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.: PACTR201301000465398 Date of Approval: 27/11/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Early infant male circumcision using devices
Official scientific title Piloting implementation of early infant male circumcision using devices in Zimbabwe
Brief summary describing the background and objectives of the trial A study to assess the feasibility, safety, acceptability and cost of rolling out early infant male circumcision to babies born within selected health facilities in Zimbabwe ¿ initially in a comparative trial of two EIMC devices: AccuCirc and Mogen clamp. The objectives are: 1) To conduct a comparative trial of AccuCirc and Mogen clamp to determine AccuCirc¿s relative safety, acceptability and costs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Early infant circumcision ultimately for HIV prevention,Infections and Infestations,Paediatrics,Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 11/11/2013
Actual trial start date 07/01/2013
Anticipated date of last follow up 01/05/2013
Actual Last follow-up date 28/06/2013
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised variable permted block randomisation (3,6,9) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Circumcision using AccuCirc N/A N/A Early infant Male Circumcision 100
Control Group Circumcision using Mogen clamp N/A N/A Early infant Male Circumcision 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Live born male infants at study sites aged 7-10 days. Ability to follow-up regularly at study clinic until 2 weeks postpartum Mother prepared to provide locator information and to be visited home between delivery and circumcision Mother prepared to provide verifiable cell phone (mobile) number Provision of written informed consent Baby should have received vitamin K (routine or offered by study staff) Neonatal sepsis or other severe illness requiring infant hospitalization Penile abnormality that might require reconstructive surgery in the future Family history of bleeding disorder Estimated infant gestational age < 36 weeks (we envisage that this information would be sufficiently and accurately recorded on the child health card by clinic staff) Infant delivery weight < 2,500 grams (we envisage that this information would be sufficiently and accurately recorded on the child health card by clinic staff) Infant >10 days of age Infant receipt of methaemoglobin-inducing agents Current involuntary incarceration of mother 7 Day(s) 60 Day(s) Male
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 25/10/2012 Medical REsearch Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazoe Street Harare Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Safety - Number of AEs (minor, moderate and severe) related to each EIMC technique 14 days
Primary Outcome ¿ Acceptability - The proportion of parents who report being satisfied with the procedure by EIMC technique 14-36 days
Primary Outcome ¿ Cost - Monetary cost of equipment usage for each technique plus training costs and labour cost associated with EIMC under each technique and the cost of AE under each technique 42 days
Secondary Outcome ¿ Proportion with complete wound healing at 7 and 14 days post circumcision for each EIMC technique 7 days post cirucmcision 14 days post cirucmcision
Secondary Outcome ¿ Time required for each EIMC technique Day of circumcision
Secondary Outcome ¿ Proportion of babies excluded due to unsuitability for circumcision Day of enrollment
Secondary Outcome ¿ Safety stratified by infant HIV exposure status 42 days
Secondary Outcome ¿ Assessment of competency of EIMC using each device 14 days post circumcision
Secondary Outcome Provider opinions of each device After recruitment completed
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Edith Oppermann Clinic Mbare Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda GatesFoundation Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Population Services International 30 The Chase , Mount Pleasant Harare Zimbabwe Commercial Sector/Industry
Primary Sponsor Bill and Melinda Gates Foundation Seattle United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr Gerald Gwinji Ministry of Health and Child Welfare Harare Zimbabwe
Dr Ismail Ticklay University of Zimbabwe Harare Zimbabwe
Dr Karin Hatzold PSI Zimbabwe Harare Zimbabwe
Dr Frances Cowan University College London London WC1E 6AU United Kingdom
Mr Christopher Samkange University of Zimbabwe Harare Zimbabwe
Ms Getrude Ncube Ministry of Health and Child Welfare Harare Zimbabwe
Mr Webster Mavhu CeSHHAR Zimbabwe Harare Zimbabwe
Ms Cynthia Chasokela Director of Nursing Services Harare Zimbabwe
Ms Margaret Nyandoro Ministry of Health and Child welfare Harare Zimbabwe
Ms Nontando Mothobi Registrar Nursing Council Harare Zimbabwe
Dr Helen Weiss London School of Hygeine and Tropical Medicine London United Kingdom
Dr Natasha Larke London School of Hygeine and Tropical Medicine London United Kingdom
Dr Harsha Thirumurthy University of North Carolina Chapel Hill United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ismail Ticklay ismail4855@gmail.com +263777005608
City Postal code Country Position/Affiliation
Harare Zimbabwe Lecturer
Role Name Email Phone Street address
Public Enquiries Webster Mavhu wmavhu@gmail.com +263712432215 21 Rowland Square
City Postal code Country Position/Affiliation
Harare Zimbabwe Coordinator
Role Name Email Phone Street address
Scientific Enquiries Frances Cowan f.cowan@ucl.ac.uk +263(0)772 257949 21 Rowland Square
City Postal code Country Position/Affiliation
Harare Zimbabwe Co-investigator
REPORTING
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Result URL Hyperlinks
Changes to trial information