Male CircumcisionPhase 4NCT01567436
A Prospective Field Study: Introducing the Shang Ring in Routine Clinical Settings
A Phase 4 study testing Shang Ring in people with Male Circumcision, run by FHI 360 at 2 sites in 2 countries.
Trial summary
Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007), based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported a protective effect of about 60% Read more about this study
- Who is it for?
- Ages 18 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- Shang Ring
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2012to Aug 2012
- Phase
- Phase 4
- 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 18 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All men enrolled in this research study must meet the following inclusion criteria:
- Must be aged 18 and 54 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must agree to HIV counseling and testing no more than one week before the procedure;
- Must be free of genital ulcerations or other visible signs of STI (on examination);
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- Must be able to understand study procedures and requirements of study participation;
- Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision;
- Must freely consent to participate in the study and sign a written informed consent form;
- Must have a cell phone or access to a cell phone; and,
- 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
- A man will be excluded from participation in this research study if he has any of the following 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); or
- Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study;
- Is currently participating in another biomedical study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kenya1 site
Homa Bay District Hospital male circumcision clinic
Homa Bay, Nyanza, 40300
About this study
Official title: A Prospective Study of Male Circumcision Using the Shang Ring in Routine Clinical Settings in Kenya & Zambia
Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007), based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported a protective effect of about 60%
Read the detailed description
The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and other global reproductive health organizations have recognized the highly protective effect of male circumcision to prevent HIV infection in men. Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in randomized controlled trials, based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported a protective effect of about 60%. Subsequent studies have confirmed the value and persistence of MC's protection against HIV infection, and have demonstrated that MC also reduces the transmission of human papillomavirus.
A wide variety of instruments, devices, and techniques are used around the world for male circumcision. The WHO, UNAIDS and JHPIEGO document entitled Manual for Male Circumcision under Local Anesthesia, includes step-by-step instructions for performing adult male circumcision using three different surgical procedures: the forceps-guided, dorsal slit, and sleeve resection methods. Procedure times for these techniques are approximately 20-30 minutes excluding anesthesia and involve control of unavoidable bleeding and a significant amount of suturing, and can be associated with complications that include hematoma formation, infection, unsatisfactory cosmetic result, lacerations of the penile or scrotal skin and injury to the glans, particularly among inexperienced surgeons. Although training is necessary regardless of method, devices for MC have the potential to reduce both training time and surgical duration because neither hemostasis nor suturing is needed for most devices.
The Shang Ring is an innovative device for adult male circumcision that has been on the Chinese market since 2005. The Shang Ring is manufactured by Wuhu SNNDA Medical Treatment Appliance Technology Co., Ltd (SNNDA).
In the current African setting, only surgical circumcision is available for adults. Devices such as the Shang Ring have the potential to simplify and shorten surgery by eliminating the need for suturing and hemostasis. Data from two small studies in Kenya suggest that the Shang Ring has an acceptable safety profile. A randomized controlled trial was conducted in Kenya and Zambia to provide further data.
Circumcision using the Shang Ring involves a few simple steps. First, a special measuring strip is used to determine which Shang Ring size to use. Following administration of local anesthesia, the inner ring is fitted at the base of the glans penis. Next, the foreskin is everted over the inner ring and the outer ring is secured (locked) over the inner ring, thus encasing the foreskin. The sterile device forms a tight seal. The foreskin is excised and several nicks are made in the foreskin on the underside of the device to prevent formation of a stiff, circumferential scab. Bleeding is minimal and no suturing or hemostasis is required. Finally, the participant returns in seven days for removal of the Shang Ring device. After removal, a bandage is applied to the wound. Men may be given a supply of bandages and told to change the bandaging daily or as needed.
- Conditions
- Male Circumcision
- Being tested
- Shang Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shang RingDevice
The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of scissors is used to remove the inner ring, and a bandage or gauze dressing is applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 42 days
Secondary outcomes (2)
Acceptability of the Shang Ring Procedure
Measured: 42 days
Percentage of men completely healed at 42 days
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionAug 2012
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 Male CircumcisionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, EngenderHealth, Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, University Teaching Hospital, Lusaka, Zambia
- Responsible party
- Sponsor
- Investigators
- Marc Goldstein, M.D., Study chair, Weill Cornell Medical College, NY, USAMark A Barone, DVM, MS, Study chair, EngenderHealth, NY, USAPhilip S Li, MD, Principal investigator, Weill Cornell Medical College, NY, USARichard Lee, MD, Principal investigator, Weill Cornell Medical College, NY, USAPaul Perchal, MA, Principal investigator, EngenderHealth, NY, USAJared Mogouche, MD ChB, Principal investigator, EngenderHealth, Kisumu, KenyaQuentin Awori, MB ChB, Principal investigator, EngenderHealth, Homa Bay, KenyaRaymond Simba, MB ChB MPH, Principal investigator, Homa Bay District Hospital, Ministry of Health, Homa Bay, Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567436
- Sponsor's protocol ID
- 10728
- Status last verified
- Sep 2012
- First submitted
- 28 Feb 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Barone MA, Li PS, Zulu R, Awori QD, Agot K, Combes S, Simba RO, Lee RK, Hart C, Lai JJ, Zyambo Z, Goldstein M, Feldblum PJ, Sokal DC. Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S18-23. doi: 10.1097/QAI.0000000000000704.
