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

July 11, 2017 updated by: Scott Barnhart, University of Washington

Evaluation of Safety, Efficacy and Acceptability of the PrePexTM Device for Rapid Scale-up of Adult Male Circumcision Programs in Zimbabwe, Phase III PrePexTM Field Implementation Trial With HIV Positive Adult Males

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
    • Harare
      • Chitungwiza, Harare, Zimbabwe
        • Zengeza Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HIV+ PrePex
PrePex male circumcision device
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of adverse events among HIV+ males using PrePex device
Time Frame: Device application through complete wound healing (up to 90 days)

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain assessment at key time points
Time Frame: Placement through complete healing (up to 90 days)
  • Subject's subjective pain, tingling, and discomfort related to PrePex when applying the system, wearing it and removing it. This will be assessed by numeric pain, tingling and discomfort VAS scale (Pain = VAS x Duration in Minutes). Measured in the post placement recovery at 15 minutes after placement, and then 1, 2, and 3 hours post placement.
  • As the necrotic process initiates, it is expected that some of subjects will have temporary discomfort during the first 2 hours after deployment (hence anaesthetic cream), which vanishes thereafter for the rest of the weeklong period when the device is in place.
  • Some pain is expected for a short duration (about 10 seconds) when extracting the Inner Ring during the removal procedure.
Placement through complete healing (up to 90 days)
Abstinence until complete wound healing
Time Frame: Post placement through complete healing (up to 90 days)
Survival analysis of the timing of resumed sexual activity among subjects
Post placement through complete healing (up to 90 days)
Factors associated with abstinence until complete wound healing
Time Frame: Post placement through complete healing (approximately 90 days for men who participate in the qualitative component)
Patient factors (knowledge, attitudes) associated with abstinence from sex until wound healing is complete
Post placement through complete healing (approximately 90 days for men who participate in the qualitative component)
Time to complete healing
Time Frame: Device placement through complete healing (up to 90 days)

Mean of days for complete healing (continuous measure) and factors associated with number of days to complete healing (continuous outcome - multiple linear regression)

  • A completely healed circumcision as defined as, "Intact epithelium (unbroken skin) covering the epithelial as judged by the provider on visual inspection, meaning that none of the following are present: sutures, scabbing, drainage, moisture, gaps between epithelial edges or ulceration.]
  • Optional validation by objective analysis of wounds by photographs
Device placement through complete healing (up to 90 days)
Cosmetic results
Time Frame: At complete healing (up to 90 days)
  • Objective analysis of photographs
  • Glans fully exposed (complete circumcision)
At complete healing (up to 90 days)
Patient satisfaction
Time Frame: 3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure
A composite measure created among patients involved in the qualitative component who will be asked about satisfaction with the PrePex™ MC procedure, barriers and motivators to uptake of VMMC through PrePex™, opinions around convenience of the device, tolerance of potential odour and whether participants would recommend PrePex™ MC to others.
3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure
Patient daily life
Time Frame: 3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure
Patients involved in the qualitative component will be asked about activities of daily living restrictions. They will complete a brief form that includes listing of activities of daily living, whether they are interrupted and for how long. This includes the average number of lost working hours (or potential working hours in unemployed). A composite measure will be created.
3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure
PrePex staff perceptions
Time Frame: 4 weeks after study implementation begins
Responses by clinicians to Likert scale questions on their beliefs about PrePex VMMC and using this procedure on HIV+ men
4 weeks after study implementation begins
PrePex staff clinical skills
Time Frame: At study closing,approximately 18 months after study initiation

An overall assessment of clinician skills as a group will be made by combining and reporting on several indirect measures. Included measures will be the proportion of clients experiencing AEs and the average procedure time.

• Assessing AE monitoring and reporting systems through

  • completeness of reporting
  • timeliness
At study closing,approximately 18 months after study initiation
PrePex AE monitoring and reporting systems
Time Frame: During all active follow-up: 90 days for participants

An ongoing assessment of AE monitoring and reporting systems through

  • completeness of reporting
  • timeliness of reports
During all active follow-up: 90 days for participants
PrePex staff perceptions of their clinical skills
Time Frame: 4 weeks after study implementation begins
Compilation report of Likert scale results from questions ascertaining PrepPex training, abilities, productivity and confidence.
4 weeks after study implementation begins
PrePex staff satisfaction
Time Frame: 4 weeks after study implementation begins
Compilation report on responses to likert scales question on their satisfaction performing PrePex on HIV+ men.
4 weeks after study implementation begins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
University of Zimbabwe
Ministry of Health and Child Welfare, Zimbabwe
Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Barnhart, MD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000126

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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