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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.: PACTR201301000458308 Date registered: 2012/11/19
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
Purpose of the trial Prevention
Anticipated trial start date 2011-10-03
Actual trial start date 2011-10-03
Anticipated date of last follow up 2012-03-30
Actual date of last follow up 2012-07-02
Anticipated target sample size (number of participants) 380   
Actual target sample size (number of participants) 325   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
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
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
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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 70 Years 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 2008/12/08 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 Company

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 Fax
Public Enquiries Mrs nadine harker burnhams nadine.harker.burnhams@ mrc.ac.za 0836414543
Street address City Postal code Country Position / Affiliation
Francie van zyl drive cape town South Africa Senior Scientist
Role Name Email Phone Fax
Scientific Enquiries Mrs Nadine Harker Burnhams nadine.harker.burnhams@ mrc.ac.za 0836414543
Street address City Postal code Country Position / Affiliation
Francie van zyl drive Cape Town South Africa Senior Scientist
Role Name Email Phone Fax
Principal Investigator Mrs Nadine Harker Burnhams nadine.harker.burnhams@ mrc.ac.za 021 9380326 021 9380342
Street address City Postal code Country Position / Affiliation
Francie van Zyl drive, Parow Cape Town 7505 South Africa Seniro Scientist