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.: PACTR201308000591418 Date of Approval: 14/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effectiveness of Two Brief Interventions to Reduce Substance Use among Patients Presenting for Emergency Services in South Africa
Official scientific title The Effectiveness of Two Brief Interventions to Reduce Substance Use among Patients Presenting for Emergency Services in South Africa: A Randomized Control Trial
Brief summary describing the background and objectives of the trial The aim of Project STRIVE (Substance use and Trauma InterVention) is to decrease substance use and its associated harms among South Africans attending emergency services by testing two brief, evidence-based interventions for risky substance use among adults presenting to emergency services in Cape Town, South Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Project STRIVE
Disease(s) or condition(s) being studied Alcohol and other drugs,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 03/01/2011
Actual trial start date 01/03/2012
Anticipated date of last follow up 31/07/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Psycho-educational Control provided with a brochure providing information on the effects of alcohol and other drug use. 120 Active-Treatment of Control Group
Experimental Group MI Group 1 session approximately 30 min An ASSIST-Linked Brief Intervention developed by the World Health Organization 120
Experimental Group Enhanced PST Group 5 sessions, 1 times a week 1st session 60 min, remaining 30 min The first session was the ASSIST-linked Brief Intervention, while the remaining sessions were based on Problem Solving Therapy (PST) 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-participants had to be at least 18 years - screen at moderate or high risk for substance-related problems using the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST, (WHO ASSIST Working Group, 2002). - severaly intoxicated and agressive patients were not approached for screening 18 Year(s) 75 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 10/09/2011 URC- Health Sciences University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Observatory 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in alcohol and drug use (with the ASSIST) baseline and 3 month followup
Secondary Outcome Depression: using the Center for Epidemiological Studies Depression Scale (CES-D) baseline and 3 month follow-up
Secondary Outcome frequency of substance use related injury baseline 3 month follow-up
Secondary Outcome frequency physical and verbal violence baseline 3 month follow-up
Secondary Outcome frequency of police interaction baseline 3 month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Khayelitsha Site B Community centre Lwandle Rd, Site B, Khayelitsha South Africa
Khayelitsha District Hospital Cnr Walter Sisulu & Steve Biko Road Khayelitsha 7704 South Africa
Elsie's River CHC Cnr. Halt Road & 29th Avenue Elsiesriver South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Western Cape Government 5th Floor 8 Riebeeck Street Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Psychiatry & Mental Health, University of Cape Town J2 Groote Schuur Hospital Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Katherine Sorsdahl J2 Groote Schuur Hospital Anzio Rd. South Africa
Dan Stein J2 Groote Schuur Hospital Anzio Rd. South Africa
Bronwyn Myers J2 Groote Schuur Hospital Anzio Rd. South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Katherine Sorsdahl katherine.sorsdahl@uct.ac.za 021 650 6567 J2 Groote Schuur Hospital, Anzio Road
City Postal code Country Position/Affiliation
Cape Town South Africa
Role Name Email Phone Street address
Public Enquiries Katherine Sorsdahl kattsorsdahl@gmail.com 021 650 6567 Anzio Road
City Postal code Country Position/Affiliation
Cape Town South Africa
Role Name Email Phone Street address
Scientific Enquiries Katherine Sorsdahl kattsorsdahl@gmail.com 021 650 6567
City Postal code Country Position/Affiliation
Anzio Rd. South Africa
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