205 United States of America
Seggane Musisi Makerere University College of Health Sciences Department of Psychiatry. Mulago Hill road P.O.BOX 7072 Kampala 256 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Etheldreda Nakimuli-Mpungu ethelmpungu@yahoo.com +256788994050 Makerere University College of Health Sciences,Department of Psychiatry P.O.BOX 7072
City Postal code Country Position/Affiliation
Kampala 256 Uganda Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Hellen Opolot info@uncst.go.ug +256414705500 Plot 6, Kimera Road, Ntinda, P.O.BOX 6884
City Postal code Country Position/Affiliation
Kampala 256 Uganda Adminstrative Assistant to Executive Secretary of the UNCST
Role Name Email Phone Street address
Scientific Enquiries Paul Kutyabami pkutyabami@med.mak.ac.ug +256772404970 Makerere University, Pharmacy Building, P.O.BOX 7072
City Postal code Country Position/Affiliation
Kampala 256 Uganda Chairperson, School of Health Sciences Research and Ethics Committee
REPORTING
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