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

NCT ID: NCT03218839

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-05-31

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.

Detailed Description

According to mathematical modeling, Voluntary Medical Male Circumcision (VMMC) has the potential to have a major impact on reducing HIV incidence in areas with high HIV prevalence and low prevalence of male circumcision, as is the case in Zimbabwe. Male circumcision devices have the potential to accelerate VMMC scale-up as the procedure is faster and simpler and can be safely performed by nurses. However, fear of social stigma and desire to avoid HIV testing remain potential barriers to those HIV+ men who would otherwise seek out VMMC. Study subjects (n=400) are HIV+ males who elect to undergo VMMC with PrePex as a study subject, and healthcare workers involved in implementation of PrePex on HIV+ male subjects. The aim of the study is to determine if PrePex can be used safely among HIV+ men with similar rates of adverse events to HIV-uninfected men. If so, then the barrier of mandatory HIV testing as part of VMMC could be removed, encouraging more men to undergo the procedure. Determining PrePex safety in HIV+ men would also allow both those with unknown status and those with positive status to undergo MC with PrePex. Determining the barriers to performing VMMC among HIV+ men among healthcare workers, if any, would also inform future policy.

Conditions

HIV Seropositivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

HIV+ PrePex

PrePex male circumcision device

Group Type: EXPERIMENTAL

PrePex male circumcision device

Intervention Type: 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.

Interventions

PrePex male circumcision 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Ministry of Health and Child Welfare, Zimbabwe

OTHER

Sponsor Role: collaborator

University of Zimbabwe

OTHER

Sponsor Role: collaborator

Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe

UNKNOWN

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Scott Barnhart

Professor, Departments of Medicine and Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Barnhart, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Zengeza Clinic

Chitungwiza, Harare, Zimbabwe

Countries

Zimbabwe

Other Identifiers

STUDY00000126

Identifier Type: -

Identifier Source: org_study_id