Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia

NCT01844102 | Completed Phase 4

• 1 other identifier: 416416
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study will measure the incidence of moderate and severe adverse events (AEs) associated with PrePex procedures among 500 men, 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 transition to follow-up at two visits (7 and 42 days) for the remaining 450 cases.

Conditions

HIV

Keywords

HIV Prevention, PrePex, voluntary medical circumcision, non-surgical,; medical device, wound healing, Zambia

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  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.

  42 days

Secondary Outcomes (5)

• Acceptability of PrePex procedures among male circumcision providers

  42 days

• Proportion of men ineligible for circumcision with PrePex

  42 days

• Follow-up outcomes

  42 days

• Costs of PrePex training and service delivery

  42 days

• Acceptability of PrePex procedures among Zambian clients

  42 days

Study Arms (1)

PrePex

EXPERIMENTAL

PrePex circumcision procedures will be offered as part of the minimum package of HIV prevention services recommended by the Zambian Ministry of Health (MOH)

Device: PrePex

Interventions

PrePex 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.

PrePex

Eligibility Criteria

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

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; and,
• Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

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; and,
• Is participating in another longitudinal biomedical research study.

Sponsors & Collaborators

• FHI 360: lead
• Population Services International: collaborator
• Population Council: collaborator
• Society for Family Health, Zambia: collaborator
• Ministry of Health, Zambia: collaborator

Study Sites (1)

Society for Family Health

Lusaka, Lusaka Province, Zambia

Location

Related Publications (2)

• Bitega JP, Ngeruka ML, Hategekimana T, Asiimwe A, Binagwaho A. Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings. J Acquir Immune Defic Syndr. 2011 Dec 15;58(5):e127-34. doi: 10.1097/QAI.0b013e3182354e65.

  PMID: 21909032 BACKGROUND

• Mutabazi V, Kaplan SA, Rwamasirabo E, Bitega JP, Ngeruka ML, Savio D, Karema C, Binagwaho A. HIV prevention: male circumcision comparison between a nonsurgical device to a surgical technique in resource-limited settings: a prospective, randomized, nonmasked trial. J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):49-55. doi: 10.1097/QAI.0b013e3182631d69.

  PMID: 22739133 BACKGROUND

Related Links

• Related Info
• complement factor I deficiency

Study Officials

• Karin Hatzold, MD, Ph.D.

  Population Services International

  PRINCIPAL INVESTIGATOR

• Paul Hewett, Ph.D.

  Population Council

  PRINCIPAL INVESTIGATOR

• Namwinga Chintu, MBChB

  Society for Family Health

  PRINCIPAL INVESTIGATOR

• Bruce Bvulani, MBChB, MMed

  Ministry of Health, Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

ZA (1)