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Trial record 21 of 67 for:    Diseases | ( Map: Mozambique )

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

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ClinicalTrials.gov Identifier: NCT03761836
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Ministry of Health, Mozambique
Centers for Disease Control and Prevention
Columbia University
Information provided by (Responsible Party):
Jhpiego

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.

Condition or disease Intervention/treatment Phase
Circumcision, Male Device: ShangRing Not Applicable

Detailed Description:

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.

Population: 1000 males aged 13 years and above who are seeking male circumcision; 3 clinic sites

Duration: Approximately 3 months of recruitment, 60 days follow-up per participant; total duration expected to be approximately 6 months in the field.

Sample size: Cumulative target of 1000 ShangRing™ procedures, based on guidance contained in the WHO Framework for clinical evaluation of devices for male circumcision. The WHO TAG on Innovations in Male Circumcision recommends active follow-up of the first 1000 clients when a new device is introduced into a program or as a new program is implemented.

Data analysis plan: Baseline demographic and behavioral characteristics of ShangRing™ clients will be summarized using counts and percentages. Association between these variables and selected outcome variables (e.g. AEs, failure to return for device removal, preference for Shang Ring) will be examined through cross tabulations and tests of association (e.g. Chi square statistics).

Data quality assurance: Data quality control efforts will include members of the national VMMC Technical Working Group, including local ShangRing™ Trainers of Trainers, conducting scheduled site assessments/monitoring as follows: Prior to the start of the active surveillance (site initiation) using site assessment checklist; and every month using a VMMC quality assessment checklist. There will be regular monthly supervision visits to the facilities to ensure proper record filing and storage of physical forms. Data will be entered into an electronic system by trained data personnel at the facility level. This data will be reviewed actively and regularly through the central database on a periodic basis. The PI, lead local investigator and co-investigators will regularly monitor and evaluate data for completeness and specifically to monitor for any adverse events that may preclude or terminate the study early. The electronic system will be monitored regularly and by limited access of study personnel.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Program Evaluation and Active Adverse Event Surveillance for Initial Implementation of WHO Prequalified ShangRing™ Circumcision in Mozambique
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: ShangRing
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
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.




Primary Outcome Measures :
  1. Proportion of ShangRing clients who experience moderate and severe adverse events [ Time Frame: 60 days postoperative ]
    Circumcision-related adverse events are classified as moderate and severe per standardized protocol definitions


Secondary Outcome Measures :
  1. Proportion of eligible men who chose ShangRing procedure [ Time Frame: Preoperative ]
    ShangRing will be offered as a neutral alternative to conventional surgery or other available methods

  2. Proportion of ShangRing™ clients who fail to return for device removal on day 7 [ Time Frame: 7 days postoperative ]
    Calculated by site and disaggregated by age group

  3. Pain scores on Visual Analog Scale [ Time Frame: Within 48 hours postoperative ]
    Peri- and post-operative pain scores as determined by visual analog scale



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male, 13 years old and above
  2. 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
  3. 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
  4. 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.

Exclusion Criteria:

  1. Males below 13 years of age
  2. Males for whom the correct fitting size of ShangRing™ Device is not available
  3. Anatomical abnormalities including adhesions
  4. Cognitive impairment
  5. 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
  6. HIV - positive (although may still undergo surgical circumcision)
  7. Anatomical variations and anomalies of genitalia
  8. Hypospadias, epispadias, or other urethral anomaly
  9. Hydrocele
  10. Scrotal hernia
  11. Other genital anomaly or disease including infectious or traumatic ulcers
  12. Dermatitis of the penis or foreskin
  13. Genital warts
  14. Urethral discharge
  15. Balanitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761836


Contacts
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Contact: M&E Director +258 84 323 3006 humberto.muquingue@jhpiego.org

Locations
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Mozambique
Matola II Health Center Not yet recruiting
Matola, Maputo, Mozambique
September 17 Health Center
Quelimane, Zambezia, Mozambique
Infulene Psychiatric Hospital Not yet recruiting
Maputo, Mozambique
Sponsors and Collaborators
Jhpiego
Ministry of Health, Mozambique
Centers for Disease Control and Prevention
Columbia University
Investigators
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Principal Investigator: Edgar Necochea, MD, MPH Jhpiego

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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03761836     History of Changes
Other Study ID Numbers: JHSPH IRB 8231
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No