Background
More than 40 observational studies and three randomized controlled trials have demonstrated that voluntary medical male circumcision (VMMC) reduces HIV acquisition among heterosexual men by approximately 60% [
1‐
4]. Extended follow-up at 66 months (Kenya) and 5 years (Uganda) also exhibited sustained reductions in HIV incidence of 64% and 73% respectively [
5,
6]. In Orange Farm, South Africa, a cross-sectional study of HIV incidence found that HIV incidence was reduced by 76% in circumcised versus [
7] confirming the long term prevention benefits of male circumcision. Given the potential impact of VMMC on HIV incidence, the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) recommended that VMMC should be part of comprehensive HIV prevention programming in regions with generalized HIV epidemics and low levels of male circumcision [
8]. Modeling projections suggest that approximately 3.36 million new HIV infections and 386,000 AIDS deaths would be averted through 2025 if 80% coverage with VMMC in 14 priority countries in Eastern and Southern Africa were achieved within five years [
9]. In order to achieve this level of coverage, an estimated 20 million VMMC procedures would need to be performed [
9].
Male circumcision is a minor surgical procedure that involves risk. Some adverse events (AEs) are expected, even when surgery is conducted in sanitary settings by trained clinicians. Several factors can minimize complications following VMMC, including client assessment and history-taking; screening for sexually transmitted infections (STIs), genital anomalies, and bleeding disorders; use of skilled VMMC providers; correct post-operative client instruction and care; client adherence to post-operative instructions; and appropriate monitoring, assessment, and management of AEs. All complications must be closely monitored to ensure that clients receive appropriate post-operative clinical management. Timely identification, proper triage and management, and accurate reporting of AEs following circumcision are critical to maintaining high-quality, safe VMMC service delivery.
AE classifications are generally defined as intra-operative if they occur during surgery or before discharge from the clinic, or post-operative if they occur following discharge from the clinic. AEs are also classified by severity (mild, moderate, or severe). Mild AEs are generally understood to be part of routine surgery and are easily managed (e.g., post-operative bleeding that is easily controlled with pressure, swelling that resolves over time). Moderate and severe AEs may require further treatment, such as antibiotics, or re-exploration of the surgical site. Definitions of AE types associated with VMMC vary slightly by country but generally include bleeding, infection, pain, swelling (hematoma), reaction to local anesthesia, wound disruption, damage to penis, sexual or erectile dysfunction, scarring, torsion of penis, excessive or insufficient skin removed, and difficulty urinating. Both intra- and post-operative AEs related to VMMC surgery are uncommon [
10‐
12].
Data on AEs following elective adolescent and adult circumcision are limited. In the three randomized controlled trials on VMMC (in Kenya, South Africa, and Uganda), the mean combined rate for all AEs was 5.0%, although adherence to post-operative instructions for wound care may have been better in trial settings than in routine service delivery [
1‐
3,
13,
14]. The trials also used different AE definitions, procedures for active follow-up surveillance, and calculations for AEs, which could account for the range in the overall AE rate: 1.7%, 3.8%, and 7.6% in the Kenyan, South African, and Ugandan clinical trials, respectively [
1‐
3]. Programmatic evidence from adolescent and adult VMMC programs suggests that AEs are generally uncommon, with post-operative infection and bleeding reported most frequently. A study of post-operative AEs in rural Kenya found that the prevalence of AEs was 1.3% among those returning for post-operative review within seven days of circumcision [
15]. Different VMMC surgical techniques can be performed by doctors and non-physicians while maintaining low AE rates [
16,
17]. During accelerated service delivery in Iringa, Tanzania, in 2010, the overall AE rate was less than 1%, and 80% of the AEs were categorized as mild or moderate, and only 20% were severe [
18]. Similarly, the moderate and severe AE rate from Kenya’s 2010 Rapid Results Initiative, which provided VMMCs to more than 55,000 adolescent and adult males in 30 working days, was 1.5% among those adhering to post-operative follow-up recommendations [
19]. In a study in Orange Farm, South Africa, which investigated the feasibility of a comprehensive VMMC program, more than 14,000 VMMC procedures were performed with a combined intra- and post-operative AE rate of 1.8%. [
20].
