Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03218839|
Recruitment Status : Completed
First Posted : July 17, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Seropositivity||Device: PrePex male circumcision device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||430 participants|
|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|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||May 2016|
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.
- 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
- 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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218839
|Chitungwiza, Harare, Zimbabwe|
|Principal Investigator:||Scott Barnhart, MD, MPH||University of Washington|