HIV Infections, HIV Prevention, Male Circumcision
Conditions
Keywords
male circumcision, HIV, Rwanda, HIV Seronegativity
Brief summary
The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda
Detailed description
Multiple randomized and controlled studies (WHO, USAID, UNAIDS) have proven that circumcised men in high risk areas reduce their risk of HIV infection by 60%. The Government of Rwanda has ranked HIV prevention as a top priority item, and wishes to decrease the HIV incidence in the country by 50%. As part of a holistic HIV prevention approach, we decided to embark upon a process of national scale up of adult male circumcision. The national HIV prevention plan calls for voluntary MC of 2 million adults by the end of 2012. The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs, to support global public health efforts to stop the spread of HIV. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, in urban or rural settings, without the need for sterile, hospital settings. As such, The PrePex System places minimal burden on the existing health care infrastructure to accomplish national circumcision programs. The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda.
Interventions
DEVICEThe PrePex a novel device for adult male circumcision
The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, without the need for sterile, hospital settings.
Sponsors
Ministry of Defence, Rwanda
Ministry of Health, Rwanda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* Male of ages 18 - 54 years * Subject wants to be circumcised * Uncircumcised * HIV sero-negative Agrees to undergo measurements of width of the penis at different areas in flaccid status * Able to understand the study procedures and requirements * Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, until the end of the follow-up that may take up to 6 weeks * 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
Exclusion criteria
* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision * HIV sero-positive * Subject with the following diseases: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias * Diabetes mellitus * Subject who have an abnormal penile anatomy or any penile diseases * Subject that to the opinion of the investigator is not a good candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy and safety of The PrePex System for adult male circumcision in Rwanda | 4 week post-procedure follow up appointment and examination | Outcome measures will include: Number of Participants with Adverse Events as a Measure of Safety, Pain as measured by Visual Analogue Scale (VAS), Wound healing rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operational scalability to mass scale up program | four week post-procedure follow up appointment and examination | Outome measure include: Duration required by diffrent personnel to perform the procedure Procedure performance by nurses |
| satisfaction & acceptability of patients | 4 weeks follow up | Outcome measure include: Quality of life and satisfaction questionnaire |
| Guidelines for utility in scale up mass circumcision program | 4 weeks follow up | Outcome measure includes: Physicians questionnaire on the clinical and practical performance of the procedure |
| compliance with post procedure instructions | 4 weeks follow up | Outcome measure include: Weekly follow up visits post procedure, compliance with post procedure instructions questionnaire |
Countries
Rwanda
Outcome results
None listed