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


Autoři: Elijah Odoyo-June aff001;  Nandi Owuor aff002;  Saida Kassim aff003;  Stephanie Davis aff004;  Kawango Agot aff005;  Kennedy Serrem aff003;  George Otieno aff006;  Quentin Awori aff007;  Jonas Hines aff004;  Carlos Toledo aff004;  Catey Laube aff002;  Christine Kisia aff008;  Appolonia Aoko aff001;  Vincent Ojiambo aff009;  Zebedee Mwandi aff002;  Ambrose Juma aff003;  Bartilol Kigen aff003
Působiště autorů: Division of Global HIV & TB, U.S. Centers for Disease Control and Prevention, Kisumu, Kenya aff001;  Jhpiego, Nairobi, Kenya aff002;  MOH-NASCOP National STD/AIDS Control Program, Ministry of Health, Nairobi, Kenya aff003;  Division of Global HIV & TB, U.S. Centers for Disease Control and Prevention, Atlanta, GA, United States of America aff004;  Impact Research and Development Organization, Kisumu, Kenya aff005;  University of Maryland Baltimore, Migori, Kenya aff006;  Population Council/Engender Health, Nairobi, Kenya aff007;  WHO Kenya Office, Nairobi, Kenya aff008;  USAID-Kenya East Africa, Nairobi, Kenya aff009
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0222942

Souhrn

Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Klíčová slova:

Adverse events – Global health – HIV – Kenya – Measurement equipment – Medical devices and equipment – Surgical and invasive medical procedures – Circumcision


Zdroje

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PLOS One


2019 Číslo 9

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