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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)

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ClinicalTrials.gov Identifier: NCT01956396
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Circumcision Adult HIV CDC Category B2 HIV Infections Device: PrePex™ device Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe
Study Start Date : October 2011
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental: PrePex™ device
Adult male circumcision by the PrePex™ device
Device: PrePex™ device
PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia


Outcome Measures

Primary Outcome Measures :
  1. The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe [ Time Frame: 8 week post-procedure follow up appointment and examination ]

    Outcome measures include:

    Clinical adverse events and device-related incidents



Secondary Outcome Measures :
  1. Evaluating the procedure duration [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    The total procedure and preparation time of the PrePex™ device circumcision procedure

  2. Evaluating the pain at key time points [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    Pain assessment at key time points using Visual Analog Scale (VAS)

  3. Evaluating the discomfort during daily activities [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    using questionnaires

  4. Evaluating the compliance during use (with follow-up) [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    compliance during use (with follow-up)using questionnaires

  5. Evaluating the procedure acceptability by Doctors [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    procedure acceptability by Doctors using questionnaires

  6. Glans fully exposed [ Time Frame: 8 week post-procedure follow up appointment and examination ]
  7. Evaluating time to complete healing [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    time to complete healing using wound assessment

  8. Evaluating the cosmetic results [ Time Frame: 8 week post-procedure follow up appointment and examination ]
  9. Procedure acceptability by Nurses [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    Procedure acceptability by Nurses using questionnaires

  10. Satisfaction by subjects [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    Satisfaction by subjects

  11. Satisfaction by providers [ Time Frame: 8 week post-procedure follow up appointment and examination ]
    using questionnaires


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes 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

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): NCT01956396


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

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: NCT01956396     History of Changes
Other Study ID Numbers: MRCZ/A/1628 Safety Study
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by Prof. Mufuta Tshimanga, Ministry of Health and Child Welfare, Zimbabwe:
male circumcision
HIV
Zimbabwe

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases