Dataset Information

Description of adverse events among adult men following voluntary medical male circumcision: Findings from a circumcision programme in two provinces of South Africa.

ABSTRACT:

Background

Clinical trials showed strong evidence that voluntary medical male circumcision (VMMC) reduces the acquisition of HIV among heterosexual men by up to 60%. However, VMMC uptake in East and Southern Africa remains suboptimal, with safety concerns identified as a barrier to uptake. We investigated the occurrence and severity of adverse events (AEs) in a routine VMMC programme implemented in Gauteng and North West provinces of South Africa.

Methods

We describe the frequency and characteristics of AEs using routinely collected data from a VMMC programme implemented between 01 May 2013 and 31 December 2014. The surgical procedure was provided at fixed clinics and mobile units in three districts. Adult men undertaking the procedure were referred for follow-up appointments where AEs were monitored.

Results

A total of 7,963 adult men were offered the VMMC service with 7,864 (98.8%) met the age and consent requirements for inclusion in a research follow-up after the surgical procedure and were followed-up for potential AEs. In total, 37 (0.5%) patients reported AEs post-surgery with infection [11 (29.7%)] and excessive bleeding [11 (29.7%)] commonly reported AEs. In terms of severity, 14 (37.8%) were classified as mild, 13 (35.1%) as moderate, and 10 (27.0%) as severe. Further, 32 (86.5%) of the AEs were classified as definitely related to the surgical procedure, with 36 (97.5%) of all AEs resolving without sequelae.

Conclusion

The VMMC programme was able to reach adult men at high risk of HIV acquisition. Reported AEs in the programme were minimal, with the observed safety profile comparable to clinical trial settings, suggesting that VMMC can be safely administered in a programmatic setting.

SUBMITTER: Muchiri E

PROVIDER: S-EPMC8370616 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRecent studies in the Sub-Saharan countries in Africa have indicated gaps and challenges for voluntary medical male circumcision (VMMC) quality of service. Less has focused on the changes in quality of service after implementation of continuous quality improvement (CQI) action plans. This study aimed to evaluate the impact of coaching, provision of standard operating procedures (SOPS) and guidelines, mentoring and on-site in-service training in improving quality of VMMC services across four Right to Care (RTC) supported provinces in South Africa.MethodThis was a pre- and post-interventional study on RTC supported VMMC sites from July 2018 to October 2019. All RTC-supported sites that were assessed at baseline and post-intervention were included in the study. Data for baseline CQI assessment and re-assessments was collected using a standardized National Department of Health (NDoH) CQI assessment tool for VMMC services from routine RTC facility level VMMC programme data. Quality improvement support was provided through a combination of coaching, provision of standard operating procedures and guidelines, mentoring and on-site in-service training on quality improvement planning and implementation. The main outcome measure was quality of service. A paired sample t-test was used to compare the difference in mean quality of service scores before and after CQI implementation by quality standard.ResultsA total of 40 health facilities were assessed at both baseline and after CQI support visits. Results showed significant increases for the overall changes in quality of service after CQI support intervention of 12% for infection prevention (95%CI: 7-17; p<0.001) and 8% for male circumcision surgical procedure, (95%CI: 3-13; p<0.01). Similarly, individual counselling, and HIV testing increased by 14%, (95%CI: 7-20; p<0.001), group counselling, registration and communication by 8%, (95%CI: 3-14; p<0.001), and 35% for monitoring and evaluation, (95%CI: 28-42; p<0.001). In addition, there were significant increases for management systems of 29%, (95%CI: 22-35; p<0.001), leadership and planning 23%, (95%CI: 13-34; p<0.001%) and supplies, equipment, environment and emergency 5%, (95%CI: 1-9; p<0.01). The overall quality of service performance across provinces increased by 18% (95%CI: 14-21; p<0.001).ConclusionThe overall quality of service performance across provinces was significantly improved after implementation of CQI support intervention program. Regular visits and intensive CQI support are required for sites that will be performing below quality standards.

