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Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe (ZW-01)

Primary Purpose

Circumcision Adult, HIV CDC Category B2, HIV Infections

Status
Completed
Phase
Phase 1
Locations
Zimbabwe
Study Type
Interventional
Intervention
PrePex™ device
Sponsored by
Ministry of Health and Child Welfare, Zimbabwe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Circumcision Adult focused on measuring male circumcision, HIV, Zimbabwe

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages 18 - 30 years
  • Uncircumcised
  • Wants to be circumcised
  • Agrees to be circumcised by any of the study methods,PrePex 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Znfpc Spilhaus Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: PrePex™ device

Arm Description

Adult male circumcision by the PrePex™ device

Outcomes

Primary Outcome Measures

The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe
Outcome measures include: Clinical adverse events and device-related incidents

Secondary Outcome Measures

Evaluating the procedure duration
The total procedure and preparation time of the PrePex™ device circumcision procedure
Evaluating the pain at key time points
Pain assessment at key time points using Visual Analog Scale (VAS)
Evaluating the discomfort during daily activities
using questionnaires
Evaluating the compliance during use (with follow-up)
compliance during use (with follow-up)using questionnaires
Evaluating the procedure acceptability by Doctors
procedure acceptability by Doctors using questionnaires
Glans fully exposed
Evaluating time to complete healing
time to complete healing using wound assessment
Evaluating the cosmetic results
Procedure acceptability by Nurses
Procedure acceptability by Nurses using questionnaires
Satisfaction by subjects
Satisfaction by subjects
Satisfaction by providers
using questionnaires

Full Information

First Posted
September 19, 2012
Last Updated
October 6, 2013
Sponsor
Ministry of Health and Child Welfare, Zimbabwe
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1. Study Identification

Unique Protocol Identification Number
NCT01956396
Brief Title
Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe
Acronym
ZW-01
Official Title
Phase I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health and Child Welfare, Zimbabwe

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline. The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings. Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circumcision Adult, HIV CDC Category B2, HIV Infections
Keywords
male circumcision, HIV, Zimbabwe

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: PrePex™ device
Arm Type
Experimental
Arm Description
Adult male circumcision by the PrePex™ device
Intervention Type
Device
Intervention Name(s)
PrePex™ device
Intervention Description
PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia
Primary Outcome Measure Information:
Title
The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe
Description
Outcome measures include: Clinical adverse events and device-related incidents
Time Frame
8 week post-procedure follow up appointment and examination
Secondary Outcome Measure Information:
Title
Evaluating the procedure duration
Description
The total procedure and preparation time of the PrePex™ device circumcision procedure
Time Frame
8 week post-procedure follow up appointment and examination
Title
Evaluating the pain at key time points
Description
Pain assessment at key time points using Visual Analog Scale (VAS)
Time Frame
8 week post-procedure follow up appointment and examination
Title
Evaluating the discomfort during daily activities
Description
using questionnaires
Time Frame
8 week post-procedure follow up appointment and examination
Title
Evaluating the compliance during use (with follow-up)
Description
compliance during use (with follow-up)using questionnaires
Time Frame
8 week post-procedure follow up appointment and examination
Title
Evaluating the procedure acceptability by Doctors
Description
procedure acceptability by Doctors using questionnaires
Time Frame
8 week post-procedure follow up appointment and examination
Title
Glans fully exposed
Time Frame
8 week post-procedure follow up appointment and examination
Title
Evaluating time to complete healing
Description
time to complete healing using wound assessment
Time Frame
8 week post-procedure follow up appointment and examination
Title
Evaluating the cosmetic results
Time Frame
8 week post-procedure follow up appointment and examination
Title
Procedure acceptability by Nurses
Description
Procedure acceptability by Nurses using questionnaires
Time Frame
8 week post-procedure follow up appointment and examination
Title
Satisfaction by subjects
Description
Satisfaction by subjects
Time Frame
8 week post-procedure follow up appointment and examination
Title
Satisfaction by providers
Description
using questionnaires
Time Frame
8 week post-procedure follow up appointment and examination

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 18 - 30 years Uncircumcised Wants to be circumcised Agrees to be circumcised by any of the study methods,PrePex 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Gwinji, MBChB, MPH
Organizational Affiliation
PS- MoHCW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Znfpc Spilhaus Center
City
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Links:
URL
http://www.mrcz.org.zw/
Description
MRCZ

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Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe

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