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HHS Public Access Author manuscript Author Manuscript Nurs Res. Author manuscript; available in PMC 2016 May 01. Published in final edited form as: Nurs Res. 2015 ; 64(3): 177–189. doi:10.1097/NNR.0000000000000083. Nursing Case Management, Peer Coaching, and Hepatitis A and B Vaccine Completion Among Homeless Men Recently Released on Parole: Randomized Clinical Trial Adeline Nyamathi, ANP, PhD, FAAN [Distinguished Professor], University of California, Los Angeles, School of Nursing Author Manuscript Benissa E. Salem, RN, MSN, PhD [Project Director], University of California, Los Angeles, School of Nursing Sheldon Zhang, PhD [Research Sociologist], San Diego State University, Department of Sociology David Farabee, PhD [Professor], University of California, Los Angeles, Integrated Substance Abuse Programs Betsy Hall, PhD [Professor], University of California, Los Angeles, Integrated Substance Abuse Programs Farinaz Khalilifard, MA, MFT [Project Director], and University of California, Los Angeles, School of Nursing Author Manuscript Barbara Leake, PhD [Senior Statistician] University of California, Los Angeles, School of Nursing Abstract Background—Although hepatitis A virus (HAV) and hepatitis B virus (HBV) infections are vaccine-preventable diseases, few homeless parolees coming out of prisons and jails have received the hepatitis A and B vaccination series. Author Manuscript Objectives—The study focused on completion of the HAV and HBV vaccine series among homeless men on parole. The efficacy of three levels of peer coaching and nurse-delivered interventions was compared at 12-month follow up: (a) intensive peer coaching and nurse case management (PC-NCM); (b) intensive peer coaching (PC) intervention condition, with minimal nurse involvement; and a (c) usual care (UC) intervention condition, which included minimal PC Corresponding Author: Adeline Nyamathi, ANP, Ph.D., FAAN, UCLA, School of Nursing, Room 2-250, Factor Building, Los Angeles, CA 90095-1702. (anyamath@sonnet.ucla.edu). Adeline Nyamathi, ANP, PhD, FAAN, is Distinguished Professor, University of California, Los Angeles, School of Nursing. Benissa E. Salem, RN, MSN, PhD, is Project Director, University of California, Los Angeles, School of Nursing. Sheldon Zhang, PhD, is Research Sociologist, San Diego State University, Department of Sociology. David Farabee, PhD, is Professor, University of California, Los Angeles, Integrated Substance Abuse Programs. Betsy Hall, PhD, is Professor, University of California, Los Angeles, Integrated Substance Abuse Programs Farinaz Khalilifard, MA, MFT, is Project Director, University of California, Los Angeles, School of Nursing. Barbara Leake, PhD, is Senior Statistician, University of California, Los Angeles, School of Nursing. The authors have no conflicts of interest to report. Nyamathi et al. Page 2 Author Manuscript and nurse involvement. Further, we assessed predictors of vaccine completion among this targeted sample. Methods—A randomized control trial was conducted with 600 recently paroled men to assess the impact of the three intervention conditions (PC-NCM vs. PC vs. UC) on reducing drug use and recidivism; of these, 345 seronegative, vaccine-eligible subjects were included in this analysis of completion of the Twinrix HAV/HAB vaccine. Logistic regression was added to assess predictors of completion of the HAV/HBV vaccine series and chi-squared analysis to compare completion rates across the three levels of intervention.
Author Manuscript Results—Vaccine completion rate for the intervention conditions were 75.4% (PC-NCM), 71.8% (PC), and 71.9% (UC) (p =. 78). Predictors of vaccine noncompletion included being Asian and Pacific Islander, experiencing high levels of hostility, positive social support, reporting a history of injection drug use, being released early from California prisons, and being admitted for psychiatric illness. Predictors of vaccine series completion included reporting six or more friends, recent cocaine use, and staying in drug treatment for at least 90 days. Discussion—Findings allow greater understanding of factors affecting vaccination completion in order to design more effective programs among the high-risk population of men recently released from prison and on parole. Keywords accelerated Twinrix hepatitis A/B vaccine; ex-offenders; homelessness; parolees; prisoners; substance abuse Author Manuscript With 1.6 million men and women behind bars, the United States (U.S.) has one of the largest numbers of incarcerated persons when compared to other nations (Pew Charitable Trusts, 2008). In California, over 130,000 are in custody and over 54,000 are on parole (California Department of Corrections and Rehabilitation, 2013b).
Incarcerated populations are at significant risk for homelessness. When compared to the general population, those who were in jail were more likely to be homeless (Greenberg & Rosenheck, 2008). In one study, homeless inmates were more likely to have past criminal justice system involvement for both nonviolent and violent offenses, to have mental health and substance abuse problems, and a lack of personal assets (Greenberg & Rosenheck, 2008). Author Manuscript Globally, incarcerated populations encounter a host of public health care issues; two such issues—hepatitis A virus (HAV) and hepatitis B virus (HBV) diseases—are vaccine preventable. In addition, viral hepatitis disproportionately impacts the homeless due to increased risky sexual behaviors and drug use (Stein, Andersen, Robertson, & Gelberg, 2012), along with substandard living conditions (Hennessey, Bangsberg, Weinbaum, & Hahn, 2009). Other risk factors include, but are not limited to, injection drug use (IDU), alcohol use and older age, which place the population at risk for being seropositive (Stein et al., 2012). As a member of the hepatovirus family, HAV is primarily transmitted via the fecal-oral route (Zuckerman, 1996). The rate of acute hepatitis in the US is 0.5 per 100,000 (Centers for Disease Control and Prevention, 2010). While the rate among paroled populations is hard Nurs Res. Author manuscript; available in PMC 2016 May 01. Nyamathi et al. Page 3 Author Manuscript to ascertain, data suggest that HAV infection is related to unsanitary living conditions, i.e., poor water sanitation (World Health Organization, 2014), for which homeless populations are at risk. Peer Coaching and Hepatitis Discussion
Author Manuscript A member of the hapdnavirus family, HBV (Immunization Action Coalition, 2013; Zuckerman, 1996) disproportionately burdens homeless (Nyamathi, Liu, et al., 2009; Nyamathi, Sinha, Greengold, Cohen, & Marfisee, 2010) and incarcerated populations (Immunization Action Coalition, 2013; Khan et al., 2005), leading to fulminant liver failure, chronic liver disease, hepatocellular carcinoma, and death (Rich et al., 2003). HBV can be transmitted through unprotected sexual activity, needle sharing, IDU (Diamond et al., 2003; Maher, Chant, Jalaludin, & Sargent, 2004), and percutaneous blood exposure. National prevalence statistics indicate that HBV affects between 13% to 47% of U.S. prison inmates (Centers for Disease Control and Prevention, 2004). Illicit drug use is a major contributor to incarceration and homelessness among ex-offenders (McNeil & Guirguis-Younger, 2012; Tsai, Kasprow, & Rosenheck, 2014), placing ex-offenders who use drugs at high risk for HBV infection. Author Manuscript Despite the availability of the HBV vaccine, there has been a low rate of completion for the three-dose core of the accelerated vaccine series (Centers for Disease Control and Prevention, 2012). Among incarcerated populations, HBV vaccine coverage is low; in a study among jail inmates, 19% had past HBV infection, and 12% completed the HBV vaccination series (Hennessey et al., 2009). While HBV vaccination is well accepted behind bars—due to a lack of funding and focus on prevention as a core in the prison system—few inmates may complete the series (Weinbaum, Sabin, & Santibanez, 2005). In addition, prevention may not be a priority for those who are struggling with managing mental health, drug use, and dependency issues, along with the need to meet basic necessities (Nyamathi, Shoptaw, et al., 2010). Authors contend that while the HBV vaccine is cost effective, it is underutilized among high-risk (Rich et al., 2003) and incarcerated populations (Hunt & Saab, 2009). For homeless men on parole, vaccination completion may be affected by level of custody; generally, the higher the level of custody, the higher the risk an inmate poses. In addition, various contract types, such as drug treatment-related, and length of time in residential drug treatment (RDT)—for those with drug histories—may also affect completion of the vaccine series. For those transitioning into the community, stress, family reunification issues, and the potential for relapse and recidivism may represent real challenges (Seiter & Kadela, 2003), and may influence vaccine completion. Author Manuscript Until 1981, the HBV vaccine was not licensed in the U.S. (Centers for Disease Control and Prevention, 2012). Twenty years later, in 2001, a combination of the HAV and HBV vaccine, Twinrix, was developed by GlaxoSmithKline and approved by the Food and Drug Administration (FDA) (Centers for Disease Control and Prevention, 2012). The standard dosing for this regimen is 0, 1, and 6 months. An alternative dosing schedule (core doses at 0, 7, and 21–31 days and a booster dose 12 months) was approved by the FDA in 2007 (Centers for Disease Control and Prevention, 2012). Thus, many individuals, particularly older individuals, may not have been vaccinated. Nurs Res. Author manuscript; available in PMC 2016 May 01. Nyamathi et al. Page 4 Author Manuscript Author Manuscript One strategy to improve vaccination for HAV and HBV among high-risk populations has been to utilize the accelerated Twinrix HAV/HBV vaccination which provides the core doses at 0 days, 7 days, and 21–30 days (Nyamathi, Liu, et al., 2009). The Twinrix recombinant vaccination is administered intramuscularly (GlaxoSmithKline, 2011) by a licensed nurse. In a randomized controlled trial (RCT) comparing vaccination completion among incarcerated IDUs in Denmark—using the accelerated versus a standard vaccine schedule (0, 1 and 6 months)—63% completed the three accelerated dose series compared to 20% of those who received the nonaccelerated series (Christensen et al., 2004). In another RCT conducted among 297 homeless adults with a history of incarceration, findings revealed that 50% completed the Twinrix vaccine series. Peer Coaching and Hepatitis Discussion
Logistic regression analysis revealed that those who were more likely to complete the HBV vaccination were over 40 years of age (p = .02), partnered (p = .02), homeless more than one year (p = .025), recent binge drinkers (p = .03), and had attended recent alcohol anonymous or narcotic anonymous meetings (p = .006) (Nyamathi, Marlow, Branson, Marfisee, & Nandy, 2012). In another RCT focused on improving HAV/HBV vaccine completion among 256 homeless adults who were on methadone maintenance, a greater percentage of participants who completed the vaccine series also reduced their alcohol consumption by 50% as compared to those who were unsuccessful in reducing their alcohol consumption (74.4% vs. 64.1%) (Nyamathi, Shoptaw, et al., 2010). Author Manuscript Finally, in a larger, three-group RCT with 865 homeless adults in shelters located in Los Angeles, individuals were randomly assigned to one of three groups: (a) nurse case managed sessions plus hepatitis education, incentives, and tracking; (b) standard hepatitis education plus incentives and tracking; and (c) standard hepatitis education and incentives only. Findings reveal that those who were in the nurse case management education, incentives, and tracking program were significantly more likely to complete a standard three-series Twinrix vaccination or core of the accelerated dosing schedule (68% vs. 61% vs. 54%, respectively; p = .01) compared to those who were in the other two programs (Nyamathi, Liu, et al., 2009). While accelerated vaccination programs have shown success in RCT studies, including those utilizing nurse case management, little is known about vaccine completion among an ex-offender population using varying intensities of nurse case management and peer coaches. Theoretical Framework Author Manuscript The comprehensive health seeking and coping paradigm (CHSCP) (Nyamathi, 1989), adapted from a coping model (Lazarus & Folkman, 1984) and the health seeking and coping paradigm (Schlotfeldt, 1981) guided this study and the variables selected (See Figure 1.).
The CHSCP has been successfully applied by our team to improve our understanding of HIV and HBV/HCV protective behaviors and health outcomes among homeless adults (Nyamathi, Liu, et al., 2009)—many of whom had been incarcerated (Nyamathi et al., 2012). In this model, a number of factors are thought to relate to the outcome variable, completion of the HAV/HBV vaccine series. These factors include sociodemographic factors, situational, personal, and social factors, and health seeking and coping responses. Nurs Res. Author manuscript; available in PMC 2016 May 01. Nyamathi et al. Page 5 Author Manuscript Sociodemographic factors that might relate to completion of the vaccine series among incarcerated populations include age, education, race/ethnicity, and marital and parental status (Hennessey, Kim, et al., 2009; Salem et al., 2013). Situational factors such as being homeless (Nyamathi et al., 2012), history of criminal activities, and severity of criminal history (level of custody and contract type) may likewise influence interest in completing a vaccination series. Similarly personal factors, such as history of psychiatric and drug use problems (Hennessey, Kim, et al., 2009; Salem et al., 2013), having hostile tendencies (Nyamathi et al., 2014), or dealing with physical and mental health problems (Nyamathi et al., 2011) may interfere with health protective strategies while having social factors present, such as social support, may facilitate health promotion. Finally, health seeking and coping strategies may also be known to impact health promotion (Nyamathi, Stein, Dixon, Longshore, & Galaif, 2003) and compliance with hepatitis vaccine completion. Author Manuscript Purpose Despite knowledge of awareness of risk factors for HBV infection, intervention programs designed to enhance completion of the three-series Twinrix HAV/HBV vaccine and identification of prognostic factors for vaccine completion have not been widely studied. The purpose of this study was to first assess whether seronegative parolees previously randomized to any one of three intervention conditions were more likely to complete the vaccine series, as well as to identify the predictors of HAV/HBV vaccine completion. Methods Design Author Manuscript An RCT where 600 male parolees from prison or jail and participating in a RDT program were randomized into one of three intervention conditions aimed at assessing program efficacy on reducing drug use and recidivism at six and 12 months, as well as vaccine completion in eligible subjects: (a) six-month intensive peer coaching and nurse case management (PC-NCM) intervention condition; (b) an intensive peer coaching (PC) intervention condition, with minimal nurse involvement; and (c) the usual care (UC) intervention condition, which had minimal PC and nurse involvement. Of these 600, 345 were eligible for the vaccine (seronegative) and constitute the sample for this report. Data were collected from February 2010 to January 2013. The study was approved by the University of California, Los Angeles Institutional Review Board and registered with Clinical Trials.gov (NCT01844414). Sample and Site Author Manuscript There were four inclusion criteria for recruitment purposes in assessing program efficacy on reducing drug use and recidivism: (a) history of drug use prior to their latest incarceration; (b) between ages of 18 and 60; (c) residing in the participating RDT program; and (d) designated as homeless as noted on the prison or jail discharge form. A homeless individual was defined as one who does not have a fixed, regular, and adequate nighttime residence (National Health Care for the Homeless Council, 2014). Exclusion criteria included: (a) monolingual speakers of languages other than English or Spanish; and (b) persons judged to Nurs Res. Author manuscript; available in PMC 2016 May 01. Nyamathi et al. Page 6 Author Manuscript be cognitively impaired by the research staff. A total of 42 men were screened out due to the following reasons: age, not being on parole, had not been released from jail or prison within six months prior to entering the study, or had not used drugs 12 months prior to their most recent incarceration. Eligibility for receiving the HAV/HBV vaccine series was not considered an inclusion criterion regarding drug use and recidivism. Among those eligible and interested, urn randomization (Stout, Wirtz, Carbonari, & Del Boca, 1994) was used to allocate participants. The variables used in the urn randomization included: age (18–29 and 30 and over), level of custody (1–2 vs. 3–4), HBV vaccine eligibility (HBV seronegative or seropositive), and level of substance use prior to prison time (low vs. moderate/high severity). For the present analysis, only vaccine-eligible subjects were included. Author Manuscript Amistad De Los Angeles (Amity) served as the main research site. For the last three decades, Amity, a nonprofit organization located in California, Arizona, and New Mexico has been focused on substance abuse treatment, and works with individuals and families (Amity Foundation, 2014) utilizing a therapeutic environment. The State of California Assembly passed criminal justice realignment legislation (AB109) on October 1, 2011 allowing low-level offenders (non-violent, non-serious and non-sex offenders) to serve their sentence in county jails instead of state prisons (California Department of Corrections and Rehabilitation, 2011). Post-realignment offenders were more likely to be convicted of a felony for drug and property crimes (California Department of Corrections and Rehabilitation, 2013a). Author Manuscript Power analysis—With at least 114 men in each intervention condition, there was 80% power to detect differences of 15 to 20 percentage points (for example, 50% vs. 70%, 75% vs. 90%) for vaccine completion between either of the two intervention conditions, and the usual care intervention condition at p = .05. Vaccine eligibility—Vaccine eligibility included being HBV seronegative and no absolute contraindications (having an allergy to yeast or neomycin, history of neurological disease [e.g., Guillian-Barre]), prior anaphylactic reaction to HAV/HBV vaccine, a fever of over 100.5 degrees Fahrenheit, and reporting any moderate or severe acute illness beyond mild cold symptoms (e.g., nonproductive cough, rhinorrhea, or other upper respiratory symptoms). Of the total sample of 600 study participants, 345 men were eligible for the HAV/HBV vaccine. Figure 2 (CONSORT diagram) reflects both the larger sample and the subsample of vaccine eligible participants. Peer Coaching and Hepatitis Discussion
Interventions Author Manuscript Building upon previous studies, we developed varying levels of peer-coached and nurse-led programs designed to improve HAV/HBV vaccine receptivity at 12-month follow up among homeless offenders recently released to parole. Peer coaching–nurse case management (PC-NCM)—The peer coach interacted weekly for about 45 minutes with their assigned participants in person, and for those who left the facility, interacted by phone. Their focus was on building effective coping skills, personal assertiveness, self-management, therapeutic nonviolent communication (NVC), and Nurs Res. Author manuscript;