Prepex

Transcript

Slide1
PrePexTM: A New Device for Male Circumcision The PrePexTM Acceptability Pilot Study in BotswanaSlide2
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 studyInclusion criteria Implications of Iitroducing PrePexTM pilot study to the SMC programContacts for more information Slide3
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 menProcedure can be conducted by nurses in simple settingsSlide4
Current SMC modalities and outputsSpacePersonnelEquipmentDemandSlide5
Program targets and achievementProgram target is 385,000 MCs by 2016Present achievement is much lower than target - approximately 30% of target for 2012Slide6
Key program challenges Low demand for services. Some barriers identified includeFear of painTime Time off workSix week duration of abstinenceHuman resources to ensure wider coverageShortage of space for SMC services in small health units Slide7
What is PrePexTM device?Inner RingDelivery RingElastic RingSlide8
The PrePexTM procedure: Day 0Measurement, Day 0Device Placement, Day 0Appearance at departure, Day 0Slide9
Appearance on return visit, day 7Device removal, day 7Appearance at 6 weeksAppearance at 3 weeksThe PrePexTM procedure: Day 7Slide10
PrePexTM device has potential to bridge program gapsLow demand for services: Addresses the identified barriers:Fear of painTime Time off workSix week duration of abstinenceThe human resources to ensure wider service coverage, and Space limitations Slide11
Known adverse events with the PrePexTM procedureAll adverse events documented to date have been mild and resolved completely Mild Swelling Mild discomfort 2-3 hours after applicationPossible social discomfortSlight pain or discomfort during removal – pain lasts less that one minute Slide12
Findings from the Rwanda PrePexTM StudiesPrePexTM device is safePrePexTM is safe and easily done by nursesMen are actively seeking the PrePexTM device for male circumcisionSlide13
HhNnnnRwandaTanzaniaUgandaZimbabweSouth AfricaLesothoMozambiquePrePexTM studies in other countriesSlide14
The PrePexTM study in BotswanaGoal To evaluate the acceptability and safety of the PrePexTM device in routine clinical settings among adult males in Botswana ObjectivesEvaluate training of nurse providers to learn PrePexTM procedure and use the device in BotswanaDescribe and assess client and provider acceptability Describe and assess safety of the PrePexTM device when the procedure is performed by nursesSlide15
Ethical approvals for the studyThe following regulatory boards for research have approved the study;HRDC-Ministry of Health, BotswanaCenter for Disease Control (CDC ) Institutional Review Board Johns Hopkins University Institutional Review Board Slide16
Study timelinesActivityStatus/ Projected TimelineProtocol Development and approvalsCompletedKey ProcurementsAlmost CompletedStaff recruitmentsOn-goingMaterials PretestingFeb 2013Site team OrientationsFeb 2013Advocacy meetingsFeb 2013Staff TrainingFeb-Mar 2013Participant recruitmentMar 2013Interim reviewMay 2013Study closureJul 2013Analysis and report writingAug 2013Dissemination of FindingsSept 2013Slide17
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 upsSample size: About 1000 men will be circumcised during the study Study will be conducted in two Ministry of Health clinics: Nkoyaphiri and Block 8 Slide18
How will the study be managed?Overall leadership and Coordination by MOHSMC Partners will support training, procure supplies provide staff and technical supportThe study is expected to last 4-6 monthsSlide19
To take part in the study, one must:Be an uncircumcised male, aged 18 to 49Agree to be circumcised using the PrePex methodBe HIV negativeAgree to return to the health care facility for at least 3 scheduled follow-up visitsAccept to provide contact information for study follow up Agree to complete study surveys and/or interviews in person on a designated scheduleBe able to communicate in English or SetswanaAgree to abstain from sex or six weeksSlide20
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 PrePexSlide21
What are the implications of introducing PrePexTM to regular SMC services?PrePexTM device will not replace the usual circumcision surgeryAbout 10-20% of men are medically not eligible for the devicePrePexTM device is currently only available for adults age 18 to 49 years old Slide22
Regular MC will remain available at study clinics, and nationwidePrePexTM procedure won’t be offered at least for some period after the study closesEventual program policy on PrePexTM device will be guided by study findingsWhat are the implications of introducing PrePexTM to regular SMC services?Slide23
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 advantagesSlide24
For more information, contact: Mr Conrad NtsuapeMinistry of [email protected] Dr Ali AliMinistry of Health+267-363-2328 [email protected] Adrian [email protected] Slide25
DCSAcknowledgements