Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT02352961
Eligibility Criteria:
Inclusion Criteria for Cross Sectional Component Inclusion Criteria:
All males who meet the following criteria will be eligible for inclusion:
* Are aged 18 years or older (no upper age limit)
* Have never been completely medically circumcised (as opposed to partial circumcision)
* Willing and able to give their written informed consent so that the information collected during the clinic visit can be analysed for research purposes.
Inclusion Criteria Qualitative Component for males
All males who meet the following criteria will be eligible for inclusion:
* Present at Aurum's male circumcision clinic during the cross sectional component or men who indicate no interest in medical male circumcision
* Are between the ages of 25 and 49 inclusive
* Are not circumcised at the time of the interview as assessed through visual examination
* Is willing and able to provide written informed consent.
* Willing for the qualitative session to be tape recorded
Inclusion Criteria for Qualitative Component for females Women who meet the following criteria will be eligible for inclusion
* Are 18 and above (no upper age limit)
* Has a partner who is participating in the cross sectional component, is not in a relationship but lives in the vicinity of Ekurhuleni North district or is part of a women's organization within the community where the clinic is located
* Is willing and able to provide written informed consent
* Willing for the qualitative session to be tape recorded
Inclusion Criteria Part II (Intervention Period) Inclusion Criteria for the "Exclusive Intervention Strategy" Men who meet the following criteria will be eligible for inclusion in the intervention period
* Are between the ages 25 and 49 years inclusive
* Has never been medically circumcised
* Is willing and able to provide written informed consent
Inclusion Criteria for the "Active Follow-up Intervention" Men who meet the following criteria will be eligible for inclusion
* Are between the ages 25 and 49 years inclusive
* Has never been medically circumcised
* Is willing and able to provide written informed consent
* Has contra-indication/s to MMC on the day of presentation for MMC
* Is willing to provide contact information for retention
Exclusion Criteria for all Aims:
* Men who are unable to communicate sufficiently (in English or local languages) to complete medical forms and/or research questionnaires for the cross sectional component.
* Men and women who do not in the opinion of staff obtaining consent have the capacity to provide written informed consent will be excluded from the research.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02352961
Study Brief:
Protocol Section:
NCT02352961