Hepatitis

INTRODUCTION

The hepatitis C virus (HCV) continues to penetrate populations in the United States with approximately 4 million people infected, and 85% of these individuals have chronic HCV (1-3). Many individuals who are HCV positive, however, do not become aware of their serostatus until several decades after the initial infection. Often they do not recognize HCV symptoms, such as fatigue, in the early stages of HCV infection. This delay in symptom recognition may result in missed opportunities for medical care until the liver is seriously compromised. The long-term damage to the liver may result in cirrhosis and liver cancer, sometimes leaving a liver transplant as the only treatment option (4,5). In fact, more than one third of current liver transplant candidates have HCV, and the annual number of patients with HCV who had a liver transplant increased five times during 1990 to 2000 (6). However, serious sequelae of the virus can be prevented by eradicating the infection through treatment with antivirals. The current gold standard in terms of treatment efficacy is the combination of peginterferon and ribavirin for 48 weeks (7,8). This treatment regimen has been shown to be moderately successful against genotype 1, the most common form of HCV in the United States, significantly diminishing the viral load in 42% to 51% of the cases (9-11). To minimize the impact of HCV and maximize the treatment options and treatment efficacy, it is essential to detect HCV at the earliest stage, before significant cirrhosis develops.

Because of the efficiency of parenteral transmission of the virus, past and present drug injectors have the highest prevalence of HCV (1,12,13), and the highest rate of new cases of HCV is among drug injectors (14). Noninjecting drug users are also at higher risk of contracting HCV than nondrug users (15,16). In particular, individuals who use cocaine intranasally may be especially at risk for contracting HCV through blood-contaminated straws (17-20). Unfortunately, because many HCV positive drug users are unaware of their chronic infection with the virus for many years (3,4,21), they may unknowingly transmit the virus to others. Even those who are aware that they are HCV positive may continue to spread the virus because they lack the knowledge that HCV can be spread through injection paraphernalia, such as cookers and cottons (12). Because drug users are a medically underserved and a difficult to reach population (22-24), public health efforts need to find ways to increase drug users' access to HCV testing and medical care. Drug treatment programs are well situated to provide such services to drug abusers. This is especially the case among methadone maintenance treatment programs (MMTPs) because they treat a large number of injectors, the majority of whom are HCV positive (17,25,26). Few drug-free programs or MMTPs, however, have instituted comprehensive HCV testing and/or medical care services, either on-site or through referral (27-29).

Because directors are key gatekeepers who can influence decisions about hiring and training of staff, program development, and the allocation of resources and funding streams, they are likely to play a key role in introducing HCV services into the treatment program's agenda, and in influencing the successful integration of these services (30-33). The lack of the drug treatment program's implementation of comprehensive HCV services may be related to a director's concerns about introducing HCV testing and HCV treatment into a program's service repertoire. In particular, directors may be concerned that if a patient tests positive for HCV during drug treatment, it may have a detrimental effect on the patient's addiction recovery (34,35). There is also concern about whether it is appropriate to treat patients in recovery because of their propensity to relapse and use alcohol or drugs, thereby compromising the effectiveness of the HCV medications (36). Adherence to the pharmacological treatment regimen may also be seen as unlikely to be followed by drug users, especially in outpatient and methadone programs where patients have more frequent contact with their social networks. Finally, there is considerable debate on whether to wait until the patient is abstinent for a fixed period of time before introducing the HCV medical treatment (37,38). Despite the important decision-making role of directors, there are few published studies that examine the relationship between a drug treatment director's beliefs and the services provided at the program. Using data from a national sample of outpatient drug-free and MMTPs, this article, therefore, examines drug treatment directors' beliefs about HCV services being delivered in drug treatment programs. It then investigates the relationship between these beliefs and their relationship to the actual provision of HCV services.

