- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01434628
Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses
One Arm, Open Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses in Resource Limited Settings for HIV Prevention
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Male circumcision can reduce the lifetime risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa. In 2009, the US Government (USAID) reported that scaling up male circumcision to reach 80 percent of adult and newborn males in 14 African countries by 2015 could potentially avert more than 4 million adult HIV infections between 2009 and 2025 and yield annual cost savings of US$1.4 - 1.8 billion after 2015, with a total net savings of US$20.2 billion between 2009 and 2025.
There are over 38 million adolescent and adult males in Africa that could benefit from male circumcision for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resource limited settings.
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.
The study will evaluate 75 subjects in training phase, 100 subjects in a pilot group and then additional 415 in a pivotal group summing up to 590.
The 503 subjects assigned to the Pivotal group will undergo standard PrePex procedure and follow up and will be the main core of the study. An interim safety report will be prepared after 100 subjects (Pilot Group). Up to 75 subjects will be enrolled to the Training group.
The study will assess the safety and efficacy of the PrePex device when circumcision is performed by nurses, among healthy adult men scheduled for voluntary circumcision, in preparation for scale up.
The Study duration per subject will be 8 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kigali, Rwanda
- Kanombe Military Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PrePex™ device
Adult male circumcision by the PrePex™ device
|
PrePex™ device for adult male circumcision.
The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the safety of the PrePex device when circumcision is performed by nurses
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluating the cost of PrePex circumcision procedure
Time Frame: 8 weeks
|
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 device training iii. Cost of staff time for follow-up visits iv. Cost of equipment and supplies needed for the circumcision procedure |
8 weeks
|
To evaluate the PrePex training needs
Time Frame: 8 weeks
|
Evaluation of the PrePex training needs and efficacy, including Direct measures by testing PrePex skills following participation in a formal training course Indirect measures of training efficacy by evaluating rate of AE and Average procedure time
|
8 weeks
|
Assessing ideal messaging for scale up sensitization, to include:
Time Frame: 8 weeks
|
Assessing ideal messaging for scale up sensitization, to include:
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Mutabazi, M.D., TRAC Plus
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RMC-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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