Tuberculosis prevention and treatment intervention for males released from Rikers Island prison

Tuberculosis (TB) Prevention and a TB-Treatment Intervention for Males Newly Released from New York City Prison/Correctional Facility (Riker's Island)

Despite significant progress in detecting and treating tuberculosis (TB) in recent years, TB remains a significant health threat, especially among institutionalized populations such as prisons. While the experts remain divided as to the precise causes for the inordinately high incidence of TB in the nation's prisons, the reasons typically cited include the fact that prisons house higher percentages of lower socioeconomic individuals that have not had access to healthcare or that have ignored their healthcare needs prior to incarceration, including alcoholism, substance abuse patterns and a higher rate of HIV infection, all of which can promote the contraction and spread of tuberculosis. The purpose of the proposed study will be to evaluate the effectiveness of tuberculosis (TB) prevention and a TB-treatment intervention on males who have been newly released from New York City Prison/Correctional Facility (Riker's Island) and who have been diagnosed with latent TB infection (LTBI) or active TB disease. To this end, a community intervention trial study is proposed, together with supporting background and rationale for the study. A summary of the research and salient findings are presented in the conclusion.

Introduction

Purpose of the Proposed Study

Specific Aims

Background and Significance

Understanding of the Problem

Rationale of the Proposed Study

Conceptual Framework

Research Methodology

Overview of Proposed Study

Study Design

Summary

Tuberculosis (TB) Prevention and a TB-Treatment Intervention for Males Newly Released from New York City Prison/Correctional Facility (Riker's Island)

This proposal will be for funding purposes for a future intervention. The proposal will follow the guidelines established by the National Institute of Health for such grant proposals (PHS 398), but will utilize the community intervention trial as its primary study design. The purpose and specific aims of the proposed study, as well as relevant background information and the significance of the proposal, are followed by a review of the peer-reviewed and scholarly literature concerning tuberculosis in general and its impact on prison populations in particular in the Understanding of the Problem segment. A presentation of the rationale of the proposed study is followed by a discussion of the conceptual framework to be used in the proposed study and a description of the community intervention trial study research methodology to be employed. An overview of the proposed study is followed by a description of the study design, and concludes with a summary of the introductory chapter.

Purpose of the Proposed Study

The purpose of the proposed study will be to evaluate the effectiveness of tuberculosis (TB) prevention and a TB-treatment intervention on males who have been newly released from New York City Prison/Correctional Facility (Riker's Island) and who have been diagnosed with latent TB infection (LTBI) or active TB disease (TB).

Specific Aims

The specific aims of the proposed study are represented by its respective goals and objectives, to-wit, the development of relevant data needed to confirm or refute the following null and alternative hypotheses.

Null Hypothesis (#1): A tuberculosis (TB) prevention and TB treatment intervention on males whom have been diagnosed with latent TB infection (LTBI) or active TB disease (TB) and are newly released from Correctional facilities will not make a difference in their knowledge of TB and their communities.

Null Hypothesis (#2): A tuberculosis (TB) prevention and TB treatment intervention on males whom have been diagnosed with latent TB infection (LTBI) or active TB disease (TB) and are newly released from New York City Correctional facilities will not reduce the rates of infection.

Alternate Hypothesis (#1): A tuberculosis (TB) prevention and TB treatment intervention on males whom have been diagnosed with latent TB infection (LTBI) or active TB disease (TB) and are newly released from Correctional facilities will make a difference in their knowledge of TB and their communities.

Alternate Hypothesis (#2): A tuberculosis (TB) prevention and TB treatment intervention on males whom have been diagnosed with latent TB infection (LTBI) or active TB disease (TB) and are newly released from New York City Correctional facilities will reduce the rates of infection.

Background and Significance

The United States incarcerates more of its citizens than any other country in the world today with some concomitant implications for healthcare providers responsible for this population (Stanko, Gillespie & Crews, 2004). In this regard, Braithwaite, Braithwaite and Poulson emphasize that, "Traditionally associated with high-risk sexual activity, drug use, poverty, disenfranchised status, population density, homelessness and poor access to preventive and primary health care, the health problems of the inmate population pose difficult programmatic and fiscal challenges for correctional policy-makers and personnel" (p. 108). Not surprisingly, infection rates for tuberculosis among inmates in federal and state prisons are far greater than for the American population as a whole (Smith, 2006; Louis, 2002). According to Smith, there are a variety of causes for this increased incidence of TB among prisons populations, but behind-bar-sex represents one of the most significant: "The high incidence of prison rape increases health care expenditures, both inside and outside of prison systems, and reduces the effectiveness of disease prevention programs by substantially increasing the incidence and spread of HIV, AIDS, tuberculosis, hepatitis B and C, and other diseases" (p. 185). As Mueller emphasizes, people with both HIV and TB are much more likely to develop active TB than others that have the TB organism alone: "When an inmate's immune system is not working well, he or she is much more likely to get TB. Health care workers consistently have to track inmates who test HIV positive because of their vulnerability to TB" (p. 101).

As with a number of other infectious diseases, though, there are a variety of causes or combinations of causes that can contribute to such higher incidence of TB among prison populations. For example, prisoners are especially susceptible to infection tuberculosis than other members of the community (Wilcox, Hammett, Widom & Epstein, 1996) and this higher rate of tuberculosis infection is consistent with the fact that prisoners typically come from lower socio-economic backgrounds and because TB is an airborne infection, overcrowded housing conditions associated with poverty facilitate its spread (Coyle, Campbell & Neufeld, 2003). Whatever its source, medical experts recommend swift and accurate diagnoses for TB in these institutionalized populations because early diagnosis can literally mean the difference between life and death (Mueller, 1996).

According to its organizational Web site, the New York City Department of Correction (NY DOC) reports that its average daily inmate population varies between 13,000 and 18,000, an amount which is more than the prison population of many state correctional systems (an overview, 2008). The site adds that, "On a typical weekday, the Department logs more than 3,000 miles transporting inmates to courts in the five boroughs and to medical and other jail or prison facilities throughout the city and state" (an overview, p. 2).

Today, Rikers Island has been enlarged to more than 400 acres and contains 10 major jails with a combined capacity of almost 17,000 inmates; among the Rikers' facilities are a jail for sentenced males, another for sentenced and detainee females, and a detention center for adolescent males (ages 16 to 18) and seven jails for adult male detainees (an overview). The Rikers' complex also features include a bakery, central laundry, tailor shop, print shop, maintenance and transportation divisions, K-9 unit and a power plant (an overview).

Understanding of the Problem

Just as many institutional settings have experienced an increase in the incidence of staphylococcus resistant methicillin strains in recent years, prisons and jails are also high-risk settings for the spread of TB infection. According to Braithwaite and his colleagues, "Living conditions are invariably crowded, and many facilities have extremely poor ventilation and air circulation. Moreover, many inmates already have elevated risk for TB because of their lifestyles, inadequate prior health care and increased prevalence of HIV / AIDS" (p. 108). In fact, a study of the New York City jail system showed that TB infection and progression to active TB disease take place at higher rates in individuals with more frequent incarceration and longer total time spent in jail (Braithwaite et al.). As these authors point out, though, "TB is not a new problem in prisons and jails. Several studies undertaken in correctional facilities in New York City, New Orleans and Arkansas between the mid-1940s and the late 1970s revealed higher rates of TB infection and disease among inmates than in the outside population. Several of these studies also documented the transmission of TB infection among inmates and from recently released offenders to people in the community" (emphasis added) (Braithwaite et al., p. 109).

There problem of TB in correctional facilities across the country is well documented, and there have been dramatic increases in TB cases reported in correctional facilities in some geographic areas of the United States in recent years (Braithwaite et al.). Among inmates in the New York state correctional system, the incidence has been staggering. In fact, the incidence of TB among this population increased from 15.4 per 100,000 in 1976 and 1978, to 105.5 per 100,000 in 1986. In 1994, the number of TB cases among residents of correctional facilities for 59 reporting areas had reached 24,361 (4.6% of the total reporting correctional population) (Braithwaite et al.). The incidence rate was 139.3 per 100,000 by 1993 and the unadjusted case rates for prison populations in many areas are significantly higher than the rates for the general population (Braithwaite et al.). According to these authors, "The 1993 TB case rate of 139.3 per 100,000 in the New York state correctional system was more than six times the case rate of 21.7 per 100,000 for the general population of New York state. Similarly, in New Jersey the incidence of TB among state inmates in 1992 was 91.3 per 100,000, compared with 12.6 per 100,000 for the state's general population in the same year" (Braithwaite et al., p. 109). At one California state prison, the annual incidence rate of TB in 1991 was 184 cases per 100,000, a rate that is more than 10 times the statewide rate and the transmission of TB also was also identified in this California prison (Braithwaite et al.).

In several recent TB outbreaks in correctional facilities, failure to detect active TB disease in inmates resulted in transmission of TB to other inmates, correctional facility employees and people in the community. Moreover, outbreaks in New York and California have involved the transmission of multidrug-resistant strains of TB to both inmates and employees of correctional facilities. Unfortunately, if tuberculosis infection is not correctly assessed and treated among in-coming prisoners, and an infected prisoner develops active tuberculosis, the extraordinarily high-density prison environment is the perfect setting for the disease to spread (Coyle et al., 2003); however, previous studies have identified deficiencies in tracking inmate tuberculosis status that have made such assessments problematic (Dolovich, 2005). In response, states across the country have refocused attention on the problem of TB in correctional facilities, and the results of these investigations have revealed a higher incidence of TB among this population than previously thought.

For instance, in one case in Pennsylvania, a court ordered the prison system to implement an appropriate tuberculosis control program throughout the state; this control program resulted in the discovery of over 400 prisoners in just one prison who, unknown to any prison authority, were infected with tuberculosis (Coyle et al., 2003). According to these authors, "The medical records of the prison were not complete enough to determine how many of these infections had resulted from the spread of tuberculosis within the prison, but there was little doubt that at least some of the active cases of tuberculosis within the system had resulted from exposure within the prison system" (Coyle et al., p. 68).

Moreover, it has been repeatedly demonstrated that tuberculosis, including highly dangerous multi-drug resistant tuberculosis, can and does spread from prisons and jails to the community. A study in San Francisco during the period 1997-1999, for example, demonstrated that slightly fewer than 44% of all persons with active tuberculosis had been incarcerated at some point before their diagnosis (Coyle et al.). In addition, medical researchers examined the DNA strains involved and determined that tuberculosis from the jail had infected the community (Coyle et al.). According to these authors, "Indeed, sixty-three percent of persons who had never been incarcerated but had developed active tuberculosis had been infected with the strain of tuberculosis associated with the jail outbreak. An earlier Centers for Disease Control study concluded that an outbreak of multidrug resistant tuberculosis in the New York State prison system involved two hospitals where prisoners were treated" (Coyle et al., p. 68).

This outbreak of TB was responsible for the deaths of 36 prisoners and one correctional officer, as well as the infection of a number of healthcare employees with a strain of multi-drug resistant tuberculosis (Dooley, Jarvis, Martone & Snider, 1992). As Mueller points out, "Medical experts say when patients stop taking the medication at some point during the year, it can keep the patient from getting well and lead to a strain of TB which is partially resistant to such treatment" (p. 101). Likewise, Eckert suggests that noncompliance with treatment regimens represents one of the most important reasons multi-drug resistant strains of TB have evolved in recent years. According to Eckert, "Many patients, for example, abandon treatment when their symptoms disappear but before all of the illness-causing pathogens are effectively killed. The tuberculosis-causing bacterium, for instance, has become increasingly difficult to treat, as too many patients have prematurely abandoned the six-month course of antibiotics" (p. 166). In this regard, Mueller points out that, "This is why health care staff members emphasize direct observation of patients taking their medication" (p. 101). Such comprehensive oversight, though, may be beyond the capabilities of some correctional facilities, as well as their ability to adequately train their staff in appropriate universal precautions that are needed when working with such populations.

Nevertheless, the need is great and time is of the essence. According to one correctional systems analyst, "Stopping the spread of TB has become a top priority because there are more than 24,000 new cases of TB every year in the United States, and TB rates in prisons and jails typically are five times higher than in the general population. Contributing to the TB challenge are the jails and prisons themselves. Most were not designed to have ventilation systems that meet standards for preventing the spread of TB" (Mueller, 1996, p. 100). Inmates and correctional healthcare workers alike are at higher risk of contracting TB than people in the general population because correctional facilities house a higher percentage of former substance abusers; in addition, HIV infections also occur in greater percentages in prisons and can facilitate the spread of TB (Mueller).

Furthermore, this analyst notes that many inmates have either not had access to adequate healthcare services prior to their incarceration or have simply ignored their healthcare needs by virtue of their past patterns of behavior, thereby making them more susceptible to contracting TB: "For many of these people it is the first time they are being examined and treated regularly for any health problems" (Mueller, p. 100).

Rationale of the Proposed Study

As early as 1904, prison management officials have recognized the need for improved care and education of inmates to help stem the incidence of TB in their institutions and to prevent its subsequent spread to the community at large (Roe, 2007). Today, treating and preventing the spread of TB in a correctional facility and the larger community in which it is situated requires a multifaceted approach (Mueller). Moreover, recidivism rates remain extraordinarily high among newly released inmates, and effecting any substantive changes in their self-destructive behaviors has defied penologists and scientists alike. Therefore, it just makes good business sense to seek to determine what will work best by asking the inmates themselves. As Braithwaite and his colleagues advise, "Inmates represent a marginalized population -- to many, an invisible population. Once inmates are convicted and sentenced to the correctional system, their debt to society often translates into simply serving time. Effective prevention efforts must garner insights from the target population (the inmates) to determine what will work best" (emphasis added) (p. 109).

Conceptual Framework

The conceptual framework to be followed in the proposed study follows the precepts of public health model wherein the goal is to effect substantive changes in health standards and practices by public health administrators. This conceptual framework is congruent with the growing body of evidence showing that major changes in health behavior can be achieved by the public health sector, and that these changes in behavior are credibly associated with public health communication, including both deliberate communication programs and normal media coverage of health issues (Hornik, 2002). For example, Leviton (1996) distinguishes public health from medical applications by examining public health's focus on the health of populations and on society as a whole and offers a dual focus on individual-level behavior and on populations as a desirable one that could impact areas such as public policy and community-based trial interventions. This conceptual framework is also consistent with Mackenback and Bakker (2002), who suggest that any meaningful public health model must seek to achieve the following:

Reduce inequalities in power, prestige, income and wealth linked to different socioeconomic positions;

Reduce the effect of health on socioeconomic position, and reducing the economic consequences of ill-health;

Reduce the effect of socioeconomic position on the risk of being exposed to specific health determinants ('intermediary' material, psychosocial and behavioral factors), or reducing the effect of these determinants in the lower socioeconomic groups;

Reduce the health effects (including the consequences of illness) of being in a lower socioeconomic position through improved healthcare interventions.

Research Methodology

The research methodology for the proposed study will be a mixed methodology, and will proceed along the timeline shown in Table 2 below.

Table 2.

Draft Timeline: January 2008 - December 2008.

ACTIVITIES/TASKS

TIME (MONTHS) (2008-2009)

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 1 Bibliographic Searches X 2 Photocopy info from non-bibliographic sources X 3 Reading X 4 Submission of thesis proposal X 5 Fine tune research question and methodology XX 8 Data collection XX 9 Data analysis XX 10 Writing up of thesis XX 11 Revision, editing and submission XX 12 Submission of thesis X

The first component of the methodology will consist of a review of the relevant peer-reviewed and scholarly literature concerning tuberculosis in general and its impact on prisons populations and healthcare workers in particular. According to Fraenkel and Gratton (2001), "Researchers usually dig into the literature to find out what has already been written about the topic they are interested in investigating. Both the opinions of experts in the field and other research studies are of interest. Such reading is referred to as a review of the literature" (p. 48). Likewise, Gratton and Jones (2003) point out that, "A literature review is the background to the research, where it is important to demonstrate a clear understanding of the relevant theories and concepts, the results of past research into the area, the types of methodologies and research designs employed in such research, and areas where the literature is deficient" (p. 51).

Overview of Proposed Study

The proposed study will use a five chapter format to achieve the above-stated research purpose. The first chapter will be used to introduce the issues under consideration, the importance and rationale of the study and the conceptual framework to be followed. Definitions of key terms and relevant research aims will also be presented. Chapter two will provide a critical review of the relevant peer-reviewed, scholarly and organizational literature and chapter three will describe more fully the research methodology used in the study and community intervention trial. Chapter four of the proposed study will provide an analysis of any statistical data that results from the study using either an Excel spreadsheet or SPSS as deemed most appropriate. Finally, chapter five of the proposed study will present a summary of the research, relevant conclusions and recommendations for policymakers and corrections facility administrators concerning the efficacy of the community intervention trial initiative envisioned herein.

Study Design

As noted above, the proposed study intends to use a community intervention trial to achieve the above-stated research purpose. According to Mackenback and Bakker (2002), an intervention is an "activity or set of activities aimed at modifying a process, course of action or sequence of events, in order to change one or several of their characteristics such as performance or expected outcome" (p. 346). This approach is congruent with a number of clinical interventions that have been used in the past to diagnose, treat and educate the population in general concerning TB (Hornik, 2002). In this regard, Mackenback and Bakker (2002) emphasize that, "Interventions and policies targeting downstream determinants at the individual level may lend themselves to conventional evaluation designs such as the randomized controlled trial, but this is generally not true for determinants at the group (school, company, neighborhood, etc.) level or for upstream determinants. In the case of relatively straightforward interventions and policies aiming at determinants at the group level, experimentation may still be feasible, for example in the form of a community intervention trial" (p. 32).

Intervention. The community intervention trial envisioned by the proposed study would identify high-risk detainees and inmates housed within the Rikers Island corrections complex and provide them with appropriate healthcare interventions and follow-up services in their communities. A community intervention trial was selected for the purposes of the proposed study because of its ability to accommodate large numbers of participants and identify salient factors that relate to individual behavior. The goal of the treatment intervention will be to diagnose and treatment known cases of TB within the target population. Site coordination will be achieved through approval of the facility director and the affected healthcare unit supervisors.

Study Sample. The study sample was consist of volunteer detainees and inmates who become seriously ill during their incarceration as well as those requiring intensive psychiatric observation while detained in prison wards operated by the NY DOC in Elmhurst General Hospital and Bellevue Hospital; likewise, volunteers from the North Infirmary Command on Rikers Island will be solicited for participation in the community intervention trial.

Target population. The target population among the study sample will be those detainees and inmates who are diagnosed with latent TB infection (LTBI) or active TB disease (TB).

Sample size. Current screening practices at Rikers Island provide the relevant assessments for individual who are at high risk of either having TB already or contracting during their detainment or incarceration. For example, prospective participants would be those identified as being diagnosed with LTBI or TB, substance abusers, HIV infected, low socioeconomic background, lack of adequate healthcare prior to entry into the NY criminal justice system, or a combination of the foregoing factors.

Sampling strategies. Because there might be up to 17,000 individuals housed within the Rikers Island complex on a given day, sampling strategies will be designed to target those individuals who are at highest risk. The above-listed factors would be assigned weights depending on their respective known contribution to the incidence of TB in the general population and those inmates and detainees scoring highest would first be solicited for participation in the community intervention trial.

Sampling frames. According to Neuman (2003), a sampling frame is "a list of cases in a population, or the best approximation of it" (p. 544). Therefore, the sampling frame to be used in the proposed study will be based on the high- and low-end estimates of the Rikers Island population on a given day of between 13,000 and 18,000 detainees and inmates (exclusive of prison staff, support services and healthcare workers) and the overall incidence of TB in the general population.

Recruitment strategies. Because the proposed community intervention trial must be conducted without disrupting any of the Rikers Island security measures, recruitment strategies will be limited to incoming arrivals who meet the criteria provided by the sampling strategies described above. New arrivals will be asked if they would like to participate in the community intervention trial during their current healthcare screening for tuberculosis whether or not they are diagnosed with LTBI or TB. As an inducement to participation, prospective participants will be offered follow-up referrals to community agencies that can provide aftercare services and will be fully apprised of the importance of their participation for others similarly situated, their families and the larger community in which they live.

Allocation to treatment aims. In order to ensure that as many of the high-risk candidates participate in the intervention as possible, only those volunteer inmates and detainees who are identified at highest risk by virtue of either already being diagnosed with LTBI or TB or by virtue of the other factors identified above will be considered for participation.

Study Variables/Measures. The key variables to be investigated in the proposed study include the independent variable of an individual being diagnosed with LTBI or TB and dependent variables including a history of substance abuse, HIV infection, low socioeconomic background, and a lack of adequate healthcare prior to entry into the NY criminal justice system. A fundamental confounder in examining this potential relationship is the reliance of self-report measures for many of the factors.

Data Collection. To facilitate data collection, the archival records of the Rikers Island healthcare database will be used to determine the overall historic rates of inmates and detainees who were at high risk of contracting TB or who already were infected to establish a benchmark. Thereafter, the impact of the proposed intervention on these rates will be analyzed periodically to discern any changes.

Data collection methods.

Data collection instrument(s).

Data Management Plan.

Data Analysis.

Overview -- goals of the data analysis; special analytic considerations

Null Hypothesis (#1): A tuberculosis (TB) prevention and TB treatment intervention on males whom have been diagnosed with latent TB infection (LTBI) or active TB disease (TB) and are newly released from Correctional facilities will not make a difference in their knowledge of TB and their communities.

Alternate Hypothesis (#1): A tuberculosis (TB) prevention and TB treatment intervention on males whom have been diagnosed with latent TB infection (LTBI) or active TB disease (TB) and are newly released from Correctional facilities will make a difference in their knowledge of TB and their communities.

Rationale: In spite of tremendous development over the years, TB still remains one of the most deadly diseases in the world, claiming more than 2 million lives annually with 10 million new cases diagnosed every year. Statistics have shown that there is a disproportionately high percentage of TB cases occur among persons incarcerated in U.S. correctional facilities. Surveillance data reported that 3.9% of all TB cases in the U.S. were diagnosed while in a correctional facility (CDC, 2007). Hence, effective TB prevention and control measures in correctional facilities are needed to increase educational knowledge of TB and reduce TB rates among inmates once released and the general U.S. population.