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

NCT ID: NCT01956370

Last Updated: 2013-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-02-29

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.

Conditions

HIV

Keywords

Male Circumcision; HIV Prevention; Medical Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PrePex™ device

Intervention 'PrePex™ device for adult male circumcision

Group Type: EXPERIMENTAL

PrePex™ device for adult male circumcision

Intervention Type: DEVICE

The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.

Surgical

Adult male surgical circumcision

Group Type: ACTIVE_COMPARATOR

Surgical circumcision

Intervention Type: PROCEDURE

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

Interventions

PrePex™ device for adult male circumcision

The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Other Intervention Names

The PrePex Device; PrePex; PrePex™

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health and Child Welfare, Zimbabwe

OTHER

Sponsor Role: lead

Responsible Party

Prof. Mufuta Tshimanga

Public Health Physician, Department of Community Medicine, University of Zimbabwe

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Gwinji, MBChB, MPH

Role: PRINCIPAL_INVESTIGATOR

PS- MoHCW

Locations

Znfpc Spilhaus Center

Harare, , Zimbabwe

Countries

Zimbabwe

References

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.

Reference Type: DERIVED

PMID: 33786810 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27227679 (View on PubMed)

Related Links

http://www.mrcz.org.zw/

MRCZ

Other Identifiers

MRCZ/A/1628 Comparative study

Identifier Type: -

Identifier Source: org_study_id