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SUPPLEMENT ARTICLE Medical Examinations at Entry to Treatment for Drug Abuse as an Opportunity to Initiate Care for Hepatitis C Virus Infection Holly Hagan,1 Shiela M. Strauss,1 Janetta M. Astone,1 and Don C. Des Jarlais1,2 1 Center for Drug Use and HIV Research, National Development and Research Institutes, and 2Baron Edmund de Rothschild Chemical Dependency Institute, Beth Israel Medical Center, New York, New York. Over the course of addiction, a substantial proportion of drug users enter drug abuse treatment programs. Data from a cross-sectional survey of drug abuse treatment programs in the United States were analyzed to describe the scope of the medical examination performed at admission to such programs. All of the methadone programs (n p 95) and 50% of drug-free programs (80 of 161) required a medical examination at entry. Most examinations included screening for signs and symptoms of liver disease and liver function testing. Nearly all methadone programs (97%) provided referral to medical care or support for patients with test results positive for antibody to hepatitis C virus (HCV), compared with 75% of drug-free programs (P ! .01 ). Drugfree programs requiring medical examinations provided education about HCV and testing for HCV to a larger proportion of their patients (P ! .05 ). With high dropout rates in the early stages of treatment for drug addiction, these medical visits may be an important opportunity for further monitoring and care for HCV infection and other conditions. An excess incidence of hepatitis C virus (HCV) infection occurs among injection drug users and persons who administer illicit drugs by other routes, such as smoking or inhaling [1–5]. HCV infection results in a chronic carrier state in 80%–85% of patients; treatment of persistent infection with pegylated IFN-a and ribavirin may result in sustained viral response in 40%– 50% of patients [6, 7]. Drug use is associated with several other acute and chronic medical conditions, including HIV infection and coinfection with HIV and HCV [8, 9]. However, despite drug users’ relatively poor health, studies have shown that access to medical care among drug users is low, compared with persons who do not use illicit drugs [10]. Of particular concern with respect to treatment of chronic illness, the use of health care may be crisis oriented, with little continuity in medical care [11]. Recent research has reported that Reprints or correspondence: Dr. Holly Hagan, Center for Drug Use and HIV Research, National Development and Research Institutes, 71 West 23rd St., New York NY 10010 ([email protected]). Clinical Infectious Diseases 2005; 40:S297–303 2005 by the Infectious Diseases Society of America. All rights reserved. 1058-4838/2005/4009S5-0007$15.00 treatment for HCV infection is offered to only a small proportion of medically eligible patients with a recent history of drug use [12]. Over the course of chronic dependence on narcotics and other hard drugs, many drug users in the United States will have contact with programs for treatment of drug abuse [13]. These treatment programs have been shown to be an important setting for increasing access to care and treatment for infectious diseases [14–16]. Although many drug abuse treatment programs are providing HCV-related services to some of their patients, important gaps remain. For example, surveys of drug abuse treatment programs in the United States and the United Kingdom have shown that a minority of programs offer screening for HCV to all of their patients [15, 17]. Methadone programs in the United States provide more HCV-related services to their patients than do drug-free treatment programs, including offering HCV screening and education to a higher proportion of patients and providing more-comprehensive HCV-related information to patients [18, 19]. Managers of both treatment modalities have reported that, if they were given the resources to do so, they would Medical Examinations in Drug Treatment Programs • CID 2005:40 (Suppl 5) • S297 Table 1. Characteristics of medical examination in relation to drug abuse treatment offered. Drug abuse treatment programs, no. (%) Characteristic Requires a medical examination at treatment enrollment Yes No Of those requiring a medical examination Provided on-site Yes No Examination performed by a physician or physician assistant Yes No Examination asks about history of Liver disease Yes No Hepatitis Yes No Jaundice Yes No Loss of appetite Yes No Enlargement of the abdomen Yes No Tendency toward bleeding or bruising Yes No Swelling of lower extremities Yes Methadone (n p 95) Drug-free (n p 161) P 95 (100) 80 (50) !.01 0 (0) 81 (50) 85 (89) 32 (40) 10 (11) 48 (60) 78 (84) 48 (62) 15 (16) 29 (38) 92 (97) 3 (3) 65 (87) 10 (13) .01 92 (97) 3 (3) 69 (90) 8 (10) .05 71 (75) 24 (25) 51 (68) 24 (32) NS 85 (89) 10 (11) 65 (86) 11 (14) NS 79 (83) 16 (17) 52 (68) 24 (32) .02 76 (80) 19 (20) 53 (71) 22 (29) NS !.01 !.01 !.01 83 (87) 49 (65) No Patient is asked about alcohol use 12 (13) 26 (35) Yes No Patient is asked about HIV seropositivity 94 (99) 1 (1) 73 (95) 4 (5) NS Yes No Examination includes 76 (80) 19 (20) 56 (74) 20 (26) NS .01 Inspection of the skin for spider angiomas or other signs of liver disease Yes 82 (86) 51 (71) No Palpation or percussion for enlarged liver Yes 13 (14) 21 (29) 78 (82) 56 (78) No Palpation or percussion for enlarged spleen Yes 17 (18) 16 (22) 81 (86) 47 (66) 13 (14) 24 (34) No NS !.01 (continued) Table 1. (Continued.) Drug abuse treatment programs, no. (%) Methadone (n p 95) Characteristic Examination includes blood testing Yes No Drug-free (n p 161) P 94 (99) 55 (72) !.01 1 (1) 21 (28) 92 (97) 3 (3) 103 (75) 34 (25) !.01 95 (100) 87 (54) !.01 0 (0) 74 (46) 67 (71) 27 (29) 43 (88) 6 (12) .03 67 (100) 35 (81) !.01 0 (0) 8 (19) 61 (91) 6 (9) 42 (100) 0 (0) .05 9 (17) 43 (83) 10 (33) 20 (67) NS Program provides referral to medical care or other support for anti-HCV–positive patientsa Yes No Program provides any medical care to patients Yes No Of those performing blood testing Blood tests typically include a liver panel Yes No Treatment staff review liver panel test results Yes No Patients are informed of their liver panel test results Yes No Follow-up testing of abnormal liver panel tests is done Only for patients with HCV risk factors All patients with abnormal results NOTE. Totals may not equal n because of missing data. All P values were calculated by x2 tests. anti-HCV, antibody to hepatitis C virus (HCV); NS, not significant. a For programs that have HCV-positive patients. be interested in providing more HCV-related services [20]. Many programs, especially methadone and residential drug abuse treatment programs, require that all of their patients undergo a medical examination before admission. The time of entry to treatment for drug abuse may be a period when drug users are motivated to make substantial lifestyle changes and improve their health. The staff of drug abuse treatment programs, including medical personnel, may have relatively longterm contact with some patients, although retention in drug abuse treatment programs overall is relatively low, with ∼50% of patients in drug-free programs leaving within the first 3 months and 25%–30% of patients in methadone programs leaving within the first year [21]. Nonetheless, the entry medical examination may detect HCV infection or symptoms indicating progression of chronic hepatitis and may serve as a point of referral to additional monitoring of HCV infection and care. Here, we analyzed data from a national survey of US drug abuse treatment programs to describe the extent to which drug abuse treatment programs are currently conducting medical examinations and what the examinations include, to under- stand the potential contribution of this relatively routine service to screening for and care of HCV infection. METHODS A cross-sectional telephone survey of drug abuse treatment programs in the United States was performed to study a broad set of research questions regarding HCV-related education, services, and medical care provided. Drug abuse treatment programs were selected at random from the October 2000 Inventory of Substance Abuse Treatment Services list of drug abuse treatment units compiled by the Substance Abuse and Mental Health Services Administration. To be included in the initial screening, programs must have provided treatment for drug abuse, dependence, or addiction; those that treated alcohol use only were excluded. Drug abuse treatment programs that provide methadone to their patients were oversampled in the survey, because patients with risk factors for HCV infection would be more likely to receive methadone treatment than other types of treatment. Randomly ordered lists of drug abuse treatment programs were created, one including those licensed to dispense Medical Examinations in Drug Treatment Programs • CID 2005:40 (Suppl 5) • S299 methadone and the other including all other types of drug abuse treatment. By use of these lists, managers of programs were contacted and asked questions to determine eligibility for the survey, including whether drug abuse treatment services were provided on-site and to ⭓50% of all patients; programs that offered only detoxification or short-term treatment of !7 days’ duration were excluded. At the time of the screening, managers were also asked a few questions about services related to HCV provided at the program, to judge whether there were systematic differences between programs that volunteered versus those that refused to join the study. Attempts were made to screen a total of 1286 programs; 42% did not meet inclusion criteria for the study or could not be contacted after repeated attempts, and 10% refused to participate in the screening. Thus, a total of 614 programs were eligible and willing to enroll in the study and completed the screening questionnaire. According to protocols approved by the institutional review board at National Development and Research Institutes, participants provided informed verbal consent prior to completion of the interview. Data were collected via a 3-h computer-assisted telephone survey by use of Questionnaire Development System software (version 2.0; NOVA Research Company). The questionnaire was divided into 3 sections, and, typically, each section was completed by the director, the staff supervisor, and the program nurse or the person most knowledgeable about the subjects covered in that section of the questionnaire. Items in the survey included characteristics of the program, such as organizational structure, source of financing, licensing, and ideology of the director; patient demographics; and staffing. A large set of questions focused on HCV- and HIV-related education, screening, and support provided by the program. The methods and instrument used in the present study were modified from a national study of outpatient substance abuse treatment programs by D’Aunno et al. [14]. The instrument and protocols were pilot tested with 25 treatment programs, and modifications were made on the basis of the pilot study. Data collection was performed from October 2001 to June 2003. Eligible programs were contacted by phone and mail to prepare them for participation in the survey; worksheets were sent to the program so that participants