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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2008060000883662 Date of Registration: 20/04/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/04/2008
Actual trial start date
Anticipated date of last follow up 02/04/2009
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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
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)
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)
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)
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)
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)
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 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 20/12/2007 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
Secondary Outcome STI incidence Baseline After 9 months
Primary Outcome self-reported sexual risk behaviour After 9 months of receiving the intervention
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
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
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
University of the Western Cape Cape Town South Africa
University of the Western Cape Cape Town South Africa
Western Cape Provincial Department of Health Cape Town South Africa
Western Cape Provincial Department of Health Cape Town South Africa
Tulane University New Orleans United States of America
Tulane University New Orleans United States of America
Brown University Providence United States of America
Brown University Providence United States of America
University of Connecticut Connecticut United States of America
University of Connecticut Connecticut United States of America
University of Western Ontario Ontario Canada
University of Western Ontario Ontario Canada
University of Cape Town: School of Public Health and Family Medicine Cape Town South Africa
University of Cape Town: School of Public Health and Family Medicine Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mickey Chopra mickey.chopra@mrc.ac.za +27 21 938 0454 Francie van Zyl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Director: Health Systems Research Unit, Medical Research Council
Role Name Email Phone Street address
Public Enquiries Sarah Dewing sarah.dewing@mrc.ac.za +27 21 938 0454 Francie van Zyl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Researcher, Health Systems Research Unit, Medical Research Council
Role Name Email Phone Street address
Scientific Enquiries Cathy Mathews cathy.mathews@mrc.ac.za +21 21 938 0454 Francie van Zyl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Senior Researcher, Health Systems Research Unit, Medical Research Council
REPORTING
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Changes to trial information