METHODS

Screening for Eligibility and the Sampling Frame

Initially, three interviewers screened a random, nationwide sample of drug treatment programs for eligibility for the research. These programs were all included in the October 1, 2000 Inventory of Substance Abuse Treatment Services (I-SATS). The eligibility screening involved a brief telephone survey with a program manager. Programs were eligible to participate in the research if they were located within the 50 United States or the District of Columbia and provided drug abuse treatment services on-site to at least 50% of their patients. Programs that provided only alcohol treatment, or only detoxification or very short-term treatment (<7 days) were excluded. Additional questions were added to the screening survey to obtain basic information about the HCV services provided by the program.

In all, we attempted to contact 1286 programs from January through October, 2001. These 1286 programs included 1) a total of 1074 outpatient and residential programs intended to be a representative nationwide sample of both drug-free and methadone programs and 2) 212 additional methadone programs so that this modality could be oversampled. Of the 1074 programs in the random nationwide sample that we attempted to contact in 2001, 46% were either not eligible for the research or could not be contacted by telephone alter repeated attempts, and 11% opted not to participate in the research at the time they were screened for eligibility. In all, 457 drug treatment programs in the random nationwide sample were determined to be eligible, completed the enhanced screening survey, and were willing to be contacted again to schedule a more extensive interview. Because residential treatment programs differ from outpatient programs in some fundamental ways [e.g., program capacity, treatment approach and intensity, patient involvement, staffing, expected length of stay, and having patients who have different drug use histories (39-42)] and because HCV education and testing services have been found to differ according to drug treatment program type (27-29), in this article we confine our attention to the 311 outpatient programs in the random nationwide sample. These 311 outpatient programs constitute the sampling frame for the survey research.

Survey Research

A 3-hour telephone survey was created to collect extensive information about the organizational characteristics of the program, as well as demographic information about the patients in the program. It also contained questions about services provided by the program (either on-site or through referral), especially those related to HIV and HCV. Of special relevance to the research reported here, program directors were asked three specific questions concerning the provision of HCV medical services: 1) Do you provide HCV testing to your patients, either on-site or off-site? 2) Do you provide HCV follow-up tests for your patients, either on-site or off-site? and 3) Do you provide HCV medications for your HCV positive patients? In addition, the survey included five-point Likert scale items that measured the director's beliefs about the provision of HCV services within a drug treatment program.

To collect the most reliable data, the survey generally involved separate interviews with the director, the staff supervisor, and the nurse (or the person most knowledgeable about the medical aspects of the program), each responding to sections that related to their area of expertise. However, in every case, only the director responded to the questions concerning the director's beliefs.

The Study Sample

By June 30, 2003, the end of the 18-month data collection period, there were 128 eligible outpatient programs that completed the interviews, and 121 of these included the responses to the directors' beliefs section (7 program directors were not available to complete this section). These 121 programs (including 107 drug-free and 14 methadone programs) constitute the study sample. Programs in the study sample did not differ from the remaining programs in the sampling frame with respect to operation by a hospital, membership in a network of programs, or for-profit ownership.

Director's HCV-Related Belief Scale

We created a Director's HCV-Related Belief Scale consisting of eight items, each of which used a five-point Likert scale, ranging from Strongly Disagree (0) to Strongly Agree (4). The items assess the degree to which the directors believe that providing HCV testing and treatment at the drug treatment program is beneficial to the patient. Each item is given a score from 0 to 4, and the items are added to form a total score ranging from 0 to 32. The greater the score, the more positive are the respondent's beliefs about providing HCV testing and treatment at the drug treatment program. We hypothesized that there would be a positive relationship between the total score on the Director's HCV-Related Belief Scale and the provision of HCV medical services by the drug treatment program.

Analyses

The scale, consisting of eight items assessing directors' beliefs about the provision of HCV services, was examined for reliability using Cronbach's alpha (43). We used t-tests to determine the relationship between the total score of the Director's HCV-Related Belief Scale and the provision of HCV services. We report p values for results that are significant at the p = 0.05 level, or less.

RESULTS

Characteristics of the Directors in the Study Sample

As can be seen in Table 1, the directors of the programs in the study sample were predominantly white, were about equally likely to be male or female, and the majority were college educated, many at the postcollege graduate level. About two thirds of the directors were licensed in the field of substance abuse. The majority attended trainings, seminars, conferences, and meetings of professional associations to obtain current information in the substance abuse field. The directors were well acquainted with drug treatment issues, because they averaged close to 17 years of experience in the field of substance abuse. On average, they spent slightly more than 9 years at their current programs, with an average of almost 7 years in the role of director.

Organizational Characteristics of the Programs in the Study Sample

Also seen in Table 1, of the 121 programs in the study sample, there was only a small proportion that dispensed methadone (11.6%) and similarly, there were few programs operated by a hospital (12.4%). The majority of the programs were private (82.5%) as opposed to public, and of those that were private, they were more likely to be not-for-profit agencies. Nearly two thirds of the programs were affiliated with a network of programs (64.5%).

Director's HCV-Related Beliefs and the Provision of HCV Medical Services

By using Cronbach's alpha, the Director's HCV-Related Belief Scale was found to have a reliability of 0.723 (43). With use of this scale, data shown in Table 2 reveal that, on average, directors are moderately supportive of HCV medical services being delivered in drug treatment programs. The average total score on the Director's HCV-Related Belief Scale was 21.60 (S.D.-3.98) out of a possible 32. The scores ranged from 13 to 32, with three quarters of the scores falling between 18 and 26. Directors most strongly agreed with the following two items: "HCV testing at drug treatment programs is more helpful than harmful to patients," and "HCV is an important issue that needs to be addressed for people in recovery, especially within the drug treatment program." In contrast, the item, "It is not necessary for patients to be abstinent from drugs/alcohol for a certain period of time before they should begin HCV drug therapy" had the lowest mean score (2.14).

In agreement with our hypotheses, Table 3 shows that there was a significant relationship between the score on the Director's HCV-Related Belief Scale and the provision of HCV antibody testing (p = 0.016), follow-up testing (p = 0.010), and the provision of HCV medication (p < 0.001).

DISCUSSION

Previous research has examined how organizational and patient characteristics influence the types of services provided in drug treatment programs (33,44). However, despite the important role that drug treatment program directors play in the adoption, implementation, and expansion of services for their patients, there is a paucity of research that has examined how and whether directors' beliefs influence the services that are actually provided in drug treatment programs. This is an important area of research, because institutional theory asserts that the greater the conformity among providers' beliefs about the delivery of a service, the more likely it will be adopted and implemented (45). In fact, our data suggest that the more positively inclined the director is toward drug treatment programs providing HCV testing and treatment, the more likely HCV testing, follow-up testing, and HCV medication will actually be provided at the program. To speed the adoption and implementation of HCV services for drug users in treatment, it may be helpful to convince influential groups with whom drug treatment program directors are in contact (e.g., professional associations and regulatory bodies) of the importance of having drug treatment programs adopt and implement the new services (46,47). They, in turn, can encourage program directors regarding the adoption of these services. In fact, organizations often depend on their environment for beliefs and rationale to justify and legitimate their activities (48).

Understanding drug treatment directors' beliefs about HCV is essential in designing research agendas whose objectives will respond to their concerns. Although directors in our sample were likely to agree that HCV treatment within drug treatment programs is important and more helpful than harmful to their patients, they were more varied in their responses to the particulars of when and how to treat patients for HCV while in recovery. As an example, directors were less sure that providing treatment for HCV positive patients in recovery is a wise course of action while there is still so much unknown about HCV treatment issues. In particular, there are still many unanswered questions about the optimal tinting of when to test and treat patients for HCV during drug treatment recovery. Once these research questions are answered, directors can use this information in their decision making as it relates to the implementation and expansion of HCV services. It is of equal importance to effectively disseminate the research to the directors of drug treatment programs so that they can be more confident that the investment of resources to test and treat their patients will have a beneficial health impact. For instance, disseminating the recent finding that drug users are able to adhere to the HCV medication regime (36,37) can be extremely helpful in a director's decision to refer patients for HCV medical care during recovery. In addition, research now appears to suggest that decisions about beginning a drug therapy regimen for HCV infection are best made on a case-by-case basis between the physician and the patient (49). Therefore, directors may expand the use of case conferences to increase the collaboration between medical and clinical staff in establishing the optimal time for a particular patient to be tested and/or treated for HCV. Although the guidelines written by the NIH Consensus Conference on the Management of HCV no longer recommend a 6-month period of abstinence prior to the initiation of HCV treatment (38), there are still serious issues for individuals who are in the early stages of their recovery. A particularly interesting finding is that 42% of the directors agree that it is not necessary for patients to be abstinent from drugs and alcohol for some period of time before starting HCV treatment (compared with 31% who are undecided and 26% who disagree). Given the neuropsychiatric side effects of the HCV medication regimen, some patients may need to become more stable in their recovery prior to beginning HCV therapy. Furthermore, research demonstrating that even small amounts of alcohol and drugs can accelerate the disease progression as well as reduce the efficiency of the HCV medication (50) may encourage clinicians to even more aggressively intervene with their patients to remain drug and alcohol free. Overall, this research demonstrates that directors' beliefs are an important area of study in view of their relationship to the provision of services.

There are a number of limitations to the research that should be acknowledged. First, the data reflect the provision of HCV-related services by drug treatment programs as reported by the program director. Because patients at the treatment programs were not interviewed, we are unable to report patients' perceptions of the adequacy or quality of these services. In addition, the 121 programs in the study sample do not differ from the remaining programs in the sampling frame in terms of a variety of organizational characteristics, but it is difficult to know for certain if they constitute a truly representative sample. Nonetheless, this study provides important information concerning drug treatment program directors' HCV-related beliefs and their relationship to HCV service provision.

ACKNOWLEDGEMENTS

Funding for this study was provided by the National Institute on Drug Abuse (Grant No. 1-R01 DA13409). Points of view do not represent the official positions of the federal government, NIDA, or NDRI. We thank Lelia Cahill, Sarah Krassenbaum, Kim Sanders, and Kristine Ziek, the project interviewers, for their efforts in collecting the data. We are grateful to Deborah Trunzo, of the Office of Applied Studies, SAMHSA, for arranging for the project to use the I-SATS database.

REFERENCES

(1.) Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med 1999; 341:556-562.

(2.) Seeff LB. Natural history of hepatitis C. Am J Med 1999; 107(6B):10S-15S.

(3.) Best D, Noble A, Finch E, Gossop M, Sidwell C, Strang J. Accuracy of perceptions of hepatitis B and C status: cross sectional investigation of opiate addicts in treatment. Br Med J 1999; 319:290-291.

(4.) Dhopesh VP, Taylor KR, Burke M. Survey of hepatitis B and C in an addiction treatment unit. Am J Drug Alcohol Abuse 2000: 26:703-707.

(5.) Simonetti RG, Camma C, Fiorello F. Hepatitis C virus infection as a risk factor for hepatocellular carcinoma in patients with cirrhosis: a case-control study. Ann Intern Med 1992:116:97-102.

(6.) Kim WR. The burden of hepatitis C in the United States. Hepatology 2002:36(5 suppl 1):S30-S34.

(7.) Zaman A, Fennerty MB, Keeffe EB. Peginterferon vs. standard interferon in the treatment of chronic hepatitis C. Aliment Pharmacol Ther 2003 (7):661-670.

(8.) Baker DE. Pegylated interferon plus ribavirin for the treatment of chronic hepatitis C. Rev Gastroenterol Disord 2003: 3(2):93-109.

(9.) Arif A, Levine RA, Sanderson SO, Bank L, Velu RP, Shah A, Mahl TC, Gregory DH. Regression of fibrosis in chronic hepatitis C after therapy with interferon and ribavirin. Dig Dis Sci 2003:48(7):1425-1430.

(10.) Patel K, McHutchison JG. Current therapies for chronic hepatitis C: drug combination achieves sustained response in more than half of patients. Postgrad Med 2003:114(1):48-52, 57-59, 62.

(11.) Salomon JA, Weinstein MC, Hammitt JK, Goldie SJ. Cost-effectiveness of treatment for chronic hepatitis C infection in an evolving patient population. JAMA 2003:290(2):228-237.

