HIV SeropositivityNCT03218839
Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males
A study testing PrePex male circumcision device in people with HIV Seropositivity, run by University of Washington at 1 site in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- PrePex male circumcision device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteZimbabwe
- Study dates
- Oct 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- PrePex male circumcision device
- Keywords
- PrePex, HIV Seropositivity
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrePex male circumcision deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ PrePex | Experimental | PrePex male circumcision device Receives: Device: PrePex male circumcision device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Device application through complete wound healing (up to 90 days)
Secondary outcomes (12)
Pain assessment at key time points
- 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.
Measured: Placement through complete healing (up to 90 days)
Abstinence until complete wound healing
Survival analysis of the timing of resumed sexual activity among subjects
Measured: Post placement through complete healing (up to 90 days)
Factors associated with abstinence until complete wound healing
Patient factors (knowledge, attitudes) associated with abstinence from sex until wound healing is complete
Measured: Post placement through complete healing (approximately 90 days for men who participate in the qualitative component)
Time to complete healing
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
Measured: Device placement through complete healing (up to 90 days)
Cosmetic results
- Objective analysis of photographs
- Glans fully exposed (complete circumcision)
Measured: At complete healing (up to 90 days)
Patient satisfaction
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.
Measured: 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
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.
Measured: 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
Responses by clinicians to Likert scale questions on their beliefs about PrePex VMMC and using this procedure on HIV+ men
Measured: 4 weeks after study implementation begins
PrePex staff clinical skills
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
Measured: At study closing,approximately 18 months after study initiation
PrePex AE monitoring and reporting systems
An ongoing assessment of AE monitoring and reporting systems through
- completeness of reporting
- timeliness of reports
Measured: During all active follow-up: 90 days for participants
PrePex staff perceptions of their clinical skills
Compilation report of Likert scale results from questions ascertaining PrepPex training, abilities, productivity and confidence.
Measured: 4 weeks after study implementation begins
PrePex staff satisfaction
Compilation report on responses to likert scales question on their satisfaction performing PrePex on HIV+ men.
Measured: 4 weeks after study implementation begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study startOct 2015
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health and Child Welfare, Zimbabwe, University of Zimbabwe, Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe
- Responsible party
- Principal investigator, Scott Barnhart, University of Washington
- Investigators
- Scott Barnhart, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218839
- Sponsor's protocol ID
- STUDY00000126
- Status last verified
- Jul 2017
- First submitted
- 5 Dec 2014
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03218839
- Acronym / sponsor ID
- STUDY00000126
- Conditions
- HIV Seropositivity
- Keywords
- PrePex, HIV Seropositivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health and Child Welfare, Zimbabwe, University of Zimbabwe, Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe
- Study start
- Oct 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| HIV+ PrePex | Experimental | Device: PrePex male circumcision devicePrePex male circumcision device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrePex male circumcision devicePrePex 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. | Device | HIV+ PrePex |
Primary outcome
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
12 secondary outcomes
Pain assessment at key time points
Time frame: Placement through complete healing (up to 90 days)
Abstinence until complete wound healing
Time frame: 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)
Time to complete healing
Time frame: Device placement through complete healing (up to 90 days)
Cosmetic results
Time frame: 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
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
PrePex staff perceptions
Time frame: 4 weeks after study implementation begins
PrePex staff clinical skills
Time frame: 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
PrePex staff perceptions of their clinical skills
Time frame: 4 weeks after study implementation begins
PrePex staff satisfaction
Time frame: 4 weeks after study implementation begins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Barnhart, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrePex male circumcision device in people with HIV Seropositivity, run by University of Washington at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events among HIV+ males using PrePex device (time frame: Device application through complete wound healing (up to 90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.