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).
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.
Study Type
OBSERVATIONAL
Enrollment
575
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.
Kahama District Hospital
Shinyanga, Tanzania
Ushetu Health Centre
Shinyanga, Tanzania
Number of Adverse Events
Total numbers and types of known adverse events (AE)s occurring among clients, including all severities of AEs (mild, moderate, severe) and serious AEs, including detailed information about all instances of device displacement/detachment/self-removal/malfunction, need for medical attention or intervention, and final outcomes in those experiencing AEs
Time frame: 49 days post device placement
Number of Clients with Adverse Events
Total number of clients with known adverse events (AEs) (may be different from above if clients experience multiple AEs), including all severities of AEs and serious AEs
Time frame: 49 days post device placement
Descriptions of Adverse Events
A description of each adverse event by type and classification, severity, time of occurrence (during placement, in situ, or during removal) time of detection (days post-application and/or post-removal) captured as date AE is diagnosed, clinical management, and resolution
Time frame: 49 days post device placement
Provider Training
Determine the training needed for proficiency, including number of procedures required under supervision to become certified as fully proficient. This will involve analyzing AE rates stratified by during training and post-training in addition to overall.
Time frame: 49 days post device placement
Client Follow-up Visit Rate
Total number of clients who return for recommended follow-up at 49 days post-device placement, divided by the total number of ShangRing-circumcised clients
Time frame: 49 days post device placement
Client Preference for ShangRing Over Surgical Circumcision
Proportion of ShangRing clients who report they would still choose ShangRing method over surgical circumcision. This was captured using multiple choice: "After having worn the ring for a week, would you still choose ShangRing for circumcision, or would you choose surgery?" 1. I would definitely choose ShangRing again 2. I would probably choose ShangRing again 3. I would probably choose surgery 4. I would definitely choose surgery 5. I don't know
Time frame: At device removal (7 days post device placement)
Client Recommendation Rate
Proportion of clients who report they would recommend VMMC using ShangRing. This was captured with a yes/no question: "At this point would you recommend ShangRing to someone you know who is considering circumcision?" Yes No I don't know
Time frame: At device removal (7 days post device placement)
Cosmetic Result Acceptability
Client reporting on the cosmetic result post-removal. This was captured with multiple choice: "How satisfied are you with the appearance of your penis?" 1. I am very satisfied 2. I am satisfied 3. I am dissatisfied 4. I am very dissatisfied 5. I don't know
Time frame: At device removal (7 days post device placement)
Client Experience While Performing Routine Activities
Client reports on their experience while wearing ShangRing. This is captured with multiple choice: "How much did the ring affect you while performing day-to-day activities?" 1. It did not affect me at all 2. It only affected me while performing certain activities 3. It affected me during all activities, but I could still do them 4. It prevented me from performing certain activities
Time frame: At device removal (7 days post device placement)
Client Discomfort
Clients' opinions discomfort while wearing the ShangRing. This was captured with multiple choice: "How much discomfort did you experience while wearing the ShangRing device over the past seven days?" 1. I had no discomfort while wearing the ring 2. I had minor discomfort while wearing the ring 3. I had moderate discomfort while wearing the ring 4. I had a lot of discomfort while wearing the ring
Time frame: At device removal (7 days post device placement)
Provider Ease of Application
Provider perceived ease of application, captured with a Likert scale: "I found ShangRing circumcisions to be easy to perform." 1. Strongly disagree 2. Disagree 3. Neither Agree nor Disagree 4. Agree 5. Strongly Agree
Time frame: Immediately after the completion of the provider ShangRing training
Provider Preference
Provider perceived preference of performing ShangRing procedures, captured with a Likert scale: "I prefer performing ShangRing procedures over surgical circumcision." 1. Strongly disagree 2. Disagree 3. Neither Agree nor Disagree 4. Agree 5. Strongly Agree
Time frame: Immediately after the completion of the provider ShangRing training
Provider Recommendation
Provider recommendation of ShangRing to potential clients, captured with a Likert scale: "I would advise that clients select ShangRing circumcision over surgical circumcision." 1. Strongly disagree 2. Disagree 3. Neither Agree nor Disagree 4. Agree 5. Strongly Agree
Time frame: Immediately after the completion of the provider ShangRing training
Description of Procedures
Measure both the ShangRing application and removal times, including the time it took for topical anesthesia to take effect
Time frame: 49 days post device placement
Healing rate
The percentage of clients determined by a clinician to be clinically healed 49-52 days post-placement of the ShangRing device (42 days post-removal), and the time at which point all clients are clinically healed
Time frame: 52 days post device placement
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