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.: PACTR201711002755428 Date registered: 11/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of Community Adolescent Treatment Supporters on linkage, retention, adherence and psychosocial wellbeing among adolescents with HIV
Official scientific title The effectiveness of Community Adolescent Treatment Supporters (CATS) in improving linkage and retention in care, adherence to ART and psychosocial well-being: a longitudinal study among adolescents with HIV in rural Zimbabwe
Brief summary describing the background and objectives of the trial This study set out to determine the effectiveness of Community Adolescent Treatment Supporters (CATS) services on improving linkage to services and retention in care, adherence and psychosocial well-being among ALHIV in Zimbabwe. A twelve-month, longitudinal survey will be conducted in Gokwe South district, Zimbabwe. Ninety-four HIV-positive adolescents, 10-15 years old, on antiretroviral therapy will be recruited to the study. 47 participants received standard of care from the Ministry of Health and Child Care and 47 received the same standard of care plus CATS services. Data collection will involve a baseline questionnaire which will be repeated at three, six, nine and twelve months for all participants. Survey responses on confidence, self-esteem and self-worth will be measured using a three-point Likert scale. Stigma, quality of life and the linkage to services and retention questions will be measured using a five-point Likert scale.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/12/2014
Actual trial start date 01/12/2014
Anticipated date of last follow up 30/11/2015
Actual Last follow-up date 30/11/2015
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 94
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care from Ministry of Health and Child Care Monthly 12 months Monthly clinic reviews, ART, adherence counselling, OI management, CD4 monitoring. Led by a professional nurse and /or counsellor 47 Active-Treatment of Control Group
Experimental Group Zvandiri Intervention group Monthly 12 months Standard of care from Ministry of Health and Child Care PLUS CATS led home visits, support groups, SMS reminders and clinic counselling 47
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV positive adolescents, 10-15 years old, on ART Aware of their HIV status Accessing ART at the study clinic Consent from caregiver Assent from adolescent Unaware of HIV status Non consent from caregiver Non assent from adolescent 10 Year(s) 15 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 01/10/2014 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Cnr Josiah Tongogara / Mazowe Street, Po Box CY 573 Causeway Harare 0000 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self reported adherence Baseline, three, six, nine and twelve months
Secondary Outcome Linkage and retention Baseline, 3, 6, 9, 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gokwe District Hospital Gokwe Town Gokwe South 0000 Zimbabwe
Sesame Clinic Gokwe Gokwe South District 0000 Zimbabwe
Krima Clinic Gokwe Town Gokwe South 0000 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Bristol Myers Squibb Foundation 54 Maxwell Drive, Woodmead 2191 Johannesburg 0000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nicola Willis 12 Stone Ridge Way North, Avondale Harare 0000 Zimbabwe Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Nicola Willis 12 Stone Ridge Way, Avondale Harare 0000 Zimbabwe
Mather Mawodzeke 12 Stone Ridge Way, Avondale Harare 0000 Zimbabwe
Chengetai Dziwa 12 Stone Ridge Way North, Avondale Harare 0000 Zimbabwe
Alice Armstrong 12 Stone Ridge Way North, Avondale Harare 0000 Zimbabwe
Amos Milanzi 3 Azac Drive, Meyrick Park Harare 0000 Zimbabwe
Victoria James 3 Anzac Drive, meyrick Park Harare 0000 Zimbabwe
Innocent Yekeye 3 Azac Drive, Meyrick Park Harare 0000 Zimbabwe
Phangisile Mtshali 54 Maxwell Drive, Woodmead Johannesburg 0000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victoria James victoria@nedico.co.zw 00 263 772 802 787 3 Anzac Drive, Meyrick Park
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Executive Director
Role Name Email Phone Street address
Public Enquiries Mather Mawodzeke mather@zvandiri.org 00 263 4 335805 12 Stone Ridge Way NOrth, Avondale
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Head of Programmes
Role Name Email Phone Street address
Scientific Enquiries Nicola Willis nicola@zvandiri.org +263 4 335805 12 Stone Ridge Way North, Avondale
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Executive Director
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 URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 15/11/2017 There was an error in the date. I have corrected this. 2015-12-01 2014-12-01
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 09/07/2018 pactr update Not Applicable