PubMed 27331585Feldblum PJ, Okech J, Ochieng R, Hart C, Kiyuka G, Lai JJ, Veena V. Longer-Term Follow-Up of Kenyan Men Circumcised Using the ShangRing Device. PLoS One. 2015 Sep 14;10(9):e0137510. doi: 10.1371/journal.pone.0137510. eCollection 2015.
PubMed 26367141
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Male Circumcision Using the Shang Ring in Routine Clinical Settings in Kenya & Zambia
- ClinicalTrials.gov ID
- NCT01567436
- Acronym / sponsor ID
- 10728
- Conditions
- Male Circumcision
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, EngenderHealth, Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, University Teaching Hospital, Lusaka, Zambia
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 30 Mar 2012 (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.
Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007), based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported a protective effect of about 60%
Detailed description
The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and other global reproductive health organizations have recognized the highly protective effect of male circumcision to prevent HIV infection in men. Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in randomized controlled trials, based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported a protective effect of about 60%. Subsequent studies have confirmed the value and persistence of MC's protection against HIV infection, and have demonstrated that MC also reduces the transmission of human papillomavirus.
A wide variety of instruments, devices, and techniques are used around the world for male circumcision. The WHO, UNAIDS and JHPIEGO document entitled Manual for Male Circumcision under Local Anesthesia, includes step-by-step instructions for performing adult male circumcision using three different surgical procedures: the forceps-guided, dorsal slit, and sleeve resection methods. Procedure times for these techniques are approximately 20-30 minutes excluding anesthesia and involve control of unavoidable bleeding and a significant amount of suturing, and can be associated with complications that include hematoma formation, infection, unsatisfactory cosmetic result, lacerations of the penile or scrotal skin and injury to the glans, particularly among inexperienced surgeons. Although training is necessary regardless of method, devices for MC have the potential to reduce both training time and surgical duration because neither hemostasis nor suturing is needed for most devices.
The Shang Ring is an innovative device for adult male circumcision that has been on the Chinese market since 2005. The Shang Ring is manufactured by Wuhu SNNDA Medical Treatment Appliance Technology Co., Ltd (SNNDA).
In the current African setting, only surgical circumcision is available for adults. Devices such as the Shang Ring have the potential to simplify and shorten surgery by eliminating the need for suturing and hemostasis. Data from two small studies in Kenya suggest that the Shang Ring has an acceptable safety profile. A randomized controlled trial was conducted in Kenya and Zambia to provide further data.
Circumcision using the Shang Ring involves a few simple steps. First, a special measuring strip is used to determine which Shang Ring size to use. Following administration of local anesthesia, the inner ring is fitted at the base of the glans penis. Next, the foreskin is everted over the inner ring and the outer ring is secured (locked) over the inner ring, thus encasing the foreskin. The sterile device forms a tight seal. The foreskin is excised and several nicks are made in the foreskin on the underside of the device to prevent formation of a stiff, circumferential scab. Bleeding is minimal and no suturing or hemostasis is required. Finally, the participant returns in seven days for removal of the Shang Ring device. After removal, a bandage is applied to the wound. Men may be given a supply of bandages and told to change the bandaging daily or as needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Must be aged 18 and 54 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must agree to HIV counseling and testing no more than one week before the procedure;
- Must be free of genital ulcerations or other visible signs of STI (on examination);
Key exclusion criteria (6 listed)
- A man will be excluded from participation in this research study if he has any of the following exclusion criteria:
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 RingThe Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of scissors is used to remove the inner ring, and a bandage or gauze dressing is applied. | Device | – |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 42 days
2 secondary outcomes
Acceptability of the Shang Ring Procedure
Time frame: 42 days
Percentage of men completely healed at 42 days
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 27 Sep 2012.
- Derived from this study: PubMed 27331585Barone MA, Li PS, Zulu R, Awori QD, Agot K, Combes S, Simba RO, Lee RK, Hart C, Lai JJ, Zyambo Z, Goldstein M, Feldblum PJ, Sokal DC. Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S18-23. doi: 10.1097/QAI.0000000000000704.
- Derived from this study: PubMed 26367141Feldblum PJ, Okech J, Ochieng R, Hart C, Kiyuka G, Lai JJ, Veena V. Longer-Term Follow-Up of Kenyan Men Circumcised Using the ShangRing Device. PLoS One. 2015 Sep 14;10(9):e0137510. doi: 10.1371/journal.pone.0137510. eCollection 2015.
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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.
Marc Goldstein, M.D. study chair
Weill Cornell Medical College, NY, USA
Mark A Barone, DVM, MS study chair
EngenderHealth, NY, USA
Philip S Li, MD principal investigator
Weill Cornell Medical College, NY, USA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shang Ring in people with Male Circumcision, run by FHI 360 at 2 sites in 2 countries.
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 11 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 27 Sep 2012. 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, Zambia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 42 days). 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 NCT01567436, 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 27 Sep 2012.