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

NCT06273696 | Completed

• 2 other identifiers: 2019-519NU2GGH001927
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 2

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).

Conditions

Penile Infection; Penile Haematoma; Penile Bleeding; Deformity

Keywords

male circumcision; ShangRing; adverse events; Tanzania; HIV/AIDS; nonsurgical circumcision; voluntary medical male circumcision; device; anesthesia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (12)

• Provider Training

  49 days post device placement

• Client Follow-up Visit Rate

  49 days post device placement

• Client Preference for ShangRing Over Surgical Circumcision

  At device removal (7 days post device placement)

• Client Recommendation Rate

  At device removal (7 days post device placement)

• Cosmetic Result Acceptability

  At device removal (7 days post device placement)

Study Arms (1)

Circumcision clients

Participants who underwent the ShangRing circumcision procedure

Device: ShangRing

Interventions

ShangRing DEVICE

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.

Circumcision clients

Eligibility Criteria

• Age: 13 Years+
• Gender Eligibility Details: Men and boys who choose to undergo voluntary medical male circumcision
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Shinyanga is one of the 31 regions, in the Lake Zone Region of Tanzania. Shinyanga covers a total of 18,555 square kilometers. As of the 2012 census, the population of the Shinyanga region was 1,534,808. The economy of the region is primarily driven by agriculture. As of 2011, the HIV prevalence of Shinyanga was 7.4%. According to the Tanzania Demographic Health Survey and Malaria Indicator Survey, 54% of men in Shinyanga reported that they are circumcised.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IntraHealth International: lead
• Ministry of Health, Tanzania: collaborator
• President Office Regional Administration and Local Government, Tanzania: collaborator
• Centers for Disease Control and Prevention: collaborator
• Jhpiego: collaborator
• World Health Organization: collaborator

Study Sites (2)

Kahama District Hospital

Shinyanga, Tanzania

Location

Ushetu Health Centre

Shinyanga, Tanzania

Location

Related 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.

  PMID: 16231970 BACKGROUND

• 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.

  PMID: 17321311 BACKGROUND

• 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.

  PMID: 17321310 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18385906 BACKGROUND

• 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.

  PMID: 19694369 BACKGROUND

• 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.

  PMID: 26816759 BACKGROUND

• 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.

  PMID: 22343180 BACKGROUND

• 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.

  PMID: 24583615 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23614991 BACKGROUND

• 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.

  PMID: 24802412 BACKGROUND

• 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.

  PMID: 23481667 BACKGROUND

• 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.

  PMID: 25162816 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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/

  PMID: 32986340 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28715157 BACKGROUND

Related Links

• The Joint United Nations Programme on HIV/AIDS (UNAIDS). Fast track commitments to end AIDS by 2030.
• 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.
• Project Improving Quality VMMC (IQ) Virtual Seminar series. Virtual Roundtable on ShangRing for VMMC: Country perspectives. September 9th 2019.
• PEPFAR Dashboards. Country and Regional Program Results, Fiscal Year (FY) 2010-2016: Tanzania. May 5, 2017.
• 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).

MeSH Terms

Conditions

Congenital Abnormalities; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lija Gissenge, MD, MMed

  Head, HIV Prevention Unit, Tanzania Ministry of Health, Community Development, Gender and Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 49 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 22, 2024
• Study Start: May 1, 2019
• Primary Completion: June 11, 2019
• Study Completion: July 30, 2019
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TA (2)