Evaluation and Adverse Event Surveillance for Initial Implementation of ShangRing Circumcision in Mozambique

NCT03761836 | Withdrawn

• 1 other identifier: JHSPH IRB 8231
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are: 1) To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and 2) To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.

Conditions

Circumcision, Male

Outcome Measures

Primary Outcomes (1)

• Proportion of ShangRing clients who experience moderate and severe adverse events

  Circumcision-related adverse events are classified as moderate and severe per standardized protocol definitions

  60 days postoperative

Secondary Outcomes (3)

• Proportion of eligible men who chose ShangRing procedure

  Preoperative

• Proportion of ShangRing™ clients who fail to return for device removal on day 7

  7 days postoperative

• Pain scores on Visual Analog Scale

  Within 48 hours postoperative

Study Arms (1)

ShangRing

EXPERIMENTAL

Males aged 13 years and above will undergo circumcision through ShangRing procedure, with regular follow-up visits to evaluate pain, wound healing and incidence of adverse events. The ShangRing will be removed after 7 days, with a last follow-up visit at 60 days.

Device: ShangRing

Interventions

ShangRing DEVICE

The ShangRing™ is a device for male circumcision that was invented by Jian Zhong Shang and has been on the Chinese market since 2005. It consists of a sterile device with two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. It currently holds a European Conformity (CE) mark, an EN ISO certificate, and is FDA approved. Clinical data from ShangRing studies in Africa were reviewed by the WHO Technical Advisory Group (TAG) on Innovations in Male Circumcision in January 2013 and were found to meet its clinical requirements. The ShangRing manufacturer was accepted by the WHO Prequalification Programme for Male Circumcision Devices in 2015.

ShangRing

Eligibility Criteria

• Age: 13 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, 13 years old and above
• Agrees to return to the facility where circumcision procedure is done for device removal on day 7 and to have home or off-site visits if deemed necessary by the ShangRing™ providers
• Is able and willing to provide a valid physical address of residence and at least one alternate address (address of employer, school, or friend/relative) for tracing
• Is able and willing to provide a valid primary phone number and at least one alternate phone number (phone number of friend/relative) and agrees to be contacted via that alternate number and person. This will facilitate telephone-based follow-up should he not return for the scheduled post-removal follow-up visits.

You may not qualify if:

• Males below 13 years of age
• Males for whom the correct fitting size of ShangRing™ Device is not available
• Anatomical abnormalities including adhesions
• Cognitive impairment
• Any health condition (reported or observed) that ShangRing™ providers deem a contraindication to the procedure. These may include history of diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness
• HIV - positive (although may still undergo surgical circumcision)
• Anatomical variations and anomalies of genitalia
• Hypospadias, epispadias, or other urethral anomaly
• Hydrocele
• Scrotal hernia
• Other genital anomaly or disease including infectious or traumatic ulcers
• Dermatitis of the penis or foreskin
• Genital warts
• Urethral discharge
• Balanitis

Sponsors & Collaborators

• Jhpiego: lead
• Ministry of Health, Mozambique: collaborator
• Centers for Disease Control and Prevention: collaborator
• Columbia University: collaborator

Study Sites (3)

Matola II Health Center

Matola, Maputo Province, Mozambique

Location

September 17 Health Center

Quelimane, Zambezia Province, Mozambique

Location

Infulene Psychiatric Hospital

Maputo, Mozambique

Location

Study Officials

• Edgar Necochea, MD, MPH

  Jhpiego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: November 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

MO (3)