(12.) Hagan H, Thiede J, Weiss NS, Hopkins SG, Duchin JS, Alexander ER. Sharing of drug preparation equipment as a risk factor for hepatitis C. Am J Public Health 2001: 91:42-46.

(13.) Williams I. Epidemiology of hepatitis C in the United States. Am J Med 1999; 107:2S-9S.

(14.) Alter MJ. Prevention of spread of hepatitis C. Hepatology 2002; 36(5 suppl 1):S93-S98.

(15.) Koblin BA, Factor SH, Wu Y, Vlahov D. Hepatitis C virus infection among noninjecting drug users in New York City. J Med Virol 2003; 70(3):387-390.

(16.) Page-Shafer KA, Cahoon-Young B, Klausner JD, Morrow S, Molitor F, Ruiz J, McFarland W, Young women's survey team. Hepatitis C virus infection in young, low income women: the role of sexually transmitted infection as a potential cofactor for HCV. Am J Public Health 2002; 92:670-676.

(17.) Askari FK. Hepatitis C: The Silent Epidemic. Cambridge, MA: Perseus Publishing, 1999.

(18.) Rosenberg SD, Goodman LA, Osher FC. Prevalence of HIV, hepatitis B and hepatitis C in people with severe mental illness. Am J Public Health 2001:91:42-46.

(19.) Rosenblum A, Nuttbrock L, McQuistion HL, Magura S, Joseph H. Hepatitis C and substance use in a sample of homeless people in New York City. J Addict Dis 20:15-25.

(20.) Tortu S, Neaigus A, McMahon J, Hagen D. Hepatitis C among non-injecting drug users: a report. Subst Use Misuse 2001:36:523-534.

(21.) Kwiatkowski CF, Fortuin E, Corsi K, Booth RE. The association between knowledge of hepatitis C virus status and risk behaviors in injection drug users. Addiction 2002; 97:1289-1294.

(22.) Bae JP. Assessing the need, use, and developments in mental health/ substance abuse care. Health Care Financ Rev 1997; 18:1-4.

(23.) Chitwood DD, McBride DC, French MT, Comerford M. Health care need and utilization: a preliminary comparison of injection drug users, other illicit drug users, and nonusers. Subst Use Misuse 1999; 34:727-746.

(24.) Contoreggi C, Rexroad VE, Lange WR. Current management of infectious complications in the injecting drug user. J Subst Abuse Treat 1998; 15:95-106.

(25.) McCarthy JJ, Flynn N. Hepatitis C in methadone maintenance patients: prevalence and public policy implications. J Addict Dis 2001; 20:19-31.

(26.) Carter H, Robinson G, Hanlon C, Hailwood C, Massarotto A. Prevalence of hepatitis B and C infection in a methadone clinic population: implications for hepatitis B vaccination. N Z Med J 2001: 114(1136):324-326.

(27.) Strauss SM, Falkin GP, Vassilev ZP, Des Jarlais DC, Astone J. A nationwide survey of hepatitis C services provided by drug treatment programs. J Subst Abuse Treat 2002; 22:55-62.

(28.) Astone J, Strauss SM, Vassilev ZP, Des Jarlais DC. Provision of hepatitis C education in a nationwide sample of drug treatment programs. J Drug Educ 2003; 33:107-117.

(29.) Strauss SM, Astone J, Vassilev ZP, Des Jarlais DC, Hagan H. Gaps in the drug-free and methadone maintenance treatment program response to hepatitis C. J Subst Abuse Treat 2003; 24:291-297.

(30.) Becker B, Marshall H. Sociometric location and innovativeness: reformulation location and extension of the diffusion model. Am Sociol Rev 1970; 35:262-282.

(31.) Clapp JD. Organizational factors related to AIDS/HIV education in outpatient substance abuse treatment units. J Health Soc Policy 1998; 9:1-13.

(32.) Hage J, Dewar R. Elite values versus organizational structure in predicting innovation. Adm Sci Q 1973; 18:279-290.

