Male CircumcisionPhase 1NCT02309710
Male Circumcision (MC) Using the ShangRing™ Device in Malawi
A Phase 1 study testing ShangRing in people with Male Circumcision, run by FHI 360 at 2 sites in Malawi.
Trial summary
This prospective study will evaluate the safety and acceptability of the ShangRing device for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- ShangRing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesMalawi
- Study dates
- Jun 2015to Dec 2015
- Phase
- Phase 1
- 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be aged 18 to 49 years;
- Must be HIV-uninfected per same-day routine HIV testing and counseling (HTC) at the clinic;
- Must be uncircumcised (on examination);
- Must be in good general health, at the discretion of the clinician;
- Must be free of genital ulcerations or other visible signs of sexually transmitted infections(STI) on examination;
- Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
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- Must be able to communicate in English or Chichewa;
- Must freely consent to participate in the study, be available for follow-up visits, and sign a written informed consent form (ICF); and
- Must provide full contact information including cell phone number, address, and other locator information
Who cannot join
- Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates ShangRing MMC;
- Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- Has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia;
- Has a self-reported allergy or sensitivity to lidocaine or other local anesthesia; or
- Is not available to be circumcised on the same day as screening.
Trial locations and contacts
2 sites in 1 country.
Malawi2 sites
Christian Health Association of Malawi
Lilongwe
St Gabriel's Hospital
Namitete
About this study
Official title: Prospective Study of Male Circumcision Using the ShangRing Device in Routine Clinical Settings in Malawi
This prospective study will evaluate the safety and acceptability of the ShangRing device for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi
Read the detailed description
Although voluntary medical male circumcision (VMMC) was adopted as a prevention strategy in 2011, MMC prevalence in Malawi is low with estimates between 2 and 20%. The 5-year national VMMC target for Malawi is 80% of men ages 15 - 49, or more than two million procedures. Since 2011, only 42,700 VMMCs have been done for HIV prevention, about 2% of the target. Of the 29 healthcare districts in Malawi, only a minority are supported by non-governmental (NGO) and U.S. government-funded VMMC programs. Major obstacles include few VMMC service-delivery points; few trained service providers; poor availability of prepackaged disposable VMMC kits requiring re-use of instruments and supplies; few organized campaigns or community mobilization programs; and drop-in services only.
Scale-up of adult MMC services in Malawi could be accelerated by the availability of simplified, bloodless methods. Methods of MMC using devices may also increase safety, efficiency and acceptability. Although many devices are available and widely used for infant circumcision, fewer devices exist for use in adult male circumcision and there are limited data on device use in adults. Small-scale safety studies, randomized controlled trials (RCTs), and field demonstration studies are required before the safety, effectiveness, acceptability, and feasibility of any device is assured.
Several devices have recently been developed that have the potential to simplify and shorten both training time and surgical duration by eliminating the need for suturing and hemostasis as well as allow for task-shifting to lower-level cadres of healthcare providers (i.e. non-physician), thereby reducing the strain on healthcare systems by having more healthcare workers available to provide MMC services. One such device is the ShangRing.
In the WHO framework, smaller bridging studies are recommended to address additional questions about particular sub-populations and specific conditions of use (WHO 2011). This research study will assess the safety and acceptability of the ShangRing within the context of routine service delivery in Namitete, Malawi. The investigators will enroll 500 HIV-uninfected adult men aged 18 to 49 years voluntarily seeking medical male circumcision. The men will be scheduled for two follow-up visits at 7 and 42 days after ShangRing placement for device removal and a healing check, respectively. Results from this study will inform the Malawi Ministry of Health (MOH) as it decides on the integration of MMC devices into its national VMMC program.
- Conditions
- Male Circumcision
- Being tested
- ShangRing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShangRingDevice
ShangRing administered to males seeking medical male circumcision
| Study group | Role | What they receive |
|---|---|---|
| ShangRing | Experimental | ShangRing administered to men seeking medical male circumcision Receives: Device: ShangRing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of men with moderate and severe adverse events will be tabulated with 95% confidence intervals
Measured: up to 42 days following circumcision procedure
Secondary outcomes (5)
proportion of men ineligible for MMC with ShangRing
The proportion and 95% confidence interval (CI) of men who did not receive ShangRing circumcision because of inability to find an appropriate size will be reported
Measured: up to four months
Percentage distribution of overall satisfaction for study participants
Study participants will be interviewed using a standardized questionnaire with items on overall satisfaction with the ShangRing procedure.
Measured: at Day 42 visit
Percentage preference for ShangRing procedure among study MC providers
Study circumcision providers will complete the first questionnaire after receiving training and completing 20 circumcision and device removal procedures. Providers will be interviewed using a standardized questionnaire that includes items on preference for ShangRing.
