Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia

The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.

Study Overview

• Status: Completed
• Conditions: Male Circumcision
• Intervention / Treatment: Device: ShangRing

Detailed Description

We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • Chilenje Urban Health Centre
  • Lusaka, Zambia
    • The University Teaching Hospital (UTH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Must be aged 18 to 49 years;
• Must be HIV-uninfected per same-day routine voluntary testing at the clinic;
• Must be uncircumcised (on examination);
• Must be in good general health, at the discretion of the clinician;
• Must be free of genital ulcerations or other visible signs of STI (on examination);
• Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
• Must freely consent to participate in the study and sign a written informed consent form;
• Must provide full contact information including cell phone number, address, and other locator information.

Exclusion Criteria:

• Has an active genital infection upon visual inspection;
• Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates ShangRing MMC;
• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid; or
• Has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia
• Has a self-reported allergy or sensitivity to lidocaine or other local
• Is not available to be circumcised on the same day as screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control: all-sizes of ShangRing; All-sizes of ShangRings will be available.	Device: ShangRing; ShangRing device for male circumcision
Active Comparator: Reduced-sizes; 7 adult sizes of ShangRings will be available	Device: ShangRing; ShangRing device for male circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.	To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of men who cannot be properly fitted with a ShangRing device	Assess the effectiveness of ShangRing procedures in the reduced-sizes arm.	42 days
Evaluate the acceptability of ShangRing procedures among participants and providers	Participant acceptability (with procedure and cosmetic appearance), pain, and time to return to normal activity after ShangRing circumcision, overall and in each arm. Provider acceptability assessing ease, duration, and complications, and preferences comparing ShangRing with other methods of circumcision, and comparing reduced-sizes with all-sizes provision.	42 days
Percentage of men with complete healing at 42 days	Percentage of men with complete healing at 42 days for all study participants, and within each arm of the trial.	Day 42

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Bill and Melinda Gates Foundation; Ministry of Health, Zambia
• Investigators: Principal Investigator: Robert Zulu, MD, University Teaching Hospital

Publications and helpful links

General Publications

• Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, Kashitala J, Veena V, Kasonde P. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 10.1097/QAI.0000000000001015.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 15, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: medical device; HIV prevention; adverse events; wound healing; Zambia; ShangRing; voluntary medical male circumcision (VMMC)
• Other Study ID Numbers: 576424; 010-04-14 (Other Identifier: UNZABREC (local IRB))