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

Phase III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses Study)

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

Study Overview

• Status: Completed
• Conditions: Circumcision Adult; HIV CDC Category B2
• Intervention / Treatment: Device: PrePex™ device

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: Interventional
• Enrollment (Actual): 603
• Phase: Phase 3

Contacts and Locations

Study Locations

• Zimbabwe
  • Harare, Zimbabwe
    • Znfpc Spilhaus Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety of the PrePex device when circumcision is performed by nurses	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	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the training needs of PrePexTM deployment using nurses	PrePex Procedure time and the resulting cost of provider's time; Cost Effectiveness • Cost of device; Evaluation of the PrePex training needs and efficacy; Acceptability of the PrePex procedure by the patients	9 weeks
Observation of in-field usability of device	Observation of in-field usability of device using questionnaires	9 weeks
Obtain user feedback from nurses	Obtain user feedback from nurses by questionnaires	9 weeks
Assess safety compared to physician deployment	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.	9 weeks
Assess practicality and acceptability among nurses and patients	Assess practicality and acceptability among nurses and patients using questionnaires.	9 weeks
Assess satisfaction of procedure among nurses and patients	Assess satisfaction of procedure among nurses and patients using questionnaires.	9 weeks
Determine cost-effectiveness compared to surgical procedure	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.	9 weeks

Collaborators and Investigators

• Sponsor: Ministry of Health and Child Welfare, Zimbabwe

Publications and helpful links

Helpful Links

• MRCZ

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: October 6, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): October 8, 2013
• Last Update Submitted That Met QC Criteria: October 6, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: HIV; Zimbabwe; male circumcision
• Other Study ID Numbers: MRCZ/A/1628 Nurses Study