Deformity, Penile Bleeding, Penile Haematoma, Penile Infection
Conditions
Keywords
male circumcision, ShangRing, adverse events, Tanzania, HIV/AIDS, nonsurgical circumcision, voluntary medical male circumcision, device, anesthesia
Brief 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.
Interventions
DEVICEShangRing
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.
Sponsors
Ministry of Health, Tanzania
President Office Regional Administration and Local Government, Tanzania
Centers for Disease Control and Prevention
Jhpiego
World Health Organization
IntraHealth International
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be an uncircumcised male aged 13 years or older * Be seeking medical circumcision at one of the study sites * Consent to an HIV test, unless they were known to be HIV-positive * Agree to be circumcised using the ShangRing device * Have their penis fit into one of the ShangRing ring sizes available during the study * Be able to understand the evaluation procedures and requirements * Agree to abstain from sexual intercourse and masturbation for six weeks after ring removal, for a total of seven weeks * Live within 30 kilometers of the facility in Shinyanga Region, Tanzania * Be willing to provide valid contact information (i.e., telephone number, address of residence, place of employment, and other locator information) and be willing to receive communications and/or follow-up visits * Have an activated mobile phone or access to a mobile phone * Agree to return for a follow-up visit to assess healing at day 49 (42 days post-removal) * Agree to a ten-day post-placement (three days post-removal) telephone call to assess and detect symptoms of AEs * Be able to communicate in English and/or Kiswahili * Be capable and willing to provide written informed consent (18 years and older) or written informed consent from a parent guardian (13-17 years) to participate for both HIV testing services and VMMC services
Exclusion criteria
* A cognitive impairment that prevented the client from providing consent * Any health condition (reported or observed) that was a contraindication to surgical VMMC in the national program or that ShangRing providers deemed a contraindication. These may include diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness. * A current sexually transmitted infection (STI) other than HIV (clients with STIs were advised to return for circumcision once the STI was treated); and/or other conditions, which in the opinion of the site supervisor, prevented the client from undergoing a circumcision with the ShangRing device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 49 days post device placement | 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 |
| Number of Clients with Adverse Events | 49 days post device placement | 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 |
| Descriptions of Adverse Events | 49 days post device placement | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client Recommendation Rate | At device removal (7 days post device placement) | 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 |
| Cosmetic Result Acceptability | At device removal (7 days post device placement) | 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 |
| Client Experience While Performing Routine Activities | At device removal (7 days post device placement) | 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 |
| Client Discomfort | At device removal (7 days post device placement) | 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 |
| Provider Training | 49 days post device placement | 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. |
| Provider Preference | Immediately after the completion of the provider ShangRing training | 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 |
| Provider Recommendation | Immediately after the completion of the provider ShangRing training | 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 |
| Description of Procedures | 49 days post device placement | Measure both the ShangRing application and removal times, including the time it took for topical anesthesia to take effect |
| Healing rate | 52 days post device placement | 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 |
| Provider Ease of Application | Immediately after the completion of the provider ShangRing training | 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 |
| Client Follow-up Visit Rate | 49 days post device placement | 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 |
| Client Preference for ShangRing Over Surgical Circumcision | At device removal (7 days post device placement) | 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 |
Countries
Tanzania
Outcome results
None listed