Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males

NCT03218839 | Completed

• 1 other identifier: STUDY00000126
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety of the PrePex device as applied to HIV positive men by assessing the rate of clinical adverse events. The study will include adult, HIV + men who are eligible to receive the PrePex procedure per the Zimbabwe Ministry of Health and Child Care (MOHCC) eligibility criteria.

Conditions

HIV Seropositivity

Keywords

PrePex; HIV Seropositivity

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events among HIV+ males using PrePex device

  The primary safety endpoint is the incidence of clinical adverse events and device-related incidents. * Clinical related incidents such as the following: * Site bleeding (bleeding that cannot be stopped with pressure of 30 seconds and requires suturing) * Penis-wide diffuse hematoma * Penis-wide diffuse edema * Incision site infection and related symptoms * Device-related incidents * Necrotic Process not initiated * Device does not remain in situ for the full 7 days (displacement) Note: This list of AEs is not exhaustive. Severity of AE will be determined according to PEPFAR/OGAC guidelines

  Device application through complete wound healing (up to 90 days)

Secondary Outcomes (12)

• Pain assessment at key time points

  Placement through complete healing (up to 90 days)

• Abstinence until complete wound healing

  Post placement through complete healing (up to 90 days)

• Factors associated with abstinence until complete wound healing

  Post placement through complete healing (approximately 90 days for men who participate in the qualitative component)

• Time to complete healing

  Device placement through complete healing (up to 90 days)

• Cosmetic results

  At complete healing (up to 90 days)

Study Arms (1)

HIV+ PrePex

EXPERIMENTAL

PrePex male circumcision device

Device: PrePex male circumcision device

Interventions

PrePex male circumcision device DEVICE

PrePex non-surgical male circumcision device applied to eligible, consenting HIV-infected men in Zimbabwe to determine the rate of adverse events as compared to non HIV-infected men.

HIV+ PrePex

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agrees to take an HIV test
• HIV sero-positive
• WHO HIV clinical stage 1 or 2
• Age 18 years and above
• Agrees to be circumcised by PrePex
• Able to understand the study procedures and requirements
• Completes VMMC counseling
• Agrees to return to the health care facility for follow-up visits or as instructed after this circumcision until complete healing 7 weeks from device application, or until cleared by a physician
• Able to comprehend and freely give informed consent for study participation

You may not qualify if:

• Known bleeding/coagulation abnormality (excessive bleeding from nosebleeds, pulled tooth, or gums)
• Uncontrolled diabetes (frequent treatment in a clinic or recent hospitalization for diabetes, frequent infections, hypertension, or kidney disease)
• Active genital infection, anatomic abnormality or any other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision using PrePex.
• HIV sero-negative
• HIV status unknown
• WHO HIV stage 3 and above
• Does not agree to PrePex

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health and Child Welfare, Zimbabwe: collaborator
• University of Zimbabwe: collaborator
• Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe: collaborator

Study Sites (1)

Zengeza Clinic

Chitungwiza, Harare, Zimbabwe

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Scott Barnhart, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Medicine and Global Health

Model Details: The study is a one arm, open label, prospective, cohort field study to assess the safety and acceptability of PrePex device circumcision device when performed by certified PrePex circumcision providers (physicians \& nurses) in a HIV-infected male population.

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: July 17, 2017
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 17, 2017

Record last verified: 2017-07

Locations

ZI (1)