| Protocol No: | ECCT/18/04/03 | Date of Protocol: | 20-01-2018 |
| Study Title: | Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision in sub-Saharan Africa
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| Study Objectives: |
Phase 1
Primary Objective
Evaluate the safety and acceptability of the no-flip ShangRing technique vs. Mogen
clamp for EIMC in infants up to 60 days old
Secondary Objectives
Assess ease of use of the ShangRing for EIMC
Evaluate satisfaction of ShangRing EIMC among parents of study participants
Evaluate satisfaction of using the ShangRing for EIMC among VMMC providers
Determine the occurrence and safety of spontaneous detachment
Determine the penile microbiome during the healing course in infants
Phase 2
Primary Objective
Evaluate the use of ShangRing EIMC in a non-comparative field study in settings of
intended use, if results from Phase I demonstrate reasonable safety and effectiveness of
the ShangRing.
Secondary Objectives
Assess ease of use of the ShangRing for EIMC
Evaluate satisfaction of ShangRing EIMC among parents of study participants
Evaluate satisfaction of using the ShangRing for EIMC among VMMC providers
Determine the occurrence and safety of spontaneous detachment
Assess the cost impact of EIMC using ShangRing vs. Mogen Clamp
Assess whether device-driven EIMC can be safely and effectively integrated into
maternal and child health (MCH) services as a method to promote demand creation.
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| Laymans Summary: |
This main aim of this trial is to compare the safety and acceptability of the ShangRing, a new device used to carry out male circumcision, vs. the Mogen clamp, another device that is approved and widely used to conduct male circumcision in children 0-60 days of age.
This study shall be carried out in Kenya, Uganda and Tanzania.
We will assess and compare adverse events, pain, wound healing and parent satisfaction. We will furthermore compare the length of time needed to carry out a circumcision using either device and the preferences of the clinicians who will use these devices.
We would also like to know how feasible leaving the ShangRing device to fall off on its own is instead of needing the children to come back again to the clinic to have the device removed.
Finally, given the concern around the bacteria that live on the surface of the penis, and how these may lead to Tetanus infection, we will also investigate this aspect on the children undergoing circumcision. This specific aim will be designed to comply with the comparative trial component of the WHO framework for such research on medical devices.
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| Abstract of Study: | Background: EIMC is technically simpler, safer, and less expensive compared to VMMC performed in older children or adults. However, scarcity of trained providers and resources in sub-Saharan Africa are a barrier to EIMC services. Device-assisted VMMC could simplify the procedure, enable safe task-shifting, thus increasing the availability of this service.
Objective: To evaluate the safety, effectiveness and acceptability of the ShangRing device for EIMC.
Study design: The study will be in two phases. In the pilot phase, 460 eligible infants will be randomised 1:1 to receive either ShangRing or Mogen clamp circumcision. Follow up will occur every seven days afterward until 42 post circumcision or until the circumcision wound is completely healed. We will assess the circumcision time, pain, adverse event (AEs), healing course, and parent and provider preferences. In the second field phase, 600 eligible infants will undergo ShangRing EIMC performed by non-physicians in routine settings. Outcomes will be similar to the first phase.
Expected results: Comparative safety of the two devices would be determined by the differences in the AE rates, pain experienced, parent/provider preferences. Safety and effectiveness of the ShangRing in routine clinical settings by non-physicians will be evaluated by the AE rates and provider preferences.
Significance of the results: This trial will determine whether the ShangRing is a safe and effective alternative for EIMC. Positive outcomes from this project could further facilitate scale-up of VMMC services in Sub-Saharan Africa. If the ShangRing is shown to be safe, effective and acceptable for EIMC, it will be the only VMMC device that can be used in males of all ages, from neonates to adults. A single device usable for all ages has substantial potential for simplification of service delivery, supply chain management, training and supervision, and educational materials. When complemented with strategies to ensure effective antiretroviral therapy for those with HIV infection, VMMC has been shown to be a cost-effective approach to move toward an AIDS-free generation. Use of the ShangRing in these efforts could help to achieve this goal.
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