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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1001

Last updated 2013-08-13

No results posted yet for this study

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

Interventions

DEVICE

PrePex™ 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.

Sponsors & Collaborators

  • Ministry of Health, Rwanda

    lead OTHER_GOV

Principal Investigators

  • Vincent Mutabazi, M.D. · Ministry of Health, Rwanda

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Rwanda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01921608 on ClinicalTrials.gov