VMMC Devices-Introducing a New Innovation to a Public Health Intervention.

Abstract

Innovation, whether related to drugs, vaccines, or even program design, can allow services to be provided in a timely and efficient manner and to be appealing to beneficiaries. Examples such as point-of-care CD4 cell counts, rapid malaria diagnostic tests, tuberculosis diagnosis by cartridge-based nucleic acid amplification test, rapid HIV test kits (and more recently HIV self-testing), and fixed-dose combination antiretroviral therapy innovations in HIV treatment and prevention improve the efficiency and reach of services. Choice is also an important factor in acceptability and uptake of health services, as seen in contraceptive programs where an increased number of options are associated with increased contraceptive uptake.1 A recent example of an innovation with potential impact is medical devices developed for adolescent and adult voluntary medical male circumcision (VMMC) HIV prevention programs. VMMC progress in the 14 priority countries of southern and East Africa is an impressive public health HIV prevention effort. By the end of 2015, 10 million males had been provided with medical circumcision by HIV prevention programs, the vast majority also receiving HIV testing, many for the first time.2 Additionally, VMMC was one of 19 global health priorities referred to by the Copenhagen Consensus Centre as a ‘best-buy’ to reach the sustainable development goals.3 Beyond the prevention of HIV infection, added benefits of VMMC include prevention of other sexually transmitted infections such as herpes simplex virus and human papillomavirus infections.4,5 Not to be forgotten is the fact that an uninfected partner is the best protection against the sexual transmission of HIV, and therefore, the HIV prevention beneficiaries of male circumcision include women and also men. A model for Zambia predicts that reaching a goal of 80% circumcision among males of 15–49 years would reduce HIV incidence among females as much as 26% in the long term.6 Models predict that in some countries, almost half of HIV infections averted within a generation's time of VMMC scale-up will be among women.7 Achieving VMMC coverage of priority populations is not without challenges and complexities, including cultural barriers, establishment of new supply chains, need for high-quality services, creation of demand for services, funding, and need for efficiencies for service delivery.8 Given the goal of VMMC scale-up at a time of decreasing resources for primary prevention modalities, strategies and innovations are needed to improve accessibility, increase uptake of services, ensure sustainability, and improve cost efficiencies, all while maintaining public trust and safety of the program. In contrast to conventional surgical methods, medical devices for circumcision of adults and adolescent males are an innovation that may alleviate some scale-up challenges through the elimination of complexities inherent to surgery, including the need for sutures and injected anesthesia. Device-based techniques are typically shorter, easier to learn, simpler to perform, and have been safely conducted by nurses. Devices have thus been promoted as a means to extend the reach of programs, reduce costs, and potentially increase demand and program efficiency, while maintaining or even improving on safety.9 Advantages need to be weighed against the requirement that clients return 7 days after device placement for removal, whereas follow-up after surgical VMMC is voluntary. Two medical devices for adolescent and adult VMMC, PrePex and ShangRing, have been prequalified by World Health Organization (WHO) and can be used in VMMC programs supported by the President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund for AIDS, Tuberculosis and Malaria.10 Initial research on devices demonstrated safety and acceptability in the setting of clinical trials.11,12 Despite this, additional questions that cannot be answered in the clinical trial setting remain, including requirements and timelines for in-country regulatory processes, safety with use in routine service delivery settings (including at fixed, outreach, and mobile service delivery sites), strategies for integration of devices into ongoing programs, client demand, impact on program reach, and the cost of services. To further explore these issues, the Bill & Melinda Gates Foundation and PEPFAR developed a systematic research agenda, independent from device manufacturers, to understand the potential of devices to accelerate VMMC scale-up. As part of the evaluation agenda, it was also important that questions be addressed in contexts as close as possible to “real-life” scaled programs. This collection of 16 articles examines research on the introduction of the 2 devices prequalified by WHO, PrePex, and ShangRing. These studies provide a firm body of evidence to inform development of recommendations regarding device introduction into VMMC programs already operating at scale. We offer a brief description of the findings on introduction, including on safety, supply, demand, and cost of VMMC using devices, as summarized in Figure ​Figure11. FIGURE 1. Framework for systematically assessing the role of devices in accelerating the scale-up and improving the efficiency of the VMMC program. COGS, cost of goods sold; HR, human resources; OR, operational research.