Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
研究概览
简要总结
The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.
详细描述
We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Must be aged 18 to 49 years;
- •Must be HIV-uninfected per same-day routine voluntary testing at the clinic;
- •Must be uncircumcised (on examination);
- •Must be in good general health, at the discretion of the clinician;
- •Must be free of genital ulcerations or other visible signs of STI (on examination);
- •Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
- •Must freely consent to participate in the study and sign a written informed consent form;
- •Must provide full contact information including cell phone number, address, and other locator information.
排除标准
- •Has an active genital infection upon visual inspection;
- •Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates ShangRing MMC;
- •Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid; or
- •Has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia
- •Has a self-reported allergy or sensitivity to lidocaine or other local
- •Is not available to be circumcised on the same day as screening.
研究组 & 干预措施
Control: all-sizes of ShangRing
All-sizes of ShangRings will be available.
干预措施: ShangRing (Device)
Reduced-sizes
7 adult sizes of ShangRings will be available
干预措施: ShangRing (Device)
结局指标
主要结局
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
时间窗: 42 days
To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.
次要结局
- Percentage of men with complete healing at 42 days(Day 42)
- Evaluate the acceptability of ShangRing procedures among participants and providers(42 days)
- Percentage of men who cannot be properly fitted with a ShangRing device(42 days)