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

Tracking Information
First Submitted Date ICMJE	September 19, 2012
First Posted Date ICMJE	October 8, 2013
Last Update Posted Date	October 8, 2013
Study Start Date ICMJE	October 2011
Actual Primary Completion Date	November 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 6, 2013)	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
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: October 6, 2013)	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; 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); Evaluating the discomfort during daily activities [ Time Frame: 8 week post-procedure follow up appointment and examination ]using questionnaires; 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; Evaluating the procedure acceptability by Doctors [ Time Frame: 8 week post-procedure follow up appointment and examination ]procedure acceptability by Doctors using questionnaires; Glans fully exposed [ Time Frame: 8 week post-procedure follow up appointment and examination ]; Evaluating time to complete healing [ Time Frame: 8 week post-procedure follow up appointment and examination ]time to complete healing using wound assessment; Evaluating the cosmetic results [ Time Frame: 8 week post-procedure follow up appointment and examination ]; Procedure acceptability by Nurses [ Time Frame: 8 week post-procedure follow up appointment and examination ]Procedure acceptability by Nurses using questionnaires; Satisfaction by subjects [ Time Frame: 8 week post-procedure follow up appointment and examination ]Satisfaction by subjects; Satisfaction by providers [ Time Frame: 8 week post-procedure follow up appointment and examination ]using questionnaires
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe
Official Title ICMJE	Phase I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Circumcision Adult; HIV CDC Category B2; HIV Infections
Intervention ICMJE	Device: PrePex™ device; PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia
Study Arms	Experimental: Experimental: PrePex™ device; Adult male circumcision by the PrePex™ device; Intervention: Device: PrePex™ device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 6, 2013)	53
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2011
Actual Primary Completion Date	November 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 30 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Zimbabwe
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01956396
Other Study ID Numbers ICMJE	MRCZ/A/1628 Safety Study
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Prof. Mufuta Tshimanga, Ministry of Health and Child Welfare, Zimbabwe
Study Sponsor ICMJE	Ministry of Health and Child Welfare, Zimbabwe
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Gerald Gwinji, MBChB, MPH PS- MoHCW
PRS Account	Ministry of Health and Child Welfare, Zimbabwe
Verification Date	October 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP