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.: PACTR201810756862405 Date of Approval: 08/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Operations research to estimate the effectiveness of a peer-led mental health intervention on virological suppression and mental health among adolescents with HIV in Zimbabwe
Official scientific title Operations research to estimate the effectiveness of a peer-led mental health intervention on virological suppression and mental health among adolescents with HIV in Zimbabwe
Brief summary describing the background and objectives of the trial Africaid’s Zvandiri programme is a model of differentiated clinical service delivery for children, adolescents and young people (CAYP), in Zimbabwe. At the forefront of Zvandiri are trained, mentored HIV positive peer supporters known as Community Adolescent Treatment Supporters (CATS) who are typically between 18-24 years old. The CATS manage a caseload of HIV positive CAYP, supporting ART initiation, adherence, linkage and retention in care. Operations research has found that this CATS model results in improved adherence and retention among ALHIV compared with adolescents receiving standard of care alone. Friendship Bench is a 6-session problem solving therapy programmed delivered by a trained lay health worker at primary care clinics. A recent cluster randomized controlled trial (cRCT) showed effectiveness of the intervention for treating common mental disorders (i.e. depression and anxiety disorders), and improving quality of life, and economic functioning. HIV positive adolescent peer counsellors in Africaid’s Zvandiri programme are witnessing the impact of poor mental health on the lives of their HIV positive peers, including an increasing number of suicides. As the only evidence-based intervention currently scaled up in Zimbabwe, Zvandiri aims to adopt the Friendship Bench problem solving therapy programme for its CATS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ALHIV Adherence Mental Health
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Psychosocial
Anticipated trial start date 01/11/2018
Actual trial start date 02/01/2019
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date 26/02/2020
Anticipated target sample size (number of participants) 840
Actual target sample size (number of participants) 842
Recruitment status Completed
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual CATS Care and Support Monthly. This includes monthly home visits, monthly support groups and counselling at clinic as per the MoHCC schedule. More vulnerable clients are seen weekly, i.e if they are unwell, defaulting from treatment, have a high viral load, or have psychosocial challenges. 12 months All eligible adolescents attending clinics allocated to the standard-care arm will receive ART, adherence support and counselling as set out in the prevailing MoHCC guidelines. This includes counselling from clinic-based nurses and primary counsellors as well as that provided by trained, mentored CATS. CATS will provide counselling and follow up support both in the clinics and homes of their designated caseloads of ALHIV. ALHIV presenting with signs of psychological distress will be referred by CATS to the clinic as per standard MoHCC and Zvandiri procedures for further assessment and management. In some districts, this will include follow up by a trained mental health nurse, where available. The control arm activities will be coordinated by a Zvandiri Mentor who will not interact with the intervention arm. The CATS in the control arm work at different health facilities and will not interact with the CATS in the intervention arm. 420 Active-Treatment of Control Group
Experimental Group PST Based CATS Care and Support 6 sessions over 12 weeks 12 months All eligible adolescents attending intervention clinics will receive ART, adherence support and counselling and CATS counselling and follow up as per standard care. In addition, CATS will be trained and supervised in the delivery of the CATS-PST intervention for their designated caseloads. The intervention arm activities will be coordinated by a Zvandiri Mentor who will not interact with the control arm. The CATS in the intervention arm work at different health facilities and will not interact with the CATS in the control arm. 420
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV-positive adolescents, aged 10–19 years, eligible for ART (i.e., either starting or already on ART), with common mental disorder, defined as SSQ-14 score greater than pr equal to 7, and able to provide informed assent and their caregiver is able to provide informed consent (those aged 18 and 19 years do not need caregiver consent)
. Inability to comprehend the nature of the study in either English, Shona or Ndebele, are currently in psychiatric care, or present with suicidal intent, end stage AIDS, current psychosis, intoxication, and/or dementia. All those excluded for medical reasons will be referred for appropriate care to one of two tertiary facilities in Harare. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 10 Year(s) 19 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 05/06/2018 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara /Mazoe Street Harare 9990 Zimbabwe
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 24/05/2018 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of adolescents with virological failure or death. Virological failure will be defined as viral load greater than or equal to 1000 copies/ml 12 months after enrolment
Secondary Outcome The proportion of adolescents with common mental disorder, defined as SSQ-14 score greater than or equal to 8, and the mean SSQ-14 and PHQ-9 scores. 12 months after enrolment
Secondary Outcome Binary PHQ-9 score 12 months after enrolment
Secondary Outcome Mean WHO-DAS score for disability; and mean EQ-5D total score for health-related quality of life 12 months after enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Majini RHC Beitbridge Beitbridge Zimbabwe
Dulivhadzimu Clinic Beitbridge Beitbridge Zimbabwe
Makakavhule Clinic Beitbridge Beitbridge Zimbabwe
Tongwe RHC Beitbridge Beitbridge Zimbabwe
Shabwe RHC Beitbridge Beitbridge Zimbabwe
Beitbridge District Hospital Beitbridge Beitbridge Zimbabwe
Chipiwa Rural Chiredzi Chiredzi Zimbabwe
Chikombedzi RHC Chiredzi Chiredzi Zimbabwe
Tsvhovani polyclinic Chiredzi Chiredzi Zimbabwe
Chizvirizvi THE Chiredzi Chiredzi Zimbabwe
Colin Saunders Chiredzi Chiredzi Zimbabwe
Chiredzi Gen Hospital Chiredzi Chiredzi Zimbabwe
Zivuku RHC Chivi Chivi Zimbabwe
Chivi District Hospital Chivi Chivi Zimbabwe
Ngundu RHC Chivi Chivi Zimbabwe
Madzivadondo RHC Chivi Chivi Zimbabwe
Nyahombe RHC Chivi Chivi Zimbabwe
Chivi Rural Hospital Chivi Chivi Zimbabwe
Tongwe Health Centre Gokwe South Gokwe South Zimbabwe
Nyanje Clinic Gokwe South Gokwe South Zimbabwe
Njelele Clinic Gokwe South Gokwe South Zimbabwe
Gokwe Hospital Gokwe South Gokwe South Zimbabwe
Cheziya Clinic Gokwe South Gokwe South Zimbabwe
Mateta Rural Clinic Gokwe South Gokwe South Zimbabwe
Mapate Clinic Gwanda Gwanda Zimbabwe
Gwanda Provincial Hospital Gwanda Gwanda Zimbabwe
Selonga Clinic Gwanda Gwanda Zimbabwe
Phakama Clinic Gwanda Gwanda Zimbabwe
Buvuma Clinic Gwanda Gwanda Zimbabwe
Gungwe Clinic Gwanda Gwanda Zimbabwe
Lupote Clinic Hwange Hwange Zimbabwe
Chinotimba Clinic Hwange Hwange Zimbabwe
St Partricks Mission Hospital Hwange Hwange Zimbabwe
Hwange Falls Hospital Hwange Hwange Zimbabwe
Lukunguni Clinic Hwange Hwange Zimbabwe
Victoria Falls Hospital Hwange Hwange Zimbabwe
Mbizo 1 1 Clinic Kwekwe Kwekwe Zimbabwe
Sidakeni Clinic Kwekwe Kwekwe Zimbabwe
Mbizo 1 Clinic Kwekwe Kwekwe Zimbabwe
Kwekwe General Hospital Kwekwe Kwekwe Zimbabwe
Ntabeni Clinic Kwekwe Kwekwe Zimbabwe
Silobela District Hospital Kwekwe Kwekwe Zimbabwe
Sankonjane RHC Matobo Matobo Zimbabwe
St Joseph Rural Hospital Matobo Matobo Zimbabwe
Mbembeswana RHC Matobo Matobo Zimbabwe
Tshelanyemba Mission Hospital Matobo Matobo Zimbabwe
Home stead RHC Matobo Matobo Zimbabwe
Maphisa District Hospital Matobo Matobo Zimbabwe
Dombwe RHC Mrehwa Mrehwa Zimbabwe
Nhowe Mission Hospital Mrehwa Mrehwa Zimbabwe
Musami District Hospital Mrehwa Mrehwa Zimbabwe
Jekwa RHC Mrehwa Mrehwa Zimbabwe
