NCT01956370

Brief Summary

The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

September 19, 2012

Last Update Submit

October 6, 2013

Conditions

HIV

Keywords

Male CircumcisionHIV PreventionMedical Device

Outcome Measures

Primary Outcomes (1)

  • Procedure time

    To compare the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure.

    9 weeks

Secondary Outcomes (11)

  • Expectations of men regarding the procedure

    9 weeks

  • Satisfaction rate of the procedure

    9 weeks

  • Attitudes towards procedure

    9 weeks

  • Sharing information with family and friends

    9 weeks

  • Perception of norms

    9 weeks

  • +6 more secondary outcomes

Study Arms (2)

PrePex™ device

EXPERIMENTAL

Intervention 'PrePex™ device for adult male circumcision

Device: PrePex™ device for adult male circumcision

Surgical

ACTIVE COMPARATOR

Adult male surgical circumcision

Procedure: Surgical circumcision

Interventions

PrePex™ device for adult male circumcisionDEVICE

The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.

Also known as: The PrePex Device, PrePex, PrePex™
PrePex™ device
Surgical circumcisionPROCEDURE

The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008

Surgical

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18 - 30 years
  • Uncircumcised
  • Wants to be circumcised
  • Agrees to be circumcised by any of the study methods,PrePexTM or Surgical as appropriate
  • HIV sero-negative
  • Able to understand the study procedures and requirements
  • Agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total)
  • Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
  • Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
  • Subject agrees to anonymous video and photographs of the procedure and follow up visits
  • Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours

You may not qualify if:

  • Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
  • HIV sero-positive
  • Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
  • Known bleeding / coagulation abnormality
  • Uncontrolled diabetes
  • Subject that to the opinion of the investigator is not a good candidate
  • Subject does not agree to anonymous video and photographs of the procedure and follow up visits
  • Refusal to take HIV test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Znfpc Spilhaus Center

Harare, Zimbabwe

Location

Related Publications (2)

  • Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T. Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions. Cochrane Database Syst Rev. 2021 Mar 31;3(3):CD012250. doi: 10.1002/14651858.CD012250.pub2.

    PMID: 33786810DERIVED

  • Tshimanga M, Mangwiro T, Mugurungi O, Xaba S, Murwira M, Kasprzyk D, Montano DE, Nyamukapa D, Tambashe B, Chatikobo P, Gundidza P, Gwinji G. A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex Device to Forceps Guided Surgical Circumcision in Zimbabwe. PLoS One. 2016 May 26;11(5):e0156220. doi: 10.1371/journal.pone.0156220. eCollection 2016.

    PMID: 27227679DERIVED

Related Links

Study Officials

  • Gerald Gwinji, MBChB, MPH

    PS- MoHCW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public Health Physician, Department of Community Medicine, University of Zimbabwe

Study Record Dates

First Submitted

September 19, 2012

First Posted

October 8, 2013

Study Start

November 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

ZI(1)