Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure … (NCT02281435) | Clinical Trial Compass
CompletedNot Applicable
Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects
Rwanda36 participantsStarted 2012-11
Plain-language summary
It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60% and by up to 73% in post-trial observation. Numerous papers on the topic have been published over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan countries.
Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011, suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80% coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up would result in averting 3.36 million new HIV infections through 2025. In addition, while the model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it would result in net savings (due to averted treatment and care costs) amounting to US$16.51 billion.
To date, there are over 38 million adolescent and adult males in Africa that could benefit from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resource limited settings.
Who can participate
Age range
21 Years – 49 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:
* Ages - 21 to 49 years
* Subject wants to be circumcised
* Uncircumcised
* HIV sero-negative
* Able to understand the study procedures and requirements
* Agrees to abstain sexual intercourse for 9 weeks
* Agrees to abstain from masturbation for 2 weeks
* Agrees to remain in the health care facility for up to 48 hours post procedure as required
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
* Subject agrees to anonymous video and photographs of the procedure and follow up visits
* Subject that was a medical screen failure in RMC-03 study.
Exclusion Criteria:
* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision according to the study procedure and can only undergo surgical MC
* HIV sero-positive
* Known bleeding / coagulation abnormality, uncontrolled diabetes
* Subject does not agree to anonymous video and photographs of the procedure and follow up visits
* Refusal to take HIV test
* Refuse to be hospitalized in the medical center for up to 48 hours post Placement as required
* Subjects that should be excluded from standard surgical MC, such as warts under the prepuce…
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.