Project description:BackgroundIn 2012, South Africa set a goal of circumcising 4.3 million men ages 15-49 by 2016. By the end of March 2014, 1.9 million men had received voluntary medical male circumcision (VMMC). In an effort to accelerate progress, South Africa undertook a modeling exercise to determine whether circumcising specific client age groups or geographic locations would be particularly impactful or cost-effective. Results will inform South Africa's efforts to develop a national strategy and operational plan for VMMC.Methods and findingsThe study team populated the Decision Makers' Program Planning Tool, Version 2.0 (DMPPT 2.0) with HIV incidence projections from the Spectrum/AIDS Impact Module (AIM), as well as national and provincial population and HIV prevalence estimates. We derived baseline circumcision rates from the 2012 South African National HIV Prevalence, Incidence and Behaviour Survey. The model showed that circumcising men ages 20-34 offers the most immediate impact on HIV incidence and requires the fewest circumcisions per HIV infection averted. The greatest impact over a 15-year period is achieved by circumcising men ages 15-24. When the model assumes a unit cost increase with client age, men ages 15-29 emerge as the most cost-effective group. When we assume a constant cost for all ages, the most cost-effective age range is 15-34 years. Geographically, the program is cost saving in all provinces; differences in the VMMC program's cost-effectiveness across provinces were obscured by uncertainty in HIV incidence projections.ConclusionThe VMMC program's impact and cost-effectiveness vary by age-targeting strategy. A strategy focusing on men ages 15-34 will maximize program benefits. However, because clients older than 25 access VMMC services at low rates, South Africa could consider promoting demand among men ages 25-34, without denying services to those in other age groups. Uncertainty in the provincial estimates makes them insufficient to support geographic targeting.

Project description:BACKGROUND:Adverse events (AE) resulting from voluntary medical male circumcision (VMMC) are commonly used to measure program quality. Mozambique's VMMC program data reports a combined moderate and severe AE rate of 0.2% through passive surveillance. With active surveillance, similar programs report AE rates ranging from 1.0 to 17.0%. The objective of this activity was to assess potential underreporting of AEs via the passive surveillance system in Mozambique. METHODS:This mixed-methods assessment randomly selected one third (16) of all 46 VMMC clinics through stratified sampling, based on volume. A retrospective record review was conducted including patient clinical files, stock records of Amoxicillin/Clavulanic Acid (the choice antibiotic for VMMC-related infections), and clinic-level AE rates from the national database. Records from the month of April 21 to May 20, 2017 were analyzed to identify both reported and potentially unreported AEs. In addition, external, expert clinicians observed post-operative visits (n = 167). Descriptive statistics were calculated, including difference between reported and identified AEs, an adjusted retrospective AE rate, and an observed prospective AE rate in each clinic. RESULTS:A total of 5352 circumcisions were performed in the 16 clinics: 8 (0.15%) AEs were reported. Retrospective clinical record reviews identified 36 AEs (0.67%); AE severity or type was unknown. Using Amoxicillin/Clavulanic Acid dispensation as a proxy for VMMC-related infections, 39 additional AEs infections were identified, resulting in an adjusted AE rate of 1.4%, an 8.3 fold increase from the reported AE rate. Prospective, post-operative visit observations of 167 clients found 10 AEs (5.9%); infection was common and boys 10-14 years old represented 80% of AE clients. CONCLUSIONS:Evidence suggests underreporting of AEs in the Mozambican VMMC program. Quality improvement efforts should be implemented in all VMMC sites to improve AE identification, documentation and prevention efforts.

Project description:BackgroundTiming of routine follow-up visits after adult male circumcision (MC) differs by country and method. Most men do not attend all routine follow-up visits. This cross-sectional study aimed to further understanding of AE timing within a large-scale, routine, MC program to improve patient safety.MethodsFrom 2013-2017, ZAZIC consortium performed 192,575 MCs in Zimbabwe; the reported adverse event (AE) rate was 0.3%. Three scheduled, routine, follow-up visits intend to identify AEs. For surgical MC, visits were days 2, 7 and 42 post-procedure. For PrePex (device-based), visits were days 7, 14 and 49. Descriptive statistics explored characteristics of those patients with AEs. For each MC method, chi-square tests were used to evaluate associations between AE timing (days from MC to AE diagnosis) and factors of interest (age, AE type, severity).ResultsOf 421 AEs, 290 (69%) were surgical clients: 55 (19%) AEs were ≤2 days post-MC; 169 (58%) between 3-7 days; 47 (16%) between days 8-14; and 19 (7%) were ≥15 post-MC. Among surgical clients, bleeding was most common AE on/before Day 2 while infections predominated in other follow-up periods (p<0.001). Younger surgical MC patients with AEs experienced AEs later than older clients (p<0.001). Among 131 (31%) PrePex clients with AEs, 46 (35%) were ≤2 days post-MC; 59 (45%) between 3-7 days; 16 (12%) between days 8-14; and 10 (7%) ≥15 post-MC. For PrePex clients, device displacements were more likely to occur early while late AEs were most commonly infections (p<0.001).ConclusionAlmost 23% of surgical and 8% of PrePex AEs occurred after Visit 2. Later AEs were likely infections. Clinicians, clients, and caregivers should be more effectively counseled that complications may arise after initial visits. Messages emphasizing attention to wound care until complete healing could help ensure client safety. Younger boys, ages 10-14, and their caregivers would benefit from improved, targeted, post-operative counseling.

