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.: PACTR201202000355384 Date of Approval: 03/02/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Screening and brief intervention of alcoholproblems in HIV patients
Official scientific title Screening and brief intervention for alcohol problems in HIV outpatients in the clinics associated with Dr George Mukhari Hospital, Ga-Rankuwa, South Africa
Brief summary describing the background and objectives of the trial The rate of alcohol use in HIV patients in Africa is high. It can lead to a broad range of negative outcomes, like reduced adherence, drug interactions, risky sexual behaviour, etc. This trial will evaluate a Screening and Brief intervention (SBI) in HIV patients and aims to describe the prevalence of alcohol use and wether the SBI is succesful in reducing alcohol use.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 16/01/2012
Actual trial start date 16/01/2012
Anticipated date of last follow up 29/03/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 552
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MREC/H/165/2011: IR Medunsa Research & Ethics Committee
2011/46 Tshwane Research 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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Brief counseling on alcohol use 1 time at inclusion 20 minutes Participant receives personalized feedback on AUDIT results, a health education leaflet, simple advice plus brief counselling about reducing excessive drinking 226
Control Group General health leaflet 1 time at inclusion 2 minutes Participant receives a health leaflet on sensible use of alcohol only 226
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-HIV 1 positive male and female patients -Outpatients -18 years and above -no mental impairment -Medium risk drinkers (8-19 for men and 7-19 for women on the AUDIT screening tool) -A score of 20 and above on the AUDIT questionnaire -A score of less than 8 for men and 7 for women on the AUDIT questionnaire -Pregnant women -Patients already under alcohol reduction treatment -Patients with mental impairment 18 Year(s) 100 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 13/10/2011 Medunsa Research & Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ga-Rankuwa 0204 South Africa
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 29/11/2011 Tshwane Research Committee
Ethics Committee Address
Street address City Postal code Country
427 Hilda Street Preotria 0001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in drinking pattern measured by AUDIT 3 months 12 months
Secondary Outcome Change in health status, QOL, sexual behaviour, adherence level to ART, virological and immunological outcome 3 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Phedisong 4 clinic Ga-Rankuwa South Africa
Maria Rantho clinic Soshanguve South Africa
KT Motubatse Soshanguve South Africa
Soshanguve clinic 3 Soshanguve South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
ABMRF The foundation for Alcohol research 1122 Kenilworth Drive, Suite 407 Baltimore MD21204 United States of America
VLIR Universiteitsplein 1 Antwerp 2610 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor VLIR Universiteitsplein 1 Antwerp 2000 Belgium Funding Agency
Primary Sponsor ABMRF The foundation for alcohol research 1122 Kenilworth Drive, Suite 407 Baltimore MD21204 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Diana Huis in 't Veld Ga-Rankuwa Pretoria 0204 South Africa
Supa Pengpid Ga-Rankuwa Pretoria 0204 South Africa
Karl Peltzer 134 Pretorius Street Pretoria 0001 South Africa
Linda Skaal Ga-Rankuwa Pretoria 0204 South Africa
John Ndimande Ga-Rankuwa Pretoria 0204 South Africa
Robert Colebunders Nationalestraat 155 Antwerp 2000 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Diana Huis in 't Veld dhuisintveld@itg.be +27728312545 Ga-Rankuwa
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa MD/PhD student/University of Antwerp
Role Name Email Phone Street address
Public Enquiries Diana Huis in 't Veld dhuisintveld@itg.be +27728312545 Ga-Rankuwa
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa MD/PhD student/University of Antwerp
Role Name Email Phone Street address
Scientific Enquiries Diana Huis in 't Veld dhuisintveld@itg.be +27728312545 Ga-Rankuwa
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa MD/PhD/ University of Antwerp
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