Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Mufuta Tshimanga, Ministry of Health and Child Welfare, Zimbabwe
ClinicalTrials.gov Identifier:
NCT01956370
First received: September 19, 2012
Last updated: October 6, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
HIV
Device: PrePex™ device for adult male circumcision
Procedure: Surgical circumcision
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)

Resource links provided by NLM:


Further study details as provided by Ministry of Health and Child Welfare, Zimbabwe:

Primary Outcome Measures:
  • Procedure time [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    To compare the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure.


Secondary Outcome Measures:
  • Expectations of men regarding the procedure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Expectations of men regarding the procedure using questionnaires

  • Satisfaction rate of the procedure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Satisfaction with procedure using questionnaires and evaluations

  • Attitudes towards procedure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Attitudes towards procedure using questionnaires

  • Sharing information with family and friends [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Sharing information with family and friends by evaluating weather subjects would recommend the procedure to others using questionnaires

  • Perception of norms [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Perception of norms using questionnaires

  • Sexual relations, performance, satisfaction [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Sexual relations, performance, satisfaction using questionnaires

  • Sexual behavior [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Sexual behavior using questionnaires. Inquiring of sexual behavior before and after the circumcision, etc.

  • Sexual partner's attitudes [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Sexual partner's attitudes using questionnaires and investigating the partner's behavior change as a result of her partner's circumcision.

  • Effect on daily activities [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Effect on daily activities using questionnaires. Inquiring and finding out if the MC procedure caused any missing of working days.

  • Costs [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

    Evaluating the cost of PrePex circumcision procedure when taking into account the following parameters:

    i. PrePex Procedure time and the resulting cost of provider's time ii. Cost of staff time for follow-up visits iii. Cost of equipment and supplies needed for the circumcision procedure


  • Cost-effectiveness [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Cost-effectiveness


Enrollment: 240
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PrePex™ device
Intervention 'PrePex™ device for adult male circumcision
Device: PrePex™ device for adult male circumcision
The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
Other Names:
  • The PrePex Device
  • PrePex
  • PrePex™
Active Comparator: Surgical
Adult male surgical circumcision
Procedure: Surgical circumcision
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
Other Name: Surgical Circumcision

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01956370

Locations
Zimbabwe
Znfpc Spilhaus Center
Harare, Zimbabwe
Sponsors and Collaborators
Ministry of Health and Child Welfare, Zimbabwe
Investigators
Principal Investigator: Gerald Gwinji, MBChB, MPH PS- MoHCW
  More Information

Additional Information:
MRCZ  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Mufuta Tshimanga, Public Health Physician, Department of Community Medicine, University of Zimbabwe, Ministry of Health and Child Welfare, Zimbabwe
ClinicalTrials.gov Identifier: NCT01956370     History of Changes
Other Study ID Numbers: MRCZ/A/1628 Comparative study
Study First Received: September 19, 2012
Last Updated: October 6, 2013
Health Authority: Zimbabwe: Medical Research Council

Keywords provided by Ministry of Health and Child Welfare, Zimbabwe:
Male Circumcision
HIV Prevention
Medical Device

ClinicalTrials.gov processed this record on April 17, 2014