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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.: PACTR201212000442288 Date registered: 2012/10/25
TRIAL DESCRIPTION
Public title ZENITH
Official scientific title Zimbabwe study for Enhancing Testing and Improving Treatment of HIV in Children
Brief summary describing the background
and objectives of the trial
We aim to conduct a cluster-randomised trial comparing a) optimised primary HIV care services alone with b) optimised primary HIV care services plus treatment support provided by lay volunteers to households with one or more HIV-infected older children. The rationale is that decentralised HIV services are insufficient to ensure good adherence and treatment outcomes, because of a constellation of risk factors for default in older children, notably their high risk of maternal orphanhood.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ZENITH
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Supportive care
Anticipated trial start date 2013-01-07
Actual trial start date
Anticipated date of last follow up 2015-11-27
Actual date of last follow up
Anticipated target sample size (number of participants) 600   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 randomisation using a randomisation table created by a computer software program Allocation 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 Clinic Based care Monthly 2 years Clinic based care 300 Active
Experimental group Provision of support to households of HIV+ve children delivered by lay workers Monthly visits 2 years Lay workers provide health education, case management, adherence and disclosure support and referral to other community-based support services to households 300 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Age 6-15 years Testing HIV-positive at the study primary care clinics Based in the study clusters (each study suburb to have demarcated clusters) Guardian consent and participant assent No Guardian consent and/or participant assent Age not 6-15 years Child not residing within study clusters Already in HIV care 6 Years 15 Years 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 2012/08/27 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazoe Street Harare CY 573 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 2012/05/08 Biomedical Research and Training Institute IRB
Ethics Committee Address
Street address City Postal code Country
Samora Machel Avenue Harare CY1753 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 2012/10/04 Harare City Health Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pennefather Avenue Harare 596 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
No 2012/11/05 London school of Hygiene and Tropical Medicine Ethics Committee
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 2 or more scheduled clinic appointments missed in 2 years Measured at end of 2 years
Secondary Outcome All-cause mortality 12 months 24 months
Secondary Outcome Numbers of and time to first hospital admission (as defined by hospital stay ¿ 24 hours) 12 months 24 months
Secondary Outcome Numbers of additional attendances (over and above routine follow-up) to PHC 12 months 24 months
Secondary Outcome Proportion of children who have an average adherence rate <80% 12 months starting ART 12 months 24 months
Secondary Outcome Proportion of children who chage to 2nd line ART as defined by Natinal Guidelines (due to reasons not rlated to toxicity, side-effects or starting TB treatment) 12 months 24 months

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kuwadzana Polyclinic Kuwadzana Harare Zimbabwe
Dzivarasekwa Polyclinic Dzivarasekwa Harare Zimbabwe
Glen View Polyclinic Glenview Harare Zimbabwe
Budiriro Polyclinic Budiriro Harare Zimbabwe
Highfieds Polyclinic Highfields Harare Zimbabwe
Mufakose Polyclinic Mufakose Harare Zimbabwe

FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston Road London +442076118888 United Kingdom

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University

COLLABORATORS
Name Street address City Postal code Country
Richard Hayes Keppel Street London WC1E 7HT United Kingdom
Liz Corbett Keppel Street London WC1E 7HT United Kingdom
Helen Weiss Keppel Street London WC1E 7HT United Kingdom
Joanna Busza Keppel Street London WC1E 7HT United Kingdom
Peter Mason Samora Machel Avenue Harare CY1753 Zimbabwe
Exnevia Gomo Samora Machel Avenue Harare CY1753 Zimbabwe
Kusum Nathoo Mazoe Street Harare A178 Zimbabwe
Hilda Mujuru Mazoe Street Harare A178 Zimbabwe
Chiratidzo Ndhlovu Mazoe Street Harare A178 Zimbabwe
Stanley Mungofa Pennefather Avenue Harare 596 Zimbabwe
Owen Mugurungi Harare CY1122 Zimbabwe
Angela Mushavi Harare CY1122 Zimbabwe

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Rashida Ferrand rashida.ferrand@lshtm.ac.uk +263772165755
Street address City Postal code Country Position / Affiliation
London United Kingdom
Role Name Email Phone Fax
Public Enquiries Dr Rashida Ferrand rashida.ferrand@lshtm.ac.uk +263772165755
Street address City Postal code Country Position / Affiliation
London United Kingdom
Role Name Email Phone Fax
Scientific Enquiries Dr Rashida Ferrand rashida.ferrand@lshtm.ac.uk +263772165755
Street address City Postal code Country Position / Affiliation
London United Kingdom