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

NCT03338699 | Completed DMC

• 1 other identifier: 1611017762
• Study Type: interventional
• Target: 1,380
• Locations: 3 countries
• Sites: 3

Brief 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. 1.To compare the rates of adverse events (AEs) with the ShangRing or Mogen clamp
2. 2.To compare pain control, time to complete wound healing and parent satisfaction with EIMC using the ShangRing or Mogen clamp
3. 3.To compare operative time and provider preference.
4. 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. 5.To assess the subpreputial microbiome of the infants prior to and after the initiation of circumcision
6. 6.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.
7. 7.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.
8. 8.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

Keywords

Early infant male circumcision; ShangRing; sub-Saharan Africa; HIV; WHO

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse events in participants undergoing circumcision with either device based on WHO/JHPIEGO definitions and guidelines.

  Adverse events will be pre-specified based on WHO/JHPIEGO definitions of the nature and severity of adverse events, and classified as related or unrelated to EIMC. Adverse events will also include device-related malfunctions and displacements.

  Up to 8 weeks post-circumcision.

Secondary Outcomes (6)

• Pain scores associated with the circumcision procedure by either device, assessed using the Neonatal Infant Pain Scale (NIPS).

  At the time of circumcision procedure.

• Time to complete wound healing based on having an intact clean scar with no dehiscence.

  Till complete wound healing is reported, up to 8 weeks post-circumcision.

• Parent satisfaction based on post-circumcision interviews.

  Up to 8 weeks post-circumcision.

• Operative time measured in minutes.

  At the time of circumcision on procedure day.

• Provider preference of circumcision device based on post-circumcision interviews.

  Up to 8 weeks post-circumcision.

Study Arms (2)

ShangRing

EXPERIMENTAL

Topical anesthesia based, no-flip ShangRing circumcision.

Device: ShangRing

Mogen clamp

ACTIVE COMPARATOR

Mogen clamp circumcision.

Device: Mogen clamp

Interventions

ShangRing DEVICE

Topical anesthesia based, no-flip ShangRing circumcision.

ShangRing

Mogen clamp DEVICE

Mogen clamp circumcision

Mogen clamp

Eligibility Criteria

• Age: 24 Hours - 60 Days
• Gender Eligibility Details: All participants in this study are male who will undergo early infant circumcision.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male infants from 24 hours up to 60 days of life
• Gestational age ≥37 weeks
• Normal birth weight (≥2.5 Kg)
• No illness requiring medical treatment
• No penile abnormality requiring surgical repair (e.g. hypospadias, chordee)
• No family history of bleeding disorders
• Consent provided by at least one parent/legally acceptable representative (LAR) of the infant
• Parent or LAR must be able to understand study procedures and requirements of study participation;
• Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
• Parent or LAR must have a cell phone or access to a cell phone

You may not qualify if:

• Consent not provided by parents/legally acceptable representatives of the infant
• If parent(s)/legally acceptable representative(s) decline(s) the procedure or is/are uncomfortable with the procedure
• Babies \<6 weeks of age to mother without previous T.T. vaccination during ANC visits for that pregnancy
• Babies \>6 weeks of age without DPT vaccination
• Any other valid health-related issues as judged by the health workers

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Population Council: collaborator
• Johns Hopkins University: collaborator
• Jhpiego: collaborator
• George Washington University: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Rakai Health Sciences Program: collaborator

Study Sites (3)

Homa Bay County Teaching and Referral Hospital

Homa Bay, Kenya

Location

Iringa Regional Referral Hospital

Iringa, Tanzania

Location

Rakai Health Sciences Program

Kalisizo, Rakai, Uganda

Location

Related Publications (25)

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• Posada Calderon L, Basourakos SP, Ballman KV, Ho K, Barone MA, Awori Q, Ouma D, Oketch J, Christensen A, Hellar A, Makokha M, Isangu A, Salim R, Lija J, Gray R, Kiboneka S, Anok A, Kigozi G, Nakabuye R, Ddamulira C, Odiya S, Goldstein M, Li PS, Lee RK. Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting. BMJ Glob Health. 2025 Sep 25;10(9):e017903. doi: 10.1136/bmjgh-2024-017903.

  PMID: 40998526 DERIVED

• Basourakos SP, Nang QG, Ballman KV, Al Awamlh OAH, Punjani N, Ho K, Barone MA, Awori QD, Ouma D, Oketch J, Christensen AE, Hellar A, Makokha M, Isangu A, Salim R, Lija J, Gray RH, Kiboneka S, Anok A, Kigozi G, Nakabuye R, Ddamulira C, Mulooki A, Odiya S, Nazziwa R, Goldstein M, Li PS, Lee RK. ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial. Lancet Glob Health. 2022 Oct;10(10):e1514-e1522. doi: 10.1016/S2214-109X(22)00326-6.

  PMID: 36113534 DERIVED

Study Officials

• Richard K Lee, MD, MBA

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Philip S Li, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the pilot phase of the study, participating infants will be allocated to circumcision with either the ShangRing or Mogen clamp. Infants will be randomized in a 1:1 fashion. (Total enrollment: 1380) In the second phase of the study, participating infants will receive circumcision with the ShangRing as part of our Field Study design. (Total enrollment: 1690) (Total trial enrollment: 3070)

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 9, 2017
• Study Start: October 1, 2018
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1); UG (1); KE (1)