Clinical trial NCT02281435: Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects
Official title: One-arm, Open Label, Phase I (Out of 3 Phases), Pilot Study to Verify the Safety of PrePex™ Device for Screen Failure Subjects (Men With Narrow Foreskin and Phimosis) for Adult Male Circumcision, Performed by Physicians, in a Male Population That is Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Circumcision
HIV Prevention
Screen Failure Subjects
Narrow Foreskin
Keywords: Male Circumcision
HIV Prevention
Screen Failure Subjects
PrePex with Incision
Lead sponsor: Ministry of Health, Rwanda
Sponsor class: OTHER_GOV
First posted: 2014-11-02
Enrollment: 36
Sex: MALE
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: Rwanda has a national plan to offer a Voluntary Medical Male Circumcision (VMMC) program to 2 million adult men in 2 years as part of a comprehensive HIV prevention strategy.

The PrePex device was granted with pre-qualification approval on May 2013 by the World Health Organization (WHO), for scaling up VMMC in Africa.

The device works by stopping the flow of blood to the distal foreskin, leading to necrosis of the tissue, which is removed with the device after 7 days.

The PrePex device was developed to facilitate rapid scale up of non-surgical adult male circumcision in resource limited settings, and it is the first MC device which was granted with a WHO recommendation in addition to CE and FDA approvals.

Prior studies showed that between 8%-12% of men are contraindicated for the standard PrePex technique due to very narrow foreskin from border cases to severe Phimosis, preventing insertion of the Inner Ring of the PrePex device.

The main objective of the study was to test the safety of a new male circumcision technique, using the same PrePex device (PrePex with incision). The new technique entails the use of local anesthesia and thereafter an incision in the foreskin. PrePex with incision technique was planned to allow PrePex non-surgical contraindicated patients to undergo VMMC with the device, thus avoiding conventional surgery and suturing. The study also included analysis of potential benefits the PrePex with incision technique has over conventional surgical circumcision.

The study has 3 phases, the current results represent Phase I - testing the feasibility and safety of the PrePex with incision procedure, intended to screen failure subjects of the standard PrePex procedure. Phase I includes performing feasibility testing on 6 subjects using 2 different techniques and once feasibility is demonstrated to include an additional Analysis phase of data collection from additional 30 subjects to reinforce the safety of the one chosen technique.

Phase II will includes a special non-surgical PrePex procedure for patients with narrow foreskin that will entail the usage of Lidocaine anesthetic cream 30 minutes pre procedure and additional force in inserting of the Inner Ring (hereto: Special PrePex procedure).

Phase III will includes performing additional PrePex with incision procedures with local anesthesia and special PrePex procedure incision to achieve a statistical significant sample size and determine the recommended guideline and procedure for performing PrePex on men with narrow foreskin and phimosis.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of clinical Adverse Events (AEs)
timeFrame: 11 months
Secondary outcomes:
measure: Rate of complete circumcision
timeFrame: 11 months
measure: Time to complete healing
timeFrame: 11 months
measure: Device related incidents
timeFrame: 11 months
measure: Optimal methodology to perform PrePex procedure on subjects with very narrow opening of the foreskin.
timeFrame: 11 months
measure: Safety and effectiveness of performing PrePex MC for subjects with tight frenulum or torn frenulum
timeFrame: 11 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Rwanda Military Hospital
Study officials:
affiliation: Ministry of Health, Rwanda
name: Vincent Mutabazi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rwanda Military Hospital
name: Jean Paul Bitega, M.D.
role: PRINCIPAL_INVESTIGATOR
References: