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

ontsuape@gov.bw

Dr Ali AliMinistry of Health+267-363-2328

alisalum@gmail.com

Dr Adrian MusiigeJhpiego

+267-318-1166amusiige@jhpiego.net

DCS

Acknowledgements