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PrePex TM : A New Device for Male Circumcision The PrePex TM Acceptability Pilot Study in Botswana.

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Presentation on theme: "PrePex TM : A New Device for Male Circumcision The PrePex TM Acceptability Pilot Study in Botswana."— Presentation transcript:

1 PrePex TM : A New Device for Male Circumcision The PrePex TM Acceptability Pilot Study in Botswana

2 Presentation Outline Background Key program limitation What is PrePex TM device and procedure Research on PrePex TM device in other countries The Botswana PrePex TM study: Goals and objectives Ethical approvals of the study Study design Management of study Inclusion criteria Implications of Iitroducing PrePex TM pilot study to the SMC program Contacts for more information

3 Background Male circumcision devices have potential to accelerate program scale up, and raise the circumcision uptake. PrePex TM is a new adult device for Male circumcision that has been researched in other African countries. Results indicate that circumcision with this device is: Faster, bloodless, no injection for anaesthesia, no stitches Require less time off work for men Procedure can be conducted by nurses in simple settings

4 Current SMC modalities and outputs Space Personnel Equipment Demand

5 Program targets and achievement Program target is 385,000 MCs by 2016 Present achievement is much lower than target - approximately 30% of target for 2012

6 Key program challenges Low demand for services. Some barriers identified include Fear of pain Time Time off work Six week duration of abstinence Human resources to ensure wider coverage Shortage of space for SMC services in small health units

7 What is PrePex TM device? Inner Ring Delivery Ring Elastic Ring

8 The PrePex TM procedure: Day 0 Measurement, Day 0 Device Placement, Day 0 Appearance at departure, Day 0

9 Appearance on return visit, day 7 Device removal, day 7 Appearance at 6 weeks Appearance at 3 weeks The PrePex TM procedure: Day 7

10 PrePex TM device has potential to bridge program gaps Low demand for services: Addresses the identified barriers: Fear of pain Time Time off work Six week duration of abstinence The human resources to ensure wider service coverage, and Space limitations

11 Known adverse events with the PrePex TM procedure All adverse events documented to date have been mild and resolved completely Mild Swelling Mild discomfort 2-3 hours after application Possible social discomfort Slight pain or discomfort during removal – pain lasts less that one minute

12 Findings from the Rwanda PrePex TM Studies PrePex TM device is safe PrePex TM is safe and easily done by nurses Men are actively seeking the PrePex TM device for male circumcision

13 Hh Nn nn Rwanda Tanzania Uganda Zimbabwe South Africa Lesotho Mozambique PrePex TM studies in other countries

14 The PrePex TM study in Botswana Goal To evaluate the acceptability and safety of the PrePex TM device in routine clinical settings among adult males in Botswana Objectives Evaluate training of nurse providers to learn PrePex TM procedure and use the device in Botswana Describe and assess client and provider acceptability Describe and assess safety of the PrePex TM device when the procedure is performed by nurses

15 Ethical approvals for the study The following regulatory boards for research have approved the study; HRDC-Ministry of Health, Botswana Center for Disease Control (CDC ) Institutional Review Board Johns Hopkins University Institutional Review Board

16 Study timelines ActivityStatus/ Projected Timeline Protocol Development and approvalsCompleted Key ProcurementsAlmost Completed Staff recruitmentsOn-going Materials PretestingFeb 2013 Site team OrientationsFeb 2013 Advocacy meetingsFeb 2013 Staff TrainingFeb-Mar 2013 Participant recruitmentMar 2013 Interim reviewMay 2013 Study closureJul 2013 Analysis and report writingAug 2013 Dissemination of FindingsSept 2013

17 Study design PrePex pilot study will be conducted in two phases: Preparatory phase: Training of health providers Implementation phase: Health providers enrolling eligible clients for the study and conducting follow ups Sample size: About 1000 men will be circumcised during the study Study will be conducted in two Ministry of Health clinics: Nkoyaphiri and Block 8

18 How will the study be managed? Overall leadership and Coordination by MOH SMC Partners will support training, procure supplies provide staff and technical support The study is expected to last 4-6 months

19 To take part in the study, one must: 1.Be an uncircumcised male, aged 18 to 49 2.Agree to be circumcised using the PrePex method 3.Be HIV negative 4.Agree to return to the health care facility for at least 3 scheduled follow-up visits 5.Accept to provide contact information for study follow up 6.Agree to complete study surveys and/or interviews in person on a designated schedule 7.Be able to communicate in English or Setswana 8.Agree to abstain from sex or six weeks

20 What will happen to those who qualify and agree to take part in this study? Screening for SMC eligibility Education on PrePex TM Consenting Examination for medical fitness Administration survey questionnaires Circumcision with PrePex TM device Follow up visits (Days 0, 7, 14, 42) Some men will still be eligible for surgical circumcision even if they may not qualify for PrePex

21 What are the implications of introducing PrePex TM to regular SMC services? PrePex TM device will not replace the usual circumcision surgery About 10-20% of men are medically not eligible for the device PrePex TM device is currently only available for adults age 18 to 49 years old

22 Regular MC will remain available at study clinics, and nationwide PrePex TM procedure wont be offered at least for some period after the study closes Eventual program policy on PrePex TM device will be guided by study findings What are the implications of introducing PrePex TM to regular SMC services?

23 What are the expectations from the SMC program about PrePex? The PrePex TM device has a potential to dramatically raise demand for SMC by addressing mens fears of pain and loss of time from work, among its other technical advantages

24 For more information, contact: Mr Conrad Ntsuape Ministry of Health Dr Ali Ali Ministry of Health Dr Adrian Musiige Jhpiego

25 DCS Acknowledgements


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