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.: PACTR201301000458308 Date of Approval: 19/11/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of a substance use and substance-related HIV prevention programme
Official scientific title The effectiveness of an evidence-based workplace substance abuse and substance related HIV-related prevention programme within a service industry in Cape Town, South Africa.
Brief summary describing the background and objectives of the trial The objective of this study was to evaluate the effectiveness of a substance use and substance-related HIV risks prevention programme that was implemented amongst employees working in safety-sensitive jobs within two divisions in a safety and security department of a local municipality in the Western Cape.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Substance abuse
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 03/10/2011
Actual trial start date 03/10/2011
Anticipated date of last follow up 30/03/2012
Actual Last follow-up date 02/07/2012
Anticipated target sample size (number of participants) 380
Actual target sample size (number of participants) 325
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
REC433/2008 University of Cape Town Human Sciences Ethics Committee
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised For the one division we used a simple randomisation using a table created by a computer software programme; and for the 2nd division we used coin tossing Allocation was determined jointly determined by the reseacher and statistician Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Team Awareness Team Awareness is an 8-hour intervention that is delivered in two 4-hour sessions, one or two weeks apart. Session I include modules 1 and 2 (4 hours), and Session II comprise of modules 3 to 6 (4 hours). The programme addresses behavioral risks amongst employees, their co-workers and indirectly, their families. 168
Control Group Wellness Talk 60 minutes 2 days 30 minutes per day Particpants were breifed on the importance of staying physically, occupationally, emotionally, environmentally well. 157 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Company and divisions were selected along the following criteria: 1. The company should have a workforce between 200-300 employees. 2. The company should be located within the Western Cape. 3. The company should have an on/off site Employee Assistance/Wellness Programme (EAP/EWP) and should be open to participating in the intervention study. 4. The company and its employees should be conversant in English as the intervention will be conducted in English although the questionnaire will be translated into the vernacular. 5. There should be stability in the workforce, in other words a 75% or more retention over a one year period. This is to ensure the likelihood that all employees who participate in initial data collection will be there for follow-up. 6. The company should have a formalized substance abuse and HIV/AIDS policy. 7. The project should be endorsed by Management, Human Resources and the trade unions. None 18 Year(s) 70 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 08/12/2008 UCT Research Ethics Committee ¿ Health Sciences Faculty
Ethics Committee Address
Street address City Postal code Country
E52- 23 Old Main Building, Groote Schuur Hospital, Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome We hypothesise that team awareness will have reduced past 30 day risky alcohol use (¿ 5 drinks on one occasion) amongst the employees studied from Time1 ¿ Time 2 ¿ Time 3. Time 1 Time 2 (two weeks later) Time 3 (3 month follow-up)
Primary Outcome Participation in team awareness will be positively associated with a reduction in last 6 months going to work with a hangover from Time 1 Time 2 Time 3
Primary Outcome Participation in team awareness will be positively associated with a reduction in last 6 months call in sick episodes because of hangover from Time 1 Time 2 Time 3
Primary Outcome Participation in team awareness will be positively associated with reduced tolerance of co-worker AOD use from . Time1 Time 2 Time 3
Primary Outcome Participation in team awareness will be positively associated with improved responsiveness in encouraging and reporting substance use problems Time 1 Time 2 Time 3
Primary Outcome We hypothesise that individual employee experience of group stress will decrease from Time1 Time 2 Time 3
Primary Outcome We hypothesise that group cohesion amongst employees will have increased from Time 1 Time 2 Time 3
Primary Outcome Participation in Team awareness is associated with a positive change in team drinking climate from Time 1 Time 2 Time 3
Primary Outcome Participation in Team awareness will be positively associated with a reduction in negative stigma perceptions from Time 1 Time 2 Time 3
Primary Outcome We hypothesise that willingness to use EAP for a personal or work-related problem would have improved from Time 1 Time 2 Time 3
Primary Outcome We hypothesise a positive change in employee perception of their substance use policy in respect of i) fairness and ii) effectiveness from Time 1 Time 2 Time 3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRC Francie Van Zul Drive Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
ADDRF APHRC Campus, 2nd Floor Nairobi 00100 South Africa
MRC Research Capacity Development Francie Van Zyl Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alcohol and Drug Abuse Research Unit Francie Van Zyl Drive Cape Town 7505 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Charles Parry Francie van Zyl Cape Town 7505 South Africa
Leslie London University of Cape Town Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nadine Harker Burnhams nadine.harker.burnhams@mrc.ac.za 021 9380326 Francie van Zyl drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Seniro Scientist
Role Name Email Phone Street address
Public Enquiries nadine harker burnhams nadine.harker.burnhams@mrc.ac.za 0836414543 Francie van zyl drive
City Postal code Country Position/Affiliation
cape town South Africa Senior Scientist
Role Name Email Phone Street address
Scientific Enquiries Nadine Harker Burnhams nadine.harker.burnhams@mrc.ac.za 0836414543 Francie van zyl drive
City Postal code Country Position/Affiliation
Cape Town South Africa Senior Scientist
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