PrePex TM : A New Device for Male Circumcision The PrePex TM Acceptability Pilot Study in Botswana.
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Transcript of PrePex TM : A New Device for Male Circumcision The PrePex TM Acceptability Pilot Study in Botswana.
PrePexTM: A New Device for Male Circumcision
The PrePexTM Acceptability Pilot Study in Botswana
Presentation OutlineBackgroundKey program limitation What is PrePexTM device and procedureResearch on PrePexTM device in other countriesThe Botswana PrePexTM study: Goals and
objectives Ethical approvals of the study Study designManagement of study Inclusion criteria Implications of Iitroducing PrePexTM pilot study to
the SMC programContacts 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
2016Present 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?
Inner Ring
Delivery Ring
Elastic Ring
The PrePexTM procedure: Day 0
Measurement, Day 0
Device Placement, Day 0
Appearance at departure, Day 0
Appearance on return visit, day 7
Device removal, day 7
Appearance at 6 weeks
Appearance at 3 weeks
The PrePexTM procedure: Day 7
PrePexTM device has potential
to bridge program gapsLow 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 safePrePexTM is safe and easily done by
nursesMen are actively seeking the PrePexTM
device for male circumcision
HhNnnn
Rwanda
Tanzania
Uganda
Zimbabwe
South AfricaLesotho
Mozambique
PrePexTM studies in other countries
The PrePexTM study in BotswanaGoal 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 timelinesActivity Status/ Projected
Timeline
Protocol Development and approvals Completed
Key Procurements Almost Completed
Staff recruitments On-going
Materials Pretesting Feb 2013
Site team Orientations Feb 2013
Advocacy meetings Feb 2013
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:1. Be an uncircumcised male, aged 18 to 492. Agree to be circumcised using the PrePex
method3. Be HIV negative4. Agree to return to the health care facility for at
least 3 scheduled follow-up visits5. Accept to provide contact information for study
follow up 6. Agree to complete study surveys and/or
interviews in person on a designated schedule7. Be able to communicate in English or
Setswana8. 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 eligibilityEducation on PrePexTM
ConsentingExamination for medical fitnessAdministration survey questionnairesCircumcision with PrePexTM deviceFollow 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
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 implications of introducing PrePexTM to regular SMC services?
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 NtsuapeMinistry of Health+267-363-2235
Dr Ali AliMinistry of Health+267-363-2328
Dr Adrian MusiigeJhpiego
DCS
Acknowledgements