NCT01757938

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
Last Updated

December 31, 2012

Status Verified

December 1, 2012

Enrollment Period

1 month

First QC Date

December 19, 2012

Last Update Submit

December 28, 2012

Conditions

HIV

Keywords

HIVPreventionAdult Male CircumcisionUgandaShang Ring

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    21 days

Secondary Outcomes (4)

  • Pain

    21 days

  • Time to resumption of normal activity

    21 days

  • Patient Satisfaction

    21 days

  • Time to complete healing

    21 days

Study Arms (2)

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.

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.

Procedure: Forceps Guided Circumcision

Interventions

Shang Ring Guided CircumcisionPROCEDURE
Shang Ring Guided Circumcision
Forceps Guided CircumcisionPROCEDURE
Forceps Guided Circumcision

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Greater than 18 years old
  • Desire for adult male circumcision
  • Presenting outpatient department of Mbarara Regional Referral Hospital
  • Provide written informed consent

You may not qualify if:

  • HIV infection
  • Chronic paraphimosis
  • Genital ulcers
  • Penile carcinoma
  • Filariasis
  • Xerotica obliterans
  • Balanitis
  • Glans-prepuce adhesions
  • Frenular scar tissue
  • Urethral anatomical abnormality such as hypospadias or epispadias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (5)

  • 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.

    PMID: 12917962BACKGROUND

  • Auvert 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.

    PMID: 16231970BACKGROUND

  • Bailey 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.

    PMID: 17321310BACKGROUND

  • Gray 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.

    PMID: 17321311BACKGROUND

  • Barone 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.

    PMID: 21346586BACKGROUND

Study Officials

  • Samuel Kanyago, MD

    Mbarara University of Scince and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 31, 2012

Study Start

April 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 31, 2012

Record last verified: 2012-12

Locations

UG(1)