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.: PACTR202006601935462 Date of Approval: 18/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Promoting Adherence to Anti-retroviral Therapy and Viral suppression among HIV positive Young People in Uganda through Group Support Psychotherapy
Official scientific title Promoting Adherence to Anti-retroviral Therapy and Viral suppression among HIV positive Young People in Uganda through Group Support Psychotherapy: Study Protocol for a Pilot Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Successful care of young people with HIV is impeded by variety of psychosocial challenges including mental health problems, poor medication adherence, socioeconomic instability, and HIV-related stigma. Consequently, they are prone to poor linkage to care, attrition from care and treatment failure. Intensive adherence counseling has long been used to mitigate non-viral suppression; however, recent findings from Ugandan studies indicate that this strategy may not be sufficient. In this study we primarily conduct community-based participatory qualitative research to obtain information on the potential usefulness of group support psychotherapy (GSP) in addressing the psychosocial challenges that impact adherence to anti-retroviral therapy among young people with HIV in northern Uganda. This qualitative data will then be used to modify GSP to suit the needs of young people. Secondarily, we will conduct a pilot randomized controlled trial to assess the feasibility, acceptability and preliminary effectiveness and cost-effectiveness of GSP in promoting ART adherence and viral suppression among HIV positive young people with non-viral suppression 6 months after initiating first-line ART at the Kitgum hospital HIV clinic. Data will be used to design a definitive trial which will test the hypothesis that group support psychotherapy promotes better ART adherence than standard care with Intensive adherence counseling among HIV positive young people with non-viral suppression 6 months after initiation of first-line ART in Uganda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/08/2020
Actual trial start date
Anticipated date of last follow up 31/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Active, not 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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site 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 of group support psychotherapy 8 weeks The content of the GSP has been described in previous publications and manual is attached to the protocol. GSP sessions for caregivers will proceed as previously described in the SEEK-GSP trial. GSP sessions for the young people will follow the same format but with a focus on challenges faced by young people living with HIV. Besides being gender specific, they will also be age specific with participants being grouped into the following age categories:13-14;15-16 and 17- 18) Regarding, the general GSP format, the first session addresses issues relevant to the group process, ground rules, and expectations. The second session will involve educating participants about triggers, symptoms, and treatment options for excessive anger, anxiety and depression in the context of HIV infection. Participants will be encouraged to share personal problems in the third and fourth sessions. For those not comfortable with sharing in a group, they will be provided with an opportunity to share in an individual session but learn all other skills in group sessions. In the fifth and sixth sessions, participants will be taught positive coping skills, problem-solving skills and skills for coping with stigma and discrimination. The last two sessions will focus on training participants in income-generating skills. GSP participants will also meet their HIV care providers to receive their standard care IAC. GSP will be delivered by previously trained lay health workers who delivered the intervention to adults in a previous trial. Booster training sessions will be provided based on alterations to content of GSP. 60
Control Group Intensive Adherence Counselling 4 individual adherence counselling sessions 12 weeks Both the World Health Organization (WHO) and the Ugandan ART guidelines recommend that asymptomatic persons living with HIV who have been identified with VL ≥ 1000 copies/mL should be offered Intensive Adherence Counseling (IAC) for 3–6 months and repeat VL testing before switching to second‐line therapy. Individuals with detectable viral load 6 months after initiating ART are invited to participate in standard care IAC in the clinic, which may consist of at least four sessions with an HIV care provider. The HIV care provider will be informed that he/she can refer participants undergoing adherence counselling to other medical services as they see fit. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participant dyads must consist of an HIV seropositive young person (10-18 years) with ≥1000 viral copies/ml 6 months after initiating first-line ART and a caregiver aged 19 years and older. Participant dyads will be excluded if they have visual or hearing impairments, active untreated major mental illness (untreated psychosis or mania or high suicide risk) or severe medical conditions (active tuberculosis or pneumonia) that would interfere with participation in interventions Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 Year(s) 18 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 30/06/2020 Makerere University School of Health Science Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Makerere University School of Health Sciences Kampala 0256 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 08/11/2021 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 Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to anti-retroviral therapy and Viral suppression Baseline, 6 months and 12 months
Secondary Outcome Depression symptoms, Post-traumatic stress symptoms, Social support, HIV stigma and Cost effectiveness Baseline, 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kitgum Hospital HIV Clinic Kitgum Road Kitgum 0256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
CRI Foundation 420 Boylston St, Suite 410, Boston, MA Boston 02116 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CRI Foundation 420 Boylston St, Suite 410, Boston, MA Boston 02116 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Panos Vostanis Department of Neuroscience, Psychology and Behaviour, George Davies Centre, University Road, Leicester LE1 7RH, United Kingdom Leicester United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Etheldreda Nakimuli Mpungu ethelmpungu@gmail.com +256788994050 Makerere University College of Health Sciences Department of Psychiatry
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Stella Imot healthsciences.irb@gmail.com +256774313924 Makerere University College of Health Sciences School of Medicine
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Member of Makerere University School of Health Sciences Research and Ethics Committee
Role Name Email Phone Street address
Scientific Enquiries Etheldreda Nakimuli Mpungu ethelmpungu@gmail.com +256788994050 Makerere University College of Health Science Department of Psychiatry
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Demographics and clinical and psycho-social variables Focus Group Discussion scripts Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years The de-identified data set and a data dictionary will be made available with publication of the trial after obtaining relevant Institutional Research Ethics Board approval of a proposal and signed data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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