1. PrePexTM: A New Device for Male Circumcision
The PrePexTM Acceptability Pilot Study in Botswana

2. Presentation Outline Background Key program limitation
What is PrePexTM device and procedure
Research on PrePexTM device in other countries
The Botswana PrePexTM study: Goals and objectives
Ethical approvals of the study
Study design
Management of study
Inclusion criteria
Implications of Iitroducing PrePexTM 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.
PrePexTM 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 PrePexTM device?
Delivery Ring
Inner Ring
Elastic Ring

8. The PrePexTM procedure: Day 0
Measurement, Day 0
Device
Placement,
Day 0
Appearance at departure, Day 0

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

10. PrePexTM 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 PrePexTM 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 PrePexTM Studies
PrePexTM device is safe
PrePexTM is safe and easily done by nurses
Men are actively seeking the PrePexTM device for male circumcision

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

14. The PrePexTM study in Botswana
Goal
To evaluate the acceptability and safety of the PrePexTM device in routine clinical settings among adult males in Botswana
Objectives
Evaluate training of nurse providers to learn PrePexTM procedure and use the device in Botswana
Describe and assess client and provider acceptability
Describe and assess safety of the PrePexTM 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 Activity Status/ Projected Timeline
Protocol Development and approvals
Completed
Key Procurements
Almost Completed
Staff recruitments
On-going
Materials Pretesting
Feb 2013
Site team Orientations
Advocacy meetings
Staff Training
Feb-Mar 2013
Participant recruitment
Mar 2013
Interim review
May 2013
Study closure
Jul 2013
Analysis and report writing
Aug 2013
Dissemination of Findings
Sept 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:
Be an uncircumcised male, aged 18 to 49
Agree to be circumcised using the PrePex method
Be HIV negative
Agree to return to the health care facility for at least 3 scheduled follow-up visits
Accept to provide contact information for study follow up
Agree to complete study surveys and/or interviews in person on a designated schedule
Be able to communicate in English or Setswana
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 PrePexTM
Consenting
Examination for medical fitness
Administration survey questionnaires
Circumcision with PrePexTM 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 PrePexTM to regular SMC services?
PrePexTM device will not replace the usual circumcision surgery
About 10-20% of men are medically not eligible for the device
PrePexTM device is currently only available for adults age 18 to 49 years old

22. What are the implications of introducing PrePexTM to regular SMC services?
Regular MC will remain available at study clinics, and nationwide
PrePexTM procedure won’t be offered at least for some period after the study closes
Eventual program policy on PrePexTM device will be guided by study findings

23. What are the expectations from the SMC program about PrePex?
The PrePexTM device has a potential to dramatically raise demand for SMC by addressing men’s 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
Dr Adrian Musiige
Jhpiego

25. Acknowledgements
DCS