HIVNCT01757938
Randomized Control Trial of Shang Ring Versus Forceps-guided Adult Male Circumcision in Southwestern Uganda.
A study testing Shang Ring Guided Circumcision and Forceps Guided Circumcision in people with HIV, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
Adult male circumcision (AMC) can reduce the incidence of HIV transmission by 40-60% in sub-Saharan Africa (SSA). The World Health Organisation and Joint United Nations Programme on HIV/AIDS advocate AMC for the reduction of HIV transmission in heterosexual men, and feasibility studies have demonstrated that AMC… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Shang Ring Guided Circumcision and Forceps Guided Circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2011to May 2011
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Greater than 18 years old
- Desire for adult male circumcision
- Presenting outpatient department of Mbarara Regional Referral Hospital
- Provide written informed consent
Who cannot join
- HIV infection
- Chronic paraphimosis
- Genital ulcers
- Penile carcinoma
- Filariasis
- Xerotica obliterans
Show all 10Show fewer
- Balanitis
- Glans-prepuce adhesions
- Frenular scar tissue
- Urethral anatomical abnormality such as hypospadias or epispadias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shang Ring Versus Forceps-guided Adult Male Circumcision: a Randomized Controlled Effectiveness Study in Southwestern Uganda.
Adult male circumcision (AMC) can reduce the incidence of HIV transmission by 40-60% in sub-Saharan Africa (SSA). The World Health Organisation and Joint United Nations Programme on HIV/AIDS advocate AMC for the reduction of HIV transmission in heterosexual men, and feasibility studies have demonstrated that AMC programmes can be effectively delivered to hyperendemic communities, such as those in SSA. Despite these recommendations, the potential effects of AMC have been attenuated by low uptake, with only 5% of all men who could benefit undergoing surgery to date. Traditional, time-consuming methods of AMC that require formal surgical training limit uptake in low-income countries. Training and implementation by non-physician health providers is dampened by a need to perform approximately 100 procedures to achieve satisfactory operative time and adverse effect rates. The investigators performed a randomised controlled effectiveness study to compare the shang ring (SR) with standard forceps-guided (FG)-AMC in a publicly funded regional referral hospital with a locally trained surgeon in Mbarara, western Uganda.
Read the detailed description
Male undergoing elective AMC were recruited from the surgical outpatient department of Mbarara Regional Referral Hospital, Uganda. Patient age, marital status, smoking history and motive to seek AMC were recorded for each participant.
The investigators performed block randomization by study day. Consenting participants selected an opaque envelope from a box for randomization to SR or FG groups. All AMC procedures were performed by a locally-trained surgeon who had performed over 100 prior FG procedures but who had no prior experience of the SR procedure.
A study surgeon performed all procedures in the hospital operating theatres. In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. The surgeon measured participants in the SR group to determine ring size. Patients for whom a suitable ring size was not available crossed over to the FG group, but remained in the SR group for intention to treat (ITT) analyses. An assistant measured operative time using a stopwatch. For the SR group, timing began as the ring began to be fitted, and ceased when the foreskin had been excised. For the FG group, timing began at the first incision and ceased when the final suture was completed. Patients were discharged on the day of procedure, provided with sterile gauze dressings, and informed to change them twice daily until the first follow-up appointment.
All pre- and post-operative assessments were performed by the lead investigator at one hour after the procedure, and on the 3rd, 7th, 14th and 21st post-operative days.
The investigators measured incidence rates of all outcomes and estimated relative risk for the SR versus FG groups by fitting Poisson regression models with robust errors. The investigators compared time to healing with Kaplan-Meier survival curves and measured for a difference between groups using the likelihood ratio test. All analyses were initially performed using ITT analysis, and were repeated with an as-treated analysis by reallocating the 7 participants who crossed into the FG group.
