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

English version

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
prolekare.web.journal.doi_sk: https://doi.org/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:

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

Zdroje

1. Bakare N. Male Circumcision in Lesotho Situation Analysis Report [Internet]. Kampala; 2008. Available from: http://hivforumannals.org/index.php/annals/article/view/11

2. World Health Organization. Overview of the Prequalification of Male Circumcision Devices; Assessment Process [Internet]. Vol. 2019. Geneva; 2011. Available from: https://www.who.int/diagnostics_laboratory/evaluations/190408_pqmc_007_overview_of_procedure_final.pdf?ua=1

3. WHO. Framework for Clinical Evaluation of Devices for Male Circumcision [Internet]. Geneva; 2012. Available from: https://apps.who.int/iris/bitstream/handle/10665/75954/9789241504355_eng.pdf?sequence=1&isAllowed=y

4. WHO. WHO Prequalification of Male Circumcision Devices Public Report Product: ShangRingTM Number: PQMC 0003-003-00 [Internet]. Geneva; 2015. Available from: https://www.malecircumcision.org/file/61590/download?token=2j0-KeHD

5. Barone MA, Ndede F, Li PS, Masson P, Awori Q, Okech J, et al. The shang ring device for adult male circumcision: A proof of concept study in Kenya. J Acquir Immune Defic Syndr. 2011;57(1).

6. Sokal D, Barone M, Li P, Simba R, Awori Q, Bowa K, et al. Minimally invasive male circumcision. J Acquir Immune Defic Syndr. 2012;59(5).

7. Barone MA, Awori QD, Li PS, Simba RO, Weaver MA, Okech JO, et al. Randomized Trial of the Shang Ring for Adult Male Circumcision With Removal at One to Three Weeks. JAIDS J Acquir Immune Defic Syndr [Internet]. 2012 Jul;60(3):e82–9. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00126334-201207010-00019 doi: 10.1097/QAI.0b013e31824ea1f2 22343180

8. Kigozi G, Musoke R, Watya S, Kighoma N, Ssebbowa P, Serwadda D, et al. The acceptability and safety of the Shang Ring for adult male circumcision in Rakai, Uganda. J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):617–21. doi: 10.1097/QAI.0b013e3182968dda 23614991; PMCID: PMC3805675.

9. WHO. Guideline on the Use of Devices for Adult Male Circumcision for HIV Prevention. Geneva, Switzerland: 2013. Available from; www.who.int/hiv/pub/malecircumcision/devices_guidelines/en/. 2013.

10. Sokal DC, Li PS, Zulu R, Awori QD, Combes SL, Simba RO, et al. Randomized Controlled Trial of the Shang Ring Versus Conventional Surgical Techniques for Adult Male Circumcision. JAIDS J Acquir Immune Defic Syndr [Internet]. 2014 Apr 1;65(4):447–55. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24583615 doi: 10.1097/QAI.0000000000000061 24583615

11. Sokal DC, Li PS, Zulu R, Awori QD, Agot K, Simba RO, et al. Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia. J Acquir Immune Defic Syndr [Internet]. 2014 Dec 1;67(4):430–7. Available from: http://journals.lww.com/jaids/Abstract/2014/12010/Field_Study_of_Adult_Male_Circumcision_Using_the.13.aspx doi: 10.1097/QAI.0000000000000321 25162816

12. Mavhu W, Hatzold K, Madidi N, Maponga B, Dhlamini R, Munjoma M, et al. (2019) Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13–17 years? Findings from routine service delivery during active surveillance in Zimbabwe. PLoS ONE 14(3): e0213399. doi: 10.1371/journal.pone.0213399 30856228

13. WHO, UNAIDS, JHPIEGO. Manual for Male circumcision under local anesthesia [Internet]. Version 3.1. 2009 [cited 2014 Nov 28]. Available from: http://www.who.int/hiv/pub/malecircumcision/who_mc_local_anesthesia.pdf?ua=1

14. Republic of Kenya, Ministry of Public Health and Sanitation. Clinical Manual for Male Circumcision under Local Anesthesia. Nairobi, Kenya. 2009. Available: http://nascop.or.ke/vmmc/. Accessed 2012 July.

15. PSI/COSECA (2016) Adverse Events Action Guide for Voluntary Medical Male Circumcision (VMMC) 2nd Edition. http://www.malecircumcision.org

16. Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, et al. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acquir Immune Defic Syndr [Internet]. 2016 Jun 1 [cited 2019 Apr 10];72 Suppl 1(Suppl 1):S30–5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27331587

17. G. Kigozi, R. Musoke, N. Kighoma, J. Nkale, D. Serwada, N. Sewankambo, et al. The acceptability and safety of the shang ring for adolescent male circumcision in Rakai, Uganda 20th International AIDS Conference, Melbourne Australia, July 20–25, 2014. http://pag.aids2014.org/Abstracts.aspx?AID=8939

18. WHO. WHO Prequalification of Male Circumcision Devices—ShangRing report version 3.0 [Internet]. 2019 [cited 2019 Apr 10]. Available from: https://www.who.int/diagnostics_laboratory/evaluations/190326_amended_final_pqpr_pqmc_0003_003_00.pdf?ua=1