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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Washington

Collaborator
Centers for Disease Control and Prevention
Ministry of Health and Child Care, Zimbabwe
University of Zimbabwe
Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe

Information provided by (Responsible Party)
Scott Barnhart, University of Washington

ClinicalTrials.gov Identifier
NCT03218839

First received: December 5, 2014
Last updated: July 11, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Seropositivity

Device : PrePex male circumcision device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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

Further study details as provided by Scott Barnhart, University of Washington:

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • 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.
  • 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
  • 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
  • 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
  • Cosmetic results [ Time Frame: At complete healing (up to 90 days) ]
    Objective analysis of photographs Glans fully exposed (complete circumcision)
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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.

Enrollment: 430
Study Start Date: October 2015
Study Completion Date: May 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03218839

Locations

Zimbabwe
Zengeza Clinic
Chitungwiza, Harare, Zimbabwe

Sponsors and Collaborators

University of Washington
Centers for Disease Control and Prevention
Ministry of Health and Child Care, Zimbabwe
University of Zimbabwe
Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe

Investigators

Principal Investigator: Scott Barnhart, MD, MPH University of Washington
More Information

More Information


Responsible Party: Scott Barnhart, Professor, Departments of Medicine and Global Health, University of Washington  
ClinicalTrials.gov Identifier: NCT03218839   History of Changes  
Other Study ID Numbers: STUDY00000126  
Study First Received: December 5, 2014  
Last Updated: July 11, 2017  

Keywords provided by Scott Barnhart, University of Washington:

PrePex
HIV Seropositivity

Additional relevant MeSH terms:
HIV Seropositivity

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.