Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 575
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49).
详细描述
Medical circumcision devices have the potential to accelerate delivery of male circumcision by making the procedure quicker and easier, while remaining as safe as surgical circumcision. Thus, circumcision devices may facilitate expansion of adult male circumcision programs for HIV prevention and address some of the common capacity issues in the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority countries for male circumcision.
One promising device for adult male circumcision is ShangRing, which was prequalified by the World Health Organization (WHO) in 2015 for males aged 13 and older. WHO has created a framework for introducing circumcision devices in a country. This framework recommends countries take a methodical approach to introducing circumcision devices, evaluating acceptability and safety within its health system before making widespread adoption.
Evaluation Goal: To evaluate the safety and acceptability of the ShangRing device for nonsurgical circumcision in routine clinical settings, as a part of a comprehensive HIV prevention program for males in voluntary medical male circumcisions (VMMC) programs.
Evaluation Endpoints: the proportion of males experiencing mild, moderate and severe adverse events (AEs) associated with ShangRing circumcision procedures, including both intra- and post-operative events, and all device-related malfunctions (e.g., early spontaneous detachment).
Evaluation Design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be an uncircumcised male aged 13 years or older
- •Be seeking medical circumcision at one of the study sites
- •Consent to an HIV test, unless they were known to be HIV-positive
- •Agree to be circumcised using the ShangRing device
- •Have their penis fit into one of the ShangRing ring sizes available during the study
- •Be able to understand the evaluation procedures and requirements
- •Agree to abstain from sexual intercourse and masturbation for six weeks after ring removal, for a total of seven weeks
- •Live within 30 kilometers of the facility in Shinyanga Region, Tanzania
- •Be willing to provide valid contact information (i.e., telephone number, address of residence, place of employment, and other locator information) and be willing to receive communications and/or follow-up visits
- •Have an activated mobile phone or access to a mobile phone
- •Agree to return for a follow-up visit to assess healing at day 49 (42 days post-removal)
- •Agree to a ten-day post-placement (three days post-removal) telephone call to assess and detect symptoms of AEs
- •Be able to communicate in English and/or Kiswahili
- •Be capable and willing to provide written informed consent (18 years and older) or written informed consent from a parent guardian (13-17 years) to participate for both HIV testing services and VMMC services
排除标准
- •A cognitive impairment that prevented the client from providing consent
- •Any health condition (reported or observed) that was a contraindication to surgical VMMC in the national program or that ShangRing providers deemed a contraindication.
- •These may include diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness.
- •A current sexually transmitted infection (STI) other than HIV (clients with STIs were advised to return for circumcision once the STI was treated); and/or other conditions, which in the opinion of the site supervisor, prevented the client from undergoing a circumcision with the ShangRing device.
结局指标
主要结局
Number of Adverse Events
时间窗: 49 days post device placement
Total numbers and types of known adverse events (AE)s occurring among clients, including all severities of AEs (mild, moderate, severe) and serious AEs, including detailed information about all instances of device displacement/detachment/self-removal/malfunction, need for medical attention or intervention, and final outcomes in those experiencing AEs
Number of Clients with Adverse Events
时间窗: 49 days post device placement
Total number of clients with known adverse events (AEs) (may be different from above if clients experience multiple AEs), including all severities of AEs and serious AEs
Descriptions of Adverse Events
时间窗: 49 days post device placement
A description of each adverse event by type and classification, severity, time of occurrence (during placement, in situ, or during removal) time of detection (days post-application and/or post-removal) captured as date AE is diagnosed, clinical management, and resolution
次要结局
- Provider Training(49 days post device placement)
- Cosmetic Result Acceptability(At device removal (7 days post device placement))
- Client Follow-up Visit Rate(49 days post device placement)
- Client Preference for ShangRing Over Surgical Circumcision(At device removal (7 days post device placement))
- Client Recommendation Rate(At device removal (7 days post device placement))
- Provider Ease of Application(Immediately after the completion of the provider ShangRing training)
- Client Experience While Performing Routine Activities(At device removal (7 days post device placement))
- Client Discomfort(At device removal (7 days post device placement))
- Provider Preference(Immediately after the completion of the provider ShangRing training)
- Provider Recommendation(Immediately after the completion of the provider ShangRing training)
- Description of Procedures(49 days post device placement)
- Healing rate(52 days post device placement)