Clinical trial NCT03218839: Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Seropositivity
Keywords: PrePex
HIV Seropositivity
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Ministry of Health and Child Welfare, Zimbabwe
name: University of Zimbabwe
name: Zimbabwe Community Health Intervention Research Project (ZiCHIRe), Zimbabwe
First posted: 2017-07-17
Enrollment: 430
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: Rate of adverse events among HIV+ males using PrePex device
timeFrame: Device application through complete wound healing (up to 90 days)
Secondary outcomes:
measure: Pain assessment at key time points
timeFrame: Placement through complete healing (up to 90 days)
measure: Abstinence until complete wound healing
timeFrame: Post placement through complete healing (up to 90 days)
measure: Factors associated with abstinence until complete wound healing
timeFrame: Post placement through complete healing (approximately 90 days for men who participate in the qualitative component)
measure: Time to complete healing
timeFrame: Device placement through complete healing (up to 90 days)
measure: Cosmetic results
timeFrame: At complete healing (up to 90 days)
measure: Patient satisfaction
timeFrame: 3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure
measure: Patient daily life
timeFrame: 3 time points: Prior to the procedure, two weeks post-procedure, and 90 days post-procedure Device placement through ~90 days post procedure
measure: PrePex staff perceptions
timeFrame: 4 weeks after study implementation begins
measure: PrePex staff clinical skills
timeFrame: At study closing,approximately 18 months after study initiation
measure: PrePex AE monitoring and reporting systems
timeFrame: During all active follow-up: 90 days for participants
measure: PrePex staff perceptions of their clinical skills
timeFrame: 4 weeks after study implementation begins
measure: PrePex staff satisfaction
timeFrame: 4 weeks after study implementation begins
Other outcomes:
Locations:
city: Chitungwiza
country: Zimbabwe
facility: Zengeza Clinic
state: Harare
Study officials:
affiliation: University of Washington
name: Scott Barnhart, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: