An Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Methods With PrePexTM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses

NCT01434628

Male Circumcision HIV Prevention

COMPLETED NA

Safety Study of the PrePex Device for Non-Surgical Adult Male Circumcision During Phased in National Implementation in an Effort to Prevent the Spread of HIV

NCT01921608

Male Circumcision

COMPLETED NA

Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting

NCT01284088

HIV

COMPLETED NA

A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

NCT01150370

Male Circumcision HIV Prevention HIV Infections

COMPLETED NA

Safety and Efficacy Study of Non-Surgical MC Device for Adolescent Male Population Including Contraindicated Subjects

NCT02581722

Circumcision, Adolescents

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Odor Levels of Study Arms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Subjects followed the current hygiene instructions, standard washing in a shower with soap.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2

Subjects cleaned the foreskin with soapy water using a syringe once a day.

Group Type ACTIVE_COMPARATOR

Subjects cleaned the foreskin with soapy water using a syringe once a day.

Intervention Type PROCEDURE

Arm 3

Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.

Group Type ACTIVE_COMPARATOR

Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Subjects cleaned the foreskin with soapy water using a syringe once a day.

Intervention Type PROCEDURE

Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes