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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.: PACTR201302000430351 Date registered: 2012/10/06
TRIAL DESCRIPTION
Public title MCUTS Trial: Male Circumcision Uptake Through Soccer
Official scientific title Effectiveness of a short, soccer-based male circumcision promotion intervention in Zimbabwe
Brief summary describing the background
and objectives of the trial
Through a cluster-randomized trial, MCUTS will evaluate the effectiveness of a short, soccer-based intervention in increasing uptake of medical male circumcision (MMC) over 3 months in Bulawayo, Zimbabwe. The study will also include a process evaluation looking at how and why the intervention is or is not effective. MMC uptake will be determined via clinical registers from two MC clinics, cross-referencing patient records with the study participant database.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) MCUTS
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2012-11-05
Actual trial start date
Anticipated date of last follow up 2013-05-31
Actual date of last follow up
Anticipated target sample size (number of participants) 1250   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
MRCZ/A/1691 Medical Research Council of Zimbabwe
MRCZ/A/1691 Medical Research Council of Zimbabwe
MRCZ/A/1691 Medical Research Council of Zimbabwe

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 Stratified by type of soccer team (professional vs social) Stakeholders involved in the trial will be invited to pick team names out of a hat and teams will be allocated sequentially to each of the three groups Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Make the Cut intervention w/soccer pros Once-off interpersonal session delivered with soccer teams by local pro soccer players 90 minutes MTC is delivered by circumcised professional soccer players. The intervention aims to build knowledge of the health benefits of MMC, improve perceptions of MMC, and increase demand for MMC. 375 Active
Experimental group Make the Cut intervention w/non-soccer pros Once-off interpersonal session delivered with soccer teams by local men 90 minutes MTC is delivered by circumcised men. The intervention aims to build knowledge of the health benefits of MMC, improve perceptions of MMC, and increase demand for MMC. 375
Control group Control Group These teams will only be offered the intervention after the trial is complete N/A N/A 500 Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
The study will include men aged 18-40 who play soccer on either a professional or social soccer team in Bulawayo. Men under the age of 18 will not be invited to participate. Men who report being circumcised at baseline will be excluded from the analysis but allowed to participate in the study. 18 Years 40 Years 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 2012/09/24 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara / Mazoe St Harare PO Box 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 2012/12/03 LSHTM Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel St. London WC1 7HT United Kingdom

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome MMC Uptake 30 Nov 2012 31 Dec 2012 30 Jan 2013 28 Feb 2013 31 Mar 2013
Secondary Outcome MC-related knowledge Nov 2012 Mar 2013
Secondary Outcome MC-related perceptions Nov 2012 Mar 2013
Secondary Outcome Sexual risk behaviour Nov 2012 Mar 2013

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Grassroot Soccer Zimbabwe 17 Selous Ave Bulawayo Zimbabwe

FUNDING SOURCES
Name of source Street address City Postal code Country
Doris Duke Charitable Foundation 650 Fifth Avenue, 19th Floor New York, NY 10019 United States of America

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Grassroot Soccer, Inc. 198 Church St Norwich, VT 05055 United States of America Foundation

COLLABORATORS
Name Street address City Postal code Country
Jeff DeCelles 38 Hout St. 5th Floor Cape Town South Africa
David Ross Keppel St. London WC1E 7HT United Kingdom
Zachary Kaufman 5365 Goodenough College, Mecklenburgh Square London WC1N 2AN United Kingdom
Kenneth Bhauti 17 Selous Ave Bulawayo Zimbabwe

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Mr Zachary Kaufman zachary.kaufman@lshtm.ac.uk 447506998037
Street address City Postal code Country Position / Affiliation
5365 Goodenough College, Mecklenburgh Square London United Kingdom PhD Candidate
Role Name Email Phone Fax
Public Enquiries Mr Zachary Kaufman zachary.kaufman@lshtm.ac.uk +44 750 699 8037
Street address City Postal code Country Position / Affiliation
United Kingdom PhD Candidate
Role Name Email Phone Fax
Scientific Enquiries Mr Zachary Kaufman zachary.kaufman@lshtm.ac.uk +44 750 699 8037
Street address City Postal code Country Position / Affiliation
London United Kingdom PhD Candidate