Odor Levels of Study ArmsRMC-10NCT02153658
An Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Methods With PrePexTM
A study testing Subjects cleaned the foreskin with soapy water using a syringe once a day. and Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day. in people with Odor Levels of Study Arms, run by Ministry of Health, Rwanda at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Odor Levels of Study Arms
- What is being tested?
- Subjects cleaned the foreskin with soapy water using a syringe once a day. and Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteRwanda
- Study dates
- Nov 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Odor Levels of Study Arms
- Being tested
- 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.
- Keywords
- PrePex, Odor, Cleaning technique, Male Circumcision, HIV, AIDS, Chlorhexidine, Soap
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects cleaned the foreskin with soapy water using a syringe once a day.Procedure or surgery
Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | Subjects followed the current hygiene instructions, standard washing in a shower with soap. |
| Arm 2 | Active comparator | Subjects cleaned the foreskin with soapy water using a syringe once a day. Receives: Procedure: Subjects cleaned the foreskin with soapy water using a syringe once a day. |
| Arm 3 | Active comparator | Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day. Receives: Procedure: Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dilution-to-Threshold" (D/T) values
The measurements were done by a Nasal Ranger device
Measured: Baseline, 3, 5 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odor Levels of Study ArmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Rwanda
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vincent Mutabazi, Ministry of Health, Rwanda
- Investigators
- Vincent Mutabazi, M.D., Principal investigator, RBC-Medical Research Centre (MRC)Jean Paul Bitega, M.D., Principal investigator, Military Insurance Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153658
- Sponsor's protocol ID
- Odor Study (RMC-10)
- Acronym
- RMC-10
- Status last verified
- May 2014
- First submitted
- 22 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26023772
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Techniques When Using the PrePexTM Device
- ClinicalTrials.gov ID
- NCT02153658
- Acronym / sponsor ID
- RMC-10 / Odor Study (RMC-10)
- Conditions
- Odor Levels of Study Arms
- Keywords
- PrePex, Odor, Cleaning technique, Male Circumcision, HIV, AIDS, Chlorhexidine, Soap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ministry of Health, RwandaOther government
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –Subjects followed the current hygiene instructions, standard washing in a shower with soap. |
| Arm 2 | Active comparator | Procedure: Subjects cleaned the foreskin with soapy water using a syringe once a day.Subjects cleaned the foreskin with soapy water using a syringe once a day. |
| Arm 3 | Active comparator | Procedure: Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjects cleaned the foreskin with soapy water using a syringe once a day. | Procedure or surgery | Arm 2 |
| Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day. | Procedure or surgery | Arm 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
- Derived from this study: PubMed 26023772Mutabazi 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.
- Biomedical CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Mutabazi, M.D. principal investigator
RBC-Medical Research Centre (MRC)
Jean Paul Bitega, M.D. principal investigator
Military Insurance Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subjects cleaned the foreskin with soapy water using a syringe once a day. and Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day. in people with Odor Levels of Study Arms, run by Ministry of Health, Rwanda at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dilution-to-Threshold" (D/T) values (time frame: Baseline, 3, 5 and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02153658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.