An Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Methods With PrePexTM
Condition: Odor Levels of Study Arms
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Subjects cleaned the foreskin with soapy water using a syringe once a day.; Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrePex; Odor; Cleaning technique; Male Circumcision; HIV; AIDS; Chlorhexidine; Soap