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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.: PACTR201105000297151 Date registered: 2011/05/15
TRIAL DESCRIPTION
Public title Implementation and Monitoring of Screening and Brief Intervention(SBI) for Alcohol Use Disorders Among Tuberculosis Patients, South Africa
Official scientific title Screening and brief interventions for hazardous and harmful alcohol use among patients with active tuberculosis attending primary care clinics in South Africa: a cluster randomized controlled trial protocol
Brief summary describing the background
and objectives of the trial
Background: In 2008 the World Health Organization (WHO) reported that South Africa had the highest tuberculosis (TB) incidence in the world. This high incidence rate is linked to a number of factors, including HIV co-infection and alcohol use disorders. The diagnosis and treatment package for TB and HIV co-infection is relatively well established in South Africa. However, because alcohol use disorders may present more insidiously, making it difficult to diagnose, those patients with active TB an
Type of trial Others
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Tuberculosis ,
Purpose of the trial Education/Counselling/Training
Anticipated trial start date 2011-05-02
Actual trial start date 2011-05-09
Anticipated date of last follow up 2012-07-31
Actual date of last follow up 2012-07-31
Anticipated target sample size (number of participants) 520   
Actual target sample size (number of participants) 468   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 randomisation created by computer software Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Alcohol health information leaflet 1 1 minute Health care provide gives alcohol health information leaflet 260 Active
Experimental group Brief alcohol counselling 2 1 month Provision of theory-based alcohol brief counselling intervention 260 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Primary Health Care Clinics Clinics with a high TB case-load (based on statistics collected by the Department of Health) in each of the three study districts with a high burden of TB will be included in the study. Patients with active TB New tuberculosis treatment patients (i.e. those patients who have been initiated or have been on anti-TB treatment for less than one month), males and females, 18 years and above who visit the primary health care facility, score 8 or more for men and 7 or more for women on the AUDIT questionnaire after screening will be included in this study New tuberculosis treatment patients under the age of 18 years will not be included. Individuals 18 years and older scoring less than 8 for men and less than 7 for women on the AUDIT questionnaire will be excluded from the study. Women who are pregnant, patients already under treatment for alcohol misuse and patients who have symptoms of psychosis and who are mentally handicapped will be excluded 18 Years 75 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 HSRC Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
134 Pretorius Street Pretoria 0002 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome change in the mean score on the AUDIT in the last 3 months and mean number of heavy drinking days in the last month of the study period compared with baseline, as measured by the AUDIT. Baseline; 3 months following intervention 6 months following intervention

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Human Sciences Research Council 134 Pretorius Street Pretoria 0002 South Africa
Department of Health 553 Vermeulen Street Pretoria 0002 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Health 553 Vermeulen Street Pretoria 0002 South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Human Sciences Research Council 134 Pretorius Street Pretoria 0002 South Africa Foundation

COLLABORATORS
Name Street address City Postal code Country
Karl Peltzer 135 Pretorius Street Pretoria 0002 South Africa
Pamela Naidoo 69-83 Plein Street Cape Town 0002 South Africa
Gladys Matseke 135 Pretorius Street Pretoria 0002 South Africa
Khangelani Zuma 134 Pretorius Street Pretoria 0002 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Scientific Enquiries Prof Karl Peltzer kpeltzer@hsrc.ac.za 012-3022000 012-3022601
Street address City Postal code Country Position / Affiliation
134 Pretorius Street Pretoria 0002 South Africa Human Sciences Research Council
Role Name Email Phone Fax
Principal Investigator Prof Karl Peltzer kpeltzer@hsrc.ac.za 082-4192475 012-3022637
Street address City Postal code Country Position / Affiliation
Role Name Email Phone Fax
Public Enquiries Prof Karl Peltzer kpeltzer@hsrc.ac.za 012-3022000
Street address City Postal code Country Position / Affiliation