The Shang Ring vs

Conventional Surgical Techniques:

an RCT in Kenya and Zambia

Session TUAC04Male Circumcision: Strategies and Impact

AIDS 2012: Tuesday, July 24

Dr. Quentin Awori

Shang Ring Procedure

Shang Ring Circumcision

1. Measure 2. Place inner ring 3. Evert foreskin 4. Place outer ring 5. Cut

2. Separate inner ring from scab

Shang Ring Removal at 7 Days

1. Open outer ring

3. Cut inner ring

4. Apply bandage

Wearing Shang Ring

Previous Safety Studies in Africa

Pilot study, Kenya, 2009 *◦40 men

Removal at Different Time Points study, Kenya, 2010 **◦50 men◦Randomized to removal at 7, 14 or 21

daysSafe & acceptable => proceeded

to RCT

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*Mark Barone et al. JAIDS. 57:e7-e12. 2011** Mark Barone et al. JAIDS . 60:e82-9. 2012*/** Studies reviewed this morning by Sokal at session: TUSA05

RCT: Shang Ring vs. ConventionalObjectives

Compare:◦Pain◦Acceptability◦Safety – adverse events◦Ease of use of Shang Ring

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RCT: Shang Ring vs. Conventional Methods / Endpoints

Standardized Shang Ring trainingConventional techniques

◦ Kenya: forceps guided technique◦ Zambia: dorsal slit technique

Visual analog pain scale & questionnairesAdverse events

◦ Documented events related to the circumcision◦ Definitions based on WHO/PSI * guidance, except

modified wound dehiscence definition for Shang RingSurgeon questionnaires* WHO/PSI. Adverse Event Action Guide for Male Circumcision. Draft, January 2011.

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Adverse Event DefinitionsModerate Wound Dehiscence

WHO/PSI definition of wound dehiscence involves sutures

Shang Ring: no sutures => modified definition◦ Moderate: Mucocutaneous gap greater than

about 1 cm and involving deeper tissues [1 cm longitudinal], but NOT requiring surgical intervention

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RCT ResultsAs Treated Population

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Kenya Zambia

Shang Ring cases 97 100

Conventional cases 103* 98**

Mean age (yrs) 20.9 24.1

Marital Status: Single 84.5% 80.3%

* One man had very thick foreskin; 2 men – ring size out of stock** Two men excluded from analysis at request of Ethics Committee due to inadequate documentation of informed consent

Kenya Zambia

1 hr post-op

Shang 4.1 3.6

Conventional 3.6 3.2

Day 2 visit

Shang 0.8 1.0

Conventional 1.1 0.9

Mean Pain Scores at Different Time Points

◦Visual Analogue Scale (VAS)◦0 = no pain to 10 = worst possible pain

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Time to Healing from Day of Ring Application

% Healed at Day 42* (95% C.I.)

Mean # Days

Shang Ring 76.3 (70 – 82) 44.1

Conventional 85.3 (80 – 90) 38.9

Difference (95% C. I.) Not done ** 5.2 (2.7 – 7.8)

p < 0.0001

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* By life table analysis; men lost to follow-up were considered not healed at . last visit and censored. ** Not done due to study site differences in healing evaluation

Adverse Events *

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Moderate

Infection 0 2

Wound dehiscence 6 4

Wound edema 1 0Hemorrhage 0 1

Shang Ring n=197

Conventionaln=201

Severe 0 0

Total (%) 7 (3.6%) 7 (3.5%)

* Excluding anesthesia-related events.

Device Related Events & an Unusual Case from Field Study

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Cutaneous pinches = small fold of skin from shaft caught in Shang Ring

Late breaker:

Six men had pinches => mild AE’s

Zambian man removed his own Shang Ring at day 4 using pliers

Client Satisfaction with Appearance: % “Very Satisfied”

Kenya ZambiaShang Ring 95.7% 96.8%

Conventional 85.9% 71.3%

p - value <0.02 <0.0001

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Shang ring Conventional

Ease of Procedure: Mean Duration (SD) in Minutes*

Kenya Zambia

Shang Ring* 7.0 (1.9) 7.3(2.1)

Conventional* 20.7(6.0) 19.8(2.9)

Shang Removal

2.5 (1.2) 3.7 (2.1)

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* p < 0.0001 at both sites; Mean times for circumcisions exclude anesthesia times

Ease of Surgery: Providers’ Opinions*4 non-physicians and 2 physiciansHow easy is Shang Ring vs.

conventional surgery? ◦Much easier (5/6)◦Easier (1/6)

Would you recommend Shang Ring compared to conventional surgery?◦Strong preference (5/6)◦Slight preference(1/6)

* Poster with review of providers’ opinions, including from recently completed field study, presented yesterday: Hart C , Combes S, Li PS. et al. AIDS 2012: MOPE683 14

Conclusions

Pain scores and adverse event rates similar

Shang Ring healing slower by about 5 days

Significantly more men “very satisfied” with appearance after Shang Ring MC

Shang Ring technique took 1/3 the time of conventional techniques

Providers preferred Shang RingShang Ring should facilitate VMMC

scale-up

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Acknowledgements

John Bratt

Stephanie Combes

Catherine Hart

Jaim Jou Lai

Mores Loolpapit

David Sokal

Michael Stalker

Debra Weiner

Lilian Were

Merywen Wigley

Quentin Awori

Mark Barone

Sharone Beatty

Jared Moguche

Paul Perchal

Carolyne Onyancha

Daniel Ouma

Rosemary Were

Cornell (WCMC)Marc Goldstein Howard KimRichard LeePhilip S. LiPuneet Masson

KenyaAlex AdudaOjwang AyomaPeter CherutichJackson KiokoNicholas MuraguriOjwang Lusi Jairus OketchRaymond OtienoJohn Wekesa

EngenderHealthFHI 360

Supported by a grant from the Bill & Melinda Gates Foundation through FHI360

ZambiaKasonde BowaHayden HawryPrisca KasondeDaniel Mashewani Christopher Mubuyaeta David MulengaMulima MuzeyaRobert ZuluZude Zyambo

With Bupivacaine (n=30)

W’out Bupivacaine (n=168)

P-values

1 hr post-op 0.7 (1.1) 3.9 (1.6) <0.0001

Day 2 visit 1.1 (1.1) 0.9 (0.9) 0.26

Zambia: Mean Pain Scores (SD) with or without Bupivacaine (combined)

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However, men receiving bupivacaine reported more pain and more trouble sleeping the first night, p<0.01.