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

HIV Clinical Trial

Official title:

Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956370
• Other study ID #: MRCZ/A/1628 Comparative study
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2012
• Last updated: October 6, 2013
• Start date: November 2011
• Est. completion date: February 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: 240
• Est. completion date: February 2012
• Est. primary completion date: February 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,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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Device:
• PrePex™ device for adult male circumcision
The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.

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

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	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	No
Secondary	Expectations of men regarding the procedure	Expectations of men regarding the procedure using questionnaires	9 weeks	No
Secondary	Satisfaction rate of the procedure	Satisfaction with procedure using questionnaires and evaluations	9 weeks	No
Secondary	Attitudes towards procedure	Attitudes towards procedure using questionnaires	9 weeks	No
Secondary	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	No
Secondary	Perception of norms	Perception of norms using questionnaires	9 weeks	No
Secondary	Sexual relations, performance, satisfaction	Sexual relations, performance, satisfaction using questionnaires	9 weeks	No
Secondary	Sexual behavior	Sexual behavior using questionnaires. Inquiring of sexual behavior before and after the circumcision, etc.	9 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Cost-effectiveness	Cost-effectiveness	9 weeks	No

External Links

•   MRCZ