Trial record 3 of 10 for:    prepex

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
  Purpose

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.


Condition Intervention
Male Circumcision
HIV Prevention
Device: PrePex™ device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Rwanda:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 590
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PrePex™ device
Adult male circumcision by the PrePex™ device
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434628

Locations
Rwanda
Kanombe Military Hospital
Kigali, Rwanda
Sponsors and Collaborators
Ministry of Health, Rwanda
Investigators
Principal Investigator: Vincent Mutabazi, M.D. TRAC Plus
  More Information

No publications provided

Responsible Party: Vincent Mutabazi, Head of Reaserch RBC/IHDPC, Ministry of Health, Rwanda
ClinicalTrials.gov Identifier: NCT01434628     History of Changes
Other Study ID Numbers: RMC-03
Study First Received: September 10, 2011
Last Updated: May 22, 2014
Health Authority: Rwanda: Ethics Committee

Keywords provided by Ministry of Health, Rwanda:
Male Circumcision
HIV Prevention
HIV Infections

ClinicalTrials.gov processed this record on September 30, 2014