Adverse Event Trends Within a Large-Scale, Routine, Voluntary Medical Male Circumcision Program in Zimbabwe, 2014-2019.
Journal
Journal of acquired immune deficiency syndromes (1999)
ISSN: 1944-7884
Titre abrégé: J Acquir Immune Defic Syndr
Pays: United States
ID NLM: 100892005
Informations de publication
Date de publication:
01 10 2021
01 10 2021
Historique:
received:
04
10
2020
accepted:
20
05
2021
pubmed:
27
6
2021
medline:
31
12
2021
entrez:
26
6
2021
Statut:
ppublish
Résumé
Between 2008 and 2020, over 22.6 million male circumcisions (MCs) were performed among men ≥10 years in 15 priority countries of East and Southern Africa. Few studies from routine MC programs operating at scale describe trends of adverse events (AEs) or AE rates over time. Routine program data from a large MC program in Zimbabwe. χ2 compared characteristics of patients with AEs. Univariable and multivariable logistic models examined factors associated with AE severity. Cochran-Armitage trend tests compared AE rate trends by year (2014-2019), age, and MC method (2017-2019). From 2014 to 2019, 469,000 men were circumcised; of the total men circumcised, 38%, 27%, and 35% were conducted among individuals aged 10-14; 15-19; and ≥20 years, respectively. Most MCs (95%) used surgical (dorsal slit or forceps-guided) methods; 5% were device based (PrePex). AEs were reported among 632 (0.13%) MCs; 0.05% were severe. From 2015 to 2019, overall AE rates declined from 34/10,000 to 5/10,000 (P-value <0.001). Severe AE rates also decreased over this period from 12/10,000 to 2/10,000 (P-value <0.001). AE rates among younger clients, aged 10-14 (18/10,000) were higher than among older age men (9/10,000) aged ≥20 years (P < 0.001); however, there was no significant association between age and AE severity. AE rates each year and over time were lower than the World Health Organization acceptable maximum (2% AEs). ZAZIC quality assurance activities ensured guideline adherence, mentored clinicians to MC competency, promoted quality client education and counseling, and improved AE reporting over time. Decreases in AE rates are likely attributed to safety gains and increasing provider experience.
Sections du résumé
BACKGROUND
Between 2008 and 2020, over 22.6 million male circumcisions (MCs) were performed among men ≥10 years in 15 priority countries of East and Southern Africa. Few studies from routine MC programs operating at scale describe trends of adverse events (AEs) or AE rates over time.
SETTING
Routine program data from a large MC program in Zimbabwe.
METHODS
χ2 compared characteristics of patients with AEs. Univariable and multivariable logistic models examined factors associated with AE severity. Cochran-Armitage trend tests compared AE rate trends by year (2014-2019), age, and MC method (2017-2019).
RESULTS
From 2014 to 2019, 469,000 men were circumcised; of the total men circumcised, 38%, 27%, and 35% were conducted among individuals aged 10-14; 15-19; and ≥20 years, respectively. Most MCs (95%) used surgical (dorsal slit or forceps-guided) methods; 5% were device based (PrePex). AEs were reported among 632 (0.13%) MCs; 0.05% were severe. From 2015 to 2019, overall AE rates declined from 34/10,000 to 5/10,000 (P-value <0.001). Severe AE rates also decreased over this period from 12/10,000 to 2/10,000 (P-value <0.001). AE rates among younger clients, aged 10-14 (18/10,000) were higher than among older age men (9/10,000) aged ≥20 years (P < 0.001); however, there was no significant association between age and AE severity.
CONCLUSION
AE rates each year and over time were lower than the World Health Organization acceptable maximum (2% AEs). ZAZIC quality assurance activities ensured guideline adherence, mentored clinicians to MC competency, promoted quality client education and counseling, and improved AE reporting over time. Decreases in AE rates are likely attributed to safety gains and increasing provider experience.
