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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201212000442288 Date of Registration: 25/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 07/01/2013
Actual trial start date 21/01/2013
Anticipated date of last follow up 27/11/2015
Actual Last follow-up date 30/06/2016
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 347
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 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) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Provision of support to households of HIV+ve children delivered by lay workers Monthly/Three monthly visits according to National guidelines 18 months Lay workers provide health education, case management, adherence and disclosure support and referral to other community-based support services to households 172 Active-Treatment of Control Group
Control Group Clinic Based care Monthly/three monthly (according to National guidelines) 18 months Clinic based care 175 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 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 27/08/2012 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 08/05/2012 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 04/10/2012 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
Yes 05/11/2012 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 18 months
Secondary Outcome Numbers of and time to first hospital admission (as defined by hospital stay of longer than 24 hours) 18 months
Secondary Outcome Numbers of additional attendances (over and above routine follow-up) to PHC 18 months
Secondary Outcome Proportion of children who have an average adherence rate <80% 12 months starting ART 12 months after starting ART
Secondary Outcome Proportion of children who change to 2nd line ART as defined by National Guidelines (due to reasons not related to toxicity, side-effects or starting TB treatment) 18 months
Primary Outcome 2 or more scheduled clinic appointments missed in 18 months years 18 months
Secondary Outcome Proportion of children who change to 2nd line ART as defined by National Guidelines (due to reasons not related to toxicity, side-effects or starting TB treatment) 18 months
Primary Outcome 2 or more scheduled clinic appointments missed in 18 months 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Highfieds Polyclinic Highfields Harare Zimbabwe
Mufakose Polyclinic Mufakose Harare Zimbabwe
Glen Norah Clinic Glen Norah Harare Zimbabwe
Kuwadzana Polyclinic Kuwadzana Harare Zimbabwe
Dzivarasekwa Polyclinic Dzivarasekwa Harare Zimbabwe
Glen View Polyclinic Glenview Harare Zimbabwe
Budiriro Polyclinic Budiriro 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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rashida Ferrand rashida.ferrand@lshtm.ac.uk +263772165755
City Postal code Country Position/Affiliation
London United Kingdom
Role Name Email Phone Street address
Public Enquiries Rashida Ferrand rashida.ferrand@lshtm.ac.uk +263772165755
City Postal code Country Position/Affiliation
London United Kingdom
Role Name Email Phone Street address
Scientific Enquiries Rashida Ferrand rashida.ferrand@lshtm.ac.uk +263772165755
City Postal code Country Position/Affiliation
London United Kingdom
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