Swaziland has the highest HIV prevalence in the world, at 31%, and prevalence is highest among females aged 15–25 years and males aged 25–33 years [
21]. The HIV epidemic is largely driven by heterosexual transmission, and intergenerational sexual partnerships are common [
22]. Swaziland’s Ministry of Health published a five-year male circumcision strategy in 2008 that highlighted the need for widespread VMMC scale-up in Swaziland [
23]. Swaziland’s VMMC program was doctor-led with task-sharing among lower cadres, and service outlets were primarily based in public hospitals and stand-alone clinics. The minimum VMMC package was offered to all clients and included HIV testing and counseling, active exclusion of STIs, provision and promotion of condoms, risk reduction counseling, and circumcision surgery. All VMMC clients were advised to return for post-operative review 48 hours and seven days following surgery. Clients with post-operative AEs were assessed and treated according to the Ministry of Health approved AE guidelines. All clinicians working on VMMC were trained in the diagnosis and clinical management of AEs. All VMMC service delivery sites, including both fixed and temporary sites, were supplied with the necessary equipment, supplies, and medicines to treat AEs. Clients testing HIV-positive were referred to HIV care and treatment services for CD-4 testing, clinical staging, and antiretroviral treatment, as needed. All clients, regardless of HIV status, were offered VMMC, although HIV-infected clients were counseled on its limited benefits.
In hopes of controlling its HIV epidemic and reducing new infections, Swaziland planned an ambitious national VMMC campaign to be conducted in 2011 that would condense its five-year strategy into a single year. The campaign was called Soka Uncobe ("circumcise and conquer" in siSwati), and it aimed to provide VMMC surgery to approximately 150,000 adolescent and adult males aged 15–49 years. The campaign used the country’s existing VMMC sites and established several temporary sites to expand service delivery sites throughout the country.
Given the expected surge of VMMC clients during the campaign, and the corresponding increase in the number of AEs, Swaziland’s Ministry of Health implemented a telephone-based VMMC hotline. The toll-free hotline served two purposes: to give Swazi citizens the opportunity to ask trained nurses general questions about VMMC, and to triage post-operative AEs. The hotline utilized staff nurses from Swaziland’s Emergency Preparedness and Response (EPR) department who routinely handled a variety of disasters and emergencies by telephone.
In the VMMC clinics, all clients were given an appointment card that contained the date and location of their next follow-up visit. This card also contained the VMMC hotline number that they could call if they needed information, advice, or assistance regarding post-operative healing and management of any AEs. The hotline number was also included on advertisements and posters and during radio spots promoting the VMMC campaign throughout the country. Prospective clients and others interested in VMMC were recommended to call the hotline with questions about VMMC. The objectives of this analysis were to describe the reasons VMMC clients called the VMMC hotline and to assess the accuracy of telephone-based triage for VMMC in differentiating among mild, moderate, and severe AEs.
Discussion
The use of a telephone triage system within an EPR department can be an appropriate first step in not only identifying life-threatening and urgent complications following VMMC surgery but also in providing information to community members with concerns and questions about VMMC services in Swaziland. A substantial proportion of hotline callers sought general information and education about VMMC, which offered insights into community perceptions of the intervention. These insights can help in crafting more precise messages for more effective VMMC communication. They also indicate a need for continuous community-level dialogue about the role of biomedical interventions in mitigating HIV transmission in Swaziland.
This analysis focused on documenting the reasons why VMMC clients called the hotline and the validity of the AE triage through telephone calls. WHO/UNAIDS recommends that VMMC clients return to the circumcising facility within seven days of surgery for routine post-operative review [
11]. The use of the VMMC hotline provided clients with an additional opportunity to communicate with trained clinicians about the healing of their wound and about VMMC in general. Several VMMC programs and studies have investigated the use of telephone or text-based reminders about follow-up visits and post-operative sexual abstinence [
24‐
27]. To our knowledge, this is the first evaluation of an AE triage system that has been employed for notification and management of AEs during a VMMC campaign.
The AE triage system used during Swaziland’s Soka Uncobe campaign demonstrated that trained nurses using clinical algorithms can provide effective reassurance and simple management for AEs deemed mild and provide referrals for moderate and severe post-operative AEs that are later confirmed and managed by clinicians at clinics. Many questions remain about the effectiveness of telephone-based triage for VMMC. It is possible that telephone-based triage would work most effectively to provide further reassurance to post-operative clients with mild complaints and save time and cost of travel to clinic. It may also function as a complement to the in-person, post-operative review process, rather than as a replacement for it.
VMMC provides a unique opportunity to provide health services to adolescent and adult males with otherwise limited access to such services. The hotline is a relatively simple mechanism that has the potential to introduce a large audience to the country’s health services. Beyond providing referrals to health clinics, the telephone-based triage can also provide general information about the benefits of VMMC, locations of fixed and mobile service delivery sites, and other basic questions related to men’s health and encourage utilization of services.
While campaigns are an effective format to deliver VMMC for HIV prevention, they may add further stress to a delicate health care system. VMMC campaigns in other countries have emphasized the required human resource and logistics needs [
18,
19,
28,
29], and having nurses staff a VMMC hotline would add to this burden. However, a telephone-based system may help reduce the number of clients visiting health facilities who do not otherwise need to see a clinic-based service provider for their post-operative questions or concerns. VMMC clients with suspected mild AEs can be given clinical instructions to manage their wounds. In many cases, this would eliminate the need for the client to return to the VMMC facility for additional follow-up care. In addition, the use of a simplified diagnostic tool, such as a clinical algorithm, could offer an opportunity to implement task-shifting. Relying on clinical algorithms to diagnose and refer the most severe complications may alleviate the burden on high-level health care workers, who are in short supply in the Eastern and Southern African countries where VMMC is being scaled up.
There are several limitations in this analysis. Initial documentation was incomplete for clients’ subsequent outcomes after AE-related calls to the hotline. It is also possible that some clients might have accessed services in non-
Soka Uncobe clinics, including hospitals not participating in the campaign or private clinics, so these clients were not tracked. While almost three-quarters of households in Swaziland have access to a telephone [
30], it is possible that some people were unable to access the hotline. In addition, the periods of analysis for the VMMC hotline and VMMC service delivery sites varied, which may have resulted in underreporting of calls made to the hotline between March and April 2011.
Acknowledgments
The views expressed in this paper are those of the authors and do not necessarily reflect the official policy or position of the United States or the Government of the Kingdom of Swaziland. The authors would like to gratefully acknowledge the Swaziland Ministry of Health, the Emergency Preparedness and Response unit of the Ministry of Health, Jhpiego Swaziland, PSI Swaziland, and FLAS Swaziland. Finally, the authors would also like to thank Jhpiego’s Publications Department for the final copy-edit and formatting of this manuscript.
Financial disclosure
This research has been supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the Centers for Disease Control and Prevention (CDC) under the terms of the Cooperative Agreement Number UPS-001-790 and the United States Agency for International Development (USAID) under the terms of Cooperative Agreement Number: 674-A-00-11-00005-00.
The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the official position of the funding agencies.
Competing interests
There are no competing interests.
Authors’ contributions
TAA and JG: Manuscript design and analysis by. MMhlanga, MMirira, RS, KM, TH, EM, LF: Provided information and review data by. TAA, JG: Analysis conducted. TAA, JG: First draft of the manuscript. EN, NB, KC, GB: Critical review of the manuscript. All authors read and approved the final manuscript.