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


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2019
Historique:
received: 04 06 2019
accepted: 10 09 2019
entrez: 27 9 2019
pubmed: 27 9 2019
medline: 13 3 2020
Statut: epublish

Résumé

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.

Identifiants

pubmed: 31557208
doi: 10.1371/journal.pone.0222942
pii: PONE-D-19-15563
pmc: PMC6762105
doi:

Types de publication

Journal Article Research Support, U.S. Gov't, Non-P.H.S. Research Support, U.S. Gov't, P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0222942

Subventions

Organisme : PEPFAR
Pays : United States

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

Références

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Auteurs

Elijah Odoyo-June (E)

Division of Global HIV & TB, U.S. Centers for Disease Control and Prevention, Kisumu, Kenya.

Nandi Owuor (N)

Jhpiego, Nairobi, Kenya.

Saida Kassim (S)

MOH-NASCOP National STD/AIDS Control Program, Ministry of Health, Nairobi, Kenya.

Stephanie Davis (S)

Division of Global HIV & TB, U.S. Centers for Disease Control and Prevention, Atlanta, GA, United States of America.

Kawango Agot (K)

Impact Research and Development Organization, Kisumu, Kenya.

Kennedy Serrem (K)

MOH-NASCOP National STD/AIDS Control Program, Ministry of Health, Nairobi, Kenya.

George Otieno (G)

University of Maryland Baltimore, Migori, Kenya.

Quentin Awori (Q)

Population Council/Engender Health, Nairobi, Kenya.

Jonas Hines (J)

Division of Global HIV & TB, U.S. Centers for Disease Control and Prevention, Atlanta, GA, United States of America.

Carlos Toledo (C)

Division of Global HIV & TB, U.S. Centers for Disease Control and Prevention, Atlanta, GA, United States of America.

Catey Laube (C)

Jhpiego, Nairobi, Kenya.

Christine Kisia (C)

WHO Kenya Office, Nairobi, Kenya.

Appolonia Aoko (A)

Division of Global HIV & TB, U.S. Centers for Disease Control and Prevention, Kisumu, Kenya.

Vincent Ojiambo (V)

USAID-Kenya East Africa, Nairobi, Kenya.

Zebedee Mwandi (Z)

Jhpiego, Nairobi, Kenya.

Ambrose Juma (A)

MOH-NASCOP National STD/AIDS Control Program, Ministry of Health, Nairobi, Kenya.

Bartilol Kigen (B)

MOH-NASCOP National STD/AIDS Control Program, Ministry of Health, Nairobi, Kenya.

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