Safety Study of the PrePex Device for Non-Surgical Adult Male Circumcision During Phased in National Implementation in an Effort to Prevent the Spread of HIV

NCT01921608 | Completed

• 1 other identifier: RMC-07
• Study Type: interventional
• Target: 1,001
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision. Numerous papers on the topic were published in the past two decades to elevate HIV prevention awareness, especially in sub-Saharan countries. Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the government is continuing to study the PrePex™ device, developed to enable rapid adult male circumcision in resource limited settings. In February 2012, Rwanda has received WHO recommendation to scale up Adult Male male circumcision (MC) using the PrePex device. Based on WHO recommendation (Use of devices for adult male circumcision in public health HIV prevention programs: Conclusions of the Technical Advisory Group on Innovations in Male Circumcision, March 2012, WHO/HIV/2012.7), which recommended that the phased implementation include an active surveillance of the first 1000 clients to identify and record all adverse events and side-effects based on standardized definitions. The active surveillance may change to passive surveillance after the first 1000 clients, if the incidence of events is reassuringly low, as determined by independent review.

Conditions

Male Circumcision

Keywords

Male Circumcision; HIV Prevention; HIV Infections

Outcome Measures

Primary Outcomes (1)

• To assess the safety of scaling up Voluntary Medical Male Circumcision (VMMC) with the PrePex device by assessing the rate of moderate and severe AEs and allowing the program to continue with passive surveillance

  2 weeks

Study Arms (1)

PrePex™ device

EXPERIMENTAL

Adult male circumcision by the PrePex™ device

Device: PrePex™ device

Interventions

PrePex™ device DEVICE

PrePex™ device for adult male circumcision programs. The PrePex™ device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures.

PrePex™ device

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages - 21 to 49 years
• Subject wants to be circumcised
• Uncircumcised
• Able to understand the study procedures and requirements
• Agrees to abstain sexual intercourse for 6 weeks post device removal
• Agrees to abstain from masturbation for 2 weeks post device removal
• Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 1 week post removal (2 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

You may not qualify if:

• Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
• 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, by questionnaire
• Subject who have an abnormal penile anatomy or any penile diseases
• 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

Sponsors & Collaborators

• Ministry of Health, Rwanda: lead

Study Sites (1)

Rwanda Military Hospital

Kigali, Rwanda

Location

Related Links

• Rwanda Biomedical Centre

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Vincent Mutabazi, M.D.

  Ministry of Health, Rwanda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Research Grants Unit

Study Record Dates

• First Submitted: February 17, 2013
• First Posted: August 13, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

RW (1)