Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe

HIV Infections Clinical Trial

— ZW-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956396
• Other study ID #: MRCZ/A/1628 Safety Study
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2012
• Last updated: October 6, 2013
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: October 2013
• Source: Ministry of Health and Child Welfare, Zimbabwe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zimbabwe: Medical Research Council
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Circumcision Adult
• HIV CDC Category B2
• HIV Infections

Intervention

Device:
• PrePex™ device
PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia

Locations

Country	Name	City	State
Zimbabwe	Znfpc Spilhaus Center	Harare

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health and Child Welfare, Zimbabwe

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Evaluating the discomfort during daily activities	using questionnaires	8 week post-procedure follow up appointment and examination	No
Secondary	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	No
Secondary	Evaluating the procedure acceptability by Doctors	procedure acceptability by Doctors using questionnaires	8 week post-procedure follow up appointment and examination	No
Secondary	Glans fully exposed		8 week post-procedure follow up appointment and examination	No
Secondary	Evaluating time to complete healing	time to complete healing using wound assessment	8 week post-procedure follow up appointment and examination	No
Secondary	Evaluating the cosmetic results		8 week post-procedure follow up appointment and examination	No
Secondary	Procedure acceptability by Nurses	Procedure acceptability by Nurses using questionnaires	8 week post-procedure follow up appointment and examination	No
Secondary	Satisfaction by subjects	Satisfaction by subjects	8 week post-procedure follow up appointment and examination	No
Secondary	Satisfaction by providers	using questionnaires	8 week post-procedure follow up appointment and examination	No

External Links

•   MRCZ