Human Immunodeficiency VirusNCT02390310

Simplifying the Shang Ring Technique for Circumcision of Men and Boys

A study testing Shang Ring, injectable anesthesia (lidocaine 1%) and topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream) in people with Human Immunodeficiency Virus, run by EngenderHealth at 2 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 10 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Shang Ring, injectable anesthesia (lidocaine 1%) and topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 574 participants
Where: 2 sitesKenya
Study dates: May 2015to Jul 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
Men only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites

Homa Bay Level IV County Hospital
Homa Bay, Homa Bay County
Vipingo Health Center
Vipingo, Kilifi County

Other trials in Kenya

About this study

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.

Read the 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
Being tested: Shang Ring, injectable anesthesia (lidocaine 1%), topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)
Keywords: male circumcision, Shang Ring, male circumcision device, prevention, voluntary medical male circumcision (VMMC)
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shang RingDevice
Also called Shang Ring No Flip Technique
Comparison of healing times at 7 day and more than 7 days after circumcision.
injectable anesthesia (lidocaine 1%)Drug
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)Drug
Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

Study groups in NCT02390310
Study group	Role	What they receive
Phase 1 - 7 Day Removal	Active comparator	Shang Ring No Flip Technique: Removal of Shang Ring and assessment of healing 7 days after circumcision with no-flip technique. Receives: Device: Shang Ring
Phase 1 - Delayed Removal	Active comparator	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. Receives: Device: Shang Ring
Phase 2 - Topical Anesthesia	Active comparator	Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery using topical anesthesia. Receives: Drug: topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)
Phase 2 - Injectable Anesthesia	Active comparator	Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery when using injectable anesthesia. Receives: Drug: injectable anesthesia (lidocaine 1%)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 42 days
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
Measured: 42 days

Secondary outcomes (6)

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
Measured: 42 days
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
Measured: 42 days
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
Measured: 42 days
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
Measured: 42 days
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
Measured: 42 days
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
Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Jul 2016

First posted17 Mar 2015 (estimated)
Study startMay 2015
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 574 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02390310
Sponsor's protocol ID: OPP1084493
Status last verified: Aug 2016
First submitted: 5 Feb 2015
Last updated: 3 Aug 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 32442198
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.
PubMed 31412032

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Simplifying the Shang Ring Technique for Circumcision of Men and Boys
ClinicalTrials.gov ID: NCT02390310
Acronym / sponsor ID: OPP1084493
Conditions: Human Immunodeficiency Virus
Keywords: male circumcision, Shang Ring, male circumcision device, prevention, voluntary medical male circumcision (VMMC)
Study type: Interventional
Recruitment status: Completed
Enrolment: 574 participants (actual)
Lead sponsor: EngenderHealthUniversity, hospital or other
Collaborators: Weill Medical College of Cornell University, Bon Sante Consulting Limited, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health
Study start: May 2015
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 17 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1 - 7 Day Removal	Active comparator	Device: Shang RingShang Ring No Flip Technique: Removal of Shang Ring and assessment of healing 7 days after circumcision with no-flip technique.
Phase 1 - Delayed Removal	Active comparator	Device: Shang RingShang 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.
Phase 2 - Topical Anesthesia	Active comparator	Drug: topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery using topical anesthesia.
Phase 2 - Injectable Anesthesia	Active comparator	Drug: injectable anesthesia (lidocaine 1%)Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery when using injectable anesthesia.

Who may qualify

Ages: 10 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (6 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Shang RingAlso: Shang Ring No Flip TechniqueComparison of healing times at 7 day and more than 7 days after circumcision.	Device	Phase 1 - 7 Day Removal, Phase 1 - Delayed Removal
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.	Drug	Phase 2 - Injectable 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.	Drug	Phase 2 - Topical Anesthesia

Primary outcome

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
Time frame: 42 days
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.
Time frame: 42 days
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

6 secondary outcomes

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
Time frame: 42 days
Phase I: Satisfaction of the no-flip Shang Ring among study participants
Time frame: 42 days
Phase I: Occurrence of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision
Time frame: 42 days
Phase I: Safety of spontaneous detachment as measured by AEs among those participants wearing the Shang Ring for more than 7 days after circumcision
Time frame: 42 days
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)
Time frame: 42 days
Phase 2: Satisfaction with topical vs. injectable anesthetic among study participants
Time frame: 42 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
Derived from this study: PubMed 32442198Al 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.
Derived from this study: PubMed 31412032Awori 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark A Barone, DVM, MS principal investigator

EngenderHealth

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390310, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.