could collect some quantitative information before completing the interview (e.g., the number of women in the program and the estimated proportion of patients who were positive for antibody to HCV [antiHCV]). During the interval between initial screening for eligibility and recontacting them, 45 programs became ineligible, and 90 could not be reached despite many attempts. This reduced the number of eligible programs to 479; among the 479, a total of 291 programs participated in the survey (61%). The primary reason for not participating in the survey was a lack of staff time and resources to complete the survey worksheets S300 • CID 2005:40 (Suppl 5) • Hagan et al. and interview. Among the 291 participating programs, 256 (88%) completed the section of the survey that asked about medical examination at enrollment. Univariate analysis was done with x2 and t tests to evaluate the statistical significance of differences in medical examinations between programs, by modality, availability of other services, and other program-level characteristics. Because our intent was to describe service availability as it exists in programs (rather than evaluating a causal relation), no multivariate models were created. RESULTS There were 95 methadone programs and 161 drug-free treatment programs in the sample. The methadone clinics were larger in terms of number of patients enrolled in the past year, with a mean of 457 patients (median, 362 patients), compared with a mean of 397 patients (median, 210 patients) enrolled in the drug-free programs. As expected, a greater proportion of patients in methadone programs had ever injected an illicit drug, with a mean of 78% (median, 89%), compared with a mean of 20% (median, 13%) in drug-free programs (P ! .01). Most methadone programs (94%) offered testing for anti-HCV to at least some of their patients, compared with 68% of drugfree programs (P ! .01). All of the methadone programs and 50% of the drug-free treatment programs required a medical examination at the time of enrollment into treatment (table 1). Among methadone programs, 89% provided those examinations on-site, and most examinations were done by a physician or physician assistant (84%). Drug-free programs were more likely to offer medical examinations off-site. In both treatment settings, the medical history obtained from patients typically included asking about past liver disease, hepatitis, and jaundice. In most of these examinations, drug users were asked whether they had experienced symptoms associated with hepatitis or liver disease, such as loss of appetite, enlargement of the abdomen, tendency toward bruising or bleeding, and swelling of lower extremities. Medical histories obtained at methadone programs tended to include asking a greater number of questions related to liver disease. A small proportion of programs of either type omitted asking about alcohol use (1%–5%) or HIV seropositivity (20%– 26%), conditions that may affect the clinical course of chronic hepatitis C disease. Medical examinations for methadone patients were more likely to include palpation for enlarged spleen and inspection of the skin for signs of liver disease. Nearly all examinations performed in methadone programs (99%) included collection of a blood specimen, compared with 72% of drug-free programs. Among programs that did perform blood testing as part of the enrollment examination, liver function tests were performed in more drug-free programs (88%) than methadone programs (71%). In drug-free programs, all patients given liver Table 2. Characteristics of medical examination in relation to other services related to hepatitis C virus (HCV) provided to patients undergoing treatment for drug abuse. Patients were actually screened for anti-HCV !50% of patients ⭓50% of patients (n p 36) (n p 48) Yes 36 (100) 48 (100) No 0 (0) 0 (0) Yes 19 (53) 42 (88) No 17 (47) 6 (13) Program, characteristic Methadone programs P HCV education was provided to: !50% of patients ⭓50% of patients (n p 30) (n p 65) 30 (100) 65 (100) 0 (0) 0 (0) 22 (73) 45 (69) 8 (12) 20 (31) P Medical examination required at enrollment … Examination includes liver panel !.01 NS Protocol for follow-up testing of abnormal LFT results Only for patients with HCV risk factors 3 (20) 4 (11) 12 (80) 31 (89) Yes 36 (100) 48 (100) No 0 (0) 0 (0) (n p 61) (n p 34) Yes 34 (56) 26 (76) No 27 (44) 8 (24) Yes 19 (63) 15 (68) No 11 (37) 7 (32) All patients with abnormal results NS 2 (12) 7 (19) 15 (88) 30 (81) 30 (100) 65 (100) 0 (0) 0 (0) (n p 77) (n p 84) 32 (42) 48 (57) 45 (58) 36 (43) 16 (57) 27 (64) 12 (43) 15 (36) NS Program helps HCV-positive patients obtain medical care or support Drug-free programs … NS Medical examination required at enrollment .04 .05 Examination includes liver panel NS NS Protocol for follow-up testing of abnormal LFT results Only for patients with HCV risk factors 2 (14) 6 (35) 12 (86) 11 (65) Yes 37 (61) 27 (79) No 24 (39) 7 (21) All patients with abnormal results NS 2 (18) 8 (32) 9 (82) 17 (68) 36 (47) 51 (61) 41 (53) 33 (39) NS Program helps HCV-positive patients obtain medical care or support .06 .08 NOTE. Data are no. (%) of programs, except where noted. Totals may not equal n because of missing data. All P values were calculated by x2 tests. LFT, liver function testing; NS, not significant. function tests were informed of the results, compared with 91% of patients in methadone programs. However, taking into account the fact that fewer drug-free programs required medical examinations or did any blood testing, a larger proportion of methadone patients received liver test results (61/95 [64%]) than did patients in drug-free programs (42/161 [26%]). Follow-up