Male CircumcisionNCT02242565
Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
A study testing ShangRing in people with Male Circumcision, run by FHI 360 at 2 sites in Zambia.
Trial summary
The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. 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 sitesZambia
- Study dates
- Oct 2014to Dec 2015
- 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 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 voluntary testing 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 STI (on examination);
- Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
- Must freely consent to participate in the study and sign a written informed consent form;
- Must provide full contact information including cell phone number, address, and other locator information.
Who cannot join
- Has an active genital infection upon visual inspection;
- 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; or
- 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
- Is not available to be circumcised on the same day as screening.
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Chilenje Urban Health Centre
Lusaka
The University Teaching Hospital (UTH)
Lusaka
About this study
The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.
Read the detailed description
We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.
- Conditions
- Male Circumcision
- Being tested
- ShangRing
- Keywords
- HIV prevention, ShangRing, adverse events, wound healing, voluntary medical male circumcision (VMMC), medical device, Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShangRingDevice
ShangRing device for male circumcision
| Study group | Role | What they receive |
|---|---|---|
| Control: all-sizes of ShangRing | Other | All-sizes of ShangRings will be available. Receives: Device: ShangRing |
| Reduced-sizes | Active comparator | 7 adult sizes of ShangRings will be available Receives: Device: ShangRing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.
Measured: 42 days
Secondary outcomes (3)
Percentage of men who cannot be properly fitted with a ShangRing device
Assess the effectiveness of ShangRing procedures in the reduced-sizes arm.
Measured: 42 days
Evaluate the acceptability of ShangRing procedures among participants and providers
Participant acceptability (with procedure and cosmetic appearance), pain, and time to return to normal activity after ShangRing circumcision, overall and in each arm.
Provider acceptability assessing ease, duration, and complications, and preferences comparing ShangRing with other methods of circumcision, and comparing reduced-sizes with all-sizes provision.
Measured: 42 days
Percentage of men with complete healing at 42 days
Percentage of men with complete healing at 42 days for all study participants, and within each arm of the trial.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Ministry of Health, Zambia
- Responsible party
- Sponsor
- Investigators
- Robert Zulu, MD, Principal investigator, University Teaching HospitalPaul Feldblum, PhD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242565
- Sponsor's protocol ID
- 576424
- Other IDs
- 010-04-14
- Status last verified
- Sep 2017
- First submitted
- 15 Sep 2014
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, Kashitala J, Veena V, Kasonde P. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 10.1097/QAI.0000000000001015.
PubMed 27331587
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
- ClinicalTrials.gov ID
- NCT02242565
- Acronym / sponsor ID
- 576424
- Conditions
- Male Circumcision
- Keywords
- HIV prevention, ShangRing, adverse events, wound healing, voluntary medical male circumcision (VMMC), medical device, Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Ministry of Health, Zambia
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Sep 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.
The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.
Detailed description
We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: all-sizes of ShangRing | Other | Device: ShangRingAll-sizes of ShangRings will be available. |
| Reduced-sizes | Active comparator | Device: ShangRing7 adult sizes of ShangRings will be available |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Must be aged 18 to 49 years;
- Must be HIV-uninfected per same-day routine voluntary testing 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 STI (on examination);
Key exclusion criteria (6 listed)
- Has an active genital infection upon visual inspection;
- 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; or
- 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
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 device for male circumcision | Device | Control: all-sizes of ShangRing, Reduced-sizes |
Primary outcome
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
Time frame: 42 days
To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.
3 secondary outcomes
Percentage of men who cannot be properly fitted with a ShangRing device
Time frame: 42 days
Evaluate the acceptability of ShangRing procedures among participants and providers
Time frame: 42 days
Percentage of men with complete healing at 42 days
Time frame: Day 42
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 2 Oct 2017.
- Results publication: PubMed 27331587Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, Kashitala J, Veena V, Kasonde P. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 10.1097/QAI.0000000000001015.
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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.
Robert Zulu, MD principal investigator
University Teaching Hospital
Paul Feldblum, PhD 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 study testing ShangRing in people with Male Circumcision, run by FHI 360 at 2 sites in Zambia.
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 8 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 2 Oct 2017. 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 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.
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?
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event. (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 NCT02242565, which also lists 1 linked publication.
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 2 Oct 2017.