Simplifying the Shang Ring Technique for Circumcision of Men and Boys

NCT ID: NCT02390310

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-07-31

Brief Summary

This is a research study in Kenya that will examine the outcomes of participants aged 10-15 and 16 and older; and provider acceptability of the Shang Ring technique for male circumcision that would simplify use. The study will be in two phases:

Phase 1 will explore the no-flip technique that has been used in China but will be used for the first time in Africa.

Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.

Detailed Description

The study, to be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use and increase its acceptability.

• Phase I will be non-comparative for exploration of the no-flip technique for Shang Ring circumcision (i.e. all participants will be circumcised using the no-flip Shang Ring technique). Historical data from standard Shang Ring circumcisions conducted in Africa (Kenya, Uganda and Zambia) will be used as the comparison group. Men will be randomized to removal at 7 days after circumcision vs. delayed removal, to assess occurrence and safety of spontaneous detachments following circumcision with the no-flip technique.
• Phase 2 will compare the use of topical vs. injectable anesthesia for Shang Ring circumcision. Participants will be randomized to topical vs. injectable anesthesia in a 2:1 ratio. The investigators rationalize the 2:1 randomization scheme given that the investigators will have just completed Phase I in which 200 men and boys will have been circumcised using the no-flip technique with injected anesthesia. However, given the subjectivity associated with using reported pain as the primary endpoint, the investigators believe it is critical to randomize participants in this phase of the study.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Phase 1 - 7 Day Removal

Shang Ring No Flip Technique: Removal of Shang Ring and assessment of healing 7 days after circumcision with no-flip technique.

Group Type: ACTIVE_COMPARATOR

Shang Ring

Intervention Type: DEVICE

Comparison of healing times at 7 day and more than 7 days after circumcision.

Phase 1 - Delayed Removal

Shang Ring No Flip Technique: Removal of ring or assessment of spontaneous detachment at more than 7 days to assess occurrence and safety following circumcision with the no-flip technique.

Group Type: ACTIVE_COMPARATOR

Shang Ring

Intervention Type: DEVICE

Comparison of healing times at 7 day and more than 7 days after circumcision.

Phase 2 - Topical Anesthesia

Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery using topical anesthesia.

Group Type: ACTIVE_COMPARATOR

topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)

Intervention Type: DRUG

Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

Phase 2 - Injectable Anesthesia

Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery when using injectable anesthesia.

Group Type: ACTIVE_COMPARATOR

injectable anesthesia (lidocaine 1%)

Intervention Type: DRUG

Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

Interventions

Shang Ring

Comparison of healing times at 7 day and more than 7 days after circumcision.

Intervention Type: DEVICE

injectable anesthesia (lidocaine 1%)

Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

Intervention Type: DRUG

topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)

Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

Intervention Type: DRUG

Other Intervention Names

Shang Ring No Flip Technique

Eligibility Criteria

Inclusion Criteria

• Aged 10 years and older;
• Uncircumcised upon clinical examination;
• In good general health;
• Free of genital ulcerations or other visible signs of sexually transmitted infections upon clinical examination;
• Participant and parent or legally acceptable representative (LAR) as applicable must be able to understand study procedures and requirements of study participation;
• Freely consents to participate in the study and signs a written informed consent form if 18 years of age or greater
• Accompanied by the parent/LAR, who freely consents and signs an informed consent form for participation of the child into the study for participants less than 18 years old;
• Assent from participant less than 18 years old who understand study procedure;
• Participant must agree to return to the study site for the full schedule of follow-up visits after his circumcision (or as appropriate the Parent or LAR must agree to bring the participant);
• Participant and parent/LAR as appropriate must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

Exclusion Criteria

• Has a known allergy or sensitivity to lidocaine or other local anesthesia;
• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
• Has known bleeding/clotting disorder (e.g. hemophilia);
• Has any congenital genitourinary abnormality;
• Has an active genital infection, anatomic abnormality or other condition (e.g. diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or,
• Is currently participating in another biomedical research study.

• Minimum Eligible Age: 10 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Bon Sante Consulting Limited

UNKNOWN

Sponsor Role: collaborator

Kenya National AIDS & STI Control Programme

OTHER

Sponsor Role: collaborator

Kenya Ministry of Health

OTHER_GOV

Sponsor Role: collaborator

EngenderHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A Barone, DVM, MS

Role: PRINCIPAL_INVESTIGATOR

EngenderHealth

Locations

Homa Bay Level IV County Hospital

Homa Bay, Homa Bay County, Kenya

Vipingo Health Center

Vipingo, Kilifi County, Kenya

Countries

Kenya

References

Al Hussein Alawamlh O, Awori QD, Barone MA, Kim SJ, Goldstein M, Li PS, Lee RK. No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya. PLoS One. 2020 May 22;15(5):e0233150. doi: 10.1371/journal.pone.0233150. eCollection 2020.

Reference Type: DERIVED

PMID: 32442198 (View on PubMed)

Awori Q, Li PS, Lee RK, Ouma D, Oundo M, Barasa M, Obura N, Mwamkita D, Simba R, Oketch J, Nyangweso N, Maina M, Kiswi N, Kirui M, Chirchir B, Goldstein M, Barone MA. Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0218066. doi: 10.1371/journal.pone.0218066. eCollection 2019.

Reference Type: DERIVED

PMID: 31412032 (View on PubMed)

Other Identifiers

OPP1084493

Identifier Type: -

Identifier Source: org_study_id