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.: PACTR201506001182385 Date of Registration: 26/06/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cape Town CircStudy
Official scientific title Effectiveness of an intervention to reduce post-operative penetrative sex in recipients of voluntary medical male circumcision
Brief summary describing the background and objectives of the trial The proposed study will develop and evaluate a mobile-Health self-care intervention to increase the adoption of safe sexual behavior during the post-operative period for medically circumcised men in Western Cape Province, South Africa. The intervention will be delivered through mobile phone technology that task-shifts behavior change communication from health care personnel to an automated phone message system, encouraging self-care. This technology is being developed by KI and partners for use in other health-related settings. Specific objectives (aims) of the study are: 1. To develop comprehensible and acceptable messages about safe sexual behavior during the healing period and in the longer term for recipients of male circumcision in the Western Cape Province. 2. To develop the safe sexual behavior messages into cheap, readily accessible, interactive and confidential audio clips in appropriate local languages, 30-120 seconds each. 3. To test the effectiveness and cost-effectiveness of customized relay of audio clips on safe sexual behavior in consenting, recently circumcised men.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CPTCS
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 21/01/2015
Actual trial start date 21/01/2015
Anticipated date of last follow up 29/02/2016
Actual Last follow-up date 29/02/2016
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants) 1200
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
N14/08/108 Health Research Ethics Committee 2, Stellenbosch University
RP100/2013 Department of Health, Western Cape
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 a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group m-health audio messaging on safe sexual behaviour 38 pre-recorded audio messages over the duration of six weeks following the circumcision procedure. 100-120 seconds per audio clip The mobile system designed by CELLIFE using Skype technology will automatically call participants twice a day for the first two days, once a day for the next four weeks and on alternative days in the last two weeks 600
Control Group Standard of Care VCT counselling prior to circumcision and a general wound-caring and health talk also prior and immediately after the operation 30 minutes This consists of the counselling session during the VCT procedure and a brief post-surgery counselling session, where they are advised on how to care for the wound and ordered to go to their local clinic after two and seven days following surgery. They are reminded here to adhere to consistant condom-use and not to engage in penetrative sex until the mandatory wound-healing period of six weeks. 600 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The population of the study will consist of men undergoing VMMC who indicate at the recruiting phase that they a) 18 or older, b) consent to participating in the study, c) possess a mobile phone and d) will be residing in the area for the next six weeks. none 18 Year(s) 99 Year(s) Male
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 20/10/2014 Health Research Ethics Committee 2
Ethics Committee Address
Street address City Postal code Country
5th Floor, Education Building, Francie van Zijl Avenue, Parow 7500, Cape Town, South Africa Tygerberg 7500 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 18/12/2014 Strategy and Health Support
Ethics Committee Address
Street address City Postal code Country
5th floor, Norton Rose House, Riebeek Street, Cape Town Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The occurrence of sexual intercourse at any time in the first 42 days after VMMC ¿ will be compared between the experimental and control groups AT 42 days (window period of 14 days thereafter)
Secondary Outcome Adoption of non-penetrative sexual behaviors in the first 42 days after the procedure AT 42 days (window period of 14 days thereafter)
Secondary Outcome Self-reported STI symptoms (as a marker of unprotected sex) At baseline and 42 days after the procedure
Secondary Outcome Sexual risk behaviour At baseline and 42 days after procedure
Secondary Outcome Sexual risk propensity at baseline (as a control for risk-taking personality) At baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Selected MMC clinics Northern Municipal Sub-Structure Cape Town Metropole South Africa
Selected MMC clinics Southern and Western Municipal Sub-Structure Cape Town Metropole South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Swedish Research Council Västra Järnvägsgatan 3 Stockholm Sweden
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Swedish Research Council Västra Järnvägsgatan 3 Stockholm Sweden Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Donald Skinner Research on Health and Society, Suite 4009, Teaching Block, Faculty of Health Sciences, University of Stellenbosch Tygerberg 7500 South Africa
Sarah Thomsen Tomtabodavagen 18a, Karolinska Institutet Stockholm Sweden
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Donald Skinner dskinner@sun.ac.za +27219389043 Research on Health and Society, Suite 4009, Teaching Block, Faculty of Health Sciences, University of Stellenbosch
City Postal code Country Position/Affiliation
Tygerberg 7500 South Africa Director
Role Name Email Phone Street address
Principal Investigator Sarah Thomsen sarah.thomsen@ki.se +46 8 524 833 64 Department of Public Health Sciences, Division of Global Health (IHCAR), Nobelsväg 9, 171 77
City Postal code Country Position/Affiliation
Stockholm Sweden Scientific Coordinator, EPI-4
Role Name Email Phone Street address
Public Enquiries Yoesrie Toefy ytoefy@sun.ac.za +27219389043 RHS, Suite 4009, Teaching Block, Tygerberg Campus, Stellenbosch University, Francie van Zyl Avenue
City Postal code Country Position/Affiliation
Tygerberg 7500 South Africa Research and Project Manager
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