Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa

Summary

The study will evaluate the safety and acceptability of the topical anesthesia-based, no-flip ShangRing technique vs. Mogen clamp for Early Infant Male Circumcision (EIMC) in neonates and infants up to 60 days of life.

The study will consist of 2 phases; a pilot phase and a field study. In the pilot phase, male infants of up to 60 days of life will be enrolled in three sub-Saharan countries, specifically Kenya, Tanzania, and Uganda. Infants will be randomized in 1:1 fashion to undergo EIMC using either the Mogen clamp or no-flip ShangRing technique using topical anesthesia. Upon completion of the pilot trial and assuming satisfactory safety results, a larger non-comparative field study of ShangRing EIMC will be initiated, as performed by non-physician providers in routine practice settings in the three sub-Saharan African countries.

Total study duration will be 3 years. The pilot phase is anticipated to encompass a total of 1 year. Completion of the field study is expected to take 2 years.

Study Endpoints include:

1. To compare the rates of adverse events (AEs) with the ShangRing or Mogen clamp
2. To compare pain control, time to complete wound healing and parent satisfaction with EIMC using the ShangRing or Mogen clamp
3. To compare operative time and provider preference.
4. To assess the rate of spontaneous ring detachment with the ShangRing as a method to decrease the need for follow-up visits after circumcision.
5. To assess the subpreputial microbiome of the infants prior to and after the initiation of circumcision

Three correlative studies will be conducted:

1. Penile microbiome study: In the pilot trial, the subpreputial microbiome of the infants undergoing circumcision will be assessed to better understand the spectrum of bacteria that may exist and play a role in infant circumcision.
2. Demand creation study: During both the pilot phase and the field study, it will be assessed whether device-driven EIMC can be safely and effectively integrated into maternal and child health services as a method to promote demand creation.
3. Cost impact study: During both the pilot phase and the field study, a comparative cost analysis of EIMC with ShangRing versus Mogen clamp will be performed, in addition to a cost analysis of ShangRing EIMC as performed in routine clinical settings in the field study. The costing of demand creation will also be assessed.

Conditions

• Circumcision

Interventions

DEVICE

ShangRing

Topical anesthesia based, no-flip ShangRing circumcision.

DEVICE

Mogen clamp

Mogen clamp circumcision

Sponsors & Collaborators

• Population Council

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Jhpiego

  collaborator OTHER

• George Washington University

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Rakai Health Sciences Program

  collaborator OTHER

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Richard K Lee, MD, MBA · Weill Medical College of Cornell University

• Philip S Li, MD · Weill Medical College of Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

24 Hours

Max Age

60 Days

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2020-12-18

Completion

2020-12-18

Countries

• Kenya
• Tanzania
• Uganda

Study Locations