(33.) D'Aunno T, Vaughn TE, McElroy P. An institutional analysis of HIV prevention efforts by the nation's outpatient drug abuse treatment units. J Health Soc Behav 1999; 40:175-192.

(34.) Wimbush J, Amicarelli A, Stein MD. Does HIV test result influence methadone maintenance treatment retention? J Subst Abuse Treat 1996; 8(2):263-269.

(35.) Gonzalez I, Rosenthal MS, Bigler MO, Alper K, Geringer W. HIV antibody testing and client retention in the therapeutic community. J Subst Abuse Treat 1994; 11(5):481-488.

(36.) Sylvestre D. Treating hepatitis C in methadone maintenance patients: an interim analysis. Drug Alcohol Depend 2002; 67(2):117-123.

(37.) Edlin BR, Seal KH, Lorvick J, Kral AH, Ciccarone DH, Morre LD, Lo B. Is it justifiable to withhold treatment for hepatitis C from illicit-drug users? J Subst Abuse Treat 2003; 24(1):81-88.

(38.) National Institutes of Health. National Institutes of Health consensus development conference statement: management of hepatitis C: 2002--June 10-12, 2002. Hepatology 2002:36:S3-S20.

(39.) Anglin MD, Hser YI, Grella CE. Drug addiction and treatment careers among clients in the drug abuse treatment outcome study (DATOS). Psychol Addict Behav 1997; 11:308-323.

(40.) Etheridge RM, Hubbard RL, Anderson J, Craddock SG, Flynn PM. Treatment structure and program services in the drug abuse treatment outcome study (DATOS). Psychol Addict Behav 1997; 11:244-260.

(41.) Broome KM, Simpson DD, Joe GW. Patient and program attributes related to treatment process indicators in DATOS. Drug Alcohol Depend 1999; 57(2): 127-135.

(42.) Schildhaus S, Gerstein D, Dugoni B, Brittingham A, Cerbone F. Services research outcome study: explanation of treatment effectiveness, using individual-level and programmatic variables. Subst Use Misuse 2000; 35(12 14):1879-1910.

(43.) Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951:16:297-334.

(44.) Friedmann PD, Lemon SC, Durkin EM, D'Aunno TA. Trends in comprehensive service availability in outpatient drug abuse treatment. J Subst Abuse Treat 2003:24:81-88.

(45.) Rogers EM. Diffusion of Innovations. 4th ed. New York: Free Press, 1995.

(46.) DiMaggio PJ, Powell WW. The iron cage revisited: institutional isomorphism and collective rationality in organizational fields. Adm Sci Q 1983; 48:147-160.

(47.) Meyer JW, Rowan B. Institutional organization: formal structure as myth and ceremony. Am J Sociol 1977; 83:340-363.

(48.) Scott WR. Innovations and Organizations. Thousand Oaks, CA: Sage, 1995.

(49.) Edlin BR. Prevention and treatment of hepatitis C in injection drug users. Hepatology 2002; 36(5):210-219.

(50.) Pessione F, Degos F, Marcellin P, Duchatelle V, Njapoum C, Martinot-Peignoux M, Degott C, Valla D, Erlinger S, Rueff B. Effect of alcohol consumption on serum hepatitis C virus RNA and histological lesions in chronic hepatitis C. Hepatology 1998; 27(6):1717-1722.

Janetta M. Astone, Ph.D., (1), * Shiela M. Strauss, Ph.D., (1) Holly Hagan, Ph.D., (1) and Don C. Des Jarlais, Ph.D. (2)

* Correspondence: Janetta M. Astone, Ph.D., National Development and Research Institutes, Inc., 71 West 23rd St., 8th floor, New York, NY 10010, USA; Fax: (917) 438-0894; E-mail: astone@ndri.org.

(1) National Development and Research Institutes, Inc., New York, New York, USA

(2) Edmond de Rothschild Foundation Chemical Dependency Institute, Beth Israel Medical Center, New York, New York, USA

COPYRIGHT 2004 Taylor & Francis Ltd.
COPYRIGHT 2004 Gale Group