Odor Levels of Study Arms Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention