Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects

NCT02281435 | Completed

• 1 other identifier: RMC-05 (Phase I)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision 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. Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011, suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80% coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up would result in averting 3.36 million new HIV infections through 2025. In addition, while the model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it would result in net savings (due to averted treatment and care costs) amounting to US$16.51 billion. To date, there are over 38 million adolescent and adult males in Africa that could benefit from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resource limited settings.

Conditions

Male Circumcision; HIV Prevention; Screen Failure Subjects; Narrow Foreskin

Keywords

Male Circumcision; HIV Prevention; Screen Failure Subjects; PrePex with Incision

Outcome Measures

Primary Outcomes (1)

• Rate of clinical Adverse Events (AEs)

  To verify that the incidence of moderate and severe Clinical AEs and device-related Adverse Events are not significantly higher than 2%.

  11 months

Secondary Outcomes (5)

• Rate of complete circumcision

  11 months

• Time to complete healing

  11 months

• Device related incidents

  11 months

• Optimal methodology to perform PrePex procedure on subjects with very narrow opening of the foreskin.

  11 months

• Safety and effectiveness of performing PrePex MC for subjects with tight frenulum or torn frenulum

  11 months

Study Arms (1)

PrePex with Incision

EXPERIMENTAL

Adult male circumcision by the PrePex™ device using foreskin incision

Device: PrePex™ device

Interventions

PrePex™ device DEVICE

PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures, but in this study the procedure consist an incision on to the foreskin.

PrePex with Incision

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages - 21 to 49 years
• Subject wants to be circumcised
• Uncircumcised
• HIV sero-negative
• Able to understand the study procedures and requirements
• Agrees to abstain sexual intercourse for 9 weeks
• Agrees to abstain from masturbation for 2 weeks
• Agrees to remain in the health care facility for up to 48 hours post procedure as required
• Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
• 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
• Subject that was a medical screen failure in RMC-03 study.

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 circumcision according to the study procedure and can only undergo surgical MC
• HIV sero-positive
• Known bleeding / coagulation abnormality, uncontrolled diabetes
• Subject does not agree to anonymous video and photographs of the procedure and follow up visits
• Refusal to take HIV test
• Refuse to be hospitalized in the medical center for up to 48 hours post Placement as required
• Subjects that should be excluded from standard surgical MC, such as warts under the prepuce, hypospadias, epispadias, un treated UTI.

Sponsors & Collaborators

• Ministry of Health, Rwanda: lead

Study Sites (1)

Rwanda Military Hospital

Kigali, Rwanda

Location

Related Links

• Rwanda Biomedical Centre

Study Officials

• Vincent Mutabazi, M.D.

  Ministry of Health, Rwanda

  PRINCIPAL INVESTIGATOR

• Jean Paul Bitega, M.D.

  Rwanda Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• 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: November 3, 2014
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

RW (1)