Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shiny… (NCT06273696) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania
Tanzania575 participantsStarted 2019-05-01
Plain-language summary
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).
Who can participate
Age range
13 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* A cognitive impairment that prevented the client from providing consent
* Any health condition (reported or observed) that was a con…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.