Mrehwa District Hospital Mrehwa Mrehwa Zimbabwe
Munamba RHC Mrehwa Mrehwa Zimbabwe
Bota RHC Zaka Zaka Zimbabwe
Ndanga District hospital Zaka Zaka Zimbabwe
Jerera Satelite Clinic Zaka Zaka Zimbabwe
Nemauku RHC Zaka Zaka Zimbabwe
Chnyabako RHC Zaka Zaka Zimbabwe
Musiso Mission Hospital Zaka Zaka Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
The Childrens Investment Fund Foundation 7 Clifford Street London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Africaid 12 Stone Ridge Way, Avondale Harare Zimbabwe Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Nicola Willis 12 Stone Ridge Way, Avondale Harare Zimbabwe
Prof. Dixon Chibanda University of Zimbabwe College of Health Sciences, Research Support Centre, Parirenyatwa Hospital, Mazoe street Harare Zimbabwe
Prof. Helen Weiss LSHTM, Keppel Street London United Kingdom
Dr Mugurungi MInistry of Health and Child Care Harare Zimbabwe
Dr Apollo MInistry of Health and CHild Care Harare Zimbabwe
Mrs Sithole Ministry of Health and Child Care Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dixon Chibanda dichi@zol.co.zw +263712204107 University of Zimbabwe College of Health Sciences, Research Support Centre, Parirenyatwa Hospital, Mazoe street
City Postal code Country Position/Affiliation
Harare Zimbabwe Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Dixon Chibanda dichi@zol.co.zw +263712204107 University of Zimbabwe College of Health Sciences, Research Support Centre, Parirenyatwa Hospital, Mazoe street
City Postal code Country Position/Affiliation
Harare Zimbabwe Principal Investigator
Role Name Email Phone Street address
Public Enquiries Nicola Willis nicola@zvandiri.org +2634335805 12 Stone Ridge Way, Avondale
City Postal code Country Position/Affiliation
Harare Zimbabwe Public Enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/05/2021 - 02 Jan 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 06/05/2021 - 26 Feb 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 06/05/2021 2 participants withdrew immediately after enrolment 842
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/05/2021 data collection completed Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/10/2018 pactr update Adolescent: 13 Year-18 Year Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 06/05/2021 follow-up was shortened Primary Outcome, The proportion of adolescents with virological failure or death. Virological failure will be defined as viral load greater than or equal to 1000 copies/ml, 18 months after enrolment Primary Outcome, The proportion of adolescents with virological failure or death. Virological failure will be defined as viral load greater than or equal to 1000 copies/ml, 12 months after enrolment
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 06/05/2021 follow-up was shortened. The SSQ-14 cutpoint was corrected from 7 to 8. Secondary Outcome, The proportion of adolescents with common mental disorder, defined as SSQ-14 score greater than or equal to 7, and the mean SSQ-14 and PHQ-9 scores., 18 months after enrolment Secondary Outcome, The proportion of adolescents with common mental disorder, defined as SSQ-14 score greater than or equal to 8, and the mean SSQ-14 and PHQ-9 scores., 12 months after enrolment
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 06/05/2021 follow-up was shortened from 18 months to 12 months Secondary Outcome, Binary PHQ-9 score, 18 months after enrolment Secondary Outcome, Binary PHQ-9 score, 12 months after enrolment
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 06/05/2021 Follow-up was shortened from 18 months to 12 months Secondary Outcome, Mean WHO-DAS score for disability; and mean EQ-5D total score for health-related quality of life , 18 months after enrolment Secondary Outcome, Mean WHO-DAS score for disability; and mean EQ-5D total score for health-related quality of life , 12 months after enrolment
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/05/2021 Added LSHTM ethics approval TRUE, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, United Kingdom, , 24 May 2018, +442079272221, ethics@lshtm.ac.uk, 3523_13225_4737.pdf