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.: PACTR201403000778207 Date of Approval: 03/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MCUTS II
Official scientific title A sport-based intervention to increase uptake of voluntary medical male circumcision
Brief summary describing the background and objectives of the trial The first Male Circumcision Uptake Through Soccer (MCUTS) trial was a cluster-randomized trial to measure the effectiveness of Make The Cut (MTC), a short, once-off soccer-based intervention aiming to increase VMMC uptake among Zimbabwean men aged 18-35y who were members of soccer teams in Bulawayo, Zimbabwe. Building on the encouraging preliminary findings from the first MCUTS trial (uptake of approximately 5.36% among uncircumcised intervention participants aged 18-29, compared to approximately 0.77% among control participants) along with qualitative findings that suggest MTC acceptability was higher among younger men, GRS, LSHTM, NUST, and PSI aim to run a second trial (MCUTS II), delivering a modified intervention with 14-19 year-old male students in secondary schools in Bulawayo. GRS will make referrals to VMMC clinics run by PSI, provide phone-based follow-up to reinforce the intervention, and offer a small soccer-related incentive to all participants completing VMMC. The trial will have more than 80% power to detect an absolute difference of 4% in VMMC uptake. If the single-session MTC+ intervention (combined with soccer-themed incentives and phone-based follow-up) can substantially and significantly increase demand for VMMC in secondary schools, GRS and partners will have demonstrated an effective, innovative and scalable solution to increasing uptake of VMMC.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MCUTS II
Disease(s) or condition(s) being studied Infections and Infestations,Reproductive-male
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 24/02/2014
Actual trial start date 05/03/2014
Anticipated date of last follow up 27/06/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 1760
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Medical Research Council of Zimbabwe MRCZ/A/1785
Observational/Interventions Research Ethics Committee, London School of Hygiene & Tropical Medicine 7042
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
Randomised Stratified allocation Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Make The Cut + (MTC+) One session 60 minutes MTC+ includes a 60-minute interactive, soccer-themed session led by a trained, circumcised coach; phone-based follow-up to make referrals for VMMC to interested participants; and soccer-based incentives (five to ten dollars in value) offered to all participants upon completion of VMMC. 880
Control Group Control Group N/A N/A Control group only receives MTC+ intervention at the end of the trial, if it has been found to be effective. 880 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male Ages 14-19 years old Enrolled in Form 3 or Form 4 at Bulawayo high schools Younger than 14 years old Older than 19 years old Female 14 Year(s) 19 Year(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 20/02/2014 Observational/Interventions Research Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM)
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
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 30/01/2014 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazoe Street Harare P.O. Box CY 573 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VMMC uptake over five months (determined via clinical registers) Every week for five months
Secondary Outcome MC-related knowledge Baseline 3-month follow-up
Secondary Outcome MC-related attitudes Baseline 3-month follow-up
Secondary Outcome Self-reported MC prevalence at endline Baseline 3-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hamilton High School Gilsland Rd Bulawayo Zimbabwe
Ihlathi Secondary School Matabeleland North, Tshabalala Bulawayo Zimbabwe
Inyanda Secondary School Luveve North Bulawayo Zimbabwe
Lobengula Secondary School A8 Bulawayo Zimbabwe
Luveve High School Luveve Bulawayo Zimbabwe
Masotsha Secondary School Intemba Rd Bulawayo Zimbabwe
Mpopoma High School Nketa Dr, Mpopoma Bulawayo Zimbabwe
Msitheli Secondary School Cleary Dr, Mpopoma Bulawayo Zimbabwe
Mzilikazi High School Old Falls Rd Bulawayo Zimbabwe
Njube High School Pelandaba Bulawayo Zimbabwe
Nkulumane High School Ndaba Rd Bulawayo Zimbabwe
Northlea Secondary School Bulawayo North Bulawayo Zimbabwe
Pumula High School Ngena Rd Bulawayo Zimbabwe
Sizane Secondary School Mamba Rd Bulawayo Zimbabwe
St. Bernards High School Pumula Bulawayo Zimbabwe
Emganwini Secondary School 4174 Nketa 7 Bulawayo Zimbabwe
Milton High School Pumula Bulawayo Zimbabwe
Amhlophe Secondary School Pumula Bulawayo Zimbabwe
Entumbane Secondary School Mpopoma Bulawayo Zimbabwe
Magwegwe Secondary School Hyde Park Rd Bulawayo Zimbabwe
Emakhandeni Secondary School Huggins Rd Bulawayo Zimbabwe
Gifford High School 16th Ave Bulawayo Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
International Initiative for Impact Evaluation (3ie) 36 Gordon Square London WC1H 0PD United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Grassroot Soccer, Inc. PO Box 712 Norwich 05055 United States of America Commercial Sector/Industry
Secondary Sponsor PSI/Zimbabwe 30 The Chase West Harare Zimbabwe Commercial Sector/Industry
Secondary Sponsor London School of Hygiene & Tropical Medicine (LSHTM) Keppel St London WC1E 7HT United Kingdom University
Secondary Sponsor National University of Science and Technology, Zimbabwe (NUST) A6 Bulawayo Zimbabwe University
COLLABORATORS
Name Street address City Postal code Country
David Ross MA, MSc, BMBCh, PhD Keppel St London WC1E 7HT United Kingdom
Tommy Clark MD PO Box 712 Norwich 05055 United States of America
Zachary Kaufman MSc (PhD expected in 2013) Keppel St London WC1E 7HT United Kingdom
Helen Weiss BSc, MSc, DPhil Keppel St London WC1E 7HT United Kingdom
Cynthia Chaibva PhD A6 Bulawayo Zimbabwe
Kenneth Bhauti, MBA Nelous St Bulawayo Zimbabwe
Karin Hatzold MD MPH 30 The Chase West Harare Zimbabwe
Abigail Harrison PhD George St Providence 02912 United States of America
Harsha Thirumurthy PhD Manning Dr Chapel Hill 27599 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Ross david.ross@lshtm.ac.uk +44 (0)20 7927 2264 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor of Epidemiology & International Public Health
Role Name Email Phone Street address
Principal Investigator Tommy Clark tclark@grassrootsoccer.org +18026492900 198 Church St
City Postal code Country Position/Affiliation
Norwich 05055 United States of America Founder and CEO, Grassroot Soccer
Role Name Email Phone Street address
Public Enquiries Kenneth Bhauti kbhauti@grassrootsoccer.org +263 778 529 046 Nelous St
City Postal code Country Position/Affiliation
Bulawayo Zimbabwe Monitoring and Evaluation Manager, Grassroot Soccer
Role Name Email Phone Street address
Scientific Enquiries Zachary Kaufman zachary.a.kaufman@gmail.com +44 20 7636 8636 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Research Fellow, London School of Hygiene & Tropical Medicine
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