The Shang Ring: A Novel Male Circumcision Device for HIV Prevention
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The efficacy and safety of the ShangRIng device for adult male circumcision in an HIV endemic region in Africa.
Study Overview
Brief Summary
The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary medical male circumcision, in order to improve the provision of male circumcision services for HIV prevention in Africa.
Detailed Description
Three randomized clinical trials (RCTs) have confirmed the benefit of voluntary medical male circumcision (VMMC) in reducing the acquisition of HIV by circumcised men. In Africa, VMMC is most commonly performed with the methods described in the WHO Manual for Male Circumcision under Local Anaesthesia (i.e., the forceps-guided, dorsal slit or sleeve method).
Modelers have estimated that to scale-up VMMC to prevent large numbers of HIV infections will require millions of circumcisions over the next 5 to 10 years, with more than 10 million circumcisions in 2012 based on aggressive scale-up plans.
Neonatal circumcision is a very common procedure and has been the subject of numerous clinical trials. With the use of simple devices, neonatal circumcision is rapid and safe. In contrast, current adult surgical techniques are done freehand. Adolescent or adult male medical circumcision has been a rarely performed procedure in most developed countries. Circumcision has suffered from little or no research that could make possible either (a) comparison or simplification of surgical techniques or (b) development of devices to facilitate the procedure. Current techniques are time consuming and require long training periods to produce skilled personnel. Each procedure typically takes 20 to 40 minutes.
A search for more efficient adult circumcision techniques has been undertaken by consultants for the World Health Organization (WHO) and the Bill & Melinda Gates Foundation. Preliminary discussions that helped to produce this proposal suggest that the Shang Ring is one of the most promising existing devices that could greatly simplify adult circumcision. More efficient and simpler techniques could potentially:
- Reduce the operating time and the cost of supplies
- Improve the safety of the procedure
- Permit more rapid training of non-physician health care providers
- Accelerate the process of scaling up this proven HIV prevention strategy
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 54 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Freely consents to participate in the study and signs an informed consent form
- •Ages 18 - 54 years
- •Uncircumcised
- •Good general health
- •HIV sero-negative
- •Able to understand the study procedures and requirements
- •Agrees to return to the health care facility for the full schedule of follow-up visits after his circumcision
Exclusion Criteria
- •Previous circumcision on examination
- •Age < 18 years or > 54 years
- •Active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon prevents the man from undergoing a circumcision
- •HIV sero-positive
- •A condition, which in the opinion of the surgeon contradicts participation in the study
Arms & Interventions
Circumcision
Males undergoing circumcision
Intervention: Shang Ring circumcision (Device)
Outcomes
Primary Outcomes
The efficacy and safety of the ShangRIng device for adult male circumcision in an HIV endemic region in Africa.
Time Frame: Six week post-operative follow up appointment and examination
Secondary Outcomes
- Behavior outcomes (surgical acceptability, satisfaction, problems encountered with the device, compliance with post-surgical instructions, and correct knowledge about the extent of the protective effect of circumcision and safe sex).(Six week post-operative follow up appointment and examination)