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

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

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

Current SMC modalities and outputs Space Personnel Equipment Demand

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

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

What is PrePexTM device? Delivery Ring Inner Ring Elastic Ring

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For more information, contact: Mr Conrad Ntsuape Ministry of Health +267-363-2235 ontsuape@gov.bw Dr Ali Ali +267-363-2328 alisalum@gmail.com Dr Adrian Musiige Jhpiego +267-318-1166 amusiige@jhpiego.net

Acknowledgements DCS