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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201105000297151 |
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Date of registration:
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15/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Implementation and Monitoring of Screening and Brief Intervention(SBI) for Alcohol Use Disorders Among Tuberculosis Patients, South Africa
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Scientific title:
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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 |
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Date of first enrolment:
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02/05/2011 |
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Target sample size:
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520 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=297 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using randomisation created by computer software,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Karl
Peltzer |
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Address:
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134 Pretorius Street
0002
Pretoria
South Africa |
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Telephone:
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012-3022000 |
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Email:
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kpeltzer@hsrc.ac.za |
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Affiliation:
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Human Sciences Research Council |
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Name:
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Karl
Peltzer |
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Address:
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Telephone:
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012-3022000 |
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Email:
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kpeltzer@hsrc.ac.za |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
18 Year(s)
Age maximum:
75 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
alcohol misuse
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alcohol misuse
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Tuberculosis
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Intervention(s)
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Brief alcohol counselling
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Alcohol health information leaflet
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Primary Outcome(s)
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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.
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Source(s) of Monetary Support
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Department of Health
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Ethics review
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Status: Approved
Approval date:
Contact:
HSRC Research Ethics Committee
012-3022006
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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