An Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Methods With PrePexTM (RMC-10)

May 29, 2014 updated by: Vincent Mutabazi, Ministry of Health, Rwanda

A Prospective, Randomized, Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Techniques When Using the PrePexTM Device

The PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing trainings and formal guidelines. As part of the Government's efforts to improve the PrePex implementation, it made efforts to improve the psychology acceptability of the PrePex by men and thus to increase the uptake with VMMC in sub-Saharan Africa.

Some men who gone through the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it is placed. This complaint was identified as potential risk for the PrePex uptake. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor to the patient foreskin hygiene technique. It was speculated that a patient that follows an appropriate foreskin hygiene technique while wearing the device will have a significantly lower foreskin odor on day 7 than a patient who does not follow such technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a study to test different hygiene cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Voluntary Medical Male Circumcision (VMMC) is a one-time, low cost intervention that shown to reduce men's risk of HIV infection by 53%-60% and by up to 73% in post-trial observation. Numerous papers on the topic have been published over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan countries.

The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS (UNAIDS) have endorsed innovative approaches to VMMC uptake in settings where HIV prevalence and incidence is high but male circumcision (MC) prevalence remains low in 14 target countries. Recent modelling commissioned by President's Emergency Plan For AIDS Relief (PEPFAR) and UNAIDS have agreed on an action plan to reach 80% coverage of VMMC in the 14 countries by 2015, this will entail performing roughly 20 million adult VMMC by 2015, averting approximately 3.36 million new HIV infections and saving US$16.5 billion.

The PrePex became the first medical device for adult male circumcision to receive WHO prequalification as an alternative to the conventional surgical circumcision methods already recognized by WHO. The PrePex VMMC procedure is bloodless and requires no injected anesthesia, suturing, or sterile setting, it applies controlled radial elastic pressure to the foreskin between a rigid Inner Ring and an Elastic Ring to cut off distal blood flow. After 7 days, the necrotic foreskin and the device are removed.

The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing trainings and formal guidelines. As part of the Government's efforts to improve the PrePex implementation, it made efforts to improve the psychology acceptability of the PrePex by men and thus to increase the uptake with VMMC in sub-Saharan Africa.

PrePex researchers from Rwanda have assumed that there is a possible relation between the level of odor from the foreskin to the foreskin hygiene technique. It was speculated that when a patient follows an appropriate foreskin hygiene technique while wearing the device, the odor before device removal (day 7) will be significantly lower than the odor of the foreskin of a subject who follows a less effective foreskin hygiene technique.

Providing scientific evidence of the direct relation between odor and specific foreskin hygiene technique, will allow VMMC implementing bodies to create a comprehensive and effective PrePex related hygiene guidelines and reduce the potential of complaints from men therefore, increasing the acceptability rate. A randomized, controlled, blinded study to assess the effectiveness of 3 different foreskin hygiene techniques was conducted at Rwanda Military Hospital Kigali, Rwanda during November 18th to December 4th, 2013.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda, 00000
        • Rwanda Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Inclusion Criteria:

    • Ages - 21 to 49 years
    • Subject wants to be circumcised
    • Uncircumcised
    • Able to understand the study procedures and requirements
    • Agrees to participate in one of the arms and to follow hygiene instructions
    • Agrees to have Independent blinded smell reviewers in the same room on Removal visit
    • Agrees that his partner will be interviewed via telephone
    • Agrees to abstain sexual intercourse for 6 weeks post device removal
    • Agrees to abstain from masturbation for 2 weeks post device removal
    • Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 1 week
    • 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, by questionnaire
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Arm 1
Subjects followed the current hygiene instructions, standard washing in a shower with soap.
ACTIVE_COMPARATOR: Arm 2
Subjects cleaned the foreskin with soapy water using a syringe once a day.
Procedure: Subjects cleaned the foreskin with soapy water using a syringe once a day.
ACTIVE_COMPARATOR: Arm 3
Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.
Procedure: Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dilution-to-Threshold" (D/T) values
Time Frame: Baseline, 3, 5 and 7 days
The measurements were done by a Nasal Ranger device
Baseline, 3, 5 and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Rwanda

Investigators

  • Principal Investigator: Vincent Mutabazi, M.D., RBC-Medical Research Centre (MRC)
  • Principal Investigator: Jean Paul Bitega, M.D., Military Insurance Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (ESTIMATE)

June 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Odor Study (RMC-10)

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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