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June 2014
Circ MedTech is proud to provide the first PrePex Newsletter in which we share the latest progress and news on PrePex Voluntary Medical Male Circumcision (VMMC) scale-up in Sub-Saharan Africa.
 
Photo: Botswana Ministry of Health 
PrePex Scale-Up News

Exciting progress in the scale-up of PrePex programs has been taking place in the priority countries in Sub-Saharan Africa. Highlights include the following:  

Rwanda:
Following the festive launch of PrePex in November of 2013, The Rwanda Ministry of Health has started scale-up of VMMC using the PrePex device at 16 sites, including 9 District Hospitals and VMMC Centers operated by Jhpiego — an affiliate to the Johns Hopkins University and Drew Cares International (DCI) — in cooperation with DoD/RDF. Procedures are performed routinely and by way of organized campaigns alongside the surgical male circumcision procedure. Additional PrePex service centers are expected to be opened in the near future.
 
Zimbabwe:
The Zimbabwe Ministry of Health and Child Welfare, together with its partners, have started a national VMMC scale-up campaign and have begun offering PrePex as an option (alongside the surgical male circumcision procedure) at 9 VMMC sites. 
So far, they have completed over 1,500 PrePex procedures as part of their active surveillance phase and will begin a further 9,000 procedures as part of a passive surveillance phase.

Uganda:
The Uganda Ministry of Health is ready to initiate the implementation of PrePex programs.
The Ministry has established two PrePex National Training Centers and is approaching completion of 1,000 PrePex procedures as part of their active surveillance phase.
The following bodies are participating in this implementation: Rakai Health Science Program, Makerere University Walter Reed Project, Infectious Diseases Institute and Kampala International Hospital.
Additionally, the Uganda AIDS Healthcare Foundation recently initiated a 2,000 Procedure PrePex pilot project in the Masaka region.  

South Africa:
Three South African organizations are now piloting PrePex programs.
The Center for HIV and AIDS Prevention Center (CHAPS) has initiated a national PrePex Training Center and commenced a PrePex 800 man pilot project.
The Society for Family Health (SFH) South Africa, together with Population Services International (PSI), has completed a PrePex pilot project that included 318 adults and 100 adolescents. As a result, they are now moving to the 1,000- procedure active surveillance phase.
In addition, The Aurum Institute is conducting a PrePex safety study on 560 men.
The Aurum Institute – along with SFH/PSI and CHAPS – will be adding to the body of evidence to guide policy on the integration of PrePex into the South African VMMC program.

Zambia:
The Society for Family Health (SFH) Zambia and Population Services International (PSI), with its partner FHI360, has completed enrollment for the PrePex 500-men pilot project. A full report will be submitted to the Zambia Ministry of Health for review.

Botswana, Kenya and Mozambique have concluded their PrePex safety and acceptability studies and are currently preparing and initiating the preliminary scale-up of a 1,000- procedure active surveillance phase.

Malawi, Swaziland, Tanzania and Lesotho are in the initial stages of PrePex safety and acceptability pilot studies. 
Men queuing for a male circumcision procedure using the PrePex device in a campaign operated by Jhpiego — in cooperation with RDF — at Ngeruka Health Center, Nyamata District, Rwanda. May 2014. 
Photo: Circ MedTech/ Alon Gilboa 
PrePex in Indonesia

Gadja Mada University, the HIV Cooperation Program for Indonesia (HCPI) and the Clinton Health Access Initiative (CHAI)- together with Provincial Health Offices, the Ministry of Health, and national and local AIDS Commissions- are planning a feasibility and acceptability pilot study of PrePex for HIV prevention in the Indonesian provinces of Papua and West Papua. A generalized HIV epidemic is emerging in both these provinces and there is a large un-circumcised adult male population that can benefit from voluntary medical male circumcision.

PrePex is being considered as a possible intervention for HIV prevention that will complement current campaigns, such as: condom promotion, education, STI control, HIV testing and treatment.  The pilot study- which will provide evidence for both Provincial Health Offices, as well as the Ministry of Health and national and local AIDS Commissions- is being funded by DFAT Australian AID.

‪PrePex master trainer Dr. Muyenzi Leon Ngeruka (of the PrePex Center of Excellence in Rwanda Military Hospital, Kigali) visited Papua to assist in the successful adult-sizing study. During his visit, Dr. Ngeruka- together with CHAI representatives- met with the Indonesian Minister of Health and other stakeholders in Papua and West Papua. Plans are underway for future training of the Indonesian teams in Rwanda and a PrePex Acceptability pilot study is expected to begin later this year.   
L to R:  Dr Steve Wignall (CHAI),  Dr. Muyenzi Leon Ngeruka (Rwanda Military Hospital), Her Excellency Dr Nafsiah Mboi (Minister of Health, Indonesia), Dr Bob Magnani (CHAI), Prescott Chow (CHAI Country Director).
Photo: CHAI
PrePex Clinical Updates:

PrePex for Adolescents:
Circ MedTech has developed a range of PrePex devices suitable for adolescent males aged 13-17 years.
Currently under clinical investigation, the company believes these devices will be available by the end of 2014, following WHO TAG review. 

Odor Study:
In late 2013, a randomized controlled study — performed in Rwanda Military Hospital — examined the relationship between the occurrence of odor while wearing the PrePex device and the daily, personal hygiene routine in a sample of 100 men. The study results indicated a direct correlation between foreskin hygiene and elimination of odor, demonstrating that the occurrence of odor is not related to the necrotic foreskin. The use of Chlorhexidine solution (diluted to 1%) was found to be highly effective in eliminating excessive odor. 
 
Recommended Hygiene Instructions:
Recently, a Hygiene Instructions Manual (Recommended Foreskin Hygiene while Wearing the PrePex Device) was distributed to PrePex Implementers. This provides guidelines under three categories, all aimed to reduce the possibility of odor development:
  1. How to avoid urine becoming trapped under the foreskin - a major contributor to odor development
  2. Recommended foreskin washing technique - steps developed during the Odor Study in Rwanda
  3. Odor elimination recommendations - derived from the Odor Study conclusions and from input received from PrePex providers
This document is freely available and provided to any implementing body, clinic or provider. Simply email a request to us at: info@prepex.com

Task Shifting from Physicians to Nurses:
A paper, recently published in the African Journal of Reproductive Health, compared various PrePex procedure outcomes - such as, Adverse Event rate, pain levels at various points, and healing. This demonstrated that the outcomes achieved from PrePex procedures performed by nurses are not significantly different than those achieved by physicians.
The full document can be found at the following link - http://www.ajrh.info/vol18_no1/index.php.

PrePex Procedure with Small Incision for Men with Phimosis:
The primary objective of this study was to test the safety of the new male circumcision technique using the PrePex device on men with Phimosis (narrow foreskin). The study enrolled 36 men and was conducted in Rwanda from November 2012 to August 2013. The differences in the current study technique are of the additional use of local anesthesia, as well as incision of the foreskin (to enable insertion of the PrePex Inner Ring). The current study results demonstrated initial safety and efficacy of PrePex with the incision technique.
The procedure has several benefits over conventional surgical circumcision. These include:
  • Local anesthesia injection versus ring block (this is the only time that injected anesthesia is required in a PrePex procedure)
  • Shorter procedure time
  • Lower rate of lost working days
  • Required minor surgical intervention - but no sutures.
Results from the study were submitted to the WHO for review. 
PrePex Center of Excellence in Rwanda Military Hospital, Kigali
PrePex Training Centers:
The focus for 2014 is to build the national capacity of providers, supervisors and domestic trainers over as many priority countries as possible. 
 
Rwanda is currently building its capacity of PrePex providers, internal training sessions have been taking place for the past several months in at least 5 districts. The plan is to continue expanding into other districts to provide full national coverage.
 
Other countries such as Lesotho, Tanzania, Kenya, Uganda and Botswana are all planning to initiate training programs in the upcoming months to also increase their service providing capacity.
 
The past few months have seen a major shift in establishing numerous national training centers in various PrePex implementing countries.

National Training Centers in Countries Implementing PrePex Programs:
  
Country Number of
Training Centers
Total Number
 of Trainers
South Africa 3 5
Uganda 2 8
Botswana 2 2
Tanzania 1 1
Lesotho 1 1
 
PrePex Training Centers in Sub- Saharan Africa 
PrePex at AIDS 2014 Conference:

We are proud to announce that the PrePex team will be attending and presenting at the AIDS 2014 in Melbourne, Australia.
Come visit our booth to receive all of our latest clinical updates, hear about new developments and learn about our PrePex device and procedure!

If you would like to meet with us during the conference, please contact:
Mr. Eddy Horowitz, CEO, eddy@prepex.com
Or Ms. Adi Kadussi, Marketing and Communications Manager, adik@prepex.com
 
PrePex is Becoming More Social!
 
Join our new social media pages and connect with us on LinkedIn, Facebook and Twitter!

You will be able to learn all about PrePex's progress, receive updates straight from the health centers and learn about exciting HIV prevention activities in Sub-Saharan Africa.

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