Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial Wi… (NCT03218839) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males
Zimbabwe430 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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
What they're measuring
1
Rate of adverse events among HIV+ males using PrePex device
Timeframe: Device application through complete wound healing (up to 90 days)