Tim Farley, Ph.D. Nyon, Switzerland Consultant to WHO/HIV Department 26 September 2012
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1 MALE CIRCUMCISION DEVICES STATUS AND RESEARCH UPDATE Tim Farley, Ph.D. Nyon, Switzerland Consultant to WHO/HIV Department 26 September 2012
2 26 September 2012 Sigma3 Services Slide 2 Outline Male circumcision devices have potenjal to accelerate programme scale up Potentially faster, simpler procedure requiring fewer instruments May require less highly-trained providers May be more acceptable Several devices used and well- documented in infants and boys, but safety, effecjveness, acceptability among adults in Africa not known Devices covered Shang Ring, PrePex, Alis Clamp, Tara KLamp
3 26 September 2012 Sigma3 Services Slide 3 SHANG RING
4 26 September 2012 Sigma3 Services Slide 4 Shang Ring Device Developed in Ningbo, China and quite extensive successful clinical use ParJcular feature of everjng foreskin over inner ring, placing outer ring then cusng off residual foreskin Leaves glans exposed during healing Device removed auer 7 days
5 26 September 2012 Sigma3 Services Slide 5 Shang Ring Clinical Data in China Low complicajon rates in case series from China 0.58% bleeding, 0.67% local infecjon, 2.42% wound dehiscence (1200 men) Peng et al (Asian J Androl. 2008;10: ) 0.6% bleeding, 0.6% wound infecjons, 0.6% wound dehiscence, 4.5% wound oedema (328 men) Cheng et al (Zhonghua Nan Ke Xue. 2009; 5: ) InfecJon 1.4%, mild oedema 2.6%, moderate oedema 1.4%, wound dehiscence 1.7%, no postoperajve bleeding (351 men) Peng et al (Zhonghua Nan Ke Xue. 2011; 16(11): 963-6)
6 26 September 2012 Sigma3 Services Slide 6 Shang Ring Research, Kenya Pilot introductory study, Homa Bay, Kenya 40 HIV negative men Device placement 4.8 (SD 2.0) minutes Device removal 3.9 (SD 2.6) minutes 6 mild adverse events (3 skin injury, 2 oedema, 1 mild infection) 3 partial ring detachments Device safe for further study in Africa Barone et al., JAIDS 2011; 57: e7
7 26 September 2012 Sigma3 Services Slide 7 Shang Ring Research, Kenya Healing Jmes and spontaneous detachment, Homa Bay, Kenya 50 men, randomised to removal at 7, 14 or 21 days 22 of 35 devices for delayed removal spontaneously detached Seven men (14%) with partial detachment requested removal due to pain/discomfort. Only 1 of 20 rings in situ on Day 21 Times to complete healing similar according to scheduled or actual removal time Partial detachment uncomfortable and somewhat painful If men do not return at 7 days, most rings will detach spontaneously by 14 days No serious consequences if men do not return on time for removal Barone et al. JAIDS 2012;60(3):e82-e89
8 26 September 2012 Sigma3 Services Slide 8 Shang Ring Research, Kenya & Zambia Comparison of the Shang Ring with ConvenJonal Surgical Methods: A Randomized Controlled Trial (400 men) Shang Ring vs. Forceps Guided (Kenya) or Dorsal Slit (Zambia) Objectives/endpoints: Compare pain and acceptability; compare safety and course of wound healing, including time to complete healing; compare the ease of methods Compare costs; assess adherence to post-surgical instructions for wound care & sexual abstinence Duration of Shang Ring procedures significantly shorter at both sites (median 7 vs. 20 minutes). Pain at 2-day visit similar between groups at both sites. AEs 3% among both study groups. Sokal AIDS2012 TUAC0404.
9 26 September 2012 Sigma3 Services Slide 9 Shang Ring Research, Kenya & Zambia A ProspecJve ObservaJonal Study of Male Circumcision Using the Shang Ring in RouJne Clinical SeSngs (Field Study) To estimate rates of adverse events during routine service delivery, especially rare or unexpected AEs Evaluate the acceptability of the Shang Ring procedure; Explore understanding of post-vmmc abstinence period and related issues; Document training methods and the cost of training; Record HIV status to evaluate whether HIV positive men are at higher risk for complications or delayed healing following Shang Ring circumcision Numbers: total 1200 men completing procedure (600 in each country) Status: Follow-up completed July 2012
10 26 September 2012 Sigma3 Services Slide 10 Shang Ring Research, Uganda Acceptability, safety and provider astudes Self-selection to device or surgery (dorsal slit) 250 men choosing Shang Ring or conventional surgery (up to 1000 men, including historical controls) Uniform recording of healing times Rakai Health Sciences Program, Uganda, Procedures completed, follow-up still ongoing, report pending
11 26 September 2012 Sigma3 Services Slide 11 Shang Ring Summary Case series China Safety and efficacy Kenya (40 initial study + 50 healing & spontaneous detachment) ComparaJve studies RCT Kenya (100) & Zambia (100) Field studies Kenya (600) & Zambia (600) Uganda (250)
12 26 September 2012 Sigma3 Services Slide 12 Shang Ring: Advantages and Disadvantages Advantages Minimally invasive No subcutaneous tissues of penile shaft exposed No haemostasis required (other than rings) No suturing required for wound closure Shorter procedure (Peng et al 2008, Barone et al 2012, Sokal et al 2012) Low complication rates (Cheng et al 2009, Barone et al 2012, Sokal et al 2012) Easy to train providers Disadvantages Multiple device sizes Device stays on for 7 days and requires removal visit Healing by secondary intention, possibly longer than for surgery
13 26 September 2012 Sigma3 Services Slide 13 PREPEX
14 26 September 2012 Sigma3 Services Slide 14 PrePex Device q q q q q q Developed in Tel Aviv, Israel with inijal clinical work conducted in Rwanda Inner ring (C) placed between glans and foreskin Outer O- ring (D) applied externally to foreskin using the applicator (A) and pinches foreskin in groove in inner ring O- ring compresses foreskin causing ischemia NecroJc foreskin removed, together with device, auer 7 days No anaesthesia required Circ MedTech, Tel Aviv, Israel hdp://
15 26 September 2012 Sigma3 Services Slide 15 PrePex Device Studies, Rwanda IniJal clinical development in Rwanda Feasibility phase 5 men, devices removed D12 (2) and D14 (3) Main phase 50 men, removal D4 (5) then D7 (45) No anaesthesia, 1 g paracetamol at placement ProspecJve randomized open label trial comparing the PrePex system to surgical circumcision 144 PrePex, 73 dorsal slit Low AE rates, substantially faster operation time, even if add removal time Healing times: PrePex 45 (SD 12.1) days vs. surgery 30 (SD 7.5) days Open label prospecjve study to assess the safety and efficacy of different management methods of the PrePex circumcision device Compare different pain-control measures Open label field study to assess the safety of PrePex circumcision device when performed by non- physicians 578 men, low complication rate, safe in hands of mid-level providers
16 26 September 2012 Sigma3 Services Slide 16 PrePex Device, Zimbabwe Safety study 53 men, completed Randomized controlled trial Methods: PrePex (160), forceps guided (80) Objectives/endpoints: Safety (Adverse events) Procedure times (placement, removal) Resource needs Healing times (photographs) Pain over first 16 h following placement and during removal Completed Field Study 600 men, device placed and removed by nurse providers All procedures complete, last follow-up 16 Oct 12
17 26 September 2012 Sigma3 Services Slide 17 PrePex Device, Uganda Field Study To assess AE rates, acceptability and costs of PrePex device in comparison with conventional surgical circumcision 1,000 men seeking MMC choosing device circumcision Compared with men choosing conventional surgery (unclear if concurrent or historical controls) Device placed and removed by nurse providers Follow-ups at 7, 14, 35 and 42 days Conducted at International Hospital of Kampala, an established high volume MMC site using sleeve resection Status: ~500 men completed. Projected date last client completes all procedures not known
18 26 September 2012 Sigma3 Services Slide 18 PrePex: Advantages and Disadvantages Advantages Minimally invasive No subcutaneous tissues of penile shaft exposed No haemostasis required (other than rings) No suturing required for wound closure Quick to apply and remove Easy to train providers No anaesthesia required during placement Disadvantages Multiple device sizes Device stays on for 7 days and requires removal visit Healing by secondary intention, longer than for surgery Pain control protocol not yet optimised Some complaints of unpleasant smell
19 26 September 2012 Sigma3 Services Slide 19 TARA KLAMP
20 26 September 2012 Sigma3 Services Slide 20 The Tara KLamp Device Taramedic Corporation, Kuala Lumpur, Malaysia Developed by Gurcharan Singh in Malaysia Successfully used in Malaysia for circumcision of boys, including in public sector hospitals and circumcision campaigns Promoted by developer in Lesotho and South Africa as an improvement on exisjng tradijonal methods
21 26 September 2012 Sigma3 Services Slide 21 Randomized Controlled Trial in Orange Farm Men from control group in Orange Farm male circumcision trial for HIV prevenjon invited to parjcipate in randomised assessment of Tara KLamp device 166 men invited, 97 declined to parjcipate, 69 randomised Tara KLamp 35 men randomised 7 did not return, 4 switched to surgery 12 adverse events (sepsis, bleeding, erythema, cellulitis, tube adhering to tissue, ) Forceps- guided surgery 34 men randomised 6 did not return 0 adverse events Retraining by manufacturer's agent did not result in improved outcomes Lagarde et al (2009) South African Medical Journal; 99:163
22 26 September 2012 Sigma3 Services Slide 22 Tara KLamp Circumcisions in KwaZulu Natal Few data have emerged from KZN circumcision camps on number of circumcisions performed and complicajon rates Lack of monitoring and absence of clinical adverse event information a serious limitation Claims made of high acceptability and low complication rates No further clinical studies of Tara KLamp planned
23 26 September 2012 Sigma3 Services Slide 23 ALI S KLAMP
24 26 September 2012 Sigma3 Services Slide 24 Ali s KLamp Device Case series Turkey, 7,500 boys up to age 15 yr Turkey, 2,000 boys circumcised over 7-day period Safety & Efficacy, Kenya, 58 men yr
25 26 September 2012 Sigma3 Services Slide 25 TIMELINE
26 26 September 2012 Sigma3 Services Slide 26 Summary Timelines Shang Ring Safety & Efficacy Study published 2011, 2012 RCT and Field study results available late 2012 PrePex Safety & Efficacy Study published 2011 RCT and Field Study Rwanda published 2012 RCT Zimbabwe completed, not yet submitted to WHO Field Study Zimbabwe to be completed Oct 12 Field Study Uganda?? Alisklamp Safety & Efficacy Study published 2011 Tara KLamp Small RCT published 2009
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