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.: PACTR201402000767141 Date of Approval: 07/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title GOAL Trial: Behavioural Effectiveness of Sport-based HIV Prevention in South African Schools
Official scientific title GOAL Trial: Behavioural Effectiveness of Sport-based HIV Prevention in South African Schools
Brief summary describing the background and objectives of the trial To assess, over two years, the effectiveness of a sport-based HIV prevention intervention in reducing sexual risk behaviour among adolescents in South African schools.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GOAL
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 05/03/2012
Actual trial start date 05/03/2012
Anticipated date of last follow up 30/09/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 4600
Actual target sample size (number of participants) 4485
Recruitment status Closed to recruitment,follow-up continuing
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
Randomised Stratified allocation based on site, school size, and anticipated attrition rate School names were blindly picked out of a box (i.e. first 8 names drawn go to intervention group) at public randomization events in each site. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Generation Skillz Approximately 13 hours of activity-based education 17 forty-five minute sessions over 12 months The Generation Skillz intervention consists of 17 interactive sessions that focus on reducing age-disparate sex, multiple partners and intimate partner violence. Generation Skillz is delivered in secondary schools over two years (Grade 9 and 10) by GRS ¿coaches,¿ 18-25 year-old local female and male role models 2173
Control Group Control Group Varies Varies Standard Department of Education HIV education 2312 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All male and female grade 9 learners in selected classes in selected schools were invited to participate. Learners needed to provide written parental consent and assent in order to participate. N/A 12 Year(s) 20 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 29/02/2012 Wits Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Postnet Suite 189, Private Bag X2600 Houghton, Johannesburg 2041 South Africa
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 23/02/2012 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel St London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Age-disparate sexual partner in last 6 months 12 months 24 months
Primary Outcome Multiple partners in last 6 months 12 months 24 months
Primary Outcome Reported rape perpetration ever (males) Baseline 12 months 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Khayalitsha Harare Cape Town 7784 South Africa
Port Elizabeth 1 Zwide, New Brighton, and Kwazakhele townships Port Elizabeth 6201 South Africa
Port Elizabeth 2 Motherwell and Uitenhage Port Elizabeth 6201 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Comic Relief 89 Albert Embankment London SE1 7TP United Kingdom
MAC AIDS Fund 130 Prince Street, 2nd Floor New York 10012 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel St London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Zachary Kaufman Mecklenburgh Square London WC1N 2AN United Kingdom
David Ross Keppel St London WC1E 7HT United Kingdom
Sinead Delany-Moretlwe 22 Esselen St Hillbrow, Johannesburg 2001 South Africa
Jeff DeCelles 38 Hout St. 5th Floor Cape Town 8000 South Africa
Elise Braunshcweig Mecklenburgh Square London WC1N 2AN United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Ross david.ross@lshtm.ac.uk 442076368636 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor of International Health
Role Name Email Phone Street address
Public Enquiries Zachary Kaufman zachary.kaufman@lshtm.ac.uk 447506998037 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Zachary Kaufman zachary.kaufman@lshtm.ac.uk 447506998037 Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom PhD Candidate
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information