protocolSection identificationModule nctId: NCT06273696, orgStudyIdInfo id: 2019-519, secondaryIdInfos id: NU2GGH001927, type: OTHER_GRANT, domain: Centers for Disease Control and Prevention, briefTitle: Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2019-06-11, completionDateStruct date: 2019-07-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: IntraHealth International, class: OTHER, collaborators name: Ministry of Health, Tanzania, collaborators name: President Office Regional Administration and Local Government, Tanzania, collaborators name: Centers for Disease Control and Prevention, collaborators name: Jhpiego, collaborators name: World Health Organization, descriptionModule briefSummary: 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)., conditionsModule conditions: Penile Infection, conditions: Penile Haematoma, conditions: Penile Bleeding, conditions: Deformity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 575, type: ACTUAL, armsInterventionsModule interventions name: ShangRing, outcomesModule primaryOutcomes measure: Number of Adverse Events, primaryOutcomes measure: Number of Clients with Adverse Events, primaryOutcomes measure: Descriptions of Adverse Events, secondaryOutcomes measure: Provider Training, secondaryOutcomes measure: Client Follow-up Visit Rate, secondaryOutcomes measure: Client Preference for ShangRing Over Surgical Circumcision, secondaryOutcomes measure: Client Recommendation Rate, secondaryOutcomes measure: Cosmetic Result Acceptability, secondaryOutcomes measure: Client Experience While Performing Routine Activities, secondaryOutcomes measure: Client Discomfort, secondaryOutcomes measure: Provider Ease of Application, secondaryOutcomes measure: Provider Preference, secondaryOutcomes measure: Provider Recommendation, secondaryOutcomes measure: Description of Procedures, secondaryOutcomes measure: Healing rate, eligibilityModule sex: MALE, minimumAge: 13 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kahama District Hospital, city: Shinyanga, country: Tanzania, geoPoint lat: -3.66393, lon: 33.42118, locations facility: Ushetu Health Centre, city: Shinyanga, country: Tanzania, geoPoint lat: -3.66393, lon: 33.42118, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2018-10-22, uploadDate: 2024-02-14T09:36, filename: Prot_000.pdf, size: 2701616, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2018-07-01, uploadDate: 2023-01-18T15:12, filename: ICF_001.pdf, size: 173615, hasResults: False