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Penile InfectionNCT06273696

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

An observational study of Penile Infection and Penile Haematoma, run by IntraHealth International at 2 sites in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 13 years and older, men onlyHealthy volunteers can take part
What is being tested?
ShangRing
Type of treatment
Medical device
How many people
575 participants
Where
2 sitesTanzania
Study dates
1 May 2019to 30 Jul 2019
How long will I take part?
49 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Tanzania2 sites

  • Kahama District Hospital

    Shinyanga

  • Ushetu Health Centre

    Shinyanga

Other trials in Tanzania

About this study

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).

Read the 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.

Being tested
ShangRing
Keywords
male circumcision, ShangRing, adverse events, Tanzania, HIV/AIDS, nonsurgical circumcision, voluntary medical male circumcision, device, anesthesia
Medical subject headings
Congenital Abnormalities, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ShangRingDevice

    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.

Study groups in NCT06273696
Study groupRoleWhat they receive
Circumcision clientsParticipants who underwent the ShangRing circumcision procedure
Receives: Device: ShangRing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 49 days post device placement

  2. 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

    Measured: 49 days post device placement

  3. 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

    Measured: 49 days post device placement

Secondary outcomes (12)

  1. 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.

    Measured: 49 days post device placement

  2. 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

    Measured: 49 days post device placement

  3. 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

    Measured: At device removal (7 days post device placement)

  4. 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

    Measured: At device removal (7 days post device placement)

  5. 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

    Measured: At device removal (7 days post device placement)

  6. 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

    Measured: At device removal (7 days post device placement)

  7. 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

    Measured: At device removal (7 days post device placement)

  8. 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

    Measured: Immediately after the completion of the provider ShangRing training

  9. 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

    Measured: Immediately after the completion of the provider ShangRing training

  10. 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

    Measured: Immediately after the completion of the provider ShangRing training

  11. Description of Procedures

    Measure both the ShangRing application and removal times, including the time it took for topical anesthesia to take effect

    Measured: 49 days post device placement

  12. 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

    Measured: 52 days post device placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start1 May 2019
  3. Primary completion11 Jun 2019
  4. Study completion30 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
575 participants (actual)
Target duration
49 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06273696
Sponsor's protocol ID
2019-519
Other IDs
NU2GGH001927
Status last verified
Feb 2024
First submitted
9 Feb 2023
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Per our data sharing agreement with the Tanzania Ministry of Health (MOH) and the local institutional review board (IRB) Ethics Review Committee, we are not authorized to share individual patient information with anyone outside the study team.

Publications

  • 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.

    PubMed 16231970

  • 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.

    PubMed 17321311

  • 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.

    PubMed 17321310

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

  • 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.

    PubMed 18385906

  • 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.

    PubMed 19694369

  • 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.

    PubMed 26816759

  • 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.

    PubMed 22343180

  • 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.

    PubMed 24583615

  • 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.

  • 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.

    PubMed 23614991

  • 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.

    PubMed 24802412

  • 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.

    PubMed 23481667

  • 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.

    PubMed 25162816

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

Questions about this trial

What is this clinical trial studying?

An observational study of Penile Infection and Penile Haematoma, run by IntraHealth International at 2 sites in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (time frame: 49 days post device placement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06273696, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.

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