NCT06273696

Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 575 (actual)
• Sponsor: IntraHealth International · Academic / Other
• Sex: Male
• Age: 13 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49).

Detailed description

Medical circumcision devices have the potential to accelerate delivery of male circumcision by making the procedure quicker and easier, while remaining as safe as surgical circumcision. Thus, circumcision devices may facilitate expansion of adult male circumcision programs for HIV prevention and address some of the common capacity issues in the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority countries for male circumcision. One promising device for adult male circumcision is ShangRing, which was prequalified by the World Health Organization (WHO) in 2015 for males aged 13 and older. WHO has created a framework for introducing circumcision devices in a country. This framework recommends countries take a methodical approach to introducing circumcision devices, evaluating acceptability and safety within its health system before making widespread adoption. Evaluation Goal: To evaluate the safety and acceptability of the ShangRing device for nonsurgical circumcision in routine clinical settings, as a part of a comprehensive HIV prevention program for males in voluntary medical male circumcisions (VMMC) programs. Evaluation Endpoints: the proportion of males experiencing mild, moderate and severe adverse events (AEs) associated with ShangRing circumcision procedures, including both intra- and post-operative events, and all device-related malfunctions (e.g., early spontaneous detachment). Evaluation Design Training Phase: this phase was used to evaluate the training requirements for implementation by mid-level providers, to preliminarily assess acceptability to providers, and to monitor logistical needs. Each clinician performed no fewer than 10 ShangRing device placements, and 5 ShangRing removals before start of the next phase (implementation pilot). Implementation Pilot: following the training period, 575 male clients were recruited to undergo circumcision with the ShangRing device in the context of routine service delivery. Data was collected at up to at least 5 points in time: at enrollment and device placement (day 0), at device removal (day 7), during a follow-up phone call (day 10), in-depth qualitative interviews for 50 purposefully selected clients (day 28), at an in-person follow-up visit to assess wound healing (day 49), and at subsequent weekly visits to assess healing for those not completely healed at day 49. Upon completion of the implementation pilot, the data was analyzed and used to assist with policy decisions and recommendations on ShangRing use in adult male circumcision programs.

Conditions

• Penile Infection
• Penile Haematoma
• Penile Bleeding
• Deformity

Interventions

Type	Name	Description
DEVICE	ShangRing	The ShangRing is a sterile, single use, disposable male circumcision (MC) device that consists of two concentric plastic rings, the inner of which is lined by a silicone pad, which provides a smooth and non-bio reactive surface against the surgical wound. The outer ring consists of 2 halves which are hinged together at the same end. On each side of the halves there is a locking clasp which allows for locking itself with inner ring. The ShangRing device is removed seven days after placement.

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-06-11
• Completion: 2019-07-30
• First posted: 2024-02-22
• Last updated: 2024-02-22

Locations

2 sites across 1 country: Tanzania