Controlling Healthcare-Associated Infections in the International Research Setting

Abstract

Standard infection control precautions and centralized prevention/education has improved health care outcomes for patients and health care workers (HCW).1–3 In resource-limited health care settings, implementation of these practices is challenging and transmission of highly resistant organisms within health care facilities is described.4–7 High rates of needle stick injuries and 8 unsafe injection practices9 occur in clinics and hospitals where blood borne infections such as hepatitis and HIV are common; post-exposure prophylaxis is infrequently accessed.10 Alcohol gels are perceived as expensive and may be unavailable and many settings lack appropriate hand washing facilities.11 Personal protective equipment is often absent, medical equipment may be old and in disrepair. Strict standards for environmental controls are difficult to maintain and health care facilities themselves are often archaic. International recommendations are available for infection control, but programs are not consistently regulated and have few monitoring and enforcement programs. 12–14 The National Institute of Allergy and Infectious Diseases (NIAID) supports six networks conducting HIV-related clinical research. Many clinical research sites (CRS) are located outside of the US in resource-limited settings. CRS that have access to the patients and resources necessary to perform high quality research are limited and usually engage in diverse research. A single site might have studies focusing on the prevention of mother-to-child transmission of HIV, intensive pK studies involving new drugs for multiresistant organisms, and protocols testing second-line antiretroviral therapy. Standard clinical care is provided in often crowded facilities where research subjects are present for many hours. Anecdotal observations have suggested there are significant variations in infection control practices among the sites. Methods A survey of the infection control resources and practices at the CRS outside of the United States was undertaken, led by the Office of HIV/AIDS Network Coordination (HANC). Sites were asked about a formal infection control program, staff safety, respiratory hygiene and tuberculosis control, hand hygiene capabilities, injection practices and blood safety. Results 74 sites overall were offered the survey, 32 returned completed surveys. 23/32 AIDS Clinical Trials Group sites completed the survey. Infection control organization 86% of sites had an infection control policy, of these 55% were specific to the CRS. 75% of sites had an infection control officer, directly employed by the sites half the time. The sites without an infection control policy frequently did not have policies addressing the domains surveyed. Respiratory 60% of sites reported a triage system to identify participants with potential respiratory infections. Commonly the study participant was placed in a well-ventilated area and provided a mask. Less than half of respondents (45.2%) conduct protocol procedures with participants with known or suspected tuberculosis (TB) in a separate clinic area. Natural and mechanical ventilation were common methods of ensuring respiratory hygiene. N95 masks were available in the general clinic in 39% of sites (12/31). Ultraviolet (UV) lights were present in 8/29 general clinic areas and 4/13 dedicated sputum collection areas indoors. A dedicated space for sputum collection was present in 55% of the CRSs. Space for sputum collection was most commonly an area outside (~55%) or a dedicated sputum collection area inside (~45%). In the space for sputum collection, natural and mechanical ventilation was used as infection control measures. 25% of sites reported surgical masks worn by patients. Staff were provided N95 masks 50% of the time in the dedicated sputum collection area; 2/11 sites reported that N95 respirators were available. Educational material on cough hygiene was available at 40% of the respondent sites. 45% of sites had TB surveillance programs for staff members in 45% and routinely screened staff for TB infection 71% of the time Hand Hygiene All sites reported sinks with running water; most had manual soap dispensers (25/32) and paper hand towels (27/32). Hand sanitizers were available at half of the sites. Water basins filled remotely were used in some areas in 15/32 sites, bar soap in 13/32 sites, and cloth hand towels in 11/32 sites. Blood safety All sites reported a policy for management of needle stick injuries and all sites have appropriate postexposure prophylaxis for HIV. The source patient is tested for hepatitis B at 58% of sites, and hepatitis C at 39%. Post exposure protocols for hepatitis B were present in 42% of sites. A majority of sites reported a needle recapping policy (71%) and 58% used safe needle systems. Sharps containers were generally available.