Observational Study of Male Circumcision Using PrePex Device

NCT01711411 | Completed

• 1 other identifier: 10376
• Study Type: observational
• Target: 427
• Locations: 1 country
• Sites: 1

Brief Summary

The study will measure the incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment. To assure complete ascertainment of AEs, study-specific forms will be used to collect standardized data from the circumcision visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will revert to routine practice (two follow-up visits) for the remaining 375 cases.

Conditions

HIV

Keywords

HIV prevention; PrePex; voluntary medical male circumcision; non-surgical; medical device; wound healing; Kenya

Outcome Measures

Primary Outcomes (1)

• The incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment.

  Number of participants with adverse events as a measure of safety, pain as measured by Visual Analogue Scale (VAS), and life table analysis of time to complete wound healing

  42 days

Secondary Outcomes (3)

• Acceptability of PrePex procedures among Kenyan clients

  42 days

• Acceptability of PrePex procedures among Kenyan male circumcision providers

  42 days

• Proportion of men ineligible for circumcision with PrePex

  42 days

Other Outcomes (2)

• Proportion of men who do not return for removal at 7 days, and the level of effort needed for their active follow-up as well as their outcomes

  42 days

• Costs of PrePex training and service delivery

  42 days

Interventions

PrePex device for male circumcision DEVICE

PrePex is a sterile device for adult male circumcision, consisting of an inner ring, elastic ring, placement ring, and verification thread. Proper sizing is facilitated by a sizing accessory. The elastic ring is loaded on to the placement ring, which is then placed at the base of the penis. The inner ring is placed inside the foreskin. The elastic ring is then deployed around the foreskin, clamping the foreskin against the inner ring. PrePex is manufactured by Circ MedTech Limited, is certified CE - Class IIa in the European Union, and has been approved by the U.S. Food and Drug Administration.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men aged 18-49 years

You may qualify if:

• Must be aged 18 to 49 years
• Must be uncircumcised (on examination)
• Must be in good general health
• Must agree to voluntary counseling and testing for HIV, or have documentation of testing no more than one week before the MC visit
• Must be HIV-uninfected
• Must be free of genital ulcerations or other visible signs of STI (on examination)
• Must be able to understand study procedures and the requirements of study participation
• Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision or be willing to receive a home visit
• Must freely consent to participate in the study and sign a written informed consent form
• Must have a cell phone or access to a cell phone.

You may not qualify if:

• Penis does not fit any of the five PrePex sizes
• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid
• Has known bleeding/clotting disorder (e.g. hemophilia)
• Has an active genital infection, anatomic abnormality (e.g. phimosis or hypospadias) or other disease or condition (e.g. extreme obesity, poorly controlled diabetes, sickle cell anemia, AIDS-like signs or symptoms) which in the investigator's opinion contraindicates MC or participation in the study
• Is participating in another longitudinal biomedical research study.

Sponsors & Collaborators

• FHI 360: lead
• Bill and Melinda Gates Foundation: collaborator
• University of Illinois at Chicago: collaborator
• Kenyan MOH, Kenyan Natinal AIDS and STI Control Programme(NASCOP): collaborator
• Nyanza Reproductive Health Society: collaborator

Study Sites (1)

Nyanza Reproductive Health Society

Kisumu, Nyanza, Kenya

Location

Related Publications (1)

• Feldblum PJ, Odoyo-June E, Obiero W, Bailey RC, Combes S, Hart C, Jou Lai J, Fischer S, Cherutich P. Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya. PLoS One. 2014 May 1;9(5):e95357. doi: 10.1371/journal.pone.0095357. eCollection 2014.

  PMID: 24788898 DERIVED

MeSH Terms

Interventions

Circumcision, Male

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Paul Feldblum, PhD

  FHI 360

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 22, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

KE (1)