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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vincent Mutabazi, Ministry of Health, Rwanda
ClinicalTrials.gov Identifier:
NCT01434628
First received: September 10, 2011
Last updated: May 22, 2014
Last verified: May 2014

September 10, 2011
May 22, 2014
July 2011
November 2011   (final data collection date for primary outcome measure)
To assess the safety of the PrePex device when circumcision is performed by nurses [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01434628 on ClinicalTrials.gov Archive Site
  • Evaluating the cost of PrePex circumcision procedure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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

  • To evaluate the PrePex training needs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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
  • Assessing ideal messaging for scale up sensitization, to include: [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    Assessing ideal messaging for scale up sensitization, to include:

    • Acceptability of the PrePex procedure by the patients and their partners
    • Indirect measures by collecting data on reasons to decline participation in the study and the percent of declining
    • Acceptability of the PrePex procedure by the care givers
  • Evaluating the cost-effectiveness of PrePex circumcision procedure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    Evaluating the cost-effectiveness 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

    iii. Cost of device training

    iv. Cost of staff time for follow-up visits

    v. Cost of equipment and supplies needed for the circumcision procedure

  • To evaluate the PrePex training needs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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
  • Assessing ideal messaging for scale up sensitization, to include: [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    Assessing ideal messaging for scale up sensitization, to include:

    • Acceptability of the PrePex procedure by the patients and their partners
    • Indirect measures by collecting data on reasons to decline participation in the study and the percent of declining
    • Acceptability of the PrePex procedure by the care givers
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Male Circumcision
  • HIV Prevention
Device: PrePex™ device
PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
Experimental: PrePex™ device
Adult male circumcision by the PrePex™ device
Intervention: Device: PrePex™ device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
590
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Male
21 Years to 54 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Rwanda
 
NCT01434628
RMC-03
No
Vincent Mutabazi, Ministry of Health, Rwanda
Ministry of Health, Rwanda
Not Provided
Principal Investigator: Vincent Mutabazi, M.D. TRAC Plus
Ministry of Health, Rwanda
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP