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.: PACTR201609001767322 Date of Approval: 05/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cluster randomised trial of the Zvandiri Programme
Official scientific title CRT of Zvandiri Programme
Brief summary describing the background and objectives of the trial Decentralisation of HIV care among adolescents was rolled out in 2014, following the launch of new HIV treatment and care guidelines in Zimbabwe in December 2013. While the overarching goal of decentralisation is to improve treatment coverage, this needs to be accompanied by high levels of retention and adherence if virological resistance and treatment failure are to be minimised. Evidence-based strategies to provide support to the growing number of Zimbabwean adolescents receiving Antiretroviral Therapy (ART) are urgently required and preliminary evidence suggests that the Zvandiri programme (a youth led, community-based intervention) has the potential to make a significant impact on the lives of adolescents living with HIV in Zimbabwe.The proposed study seeks to conduct a cluster randomised trial of the Zvandiri programme in order to generate evidence of its effectiveness and cost-effectiveness.The objectives of the study are to provide evidence on whether enhancing community-based support for children and adolescents on ART through the Zvandiri programme will: i) improve retention in care ii) reduce the cumulative incidence of ART treatment failure iii) reduce the prevalence of anxiety and depression at 48 and 96 weeks iv) reduce rates of non-disclosure of HIV status to sexual partners when compared to usual care.
Type of trial RCT
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 Treatment: Other
Anticipated trial start date 03/10/2016
Actual trial start date
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program 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 Care Monthly 2 years All adolescents attending clinics allocated to the usual care arm will receive ART and adherence support as set out the in the prevailing MoHCC Guidelines, currently for 2013 but likely to be revised prior to trial commencement. Adherence support is provided by adult counsellors and nursing staff. After ART initiation adolescents are seen monthly, with CD4 monitoring at 6 monthly intervals. 240 Active-Treatment of Control Group
Experimental Group ART adherence Monthly 2 years Adolescents attending clinics receiving the enhanced intervention will receive MoHCC usual care. In addition, one-three (ideally at least one male, one female) trained and supported Child Adherence Treatment Supporters (CATS) will be allocated to the clinic to provide adherence counselling and support to adolescents at their clinic visits as well as on-going individualised community-based support. 240 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV positive adolescents Age 13-19 Eligible for ART (i.e. either starting ART soon or are already on ART Able to provide informed assent and their caregiver is able to provide informed consent (those aged 18 and 19 will be able to give written consent) Too physically or psychologically unwell (i.e. psychotic)or unable to give informed consent 13 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 01/06/2016 Medical Research Council Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogar 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 16/05/2016 LSHTM ethiccs
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 Proportion failing HIV treatment at 48 (and 96) weeks. Outcomes will only be assessed at 96 weeks if funding extended.
Secondary Outcome Proportion of participants not retained in clinic serves at 48 (and 96) weeks
Secondary Outcome Proportion of participants who discontinue ART At 48 (and 96) weeks
Secondary Outcome Proportion of participants with depression 48 (and 96) weeks
Secondary Outcome Proportion of participants with common mental disorders (depression and/or anxiety) 48 (and 96 weeks)
Secondary Outcome Proportion of participants with poor quality of life 48 (and 96) weeks
Secondary Outcome Proportion of participants self-reporting disclosure of HIV status to sexual partners 48 (and 96 weeks)
Secondary Outcome Proportion of participante self-reporting perceived stigma 48 (and 96) weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bindura Clinics Bindura Bindura 9990 Zimbabwe
Shamva clinics Shamva Shamva 9990 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
ViiV Healthcare 980 Great West Road Brentford TW8 9GS United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CeSHHAR Zimbabwe 9 Monmouth Road, Avondale Harare 9990 Zimbabwe Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Africaid 12 Stoneridge, Avondale Harare 9990 Zimbabwe
LSHTM Keppel Street London WC1E 7HT United Kingdom
UZ-CHS Mazowe Harare 9990 Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frances Cowan francesmcowan@yahoo.co.uk +2634304583 9 Monmouth Road, Avondale
City Postal code Country Position/Affiliation
Harare 9990 Zimbabwe Executive Director
Role Name Email Phone Street address
Public Enquiries Juliet Mufuka jmufuka10@gmail.com +2634333393 9 Monmouth Road, Avondale
City Postal code Country Position/Affiliation
Harare 9990 Zimbabwe Coordinator
Role Name Email Phone Street address
Scientific Enquiries Webster Mavhu wmavhu@gmail.com +26343333393 9 Monmouth Road, Avondale
City Postal code Country Position/Affiliation
Harare 9990 Zimbabwe Co-Investigator
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