Identifiants
pubmed: 34173789
doi: 10.1097/QAI.0000000000002751
pii: 00126334-202110010-00008
pmc: PMC8434989
mid: NIHMS1715740
doi:
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
173-180Subventions
Organisme : CGH CDC HHS
ID : U2G GH000972
Pays : United States
Organisme : PEPFAR
Pays : United States
Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
The authors have no conflicts of interest to disclose.
Références
Joint United Nations Programme on HIV/AIDS (UNAIDS). Neonatal and Child Male Circumcision : A Global Review. Geneva, Switzerland: UNAID;2010. Available at: https://www.who.int/hiv/pub/malecircumcision/neonatal_child_MC_UNAIDS.pdf . Accessed April 1, 2021.
Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007;369:643–656.
Auvert B, Taljaard D, Lagarde E, et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 trial. PLoS Med. 2005;2:1112–1122.
Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369:657–666.
Joint United Nations Programme on HIV/AIDS (UNAIDS). Understanding Fast-Track Targets. Accelerating Action to End the AIDS Epidemic by 2030. Available at: https://www.unaids.org/en/resources/documents/2014/JC2686_WAD2014report . Accessed April 1, 2021.
Pintye J, Baeten JM. Benefits of male circumcision for MSM: evidence for action. Lancet Glob Heal. 2019;7:e388–e389.
Yuan T, Fitzpatrick T, Ko NY, et al. Circumcision to prevent HIV and other sexually transmitted infections in men who have sex with men: a systematic review and meta-analysis of global data. Lancet Glob Heal. 2019;7:e436–e447.
World Health Organization. Voluntary Medical Male Circumcision for HIV Prevention Progress Brief; 2021. Available at: https://www.malecircumcision.org/resource/unaids-and-who-progress-brief-voluntary-medical-male-circumcision-february-2021 . Accessed May 7, 2021.
Brito A, Korn A, Monteiro L, et al. Need for improved detection of voluntary medical male circumcision adverse events in Mozambique: a mixed-methods assessment. BMC Health Serv Res. 2019;19:855.
Bochner AF, Feldacker C, Makunike B, et al. Adverse event profile of a mature voluntary medical male circumcision programme performing PrePex and surgical procedures in Zimbabwe. J Int AIDS Soc. 2017;20:21394.
Feldacker C, Bochner AF, Murenje V, et al. Timing of adverse events among voluntary medical male circumcision clients: implications from routine service delivery in Zimbabwe. PLoS One. 2018;13:e0203292.
Galukande M, Duffy K, Bitega JP, et al. Adverse events profile of PrePex a non-surgical device for adult male circumcision in a Ugandan urban setting. PLoS One. 2014;9:2–9.
Galukande M, Kahendehe C, Buuza E, et al. A rare but important adverse event associated with adult voluntary medical male circumcision: prolonged bleeding. Int J Emerg Med. 2015;8:8.
Hellar A, Plotkin M, Lija G, et al. Adverse events in a large-scale VMMC programme in Tanzania: findings from a case series analysis. J Int AIDS Soc. 2019;22:e25369.
Phili R, Abdool-Karim Q, Ngesa O. Low adverse event rates following voluntary medical male circumcision in a high HIV disease burden public sector prevention programme in South Africa. J Int AIDS Soc. 2014;17:1–7.
Reed JB, Grund J, Liu Y, et al. Evaluation of loss-to-follow-up and postoperative adverse events in a voluntary medical male circumcision program in Nyanza Province, Kenya. J Acquir Immune Defic Syndr. 2015;69:e13–e23.
Ford N, Chu K, Mills EJ. Safety of task-shifting for male medical circumcision: a systematic review and meta-analysis. Aids. 2011;26:559–566.
Kohler PK, Namate D, Barnhart S, et al. Classification and rates of adverse events in a Malawi male circumcision program: impact of quality improvement training Quality, performance, safety and outcomes. BMC Health Serv Res. 2016;16:61.
Centers for Disease Control and Prevention. Centers for Disease Control and Prevention. Voluntary Medical Male Circumcision-Southern and Eastern Africa, 2010-2012 [Internet]. MMWR Morb Morta Wkly Rep. 2013;62:953.
Lissouba P, Taljaard D, Rech D, et al. A model for the roll-out of comprehensive adult male circumcision services in African low-income settings of high HIV incidence: the ANRS 12126 Bophelo Pele Project. Plos Med. 2010;7:e1000309.
Maponga BA, Chirundu D, Shambira G, et al. Evaluation of the notifiable diseases surveillance system in sanyati district, Zimbabwe, 2010-2011. Pan Afr Med J. 2014;19:278.
World Health Organization (WHO). Country Health Information Systems: A Review of the Current Situation and Trends. Geneva, Switzerland: WHO; 2011. Available at: http://apps.who.int/healthmetrics/news/chis_report.pdf . Accessed May 6, 2021.
Herman-Roloff A, Bailey RC, Agot K. Factors associated with the safety of voluntary medical male circumcision in Nyanza province, Kenya. Bull World Health Organ. 2012;90:773–781.
Marongwe P, Gonouya P, Madoda T, et al. Trust but verify: is there a role for active surveillance in monitoring adverse events in Zimbabwe's large-scale male circumcision program? PLoS One. 2019;14:1–13.
Bailey RC, Egesah O, Rosenberg S. Male circumcision for HIV prevention: a prospective study of complications in clinical and traditional settings in Bungoma, Kenya. Bull World Health Organ. 2008;86:669–677.
World Health Organization. World Health Organization Regional Office for Africa. Progress in Scaling up Voluntary Medical Male Circumcision or HIV Prevention in Est and Southern Africa January-December 2012. October 27, 2014. Available at: https://apps.who.int/iris/handle/10665/204479 . Accessed July 14, 2021.
Byabagambi J, Kigonya A, Lawino A, et al. A Guide to Improving the Quality of Safe Male Circumcision. A Guid to Improv Qual Safe Male Circumcision Uganda. 2015.
Population Services International, College of Surgeons of East C and SA (COSECSA). Adverse VMMC by Surgery or Device. 2nd ed. 2020 (New; includes all appendices). Available at: https://www.malecircumcision.org/resource/adverse-event-action-guide-vmmc-surgery-or-device-2nd-edition-updated-december-2020-new . Accessed July 14, 2021.
Musiige AM, Ashengo TA, Stolarsky G, et al. Participant experiences and views of odor and PrePex device removal pain in a VMMC pilot study in Botswana. J Acquir Immune Defic Syndr. 2016;72(suppl 1):S73–S77.
Feldblum PJ, Odoyo-June E, Obiero W, et al. Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya. PLoS One. 2014;9:e95357.
Lebina L, Taruberekera N, Milovanovic M, et al. Piloting PrePex for adult and adolescent male circumcision in South Africa - pain is an issue. PLoS One. 2015;10:e0138755.
Hellar A, Plotkin M, Lija G, et al. Adverse events in a large-scale VMMC programme in Tanzania: findings from a case series analysis. J Int AIDS Soc. 2019;22:e25369.
Galukande M, Sekavuga DB, Muganzi A, et al. Fournier's gangrene after adult male circumcision. Int J Emerg Med. 2014;7:37.
Manentsa M, Mukudu H, Koloane N, et al. Complications of high volume circumcision: glans amputation in adolescents; A case report. BMC Urol. 2019;19:65.
Lucas TJ, Toledo C, Davis SM, et al. Case series of glans injuries during voluntary medical male circumcision for HIV prevention - eastern and southern Africa, 2015-2018. BMC Urol. 2020;20:45.
Grund JM, Toledo C, Davis SM, et al. Tetanus Cases after Voluntary Medical Male Circumcision for HIV Prevention-Eastern and Southern Africa, 2012-2015. San Diego, CA: Naval Health Research Center; 2016.
World Health Organization. WHO Technical Advisory Group on Innovations in Male Circumcision, Meeting Report, 30 September-2 October 2014, Geneva, Switzerland. Available at: https://www.who.int/hiv/pub/malecircumcision/tag_devices/en/ . Accessed April 1, 2021.
