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The Shang Ring vs Conventional Surgical Techniques: an RCT in Kenya and Zambia

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. 2. Place inner ring. 3. Evert foreskin.

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The Shang Ring vs Conventional Surgical Techniques: an RCT in Kenya and Zambia

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

  2. Shang Ring Procedure Shang Ring Circumcision 2. Place inner ring 3. Evert foreskin 4. Place outer ring 5. Cut 1. Measure Shang Ring Removal at 7 Days Wearing Shang Ring 2. Separate inner ring from scab 1. Open outer ring 3. Cut inner ring 4. Apply bandage

  3. Previous Safety Studies in Africa *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 • 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

  4. RCT: Shang Ring vs. ConventionalObjectives • Compare: • Pain • Acceptability • Safety – adverse events • Ease of use of Shang Ring

  5. 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 2011.

  6. 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

  7. RCT ResultsAs Treated Population * 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

  8. Mean Pain Scores at Different Time Points • Visual Analogue Scale (VAS) • 0 = no painto 10 = worst possible pain

  9. Time to Healing from Day of Ring Application * 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

  10. Adverse Events * * Excluding anesthesia-related events.

  11. Device Related Events & an Unusual Case from Field Study • Cutaneous pinches = small fold of skin from shaft caught in Shang Ring • Six men had pinches => mild AE’s • Late breaker: Zambian man removed his own Shang Ring at day 4 using pliers

  12. Client Satisfaction with Appearance: % “Very Satisfied” Conventional Shang ring

  13. Ease of Procedure: Mean Duration (SD) in Minutes* * p < 0.0001 at both sites; Mean times for circumcisions exclude anesthesia times

  14. 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

  15. 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

  16. Acknowledgements EngenderHealth Cornell (WCMC) FHI 360 Marc Goldstein Howard Kim Richard Lee Philip S. Li Puneet Masson Kenya Zambia Alex Aduda OjwangAyoma Peter Cherutich Jackson Kioko Nicholas Muraguri OjwangLusi JairusOketch Raymond Otieno John Wekesa Kasonde Bowa Hayden Hawry Prisca Kasonde Daniel Mashewani Christopher Mubuyaeta David Mulenga Mulima Muzeya Robert Zulu Zude Zyambo • Supported by a grant from the Bill & Melinda Gates Foundation through FHI360 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

  17. Zambia: Mean Pain Scores (SD) with or without Bupivacaine (combined) However, men receiving bupivacaine reported more pain and more trouble sleeping the first night, p<0.01.

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