- Conditions
- HIV
- Being tested
- Shang Ring Guided Circumcision, Forceps Guided Circumcision
- Keywords
- HIV, Prevention, Adult Male Circumcision, Uganda, Shang Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shang Ring Guided CircumcisionProcedure or surgery
Forceps Guided CircumcisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Shang Ring Guided Circumcision | Experimental | The Shang Ring (SR) (Wuhu Santa Medical Devices Technology Co Ltd, China) male circumcision performed by study surgeon (study PI). In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. The surgeon measured participants in the SR group to determine ring size. Patients for whom a suitable ring size was not available crossed over to the FG group, but remained in the SR group for intention to treat (ITT) analyses. Receives: Procedure: Shang Ring Guided Circumcision |
| Forceps Guided Circumcision | Active comparator | Standard forceps guided adult male circumcision was performed. In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. Receives: Procedure: Forceps Guided Circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Time
Primary outcomes of interest was procedure time. An assistant measured operative time using a stopwatch. For the SR group, timing began as the ring began to be fitted, and ceased when the foreskin had been excised. For the FG group, timing began at the first incision and ceased when the final suture was completed.
Measured: 21 days
Major Complication
We considered a major complication as one requiring assessment by a clinician, including any of: a) SR slippage; b) infection requiring antibiotics, or c) any persistent complication on day 14.
Measured: 21 days
Secondary outcomes (4)
Pain
Pain scales were measured on post-op day 1, 3, 7, 14, and 21 using a visual analogue scale.
Measured: 21 days
Time to resumption of normal activity
Self-reported time to resumption of normal activity (defined as attendance at university classes)
Measured: 21 days
Patient Satisfaction
Patient satisfaction taken at conclusion of follow-up (rated as 'low', 'average', 'high' or "very high" and dichotomized as low/average or high/very high for analyses)
Measured: 21 days
Time to complete healing
As measured by primary surgeon (study primary investigator) at follow-up visits. Missing outcome data for patients in the FG group who did not return were allocated as favourable for analysis of outcomes to bias estimates of a superiority of the SR towards the null. Thus, for patients in the FG group who did not return, we considered them to have high satisfaction and no major complications.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Kanyago, MD, Principal investigator, Mbarara University of Scince and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757938
- Sponsor's protocol ID
- MUST2012-1
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Siegfried N, Muller M, Volmink J, Deeks J, Egger M, Low N, Weiss H, Walker S, Williamson P. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev. 2003;(3):CD003362. doi: 10.1002/14651858.CD003362.
PubMed 12917962Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.
PubMed 16231970Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.
PubMed 17321310Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
PubMed 17321311Barone MA, Ndede F, Li PS, Masson P, Awori Q, Okech J, Cherutich P, Muraguri N, Perchal P, Lee R, Kim HH, Goldstein M. The Shang Ring device for adult male circumcision: a proof of concept study in Kenya. J Acquir Immune Defic Syndr. 2011 May 1;57(1):e7-12. doi: 10.1097/QAI.0b013e3182158967.
PubMed 21346586
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shang Ring Versus Forceps-guided Adult Male Circumcision: a Randomized Controlled Effectiveness Study in Southwestern Uganda.
- ClinicalTrials.gov ID
- NCT01757938
- Acronym / sponsor ID
- MUST2012-1
- Conditions
- HIV
- Keywords
- HIV, Prevention, Adult Male Circumcision, Uganda, Shang Ring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Dec 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.
Adult male circumcision (AMC) can reduce the incidence of HIV transmission by 40-60% in sub-Saharan Africa (SSA). The World Health Organisation and Joint United Nations Programme on HIV/AIDS advocate AMC for the reduction of HIV transmission in heterosexual men, and feasibility studies have demonstrated that AMC programmes can be effectively delivered to hyperendemic communities, such as those in SSA. Despite these recommendations, the potential effects of AMC have been attenuated by low uptake, with only 5% of all men who could benefit undergoing surgery to date. Traditional, time-consuming methods of AMC that require formal surgical training limit uptake in low-income countries. Training and implementation by non-physician health providers is dampened by a need to perform approximately 100 procedures to achieve satisfactory operative time and adverse effect rates. The investigators performed a randomised controlled effectiveness study to compare the shang ring (SR) with standard forceps-guided (FG)-AMC in a publicly funded regional referral hospital with a locally trained surgeon in Mbarara, western Uganda.
Detailed description
Male undergoing elective AMC were recruited from the surgical outpatient department of Mbarara Regional Referral Hospital, Uganda. Patient age, marital status, smoking history and motive to seek AMC were recorded for each participant.
The investigators performed block randomization by study day. Consenting participants selected an opaque envelope from a box for randomization to SR or FG groups. All AMC procedures were performed by a locally-trained surgeon who had performed over 100 prior FG procedures but who had no prior experience of the SR procedure.
A study surgeon performed all procedures in the hospital operating theatres. In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. The surgeon measured participants in the SR group to determine ring size. Patients for whom a suitable ring size was not available crossed over to the FG group, but remained in the SR group for intention to treat (ITT) analyses. An assistant measured operative time using a stopwatch. For the SR group, timing began as the ring began to be fitted, and ceased when the foreskin had been excised. For the FG group, timing began at the first incision and ceased when the final suture was completed. Patients were discharged on the day of procedure, provided with sterile gauze dressings, and informed to change them twice daily until the first follow-up appointment.
All pre- and post-operative assessments were performed by the lead investigator at one hour after the procedure, and on the 3rd, 7th, 14th and 21st post-operative days.
The investigators measured incidence rates of all outcomes and estimated relative risk for the SR versus FG groups by fitting Poisson regression models with robust errors. The investigators compared time to healing with Kaplan-Meier survival curves and measured for a difference between groups using the likelihood ratio test. All analyses were initially performed using ITT analysis, and were repeated with an as-treated analysis by reallocating the 7 participants who crossed into the FG group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shang Ring Guided Circumcision | Experimental | Procedure: Shang Ring Guided CircumcisionThe Shang Ring (SR) (Wuhu Santa Medical Devices Technology Co Ltd, China) male circumcision performed by study surgeon (study PI). In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. The surgeon measured participants in the SR group to determine ring size. Patients for whom a suitable ring size was not available crossed over to the FG group, but remained in the SR group for intention to treat (ITT) analyses. |
| Forceps Guided Circumcision | Active comparator | Procedure: Forceps Guided CircumcisionStandard forceps guided adult male circumcision was performed. In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Greater than 18 years old
- Desire for adult male circumcision
- Presenting outpatient department of Mbarara Regional Referral Hospital
- Provide written informed consent
Key exclusion criteria (10 listed)
- HIV infection
- Chronic paraphimosis
- Genital ulcers
- Penile carcinoma
- Filariasis
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 Ring Guided Circumcision | Procedure or surgery | Shang Ring Guided Circumcision |
| Forceps Guided Circumcision | Procedure or surgery | Forceps Guided Circumcision |
Primary outcome
Procedure Time
Time frame: 21 days
Primary outcomes of interest was procedure time. An assistant measured operative time using a stopwatch. For the SR group, timing began as the ring began to be fitted, and ceased when the foreskin had been excised. For the FG group, timing began at the first incision and ceased when the final suture was completed.
Major Complication
Time frame: 21 days
We considered a major complication as one requiring assessment by a clinician, including any of: a) SR slippage; b) infection requiring antibiotics, or c) any persistent complication on day 14.
4 secondary outcomes
Pain
Time frame: 21 days
Time to resumption of normal activity
Time frame: 21 days
Patient Satisfaction
Time frame: 21 days
Time to complete healing
Time frame: 21 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 31 Dec 2012.
- Background: PubMed 12917962Siegfried N, Muller M, Volmink J, Deeks J, Egger M, Low N, Weiss H, Walker S, Williamson P. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev. 2003;(3):CD003362. doi: 10.1002/14651858.CD003362.
- Background: PubMed 16231970Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.
- Background: PubMed 17321310Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.
- Background: PubMed 17321311Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
- Background: PubMed 21346586Barone MA, Ndede F, Li PS, Masson P, Awori Q, Okech J, Cherutich P, Muraguri N, Perchal P, Lee R, Kim HH, Goldstein M. The Shang Ring device for adult male circumcision: a proof of concept study in Kenya. J Acquir Immune Defic Syndr. 2011 May 1;57(1):e7-12. doi: 10.1097/QAI.0b013e3182158967.
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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.
Samuel Kanyago, MD principal investigator
Mbarara University of Scince and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shang Ring Guided Circumcision and Forceps Guided Circumcision in people with HIV, run by Mbarara University of Science and Technology at 1 site in Uganda.
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 5 inclusion and 10 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 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
Procedure Time (time frame: 21 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 NCT01757938, which also lists 5 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 31 Dec 2012.