The Shang Ring vs Conventional Surgical Techniques: an RCT in Kenya and Zambia Session TUAC04 Male Circumcision: Strategies and Impact AIDS 2012: Tuesday, July 24 Dr. Quentin Awori

Shang Ring Procedure Shang Ring Circumcision 1. Measure 2. Place inner ring3. Evert foreskin4. Place outer ring5. 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 days Safe & acceptable => proceeded to RCT 3 *Mark Barone et al. JAIDS. 57:e7-e ** Mark Barone et al. JAIDS. 60:e */** Studies reviewed this morning by Sokal at session: TUSA05

RCT: Shang Ring vs. Conventional Objectives Compare: ◦ Pain ◦ Acceptability ◦ Safety – adverse events ◦ Ease of use of Shang Ring 4

RCT: Shang Ring vs. Conventional Methods / Endpoints Standardized Shang Ring training Conventional techniques ◦ Kenya: forceps guided technique ◦ Zambia: dorsal slit technique Visual analog pain scale & questionnaires Adverse events ◦ Documented events related to the circumcision ◦ Definitions based on WHO/PSI * guidance, except modified wound dehiscence definition for Shang Ring Surgeon questionnaires * WHO/PSI. Adverse Event Action Guide for Male Circumcision. Draft, January

Adverse Event Definitions Moderate 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 6

RCT Results As Treated Population 7 KenyaZambia Shang Ring cases97100 Conventional cases103* 98** Mean age (yrs) Marital Status: Single84.5%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

KenyaZambia 1 hr post-op Shang Conventional Day 2 visit Shang Conventional Mean Pain Scores at Different Time Points ◦ Visual Analogue Scale (VAS) ◦ 0 = no pain to 10 = worst possible pain 8

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 < * 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 * 10 Moderate Infection 02 Wound dehiscence 64 Wound edema 10 Hemorrhage 01 Shang Ring n=197 Conventional n=201 Severe 00 Total (%) 7 (3.6%)7 (3.5%) * Excluding anesthesia-related events.

Device Related Events & an Unusual Case from Field Study 11 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” KenyaZambia Shang Ring95.7%96.8% Conventional85.9%71.3% p - value<0.02< Shang ring Conventional

Ease of Procedure: Mean Duration (SD) in Minutes * KenyaZambia 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) 13 * p < at both sites; Mean times for circumcisions exclude anesthesia times

Ease of Surgery: Providers’ Opinions* 4 non-physicians and 2 physicians How 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 Ring Shang Ring should facilitate VMMC scale-up 15

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 Kim Richard Lee Philip S. Li Puneet Masson Kenya Alex Aduda Ojwang Ayoma Peter Cherutich Jackson Kioko Nicholas Muraguri Ojwang Lusi Jairus Oketch Raymond Otieno John Wekesa EngenderHealth FHI 360 Supported by a grant from the Bill & Melinda Gates Foundation through FHI360 Zambia Kasonde Bowa Hayden Hawry Prisca Kasonde Daniel Mashewani Christopher Mubuyaeta David Mulenga Mulima Muzeya Robert Zulu Zude Zyambo

With Bupivacaine (n=30) W’out Bupivacaine (n=168) P-values 1 hr post-op 0.7 (1.1)3.9 (1.6)< Day 2 visit 1.1 (1.1)0.9 (0.9)0.26 Zambia: Mean Pain Scores (SD) with or without Bupivacaine (combined) 17 However, men receiving bupivacaine reported more pain and more trouble sleeping the first night, p<0.01.