Simplifying the Shang Ring Technique for Circumcision of Men and Boys

Human Immunodeficiency Virus Clinical Trial

Official title:

Simplifying the Shang Ring Technique for Circumcision of Men and Boys

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390310
• Other study ID #: OPP1084493
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: August 2, 2016
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: EngenderHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: KEMRI
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 10 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Device:
• Shang Ring
Comparison of healing times at 7 day and more than 7 days after circumcision.

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Kenya	Homa Bay Level IV County Hospital	Homa Bay	Homa Bay County
Kenya	Vipingo Health Center	Vipingo	Kilifi County

Sponsors (5)

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

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	42 days	Yes
Primary	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	42 days	No
Secondary	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	42 days	No
Secondary	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	42 days	No
Secondary	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	42 days	Yes
Secondary	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	42 days
Secondary	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	42 days	Yes
Secondary	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	42 days	No