Program Evaluation and Active Adverse Event Surveillance for Initial Implementation of WHO Prequalified ShangRing™ Circumcision in Mozambique
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Jhpiego
- 试验地点
- 3
- 主要终点
- Proportion of ShangRing clients who experience moderate and severe adverse events
研究概览
简要总结
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are: 1) To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and 2) To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.
详细描述
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are:
- To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and
- To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.
Population: 1000 males aged 13 years and above who are seeking male circumcision; 3 clinic sites
Duration: Approximately 3 months of recruitment, 60 days follow-up per participant; total duration expected to be approximately 6 months in the field.
Sample size: Cumulative target of 1000 ShangRing™ procedures, based on guidance contained in the WHO Framework for clinical evaluation of devices for male circumcision. The WHO TAG on Innovations in Male Circumcision recommends active follow-up of the first 1000 clients when a new device is introduced into a program or as a new program is implemented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male, 13 years old and above
- •Agrees to return to the facility where circumcision procedure is done for device removal on day 7 and to have home or off-site visits if deemed necessary by the ShangRing™ providers
- •Is able and willing to provide a valid physical address of residence and at least one alternate address (address of employer, school, or friend/relative) for tracing
- •Is able and willing to provide a valid primary phone number and at least one alternate phone number (phone number of friend/relative) and agrees to be contacted via that alternate number and person. This will facilitate telephone-based follow-up should he not return for the scheduled post-removal follow-up visits.
排除标准
- •Males below 13 years of age
- •Males for whom the correct fitting size of ShangRing™ Device is not available
- •Anatomical abnormalities including adhesions
- •Cognitive impairment
- •Any health condition (reported or observed) that ShangRing™ providers deem a contraindication to the procedure. These may include history of diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness
- •HIV - positive (although may still undergo surgical circumcision)
- •Anatomical variations and anomalies of genitalia
- •Hypospadias, epispadias, or other urethral anomaly
- •Scrotal hernia
- •Other genital anomaly or disease including infectious or traumatic ulcers
- •Dermatitis of the penis or foreskin
- •Genital warts
- •Urethral discharge
结局指标
主要结局
Proportion of ShangRing clients who experience moderate and severe adverse events
时间窗: 60 days postoperative
Circumcision-related adverse events are classified as moderate and severe per standardized protocol definitions
次要结局
- Pain scores on Visual Analog Scale(Within 48 hours postoperative)
- Proportion of ShangRing™ clients who fail to return for device removal on day 7(7 days postoperative)
- Proportion of eligible men who chose ShangRing procedure(Preoperative)