A prospective cohort study of safety and patient satisfaction of voluntary medical male circumcision in Botswana

Abstract

Randomized trials have shown that voluntary medical male circumcision (VMMC) significantly reduces the risk of HIV acquisition in men. However, the rate of complications associated with the surgical procedure varies from 0.7% to 37.4% in real-world settings. We assessed the frequency, type and severity of adverse events following VMMC among 427 adult men surgically circumcised in southeastern Botswana; 97% completed ≥1 follow-up visit within seven days post-circumcision. Thirty moderate AEs were observed in 28 men resulting in an overall AE rate of 6.7%. Patient satisfaction was high: >95% were very or somewhat satisfied with the procedure and subsequent follow-up care.

Timing of adverse events among voluntary medical male circumcision clients: Implications from routine service delivery in Zimbabwe

“…This study fills gaps in the literature. Although many previous studies report on moderate and severe AEs, noting rates ranging from 0.5% to 8% [ 14 , 19 , 29 – 40 ], these data come from controlled trials and pilot programs with active surveillance, conditions that are largely dissimilar to the routine program implementation setting discussed here. To the authors’ knowledge, few publications detail information on AEs within MC programs operating at scale or within routine program settings.…”

Need for improved detection of voluntary medical male circumcision adverse events in Mozambique: a mixed-methods assessment

“…Field studies in other sub-Saharan African settings that report low AE rates (< 2%) also found sub-optimal retention in post-procedure follow-up [23–27], especially after Day 2, suggesting that some AEs may not be identified, in part as clients may seek care outside of routine VMMC settings. Indeed, experiences in Kenya [8] and Botswana [11] with high retention found more AEs, with AE rates of 5.1 and 6.7%, respectively. Although Mozambique national VMMC data from 2013 to 2017 report that Day 2 follow-up rates increased from 25% (2013) to 80% (2017) and that Day 7 follow-up increased from 15% (2013) to 64% (2017) [15], there remains a large proportion of men who do not return to routine VMMC settings, some of whom may have undetected - and unreported - AEs.…”

“…Overall, VMMC is considered safe. Adverse events (AE) rates, a key indicator of VMMC service delivery quality, range from 0.5 to 7% in randomized control trials and active surveillance settings [1–3, 8–11]. Further meta-analysis results from a larger pool of VMMC programs recently found a pooled average AE proportion of 2.3% [12].…”

Early resumption of sex after voluntary medical male circumcision for HIV prevention within a programmatic delivery setting in Botswana

“…The parent study enrolled men between November 2013 and April 2015 and was designed to prospectively assess sexual behaviors and adverse events following VMMC. 25 Parent study procedures have been previously described in detail. 25 Briefly, the study was collaboratively conducted by the Botswana Ministry of Health (MOH) and the International Training and Education Center for Health, a collaboration between the University of Washington and University of California, San Francisco.…”

“…25 Parent study procedures have been previously described in detail. 25 Briefly, the study was collaboratively conducted by the Botswana Ministry of Health (MOH) and the International Training and Education Center for Health, a collaboration between the University of Washington and University of California, San Francisco. Recruitment and enrollment of study participants occurred before undergoing VMMC but after individuals completed group education about the risks and benefits of VMMC, received individual counseling with clinic staff (including HIV testing), and provided written informed consent for VMMC.…”