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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Rate of adverse events among HIV+ males using PrePex device
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HIV+ PrePex
PrePex male circumcision device
干预措施: PrePex male circumcision device (Device)
结局指标
主要结局
Rate of adverse events among HIV+ males using PrePex device
时间窗: 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
次要结局
- Cosmetic results(At complete healing (up to 90 days))
- PrePex AE monitoring and reporting systems(During all active follow-up: 90 days for participants)
- Pain assessment at key time points(Placement through complete healing (up to 90 days))
- Abstinence until complete wound healing(Post placement through complete healing (up to 90 days))
- PrePex staff perceptions(4 weeks after study implementation begins)
- Factors associated with abstinence until complete wound healing(Post placement through complete healing (approximately 90 days for men who participate in the qualitative component))
- Patient satisfaction(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(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 of their clinical skills(4 weeks after study implementation begins)
- Time to complete healing(Device placement through complete healing (up to 90 days))
- PrePex staff clinical skills(At study closing,approximately 18 months after study initiation)
- PrePex staff satisfaction(4 weeks after study implementation begins)
研究者
Scott Barnhart
Professor, Departments of Medicine and Global Health
University of Washington