Grund JM, Toledo C, Davis SM, et al. Notes from the field: tetanus cases after voluntary medical male circumcision for HIV prevention—eastern and southern Africa, 2012-2015. MMWR Morb Mortal Wkly Rep. 2016;65:36–37.
World Health Organization. Tetanus and Voluntary Medical Male Circumcision: Risk According to Circumcision Method and Risk Mitigation. Geneva, Switzerland. 2016. Available at: https://www.who.int/hiv/pub/malecircumcision/tetanus-vmmc-report/en/ . Accessed April 1, 2021.
Feldacker C, Makunike-Chikwinya B, Holec M, et al. Implementing voluntary medical male circumcision using an innovative, integrated, health systems approach: experiences from 21 districts in Zimbabwe. Glob Health Action. 2018;11:1414997.
U.S. President's Emergency Plan for AIDS Relief. Monitoring, evaluation, and reporting indicator reference guide. Available at: https://www.state.gov/wp-content/uploads/2019/10/PEPFAR-MER-Indicator-Reference-Guide-Version-2.4-FY20.pdf . Accessed April 1, 2021.
Somanathan H, Mali S, Borges RM, et al. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing. Oecologia; 2004. Available at: http://tropicalconservationscience.mongabay.com/public/old/tropicalconservationscience/_/ojs/index.php/tcs/article/view/58%5Cnhttp://doi.wiley.com/10.1111/j.1744-7429.2003.tb00280.x%5Cn%3CGo to ISI%3E://A1997XW01300010%5Cn%3CGo to ISI%3E://000253477500007 . Accessed April 1, 2021.
StataCorp LLC. Stata Statistical Software: Release 15. College Station, TX, 2017. Available at: www.stata.com/features/documentation/ . Accessed April 1, 2021.
Edouard L, Okonofua F. Male circumcision for HIV prevention: evidence and expectations. Afr J Reprod Health. 2006;10:7–13.
Mavhu W, Hatzold K, Dam KH, et al. Adolescent wound-care self-efficacy and practices after voluntary medical male circumcision - a multicountry assessment. Clin Infect Dis. 2018;66:S229–S235.
Lane C, Bailey RC, Luo C, et al. Adolescent male circumcision for HIV prevention in high priority countries: opportunities for improvement. Clin Infect Dis. 2018;66:S161–S165.
World Health Organization. Technical Brief: Improving Surgical Male Circumcision Practice Through Experience: Preventing Urethral Fistula. Available at: https://www.who.int/hiv/pub/malecircumcision/male-circumcision-preventing-urethral-fistula/en/ . Accessed April 1, 2021.
Edouard L, Okonofua F. Male Circumcision for HIV Prevention: Evidence and Expectations . Afr J Reprod Health. 2006;10:7–13.
U.S. President's Emergency Plan for AIDS Relief. PEPFAR 2021 Country and Regional Operational Plan (COP/ROP) Guidance for all PEPFAR Countries. Available at: https://www.state.gov/wp-content/uploads/2020/12/PEPFAR-COP21-Guidance-Final.pdf . Accessed April 1, 2021.
Boyee D, Peacock E, Plotkin M, et al. What messages are adolescent voluntary medical male circumcision (VMMC) clients getting and how? Findings from an observational study in Tanzania. AIDS Behav. 2017;21:1383–1393.
Feldacker C, Murenje V, Holeman I, et al. Reducing provider workload while preserving patient safety: a randomized Control trial using 2-way texting for postoperative follow-up in Zimbabwe's voluntary medical male circumcision program. J Acquir Immune Defic Syndr. 2020;83:16–23.
Feldacker C, Murenje V, Makunike-Chikwinya B, et al. Balancing competing priorities: quantity versus quality within a routine, voluntary medical male circumcision program operating at scale in Zimbabwe. PLoS One. 2020;15:e0240425.
Xiao Y, Bochner AF, Makunike B, et al. Challenges in data quality: the influence of data quality assessments on data availability and completeness in a voluntary medical male circumcision programme in Zimbabwe. BMJ Open. 2017;7:e013562.