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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.: PACTR2008060000883662 Date registered: 2008/03/07
TRIAL DESCRIPTION
Public title Options Western Cape
Official scientific title Options Western Cape: Implementation and evaluation of a positive prevention intervention on sexual risk behaviour among HIV positive people on ARVs
Brief summary describing the background
and objectives of the trial
The focus of this study is the implementation and evaluation of a clinic-based behavioral intervention aimed at reducing risky sexual behavior among HIV positive patients on ARVs attending clinics in the Western Cape. Objectives are to: pilot the intervention in two clinics; conduct an outcome evaluation; conduct a process evaluation.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 2400   
Recruitment status Terminated
Secondary Ids Issuing authority/Trial register Links to Secondary ID
1U51PS00729-01 Center for Disease Control (CDC)

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
Crossover: all participants receive all interventions in different sequence during study Randomised The unit of randomisation is the ARV clinic. Clinics were stratified according to patient load and satus as a hospital or clinic/CHC Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Options for Health once monthly 9 months The Options for Health intervention involves the delivery of an IMB model-based intervention by an adherence counsellor. The approach delivers critical HIV risk-reduction information, motivation and behavioural skills content using Motivational Interviewing (MI) techniques in attempting to assist PLWH to reduce HIV transmission risk behaviour. 1200
Control group Standard of Care once monthly 9 months Patients receive standard of care counselling focused mainly around adherence to medication 1200 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Patients over the age of 18 years Patients who know their HIV status Patients who have been on ART for 1 or 2 months Patients on ART for more than 3 months HIV-positive patients not on ART 18 nulls 80 nulls 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 2007/12/20 University of Cape Town Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital, Old Main Building, Observatory Cape Town 7925 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome self-reported sexual risk behaviour After 9 months of receiving the intervention
Secondary Outcome STI incidence Baseline After 9 months

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
80 patients will be recruited from each of 30 ARV clinics in the Cape Town metropolitan area Cape Town South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Centers for Disease Control and Prevention Atlanta United States of America
Centers for Disease Control and Prevention Atlanta United States of America

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Human Sciences Research Council Plein Park Building, 69-83 Plein Street, Cape Town 8001 South Africa Funding Agency
Primary Sponsor Medical Research Council of South Africa Francie van Zyl Drive, Parow Valley Cape Town 7500 South Africa Funding Agency
Secondary Sponsor Human Sciences Research Council Plein Park Building, 69-83 Plein Street, Cape Town 8001 South Africa Funding Agency
Primary Sponsor Medical Research Council of South Africa Francie van Zyl Drive, Parow Valley Cape Town 7500 South Africa Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Tulane University New Orleans United States of America
Brown University Providence United States of America
University of Connecticut Connecticut United States of America
University of Western Ontario Ontario Canada
University of Cape Town: School of Public Health and Family Medicine Cape Town South Africa
University of the Western Cape Cape Town South Africa
Western Cape Provincial Department of Health Cape Town South Africa
Tulane University New Orleans United States of America
Brown University Providence United States of America
University of Connecticut Connecticut United States of America
University of Western Ontario Ontario Canada
University of Cape Town: School of Public Health and Family Medicine Cape Town South Africa
University of the Western Cape Cape Town South Africa
Western Cape Provincial Department of Health Cape Town South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Mickey Chopra mickey.chopra@mrc.ac.za +27 21 938 0454 +27 21 938 0483
Street address City Postal code Country Position / Affiliation
Francie van Zyl Drive, Parow Valley Cape Town 7500 South Africa Director: Health Systems Research Unit, Medical Research Council
Role Name Email Phone Fax
Public Enquiries Ms Sarah Dewing sarah.dewing@mrc.ac.za +27 21 938 0454 +27 21 938 0483
Street address City Postal code Country Position / Affiliation
Francie van Zyl Drive, Parow Valley Cape Town 7500 South Africa Researcher, Health Systems Research Unit, Medical Research Council
Role Name Email Phone Fax
Scientific Enquiries Dr Cathy Mathews cathy.mathews@mrc.ac.za +21 21 938 0454 +27 21 938 0483
Street address City Postal code Country Position / Affiliation
Francie van Zyl Drive, Parow Valley Cape Town 7500 South Africa Senior Researcher, Health Systems Research Unit, Medical Research Council