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

NCT01434628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2014-05-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, Rwanda

    lead OTHER_GOV

Principal Investigators

  • Vincent Mutabazi, M.D. · TRAC Plus

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-11-30
Completion
2011-12-31

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 NCT01434628 on ClinicalTrials.gov