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: www.pactr.org
Trial no.: PACTR201802003141213 Date of Approval: 23/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON OF ROUTINE VERSUS SELECTIVE SCREENING FOR DEPRESSION STRATEGIES AMONG PLHIV ATTENDING PRINCESS DIANA MEMORIAL HEALTH CENTRE IV SOROTI
Official scientific title A RCT COMPARING ROUTINE AND SELECTIVE SCREENING FOR DEPRESSION STRATEGIES AMONG PLHIV ATTENDING PRINCESS DIANA MEMORIAL HC IV SOROTI
Brief summary describing the background and objectives of the trial Introduction: Depression is the leading cause of disability worldwide with over 300 million people affected (4.4% of the world¿s population) (UN health agency, 2017). It is one of the most prevalent mental health comorbidities among People Living with Human Immunodeficiency Virus (PLHIV) (Benton, 2008; Okeke & Wagner, 2013), and it is 2 to 3 times more prevalent among PLHIV in Sub-Saharan Africa (SSA) (Charlotte, Dabis, & de Rekeneire, 2017). In 2016, there were 36.7 million PLHIV worldwide accounting for 0.8% of the world¿s population aged 15-49 years(¿Fact sheet - AIDS epidemic status,¿ 2016). People living with HIV are at risk of developing depression. Depression has been found to worsen their well-being, the ability to adhere to treatment, to increase loss to follow up among others. The approach recommended by the Uganda ministry of health of ¿selective screening¿ could be living a gap in detection in screening for depression given that it does not cover all the risk factors. The alternative routine screening offers an advantage of all PLHIV to be screened on every clinic visit though with possibly more resources required. Knowing how to strategise screening for depression will contribute towards the knowledge needed to develop guidelines for screening for depression among people living with HIV in Uganda and perhaps in other countries. Major objective: To determine whether routine screening strategy differs from selective screening strategy in depression case detection, and to describe the perceptions of stakeholders on the strategies for screening depression among PLHIV. Specific objectives: a) To determine whether there is a difference in cases of depression detected when using routine or selective screening strategies among PLHIV. b) To describe the perceptions of stakeholders on the screening strategies for depression among PLHIV.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Depression in HIV,Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 19/03/2018
Actual trial start date 05/03/2018
Anticipated date of last follow up 21/05/2018
Actual Last follow-up date 05/02/2018
Anticipated target sample size (number of participants) 344
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 The allocation Sequence is to be generated by an independent Statistician using a computer. Randomly varying block sizes of 4,6,8,10, and 12. Sequentially sealed Opaque envelopes will be used. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised The allocation Sequence is to be generated by an independent Statistician using a computer. Randomly varying block sizes of 4,6,8,10, and 12. Sequentially sealed Opaque envelopes will be used. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised The allocation Sequence is to be generated by an independent Statistician using a computer. Randomly varying block sizes of 4,6,8,10, and 12. Sequentially sealed Opaque envelopes will be used. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised The allocation Sequence is to be generated by an independent Statistician using a computer. Randomly varying block sizes of 4,6,8,10, and 12. Sequentially sealed Opaque envelopes will be used. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Selective Screening for depression among people living with HIV Screening for depression on every clinic visit During the study period (approximately 3 months) The control arm is the standard of care which is selective screening. A patient who consents to the study will be subjected to the PHQ2 and later (PHQ2 ¿ 3) PHQ 9 when the clinician finds it appropriate especially at the crisis points in life in accordance with the ministry of health 2016 guidelines for prevention and treatment of HIV in Uganda. After, all patients will be evaluated with the MINI. 172 Active-Treatment of Control Group
Experimental Group Routine screening for depression among people living with HIV Every Clinic Visit During the study period (approximately 3 months) The intervention will be comprised of routine screening. In this strategy PLHIV who consent will be subjected to the PHQ-2 and if the patient has a value greater than or equal to 3 in the PHQ-2 the patient will be subjected to PHQ-9. After wards all patients will be subjected to the M.I.N.I to confirm cases of major depressive disorder (MDD), and to identify the missed cases of MDD. 172
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All PLHIV aged 18 years and above attending the HIV clinics in the study site during the study period and who consent to participate in the study. PLHIV who are too ill to withstand the study procedures will be excluded from the study. 18 Year(s) 100 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 15/03/2018 School Of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mulago Hill road Kampala P.O.BOX 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression case detection Every HIV clinic visit during the consultation upon evaluation after screening with the Patient Health Questionnaires (2 and 9).
Secondary Outcome Missed cases of depression. Every HIV clinic visit. Upon evaluation using the Mini international neuropsychiatric interview (MINI) by a psychiatric nurse or medical clinical officer following the evaluation using the PHQ2 and PHQ9.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Princess Diana Memorial Health Center IV Moroto Road Soroti 61 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal savings Eneku Soroti 61 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Paul Okimat Eneku Soroti 61 Uganda Charities/Societies/Foundation
Secondary Sponsor Makerere University Bombo road Kampala P.O. Box 7072 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Soroti District Local Government Main Street Soroti 61 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Okimat paulokimat@gmail.com +256773171033 Eneku
City Postal code Country Position/Affiliation
Soroti 61 Uganda Student (Msc. Clinical Epidemiology an Biostatistics )
Role Name Email Phone Street address
Public Enquiries Dickens Akena akenadickens@yahoo.co.uk +256-392-943080 Mulago Hill
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Psychiatrist and Lecturer
Role Name Email Phone Street address
Scientific Enquiries Charles Karamgi ckaramagi2000@yahoo.com +256772545942 Mulago Hill
City Postal code Country Position/Affiliation
Kampala P.O.BOX 7062 Mak Uganda Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 26/02/2018 The actual date had not yet been entered. 2018-03-05
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 08/04/2018 Modified Not yet recruiting Open to recruitment: actively recruiting participants
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 23/02/2018 The word Exclusion Criteria was repeated. Exclusion criteria PLHIV who are too ill to withstand the study procedures will be excluded from the study. PLHIV who are too ill to withstand the study procedures will be excluded from the study.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 01/06/2018 Title was incomplete. It was not clearly indicating the location of the site of the study. COMPARISON OF ROUTINE VERSUS SELECTIVE SCREENING FOR DEPRESSION STRATEGIES AMONG PLHIV ATTENDING PRINCESS DIANA MEMORIAL HEALTH CE COMPARISON OF ROUTINE VERSUS SELECTIVE SCREENING FOR DEPRESSION STRATEGIES AMONG PLHIV ATTENDING PRINCESS DIANA MEMORIAL HEALTH CENTRE IV SOROTI
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 26/02/2018 The actual date had not been entered. 2018-02-05
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 23/02/2018 The word Inclusion Criteria was repeated Inclusion criteria All PLHIV aged 18 years and above attending the HIV clinics in the study site during the study period and who consent to participate in the study. All PLHIV aged 18 years and above attending the HIV clinics in the study site during the study period and who consent to participate in the study.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 24/02/2018 We are studying screening for depression among People Living with HIV. HIV/AIDS , null Depression in HIV
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 23/02/2018 Main disease of interest is depression. Depression is being Studied among People living with HIV. HIV/AIDS , null HIV/AIDS , Depression
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 05/07/2018 pactr update Other Mental and Behavioural Disorders, Other
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Sub disease(s) 05/07/2018 pactr update HIV/AIDS