Odor Levels of Study Arms Clinical Trial
— RMC-10Official title:
A Prospective, Randomized, Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Techniques When Using the PrePexTM Device
Verified date | May 2014 |
Source | Ministry of Health, Rwanda |
Contact | n/a |
Is FDA regulated | No |
Health authority | Rwanda: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 49 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Rwanda | Rwanda Military Hospital | Kigali |
Lead Sponsor | Collaborator |
---|---|
Ministry of Health, Rwanda |
Rwanda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Dilution-to-Threshold" (D/T) values | The measurements were done by a Nasal Ranger device | Baseline, 3, 5 and 7 days | No |