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

Circumcision Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956383
• Other study ID #: MRCZ/A/1628 Nurses Study
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2012
• Last updated: October 6, 2013
• Start date: April 2012
• Est. completion date: September 2012

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: 603
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• 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

Intervention

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

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	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	Yes
Secondary	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	No
Secondary	Observation of in-field usability of device	Observation of in-field usability of device using questionnaires	9 weeks	No
Secondary	Obtain user feedback from nurses	Obtain user feedback from nurses by questionnaires	9 weeks	No
Secondary	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	Yes
Secondary	Assess practicality and acceptability among nurses and patients	Assess practicality and acceptability among nurses and patients using questionnaires.	9 weeks	No
Secondary	Assess satisfaction of procedure among nurses and patients	Assess satisfaction of procedure among nurses and patients using questionnaires.	9 weeks	No
Secondary	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	No

External Links

•   MRCZ