testing (including anti-HCV, serologic testing for hepatitis B virus, and other tests) was usually performed for all patients with abnormal liver function test results; in some cases, further testing was performed only when patients had risk factors for HCV infection, such as history of drug injection. Nearly all methadone programs (97%) provided referral to medical care for anti-HCV–positive patients, as did a large majority of drug-free programs (75%; P ! .01). All methadone programs provided some form of medical care to their patients, compared with 54% of drug-free programs (P ! .01). In table 2, provision of specific components of the medical examination is shown in relation to the availability of other services related to hepatitis C disease in treatment program by modality. Medical examinations were more likely to be required in drug-free programs, in which more than half of patients actually received anti-HCV screening and education. Among methadone programs, liver function tests were more likely to be done in programs in which the majority of patients were tested for anti-HCV. Among drug-free programs that provided education and screening for HCV to more than half of their patients, a slightly higher proportion also helped HCV-positive patients obtain medical care and treatment. DISCUSSION In the present study, a large proportion of patients enrolled in drug abuse treatment programs in the United States received a medical examination at time of enrollment. In most cases, this examination included screening for signs and symptoms of liver disease. Because many drug-free programs include a high proportion of patients with a history of alcohol abuse, the examination may also be intended to detect alcohol-related cirrhosis. Nearly all programs inform patients of the results of blood tests for liver abnormalities and do follow-up testing to Medical Examinations in Drug Treatment Programs • CID 2005:40 (Suppl 5) • S301 discover underlying causes for abnormal tests results. Patients are also usually asked about HIV infection and alcohol use. Thus, in the majority of drug abuse treatment programs, the entry physical examination may be an excellent starting point for addressing a number of issues related to HCV, HIV, coinfection, liver disease, and alcohol use. Several differences between methadone and drug-free treatment programs were also noted. The data showed that enrollment into methadone treatment programs includes a somewhat more extensive examination for signs and symptoms of hepatitis and that blood testing for liver abnormalities was more likely to be performed. Level and type of medical screening and examination at the time of enrollment would be expected to vary between programs that provide a highly regulated medication, such as methadone, versus those that primarily provide counseling. Methadone programs were more likely to help antiHCV–positive patients obtain medical care or other support and were more likely to have provided any medical care to their patients. This may be related to the fact that methadone programs are a more medically oriented environment, with medically trained staff and facilities. The present study has several limitations, including that the sample may not be fully representative of all drug abuse treatment programs in the United States. It is conceivable that programs that offered more HCV-related services would be more likely to participate in a study of this type, although comparison of those programs that agreed to participate and those that did not showed no systematic differences in terms of factors that may be related to the provision of medical examinations (such as hospital affiliation, ownership of the unit, membership in a network of units, number of patients treated each month, and number of staff members who have direct contact with patients). Because the data were obtained by self-report from staff of the programs, it is also possible that there was misclassification of programs with respect to the characteristics we studied. This potential bias was addressed in the design of the study, by having programs complete worksheets in advance of the interview to allow program staff to examine records and collect quantitative data with more accuracy. Because they are done in such a large proportion of drug abuse treatment settings, these medical examinations can be an important point of entry to additional medical care for HCV and other infectious diseases. Examinations that establish a clinician-patient relationship can also set the stage for followup HCV-related education and counseling. To a limited extent, some coordination already occurs, because programs that required medical examinations were also more likely to provide anti-HCV screening and education to all patients. Blood testing for liver abnormalities also tended to occur in settings in which a majority of patients were likely to receive screening for antiHCV. In our survey, methadone treatment programs provided S302 • CID 2005:40 (Suppl 5) • Hagan et al. a more comprehensive examination than did drug-free programs, and only half of drug-free programs required any medical examinations at entry. These differences are attributable somewhat to regulations governing methadone programs but also indicate that too few drug-free programs are using an opportunity to address important medical issues with their patients. Clearly, underutilized capacity exists in a large proportion of drug abuse treatment programs in the United States to serve as sites for medical care and support for their patients who are at risk of acquiring HCV and other infections. 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