Clinical trial NCT01757938: Randomized Control Trial of Shang Ring Versus Forceps-guided Adult Male Circumcision in Southwestern Uganda.
Official title: Shang Ring Versus Forceps-guided Adult Male Circumcision: a Randomized Controlled Effectiveness Study in Southwestern Uganda.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Prevention
Adult Male Circumcision
Uganda
Shang Ring
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 138
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Procedure Time
timeFrame: 21 days
measure: Major Complication
timeFrame: 21 days
Secondary outcomes:
measure: Pain
timeFrame: 21 days
measure: Time to resumption of normal activity
timeFrame: 21 days
measure: Patient Satisfaction
timeFrame: 21 days
measure: Time to complete healing
timeFrame: 21 days
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Mbarara University of Scince and Technology
name: Samuel Kanyago, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.