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Simplifying the Shang Ring Technique for Circumcision of Men and Boys

Primary Purpose

Human Immunodeficiency Virus

Status

Completed

Phase

Not Applicable

Locations

Kenya

Study Type

Interventional

Intervention

Shang Ring

injectable anesthesia (lidocaine 1%)

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

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring male circumcision, Shang Ring, male circumcision device, prevention, voluntary medical male circumcision (VMMC)

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Homa Bay Level IV County Hospital
Vipingo Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Phase 1 - 7 Day Removal

Phase 1 - Delayed Removal

Phase 2 - Topical Anesthesia

Phase 2 - Injectable Anesthesia

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

Phase I: Combined rate of moderate and severe adverse events (AEs) as a measure of safety of the no-flip technique for Shang Ring circumcision in males aged 10 years and older

We will evaluate the rate of moderate and severe AEs (combined) following Shang Ring MC using the no-flip technique based on clinical exam findings.

Phase 2: Pain measured with the visual analogue scale (VAS) experienced during the Shang Ring circumcision procedure with topical (EMLA Cream; lidocaine 2.5% and prilocaine 2.5%) vs. injectable (1% lidocaine) anesthesia.

The outcome metric for the primary outcome will be maximum pain reported to have been experienced by participants during the Shang Ring circumcision, assessed using the visual analogue scale (VAS), reported immediately after completion of the Shang Ring circumcision procedure

Secondary Outcome Measures

Phase I: Ease of use of the Shang Ring with the no-flip technique as measured by MC procedure and device removal times and problems encountered during MC and removal procedures

To evaluate ease of use with the no-flip technique we will document MC procedure and device removal times and problems encountered during MC and removal procedures

Phase I: Satisfaction of the no-flip Shang Ring among study participants

we will interview participants/parents/guardians to document acceptability and satisfaction with the Shang Ring circumcision, procedure and post-procedure pain, and time to return to normal activity

Phase I: Occurrence of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision

we will gather data on timing of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision

Phase I: Safety of spontaneous detachment as measured by AEs among those participants wearing the Shang Ring for more than 7 days after circumcision

we will gather data to document AEs among those participants wearing the Shang Ring for more than 7 days after circumcision

Phase 2: Safety of topical vs. injectable anesthesia for local anesthesia during Shang Ring circumcision as measured by rates of moderate and severe AEs (combined rates)

we will document rates of moderate and severe AEs among those having a Shang Ring circumcision with topical vs. injectable anesthesia

Phase 2: Satisfaction with topical vs. injectable anesthetic among study participants

we will interview study participants and their parents/guardians appropriate to document acceptability and satisfaction with the circumcision, the Shang Ring procedure, post-procedure pain, and time to return to normal activity between the two techniques

Full Information

NCT ID

NCT02390310

First Posted

February 5, 2015

Last Updated

August 2, 2016

Sponsor

EngenderHealth

Collaborators

Weill Medical College of Cornell University, Bon Sante Consulting Limited, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health

1. Study Identification

Unique Protocol Identification Number

NCT02390310

Brief Title

Simplifying the Shang Ring Technique for Circumcision of Men and Boys

Official Title

Simplifying the Shang Ring Technique for Circumcision of Men and Boys

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EngenderHealth

Collaborators

Weill Medical College of Cornell University, Bon Sante Consulting Limited, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus

Keywords

male circumcision, Shang Ring, male circumcision device, prevention, voluntary medical male circumcision (VMMC)

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

574 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 - 7 Day Removal

Arm Type

Active Comparator

Arm Description

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

Arm Title

Phase 1 - Delayed Removal

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Phase 2 - Topical Anesthesia

Arm Type

Active Comparator

Arm Description

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

Arm Title

Phase 2 - Injectable Anesthesia

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Shang Ring

Other Intervention Name(s)

Shang Ring No Flip Technique

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

injectable anesthesia (lidocaine 1%)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Phase I: Combined rate of moderate and severe adverse events (AEs) as a measure of safety of the no-flip technique for Shang Ring circumcision in males aged 10 years and older

Description

We will evaluate the rate of moderate and severe AEs (combined) following Shang Ring MC using the no-flip technique based on clinical exam findings.

Time Frame

42 days

Title

Description

Time Frame

42 days

Secondary Outcome Measure Information:

Title

Phase I: Ease of use of the Shang Ring with the no-flip technique as measured by MC procedure and device removal times and problems encountered during MC and removal procedures

Description

To evaluate ease of use with the no-flip technique we will document MC procedure and device removal times and problems encountered during MC and removal procedures

Time Frame

42 days

Title

Phase I: Satisfaction of the no-flip Shang Ring among study participants

Description

we will interview participants/parents/guardians to document acceptability and satisfaction with the Shang Ring circumcision, procedure and post-procedure pain, and time to return to normal activity

Time Frame

42 days

Title

Phase I: Occurrence of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision

Description

we will gather data on timing of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision

Time Frame

42 days

Title

Phase I: Safety of spontaneous detachment as measured by AEs among those participants wearing the Shang Ring for more than 7 days after circumcision

Description

we will gather data to document AEs among those participants wearing the Shang Ring for more than 7 days after circumcision

Time Frame

42 days

Title

Phase 2: Safety of topical vs. injectable anesthesia for local anesthesia during Shang Ring circumcision as measured by rates of moderate and severe AEs (combined rates)

Description

we will document rates of moderate and severe AEs among those having a Shang Ring circumcision with topical vs. injectable anesthesia

Time Frame

42 days

Title

Phase 2: Satisfaction with topical vs. injectable anesthetic among study participants

Description

Time Frame

42 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark A Barone, DVM, MS

Organizational Affiliation

EngenderHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

Homa Bay Level IV County Hospital

City

Homa Bay

State/Province

Homa Bay County

Country

Kenya

Facility Name

Vipingo Health Center

City

Vipingo

State/Province

Kilifi County

Country

Kenya

12. IPD Sharing Statement

Citations:

PubMed Identifier

32442198

Citation

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.

Results Reference

derived

PubMed Identifier

31412032

Citation

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.

Results Reference

derived

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Simplifying the Shang Ring Technique for Circumcision of Men and Boys

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