PrePex Device for Rapid Scale up of Male Circumcision Programmes in Zimbabwe: Results of 3 Studies Prof. Mufuta Tshimanga Co-Principal Investigator.

PrePex Device for Rapid Scale up of Male Circumcision Programmes in Zimbabwe:

Results of 3 Studies

Prof. Mufuta TshimangaCo-Principal Investigator

Background• Zimbabwe started VMMC programme in mid 2009– Part of a comprehensive HIV prevention programme– Phased approach with learning phase– Different models of service delivery, integrated, fixed,

outreach and mobile services • Target: 1.3 Million , 80% of 13-29 age group by 2015, reached

75,000 since inception • MOHCW interested in innovative models to increase scale up

of VMMC • MOVE• Adult male circumcision devices, such as PrePex

Trial Phases

– Phase 1 - Safety and Efficacy study– Phase 2- RCT surgery vs device– Phase 3 - Field studies 

• Each phase examines safety and acceptability

• Above 18 years• Agrees to be circumcised by any of the study methods, PrePex

or Surgical, accepts study procedures and requirements• HIV sero-negative

Inclusion Criteria

Procedures • Screening • Psychosocial Interview• Deployment of Device• Removal of Device• Follow-up visits to day 90

Safety Study

• One arm, open label, prospective study to assess safety and efficacy

• 53 Men • Overall procedure duration was 11 minutes 33

sec (SD=3.19 min) for deployment and removal

• Median time for complete healing was 35 days post device removal

• No SAE recorded

Time VAS Scale Pain N Level 0  Level 2 Level 4

During device Placement

53 48 (90.6%) 5 (9.4)

3 hours post-Placement

53 53 (100%)

2 days post-Placement

53 33 (62.3%) 19 (35.8%) 1 (1.9%)

Before device and foreskin removal

52 27 (50.9%) 21 (39.6%) 4 (7.5%)

During device removal

52 1 (1.9%) 26 (50.0%) 25(48.1%)

1 minute post-device removal

52 12 (23.1%) 38 (73.1%) 2 (3.8%)

2 week post-device removal

48 43 (89.6%) 4 (8.3%) 1 (2.1%)

Safety Study-Pain Scores

Safety Study Acceptability

• All participants were satisfied with the circumcision procedure and the aesthetic result 90 days post-procedure

• 55.5% stated the abstinence period as too long

Comparative Study - Design

• RCT comparing PrePex (n=160) to Forceps Guided Surgery (n=80)

• Compare the surgery and PrePex :• Procedure time• Time to complete healing• Costing

Comparative Study-ResultsSurgical MC Prepex MC

( placement and removal)

Median Procedure Time*

15.3 Min (Q1=15.3, Q3=23.9)

4.6 Min(Q1=4.0, Q3=5.8)

Time to complete healing (Median)

42 days(Q1=42, Q3=42)

35 days(Q1=35, Q3=42)

*p<0.001

Ongoing Field Study

• One arm, open label, prospective, cohort field study, 600 participants

• Assess safety of PrePex when circumcision is performed by nurses

• Evaluate PrePex training needs• Evaluate acceptability of PrePex by patients,

partners and care givers• Evaluate the effectiveness and cost-

effectiveness of the PrePex device

Field Study-Preliminary Results• Recruitment started 9th May, 2012 at 3 study sites• 750 devices were successfully deployed and removed

by Nurses– 150 during training phase– Recruitment completed 9th July, 2012

• No SAE recorded• Follow up visits, to end on 16 Oct, 2012

Conclusions

• PrePex device is safe to use for MC delivered by physicians and nurses

• Pain related to PrePex appears to be minor• Our findings reaffirm and validate similar

clinical studies on PrePex done in Rwanda

Investigators• Dr Gerald Gwinji, MBChB, MPH. PS MoHCW, Principal Investigator• Prof Mufuta Tshimanga, MD; Department of Community Medicine,

University of Zimbabwe, Co-Principal Investigator• Dr. Tonderai Mangwiro,MMed Urology, Department of Surgery,

University of Zimbabwe• Dr. Owen Mugurungi, MBChB, Msc; Director AIDS /TB unit , MoHCW• Dr. Munyaradzi Murwira, MBChB, MPH, Director ZNFPC• Dr. Dan Montano, PhD, Batelle Memorial Institute• Dr. Danuta Kasprzyk, PhD, Batelle Memorial Institute• Mrs. Daisy Nyamukapa, Program Officer, UNFPA• Mr. Sinokuthemba Xaba, MC Program Officer, MOHCW• Dr Karin Hatzold, MD, MPH, Deputy Director SRH, HIV &TB, PSI• Dr Christopher Samkange, Director ICHE, College of Health Sciences,

University of Zimbabwe

Acknowledgements

• MoHCW• ZNFPC• UNFPA• Gates Foundation• PSI• ZiCHIRe

Summary of Scientific Validation and Implementation of PrePex for Non-Surgical Adult Male Circumcision

MUTABAZI VincentRwanda Ministry of Health

AIDS 2012 Conference July 22nd-27th , 2012

Rwanda has a national goal to significantly decrease its HIV incidence rate, by launching a VMMC to reach 2 million adults in 2 years as part of a comprehensive HIV prevention strategy. 

WHO TAG recommendation to scale up PrePex MC in Rwanda received in March 2012.

Background

Non Surgical MC

◦ No injected anesthesia

◦ Bloodless procedure

◦ No sutures

◦ No sterile settings

◦ FDA approved, CE Mark

PrePex Innovation

PrePex Placement Procedure

PrePex Removal Procedure

Clinical studies of PrePex were planned using the WHO Evaluation Framework of Adult MC Devices.

PrePex Safety & Efficacy Study - 105 subjects, including first cases of natural detachment by day 15 that was found to be safeVisited onsite by WHO, Gates. Manuscript Published in JAIDS. CROI, AUA

Comparison Study – 144 PrePex/73 SurgeryAudited onsite by WHO, USAID. Manuscript accepted (not yet published) to JAIDS

Nurses Feasibility Study – 49 subjects, 6 nurses

Nurses cohort Study – 590 subjects, 10 nursesOral Presentation in ICASA Dec 2011, IAS 2012

Clinical Roadmap

6 physicians and 41 nurses were successfully trained as PrePex operators in Rwanda.

Teams from Zimbabwe were trained by Rwanda. Hosted delegations from Uganda, Botswana, USA and more in 2012.

1 paper published, 1 accepted, 1 under review and 2 in writing.

PrePex Train the Trainer available to train Sub-Saharan Africa. Gates Foundation to sponsor capacity building for PrePex Center of Excellence.

PrePex Center of Excellence

Hearts & Hands Campaign (June 2012) – Sponsored by Korean NGO, 6 nurses from Byumba hospital (rural),1,000 successful MC within 3 weeks with a total of 7 mild AEs, (0.7%). The campaign was closely supervised by MoH, physicians and nurses from PrePex Center of Excellence, All AEs gathered and analyzed.

Army Week Campaign (July 2012) – Sponsored by the Rwanda Military Hospital, 7 teams of nurses performed 1,500 procedures within two weeks on 8 rural health centers across the Cyangugu district. Closely supervised for AEs, 6 mild AEs, AE rate 0.4%.

Operational Pilot Demonstration (Q3 2012) – Sponsored by Global Fund and Bill & Melinda Gates Foundation. Defining parameters for scale up and studying removal with one nurse and AE monitoring for scale up. 10,000 clients.

First Steps Towards Scale-up

SAFE: Very low AE rate demonstrating high safety of PrePex by nurses.

18 related AES from total of 4166 procedures (0.46%)

EASY TO TRAIN: Nurses with no prior knowledge, can be trained in 3

days course to perform Safe, Effective and Efficient MC. Proper

supervision is important to ensure safe implementation before releasing

to the field.

NATURAL DETACHMENT – a pre-safety study was conducted in

March 2009, to alleviate concerns about men not returning for removal.

The outcome assured us that PrePex was safe, and would naturally

detach for complete circumcision, if men did not come back to the clinic.

Key Takeaways

Scale up – Q3 2012 Rwanda plans to initiate scale up program◦ Pilot of 10,000 to inform scale up (Global Fund, Gates)◦ 2 Million MCs in 2 years◦ ~150 teams of 2 nurses (full time – 8 hours a day)◦ 54 procedures per team per day (Placement +Removal)◦ 4000 MCs Per day (4000 placements 4000 removals)◦ 250 working days per year

Adolescents study – 10 to 17 years old

Next Steps

Thank You