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

Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative 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: HIV
• Intervention / Treatment: Device: PrePex™ device for adult male circumcision; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

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: Yes
• 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,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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	To compare the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure.	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectations of men regarding the procedure	Expectations of men regarding the procedure using questionnaires	9 weeks
Satisfaction rate of the procedure	Satisfaction with procedure using questionnaires and evaluations	9 weeks
Attitudes towards procedure	Attitudes towards procedure using questionnaires	9 weeks
Sharing information with family and friends	Sharing information with family and friends by evaluating weather subjects would recommend the procedure to others using questionnaires	9 weeks
Perception of norms	Perception of norms using questionnaires	9 weeks
Sexual relations, performance, satisfaction	Sexual relations, performance, satisfaction using questionnaires	9 weeks
Sexual behavior	Sexual behavior using questionnaires. Inquiring of sexual behavior before and after the circumcision, etc.	9 weeks
Sexual partner's attitudes	Sexual partner's attitudes using questionnaires and investigating the partner's behavior change as a result of her partner's circumcision.	9 weeks
Effect on daily activities	Effect on daily activities using questionnaires. Inquiring and finding out if the MC procedure caused any missing of working days.	9 weeks
Costs	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	9 weeks
Cost-effectiveness	Cost-effectiveness	9 weeks

Collaborators and Investigators

• Sponsor: Ministry of Health and Child Welfare, Zimbabwe

Publications and helpful links

General Publications

• Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T. Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions. Cochrane Database Syst Rev. 2021 Mar 31;3(3):CD012250. doi: 10.1002/14651858.CD012250.pub2.
• Tshimanga M, Mangwiro T, Mugurungi O, Xaba S, Murwira M, Kasprzyk D, Montano DE, Nyamukapa D, Tambashe B, Chatikobo P, Gundidza P, Gwinji G. A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex Device to Forceps Guided Surgical Circumcision in Zimbabwe. PLoS One. 2016 May 26;11(5):e0156220. doi: 10.1371/journal.pone.0156220. eCollection 2016.

Helpful Links

• MRCZ

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 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 Prevention; Medical Device; Male Circumcision
• Other Study ID Numbers: MRCZ/A/1628 Comparative study