Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses

NCT01434628 | Completed

• 1 other identifier: RMC-03
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

Brief Summary

A range of observational and epidemiological studies have shown that the lifetime risk of HIV infection can be reduced by 70% through male circumcision. Rwanda has a national plan to offer a voluntary male circumcision (MC) program to 2 million adult men in 2 years as part of a comprehensive HIV prevention strategy. To achieve this goal, the government launched a national study, based on the WHO Framework for Evaluation of Adult MC Devices, to assess the safety, efficacy and supremacy of the PrePex™ device when compared to surgical circumcision. The PrePex device was developed to facilitate rapid scale up of non-surgical adult male circumcision in resource limited settings. Rwanda validated the aforementioned endpoints via physicians in a Safety and Efficacy Study (NCT01150370) and Randomized, Controlled Comparison Study (NCT01284088). The procedure was bloodless, required no anesthesia, no sutures and no sterile settings, with 1 AE that was managed with minimal intervention. Evidence submitted to members of WHO, USAID, UNAIDS and the Bill and Melinda Gates Foundation, and WHO audited the study site. The Safety and Efficacy study results were published in the JAIDS Journal of Acquired Immune Deficiency Syndromes, Sept 8, 2011, and presented in CROI 2011 and AUA 2011. To achieve its national "catch up" campaign with minimal burden to the overly strained health system, which lacks physicians and surgical infrastructure, Rwanda needs to task shift the procedure to nurses. This study is meant to test the Safety and Efficacy in the hands of non-surgically trained nurses from the A1 and A2 cadres.

Conditions

Male Circumcision; HIV Prevention

Keywords

Male Circumcision; HIV Prevention; HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (3)

• Evaluating the cost of PrePex circumcision procedure

  8 weeks

• To evaluate the PrePex training needs

  8 weeks

• Assessing ideal messaging for scale up sensitization, to include:

  8 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. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures

PrePex™ device

Eligibility Criteria

• Age: 21 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 21 - 54 years
• Subject wants to be circumcised
• Uncircumcised
• Able to understand the study procedures and requirements
• Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, for 8 weeks.
• Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 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
• 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
• Refusal to take HIV test

Sponsors & Collaborators

• Ministry of Health, Rwanda: lead

Study Sites (1)

Kanombe Military Hospital

Kigali, Kigali, Rwanda

Location

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.

  TRAC Plus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Reaserch RBC/IHDPC

Study Record Dates

• First Submitted: September 10, 2011
• First Posted: September 15, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

RW (1)