Measured: an expected average of one month after study initiation
Complete Healing at final follow up visit
Percentage of men with complete healing at 42 days for all study participants
Measured: up to 42 days
Percentage preference for ShangRing procedure among study MC providers
Providers will complete a second questionnaire at the end of the study after all follow-up visits are completed. Study circumcision providers will be interviewed using a standardized questionnaire that includes items on preference for ShangRing.
Measured: An expected average of six months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Feldblum, Ph.D., Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309710
- Sponsor's protocol ID
- 595330-3
- Status last verified
- Jan 2016
- First submitted
- 21 Nov 2014
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Male Circumcision Using the ShangRing Device in Routine Clinical Settings in Malawi
- ClinicalTrials.gov ID
- NCT02309710
- Acronym / sponsor ID
- 595330-3
- Conditions
- Male Circumcision
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Dec 2014 (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.
This prospective study will evaluate the safety and acceptability of the ShangRing device for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi
Detailed description
Although voluntary medical male circumcision (VMMC) was adopted as a prevention strategy in 2011, MMC prevalence in Malawi is low with estimates between 2 and 20%. The 5-year national VMMC target for Malawi is 80% of men ages 15 - 49, or more than two million procedures. Since 2011, only 42,700 VMMCs have been done for HIV prevention, about 2% of the target. Of the 29 healthcare districts in Malawi, only a minority are supported by non-governmental (NGO) and U.S. government-funded VMMC programs. Major obstacles include few VMMC service-delivery points; few trained service providers; poor availability of prepackaged disposable VMMC kits requiring re-use of instruments and supplies; few organized campaigns or community mobilization programs; and drop-in services only.
Scale-up of adult MMC services in Malawi could be accelerated by the availability of simplified, bloodless methods. Methods of MMC using devices may also increase safety, efficiency and acceptability. Although many devices are available and widely used for infant circumcision, fewer devices exist for use in adult male circumcision and there are limited data on device use in adults. Small-scale safety studies, randomized controlled trials (RCTs), and field demonstration studies are required before the safety, effectiveness, acceptability, and feasibility of any device is assured.
Several devices have recently been developed that have the potential to simplify and shorten both training time and surgical duration by eliminating the need for suturing and hemostasis as well as allow for task-shifting to lower-level cadres of healthcare providers (i.e. non-physician), thereby reducing the strain on healthcare systems by having more healthcare workers available to provide MMC services. One such device is the ShangRing.
In the WHO framework, smaller bridging studies are recommended to address additional questions about particular sub-populations and specific conditions of use (WHO 2011). This research study will assess the safety and acceptability of the ShangRing within the context of routine service delivery in Namitete, Malawi. The investigators will enroll 500 HIV-uninfected adult men aged 18 to 49 years voluntarily seeking medical male circumcision. The men will be scheduled for two follow-up visits at 7 and 42 days after ShangRing placement for device removal and a healing check, respectively. Results from this study will inform the Malawi Ministry of Health (MOH) as it decides on the integration of MMC devices into its national VMMC program.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ShangRing | Experimental | Device: ShangRingShangRing administered to men seeking medical male circumcision |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Must be aged 18 to 49 years;
- Must be HIV-uninfected per same-day routine HIV testing and counseling (HTC) at the clinic;
- Must be uncircumcised (on examination);
- Must be in good general health, at the discretion of the clinician;
- Must be free of genital ulcerations or other visible signs of sexually transmitted infections(STI) on examination;
Key exclusion criteria (5 listed)
- Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates ShangRing MMC;
- Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- Has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia;
- Has a self-reported allergy or sensitivity to lidocaine or other local anesthesia; or
- Is not available to be circumcised on the same day as screening.
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 |
|---|---|---|
| ShangRingShangRing administered to males seeking medical male circumcision | Device | ShangRing |
Primary outcome
The percentage of men with moderate and severe adverse events will be tabulated with 95% confidence intervals
Time frame: up to 42 days following circumcision procedure
5 secondary outcomes
proportion of men ineligible for MMC with ShangRing
Time frame: up to four months
Percentage distribution of overall satisfaction for study participants
Time frame: at Day 42 visit
Percentage preference for ShangRing procedure among study MC providers
Time frame: an expected average of one month after study initiation
Complete Healing at final follow up visit
Time frame: up to 42 days
Percentage preference for ShangRing procedure among study MC providers
Time frame: An expected average of six months after study initiation
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 21 Jan 2016.
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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.
Paul Feldblum, Ph.D. principal investigator
FHI 360
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ShangRing in people with Male Circumcision, run by FHI 360 at 2 sites in Malawi.
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 9 inclusion and 5 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 21 Jan 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 Malawi. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The percentage of men with moderate and severe adverse events will be tabulated with 95% confidence intervals (time frame: up to 42 days following circumcision procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2016; AzTrials last refreshed its copy on 2 Nov 2026.