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

Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06273696
• Other study ID #: 2019-519
• Secondary ID: NU2GGH001927
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: February 2024
• Source: IntraHealth International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 575
• Est. completion date: July 30, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deformity
• Hematoma

Intervention

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.

Locations

Country	Name	City	State
Tanzania	Kahama District Hospital	Shinyanga
Tanzania	Ushetu Health Centre	Shinyanga

Sponsors (6)

Lead Sponsor	Collaborator
IntraHealth International	Centers for Disease Control and Prevention, Jhpiego, Ministry of Health, Tanzania, President Office Regional Administration and Local Government, Tanzania, World Health Organization

Country where clinical trial is conducted

Tanzania, 

References & Publications (19)

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. Erratum In: PLoS Med. 2006 May;3(5):e298. — View Citation

Awori QD, Lee RK, Li PS, Moguche JN, Ouma D, Sambai B, Goldstein M, Barone MA. Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study. J Int AIDS Soc. 2017 Jul 12;20(1):21588. doi: 10.7448/IAS.20.1.21588. — View 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. — View Citation

Barone MA LP, Zulu R, Awori QD, et al. A Field Study of Male Circumcision Using the Shang Ring, a Minimally Invasive Disposable Device, in Routine Clinical Settings in Kenya and Zambia. 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention; Kuala Lumpur, Malaysia, 2013.

Barone MA, Awori QD, Li PS, Simba RO, Weaver MA, Okech JO, Aduda AO, Cherutich P, Muraguri N, Wekesa JM, Nyanchoka J, Perchal P, Masson P, Lee R, Goldstein M, Kioko J, Lusi O, Sokal DC. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment. J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):e82-9. doi: 10.1097/QAI.0b013e31824ea1f2. — View Citation

Barone MA, Li PS, Awori QD, Lee R, Goldstein M. Clinical trials using the Shang Ring device for male circumcision in Africa: a review. Transl Androl Urol. 2014 Mar;3(1):113-24. doi: 10.3978/j.issn.2223-4683.2014.01.09. — View Citation

Bratt JH, Zyambo Z. Comparing direct costs of facility-based Shang Ring provision versus a standard surgical technique for voluntary medical male circumcision in Zambia. J Acquir Immune Defic Syndr. 2013 Jul 1;63(3):e109-12. doi: 10.1097/QAI.0b013e31828e9526. — View Citation

Cheng Y, Peng YF, Liu YD, Tian L, Lu NQ, Su XJ, Yan ZJ, Hu JS, Lee R, Kim HH, Sokal DC, Li PS. [A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China]. Zhonghua Nan Ke Xue. 2009 Jul;15(7):584-92. Chinese. — View 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. — View Citation

Kigozi G, Musoke R, Kighoma NGR. The acceptability and safety of the ShangRing for adolescent male circumcision in Rakai, Uganda. International AIDS Society Conference; 2014; Melbourne, Australia. TUPE148 p.

Kigozi G, Musoke R, Watya S, Kighoma N, Ssebbowa P, Serwadda D, Nalugoda F, Makumbi F, Li P, Lee R, Goldstein M, Wawer M, Sewankambo N, Gray RH. The acceptability and safety of the Shang Ring for adult male circumcision in Rakai, Uganda. J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):617-21. doi: 10.1097/QAI.0b013e3182968dda. — View Citation

Peng YF, Cheng Y, Wang GY, Wang SQ, Jia C, Yang BH, Zhu R, Jian SC, Li QW, Geng DW. Clinical application of a new device for minimally invasive circumcision. Asian J Androl. 2008 May;10(3):447-54. doi: 10.1111/j.1745-7262.2008.00411.x. — View Citation

Preventing HIV Through Safe Voluntary Medical Male Circumcision for Adolescent Boys and Men in Generalized HIV Epidemics: Recommendations and Key Considerations. Geneva: World Health Organization; 2020 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK562463/ — View Citation

Rech D, Bertrand JT, Thomas N, Farrell M, Reed J, Frade S, Samkange C, Obiero W, Agot K, Mahler H, Castor D, Njeuhmeli E. Surgical efficiencies and quality in the performance of voluntary medical male circumcision (VMMC) procedures in Kenya, South Africa, Tanzania, and Zimbabwe. PLoS One. 2014 May 6;9(5):e84271. doi: 10.1371/journal.pone.0084271. eCollection 2014. — View Citation

Sokal DC, Li PS, Zulu R, Awori QD, Agot K, Simba RO, Combes S, Lee RK, Hart C, Lai JJ, Zyambo Z, Goldstein M, Feldblum PJ, Barone MA. Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia. J Acquir Immune Defic Syndr. 2014 Dec 1;67(4):430-7. doi: 10.1097/QAI.0000000000000321. — View Citation

Sokal DC, Li PS, Zulu R, Awori QD, Combes SL, Simba RO, Lee R, Hart C, Perchal P, Hawry HJ, Bowa K, Goldstein M, Barone MA. Randomized controlled trial of the shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability. J Acquir Immune Defic Syndr. 2014 Apr 1;65(4):447-55. doi: 10.1097/QAI.0000000000000061. — View Citation

Tanzania Commission for AIDS (TACAIDS), Zanzibar AIDS Commission (ZAC). Tanzania HIV Impact Survey (THIS) 2016-2017: Final Report. Dar es Salaam, Tanzania. December 2018.

The United Republic of Tanzania, Voluntary medical male circumcision country operational plan: 2014-2017. November 2014.

WHO Prequalification of Male Circumcision Devices Public Report. Product: ShangRing. WHO reference number: PQMC 0003-003-00. March 2019, version 3.0.

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	49 days post device placement
Primary	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	49 days post device placement
Primary	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	49 days post device placement
Secondary	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.	49 days post device placement
Secondary	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	49 days post device placement
Secondary	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?"; I would definitely choose ShangRing again; I would probably choose ShangRing again; I would probably choose surgery; I would definitely choose surgery; I don't know	At device removal (7 days post device placement)
Secondary	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	At device removal (7 days post device placement)
Secondary	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?"; I am very satisfied; I am satisfied; I am dissatisfied; I am very dissatisfied; I don't know	At device removal (7 days post device placement)
Secondary	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?"; It did not affect me at all; It only affected me while performing certain activities; It affected me during all activities, but I could still do them; It prevented me from performing certain activities	At device removal (7 days post device placement)
Secondary	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?"; I had no discomfort while wearing the ring; I had minor discomfort while wearing the ring; I had moderate discomfort while wearing the ring; I had a lot of discomfort while wearing the ring	At device removal (7 days post device placement)
Secondary	Provider Ease of Application	Provider perceived ease of application, captured with a Likert scale: "I found ShangRing circumcisions to be easy to perform."; Strongly disagree; Disagree; Neither Agree nor Disagree; Agree; Strongly Agree	Immediately after the completion of the provider ShangRing training
Secondary	Provider Preference	Provider perceived preference of performing ShangRing procedures, captured with a Likert scale: "I prefer performing ShangRing procedures over surgical circumcision."; Strongly disagree; Disagree; Neither Agree nor Disagree; Agree; Strongly Agree	Immediately after the completion of the provider ShangRing training
Secondary	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."; Strongly disagree; Disagree; Neither Agree nor Disagree; Agree; Strongly Agree	Immediately after the completion of the provider ShangRing training
Secondary	Description of Procedures	Measure both the ShangRing application and removal times, including the time it took for topical anesthesia to take effect	49 days post device placement
Secondary	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	52 days post device placement

External Links

•   PEPFAR Dashboards. Country and Regional Program Results, Fiscal Year (FY) 2010-2016: Tanzania. May 5, 2017.
•   Project Improving Quality VMMC (IQ) Virtual Seminar series. Virtual Roundtable on ShangRing for VMMC: Country perspectives. September 9th 2019.
•   Tetanus and VMMC: risk according to circumcision method and risk mitigation. Report of the WHO Technical Advisory Group on Innovations in Male Circumcision - consultative review of additional information, 12 August 2016.
•   The Joint United Nations Programme on HIV/AIDS (UNAIDS). Fast track commitments to end AIDS by 2030.
•   World Health Organization. Framework for clinical evaluation of devices for male circumcision. September 2012.
•   World Health Organization. Manual for male circumcision under local anesthesia and HIV prevention services for adolescent boys and men (2018).