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

Phase I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe

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 Infections; 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): 53
• Phase: Phase 1

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,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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe	Outcome measures include: Clinical adverse events and device-related incidents	8 week post-procedure follow up appointment and examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the procedure duration	The total procedure and preparation time of the PrePex™ device circumcision procedure	8 week post-procedure follow up appointment and examination
Evaluating the pain at key time points	Pain assessment at key time points using Visual Analog Scale (VAS)	8 week post-procedure follow up appointment and examination
Evaluating the discomfort during daily activities	using questionnaires	8 week post-procedure follow up appointment and examination
Evaluating the compliance during use (with follow-up)	compliance during use (with follow-up)using questionnaires	8 week post-procedure follow up appointment and examination
Evaluating the procedure acceptability by Doctors	procedure acceptability by Doctors using questionnaires	8 week post-procedure follow up appointment and examination
Glans fully exposed		8 week post-procedure follow up appointment and examination
Evaluating time to complete healing	time to complete healing using wound assessment	8 week post-procedure follow up appointment and examination
Evaluating the cosmetic results		8 week post-procedure follow up appointment and examination
Procedure acceptability by Nurses	Procedure acceptability by Nurses using questionnaires	8 week post-procedure follow up appointment and examination
Satisfaction by subjects	Satisfaction by subjects	8 week post-procedure follow up appointment and examination
Satisfaction by providers	using questionnaires	8 week post-procedure follow up appointment and examination

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: October 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

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
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: MRCZ/A/1628 Safety Study