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Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya

PloS one, 2019-09, Vol.14 (9), p.e0222942-e0222942 [Peer Reviewed Journal]

This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication: https://creativecommons.org/publicdomain/zero/1.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;ISSN: 1932-6203 ;EISSN: 1932-6203 ;DOI: 10.1371/journal.pone.0222942 ;PMID: 31557208

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Title:
Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya
Author: Odoyo-June, Elijah ; Owuor, Nandi ; Kassim, Saida ; Davis, Stephanie ; Agot, Kawango ; Serrem, Kennedy ; Otieno, George ; Awori, Quentin ; Hines, Jonas ; Toledo, Carlos ; Laube, Catey ; Kisia, Christine ; Aoko, Appolonia ; Ojiambo, Vincent ; Mwandi, Zebedee ; Juma, Ambrose ; Kigen, Bartilol
Mavhu, Webster
Subjects: Acquired immune deficiency syndrome ; Adolescent ; Adult ; AIDS ; Biology and Life Sciences ; Bleeding ; Circumcision ; Circumcision, Male - adverse effects ; Circumcision, Male - instrumentation ; Circumcision, Male - methods ; Circumcision, Male - statistics & numerical data ; Clients ; Complications ; Dehiscence ; Disease prevention ; Engineering and Technology ; Epidemiological Monitoring ; HIV ; Human immunodeficiency virus ; Humans ; Kenya - epidemiology ; Male ; Males ; Medicine and Health Sciences ; Middle Aged ; Patient Acceptance of Health Care - statistics & numerical data ; Patient Satisfaction ; People and Places ; Placement ; Postoperative Complications - epidemiology ; Postoperative Complications - etiology ; Program Evaluation ; Research and Analysis Methods ; Short message service ; Surgery ; Surveillance ; Telephone calls ; Voluntary Programs - statistics & numerical data ; Wounds ; Young Adult
Is Part Of: PloS one, 2019-09, Vol.14 (9), p.e0222942-e0222942
Description: Since 2011, Kenya has been evaluating ShangRing device for use in its voluntary medical male circumcision (VMMC) program according to World Health Organization (WHO) guidelines. Compared to conventional surgical circumcision, the ShangRing procedure is shorter, does not require suturing and gives better cosmetic outcomes. After a pilot evaluation of ShangRing in 2011, Kenya conducted an active surveillance for adverse events associated with its use from 2016-2018 to further assess its safety, uptake and to identify any operational bottlenecks to its widespread use based on data from a larger pool of procedures in routine health care settings. From December 2017 to August 2018, HIV-negative VMMC clients aged 13 years or older seeking VMMC at six sites across five counties in Kenya were offered ShangRing under injectable local anesthetic as an alternative to conventional surgical circumcision. Providers described both procedures to clients before letting them make a choice. Outcome measures recorded for clients who chose ShangRing included the proportions who were clinically eligible, had successful device placement, experienced adverse events (AEs), or failed to return for device removal. Clients failing to return for follow up were sought through phone calls, text messages or home visits to ensure removal and complete information on adverse events. Out of 3,692 eligible clients 1,079 (29.2%) chose ShangRing; of these, 11 (1.0%) were excluded due to ongoing clinical conditions, 17 (1.6%) underwent conventional surgery due to lack of appropriate device size at the time of the procedure, 97.3% (1051/1079) had ShangRing placement. Uptake of ShangRing varied from 11% to 97% across different sites. There was one severe AE, a failed ShangRing placement (0.1%) managed by conventional wound suturing, plus two moderate AEs (0.2%), post removal wound dehiscence and bleeding, that resolved without sequelae. The overall AE rate was 0.3%. All clients returned for device removal from fifth to eleventh day after placement. ShangRing circumcision is effective and safe in the Kenyan context but its uptake varies widely in different settings. It should be rolled out under programmatic implementation for eligible males to take advantage of its unique benefits and the freedom of choice beyond conventional surgical MMC. Public education on its availability and unique advantages is necessary to optimize its uptake and to actualize the benefit of its inclusion in VMMC programs.
Publisher: United States: Public Library of Science
Language: English
Identifier: ISSN: 1932-6203
EISSN: 1932-6203
DOI: 10.1371/journal.pone.0222942
PMID: 31557208
Source: GFMER Free Medical Journals
MEDLINE
PubMed Central
Public Library of Science (PLoS)
ProQuest Central
DOAJ Directory of Open Access Journals

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Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya

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