Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Mufuta Tshimanga, Ministry of Health and Child Welfare, Zimbabwe
ClinicalTrials.gov Identifier:
NCT01956383
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
Circumcision Adult
HIV CDC Category B2
Device: PrePex™ device
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses Study)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To assess the safety of the PrePex device when circumcision is performed by nurses [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate when circumcision is performed by nurses


Secondary Outcome Measures:
  • Evaluate the training needs of PrePexTM deployment using nurses [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    1. PrePex Procedure time and the resulting cost of provider's time
    2. Cost Effectiveness • Cost of device
    3. Evaluation of the PrePex training needs and efficacy
    4. Acceptability of the PrePex procedure by the patients

  • Observation of in-field usability of device [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Observation of in-field usability of device using questionnaires

  • Obtain user feedback from nurses [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Obtain user feedback from nurses by questionnaires

  • Assess safety compared to physician deployment [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
    1. To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate, when circumcision is performed by nurses comparing to Physicians.

  • Assess practicality and acceptability among nurses and patients [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Assess practicality and acceptability among nurses and patients using questionnaires.

  • Assess satisfaction of procedure among nurses and patients [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Assess satisfaction of procedure among nurses and patients using questionnaires.

  • Determine cost-effectiveness compared to surgical procedure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    1. Evaluating the cost-effectiveness when taking into account the following parameters: i. PrePex Procedure time and the resulting cost of provider's time compared to surgical procedure ii. Cost of device compared to surgical procedure iii. Cost of device training compared to surgical procedure training iv. Cost of staff time for follow-up visits compared to compared to surgical procedure staff time v. Cost of equipment and supplies needed for the circumcision procedure for both PrePex and surgical circumcision.


Enrollment: 603
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PrePex™ device
Adult male circumcision by the PrePex™ device
Device: PrePex™ device
PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures

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 ,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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01956383

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: NCT01956383     History of Changes
Other Study ID Numbers: MRCZ/A/1628 Nurses 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
Zimbabwe

ClinicalTrials.gov processed this record on April 17, 2014