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.: PACTR202210880715567 Date of Approval: 03/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness and Cost-Effectiveness of Group Support Psychotherapy in improving HIV Treatment Outcomes among Young People Living with HIV in Uganda
Official scientific title Effectiveness and Cost-Effectiveness of Group Support Psychotherapy in improving HIV Treatment Outcomes among Young People Living with HIV in Uganda: A Cluster Randomized Trial
Brief summary describing the background and objectives of the trial The prior pilot randomized clinical trial of group support psychotherapy among young people living with HIV served to test procedures, recruitment, and retention, and explore its preliminary effectiveness in improving ART adherence and viral suppression. Results from this trial indicate that group support psychotherapy with intensive adherence counseling was more likely to improve viral suppression than intensive adherence counseling alone. However, exit interviews with trial participants and intervention deliverers indicate there was extensive contamination between the two trial groups. In this study, we are conducting a definitive cluster randomized trial that will test the hypothesis that group support psychotherapy with intensive adherence counseling promotes better ART adherence and viral suppression than intensive adherence counseling alone among HIV-positive young people with non-viral suppression 6 months after initiation of first-line ART in Uganda. This trial will provide robust evidence for the change processes and outcomes we observed in the pilot trial. Further, the trial will demonstrate the potential for dissemination and integration into existing HIV service delivery platforms of a culturally sensitive first-line treatment for mild to moderate depression among young people living with HIV.
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 05/12/2022
Actual trial start date
Anticipated date of last follow up 06/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 360
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 A session per week for 8 weeks 8 weeks The content of the GSP has been described in previous publications and the manual is attached to the protocol [28, 29]. GSP sessions for caregivers will proceed as previously described in the SEEK-GSP trial [20]. GSP sessions for 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: 10-14;15- 18) GSP will be delivered in eight sessions held weekly, lasting 2–3 h each. Participants will be divided into gender-specific groups of 10–12 participants. Intervention facilitators will be trained lay health workers, of the same gender as the participants, and they will deliver the intervention material following a scripted intervention manual. 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 the content of GSP. 240
Control Group Standard of Care Intensive Adherence Counseling (IAC) for 3 - 6 months 3 - 6 months 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. 240 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible for the study, 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
No 20/09/2022 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
No 27/09/2022 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 0256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to ART and Viral Load Baseline, 6 months and 12 months
Secondary Outcome Depression symptoms, Anxiety symptoms, Suicide risk, Post-traumatic stress symptoms, Social support and Stigma Baseline, 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lamwo PHCs Lamwo Town Council Lamwo 0256 Uganda
Agago PHCs Agago Town Council Agago 0256 Uganda
Pader PHCs Pader Town Council Pader 0256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
CRI Foundation 420 Boylston St, Suite 410, 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
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
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@yahoo.com +256788994050 Makerere University College of Health Sciences 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 Data Sharing Statements We will make available individual participant data (including data dictionaries). For each published article, the individual participant data that underlie the results reported including text, tables, figures, and appendices) will be shared. Further, the study protocol, statistical Analysis Plan, and analytic Code will be made available in open-access peer-reviewed journals. This data can be accessed by investigators whose proposed use of the data has been approved by an independent review committee beginning 12 months and ending 36 months following article publication. Proposals should be directed to etheldreda.nakimuli@mak.ac.ug To gain access, data requestors will need to sign a data sharing agreement. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year and 6 months The de-identified data set and a data dictionary will be made available with the 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