Clinical trial NCT02390310: 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
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: male circumcision
Shang Ring
male circumcision device
prevention
voluntary medical male circumcision (VMMC)
Lead sponsor: EngenderHealth
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: Bon Sante Consulting Limited
name: Kenya National AIDS & STI Control Programme
name: Kenya Ministry of Health
First posted: 2015-03-17
Enrollment: 574
Sex: MALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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
timeFrame: 42 days
measure: 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.
timeFrame: 42 days
Secondary outcomes:
measure: 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
timeFrame: 42 days
measure: Phase I: Satisfaction of the no-flip Shang Ring among study participants
timeFrame: 42 days
measure: Phase I: Occurrence of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision
timeFrame: 42 days
measure: Phase I: Safety of spontaneous detachment as measured by AEs among those participants wearing the Shang Ring for more than 7 days after circumcision
timeFrame: 42 days
measure: 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)
timeFrame: 42 days
measure: Phase 2: Satisfaction with topical vs. injectable anesthetic among study participants
timeFrame: 42 days
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Homa Bay Level IV County Hospital
state: Homa Bay County
city: Vipingo
country: Kenya
facility: Vipingo Health Center
state: Kilifi County
Study officials:
affiliation: EngenderHealth
name: Mark A Barone, DVM, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.