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.: PACTR201105000297151 Date of Approval: 15/05/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
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 RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied alcohol misuse,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 02/05/2011
Actual trial start date 09/05/2011
Anticipated date of last follow up 31/07/2012
Actual Last follow-up date 31/07/2012
Anticipated target sample size (number of participants) 520
Actual target sample size (number of participants) 468
Recruitment status Completed
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 randomisation created by computer software Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Brief alcohol counselling 2 1 month Provision of theory-based alcohol brief counselling intervention 260 Active-Treatment of Control Group
Control Group Alcohol health information leaflet 1 1 minute Health care provide gives alcohol health information leaflet 260 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 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 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 Charities/Societies/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 Street address
Principal Investigator Karl Peltzer kpeltzer@hsrc.ac.za 082-4192475
City Postal code Country Position/Affiliation
Role Name Email Phone Street address
Public Enquiries Karl Peltzer kpeltzer@hsrc.ac.za 012-3022000
City Postal code Country Position/Affiliation
Role Name Email Phone Street address
Scientific Enquiries Karl Peltzer kpeltzer@hsrc.ac.za 012-3022000 134 Pretorius Street
City Postal code Country Position/Affiliation
Pretoria 0002 South Africa Human Sciences Research Council
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information