Project description:BackgroundThe epidemiological and programmatic implications of inclusivity of HIV-positive males in voluntary medical male circumcision (VMMC) programs are uncertain. We modeled these implications using Zambia as an illustrative example.Methods and findingsWe used the Age-Structured Mathematical (ASM) model to evaluate, over an intermediate horizon (2010-2025), the effectiveness (number of VMMCs needed to avert one HIV infection) of VMMC scale-up scenarios with varying proportions of HIV-positive males. The model was calibrated by fitting to HIV prevalence time trend data from 1990 to 2014. We assumed that inclusivity of HIV positive males may benefit VMMC programs by increasing VMMC uptake among higher risk males, or by circumcision reducing HIV male-to-female transmission risk. All analyses were generated assuming no further antiretroviral therapy (ART) scale-up. The number of VMMCs needed to avert one HIV infection was projected to increase from 12.2 VMMCs per HIV infection averted, in a program that circumcises only HIV-negative males, to 14.0, in a program that includes HIV-positive males. The proportion of HIV-positive males was based on their representation in the population (e.g. 12.6% of those circumcised in 2010 would be HIV-positive based on HIV prevalence among males of 12.6% in 2010). However, if a program that only reaches out to HIV-negative males is associated with 20% lower uptake among higher-risk males, the effectiveness would be 13.2 VMMCs per infection averted. If improved inclusivity of HIV-positive males is associated with 20% higher uptake among higher-risk males, the effectiveness would be 12.4. As the assumed VMMC efficacy against male-to-female HIV transmission was increased from 0% to 20% and 46%, the effectiveness of circumcising regardless of HIV status improved from 14.0 to 11.5 and 9.1, respectively. The reduction in the HIV incidence rate among females increased accordingly, from 24.7% to 34.8% and 50.4%, respectively.ConclusionImproving inclusivity of males in VMMC programs regardless of HIV status increases VMMC effectiveness, if there is moderate increase in VMMC uptake among higher-risk males and/or if there is moderate efficacy for VMMC against male-to-female transmission. In these circumstances, VMMC programs can reduce the HIV incidence rate in males by nearly as much as expected by some ART programs, and additionally, females can benefit from the intervention nearly as much as males.

Project description:BackgroundOverwhelming evidence, including three clinical trials, shows that male circumcision (MC) reduces the risk of HIV infection among men. However, data from recent Lesotho Demographic and Health Surveys do not demonstrate MC to be protective against HIV. These contradictory findings could partially be due to inaccurate self-reported MC status used to estimate MC prevalence. This study describes MC characteristics among men applying for Lesotho Defence Force recruitment and seeks to assess MC self-reported accuracy through comparison with physical-examination-based data.Methods and findingsDuring Lesotho Defence Force applicant screening in 2009, 241 (77%) of 312 men, aged 18-25 y, consented to a self-administered demographic and MC characteristic survey and physician-performed genital examination. The extent of foreskin removal was graded on a scale of 1 (no evidence of MC) to 4 (complete MC). MC was self-reported by 27% (n?=?64/239) of participants. Of the 64 men self-reporting being circumcised, physical exam showed that 23% had no evidence of circumcision, 27% had partial circumcision, and 50% had complete circumcision. Of the MCs reportedly performed by a medical provider, 3% were Grade 1 and 73% were Grade 4. Of the MCs reportedly performed by traditional circumcisers, 41% were Grade 1, while 28% were Grade 4. Among participants self-reporting being circumcised, the odds of MC status misclassification were seven times higher among those reportedly circumcised by initiation school personnel (odds ratio?=?7.22; 95% CI?=?2.29-22.75).ConclusionsApproximately 27% of participants self-reported being circumcised. However, only 50% of these men had complete MC as determined by a physical exam. Given this low MC self-report accuracy, countries scaling up voluntary medical MC (VMMC) should obtain physical-exam-based MC data to guide service delivery and cost estimates. HIV prevention messages promoting VMMC should provide comprehensive education regarding the definition of VMMC.