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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| Bon Sante Consulting Limited | UNKNOWN |
| Kenya National AIDS & STI Control Programme | OTHER |
| Kenya Ministry of Health |
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This is a research study in Kenya that will examine the outcomes of participants aged 10-15 and 16 and older; and provider acceptability of the Shang Ring technique for male circumcision that would simplify use. The study will be in two phases:
Phase 1 will explore the no-flip technique that has been used in China but will be used for the first time in Africa.
Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.
The study, to be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use and increase its acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 - 7 Day Removal | Active Comparator | Shang Ring No Flip Technique: Removal of Shang Ring and assessment of healing 7 days after circumcision with no-flip technique. |
|
| Phase 1 - Delayed Removal | Active Comparator | Shang Ring No Flip Technique: Removal of ring or assessment of spontaneous detachment at more than 7 days to assess occurrence and safety following circumcision with the no-flip technique. |
|
| Phase 2 - Topical Anesthesia | Active Comparator | Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery using topical anesthesia. |
|
| Phase 2 - Injectable Anesthesia | Active Comparator | Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery when using injectable anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shang Ring | Device | Comparison of healing times at 7 day and more than 7 days after circumcision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Combined rate of moderate and severe adverse events (AEs) as a measure of safety of the no-flip technique for Shang Ring circumcision in males aged 10 years and older | We will evaluate the rate of moderate and severe AEs (combined) following Shang Ring MC using the no-flip technique based on clinical exam findings. | 42 days |
| Phase 2: Pain measured with the visual analogue scale (VAS) experienced during the Shang Ring circumcision procedure with topical (EMLA Cream; lidocaine 2.5% and prilocaine 2.5%) vs. injectable (1% lidocaine) anesthesia. | The outcome metric for the primary outcome will be maximum pain reported to have been experienced by participants during the Shang Ring circumcision, assessed using the visual analogue scale (VAS), reported immediately after completion of the Shang Ring circumcision procedure | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Ease of use of the Shang Ring with the no-flip technique as measured by MC procedure and device removal times and problems encountered during MC and removal procedures | To evaluate ease of use with the no-flip technique we will document MC procedure and device removal times and problems encountered during MC and removal procedures | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Barone, DVM, MS | EngenderHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homa Bay Level IV County Hospital | Homa Bay | Homa Bay County | Kenya | |||
| Vipingo Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32442198 | Derived | Al Hussein Alawamlh O, Awori QD, Barone MA, Kim SJ, Goldstein M, Li PS, Lee RK. No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya. PLoS One. 2020 May 22;15(5):e0233150. doi: 10.1371/journal.pone.0233150. eCollection 2020. | |
| 31412032 | Derived | Awori Q, Li PS, Lee RK, Ouma D, Oundo M, Barasa M, Obura N, Mwamkita D, Simba R, Oketch J, Nyangweso N, Maina M, Kiswi N, Kirui M, Chirchir B, Goldstein M, Barone MA. Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0218066. doi: 10.1371/journal.pone.0218066. eCollection 2019. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2018 | |
| Reset | Sep 20, 2018 | |
| Release | Feb 18, 2021 | |
| Reset | Mar 10, 2021 | |
| Release | Apr 19, 2021 | |
| Reset | May 11, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2018 | Sep 20, 2018 | |||
| Feb 18, 2021 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D008012 | Lidocaine |
| D011318 | Prilocaine |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
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| OTHER_GOV |
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| injectable anesthesia (lidocaine 1%) | Drug | Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia. |
|
| topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream) | Drug | Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia. |
|
| Phase I: Satisfaction of the no-flip Shang Ring among study participants | we will interview participants/parents/guardians to document acceptability and satisfaction with the Shang Ring circumcision, procedure and post-procedure pain, and time to return to normal activity | 42 days |
| Phase I: Occurrence of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision | we will gather data on timing of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision | 42 days |
| Phase I: Safety of spontaneous detachment as measured by AEs among those participants wearing the Shang Ring for more than 7 days after circumcision | we will gather data to document AEs among those participants wearing the Shang Ring for more than 7 days after circumcision | 42 days |
| Phase 2: Safety of topical vs. injectable anesthesia for local anesthesia during Shang Ring circumcision as measured by rates of moderate and severe AEs (combined rates) | we will document rates of moderate and severe AEs among those having a Shang Ring circumcision with topical vs. injectable anesthesia | 42 days |
| Phase 2: Satisfaction with topical vs. injectable anesthetic among study participants | we will interview study participants and their parents/guardians appropriate to document acceptability and satisfaction with the circumcision, the Shang Ring procedure, post-procedure pain, and time to return to normal activity between the two techniques | 42 days |
| Vipingo |
| Kilifi County |
| Kenya |
| Mar 10, 2021 |
| Apr 19, 2021 | May 11, 2021 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |