An Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Methods With PrePexTM
RMC-10
A Prospective, Randomized, Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Techniques When Using the PrePexTM Device
1 other identifier
interventional
101
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
June 3, 2014
CompletedJune 3, 2014
May 1, 2014
1 month
May 22, 2014
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Dilution-to-Threshold" (D/T) values
The measurements were done by a Nasal Ranger device
Baseline, 3, 5 and 7 days
Study Arms (3)
Arm 1
NO INTERVENTIONSubjects followed the current hygiene instructions, standard washing in a shower with soap.
Arm 2
ACTIVE COMPARATORSubjects cleaned the foreskin with soapy water using a syringe once a day.
Arm 3
ACTIVE COMPARATORSubjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rwanda Military Hospital
Kigali, 00000, Rwanda
Related Publications (1)
Mutabazi V, Bitega JP, Ngeruka LM, Karema C, Binagwaho A. Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision. PLoS One. 2015 May 29;10(5):e0126664. doi: 10.1371/journal.pone.0126664. eCollection 2015.
PMID: 26023772DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Mutabazi, M.D.
RBC-Medical Research Centre (MRC)
- PRINCIPAL INVESTIGATOR
Jean Paul Bitega, M.D.
Military Insurance Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Research Grants Unit
Study Record Dates
First Submitted
May 22, 2014
First Posted
June 3, 2014
Study Start
November 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 3, 2014
Record last verified: 2014-05