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Randomized Controlled Trial of Interventions to Improve Follow-up for Latent Tuberculosis Infection After Release From Jail
Mary Castle White, MPH, PhD, FAAN;
Jacqueline P. Tulsky, MD;
Joe Goldenson, MD;
Carmen J. Portillo, RN, PhD, FAAN;
Masae Kawamura, MD;
Enrique Menendez, MD
Arch Intern Med. 2002;162:1044-1050.
ABSTRACT
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Background Adherence to treatment of persons with latent tuberculosis infection
after release from jail has been poor.
Methods A randomized controlled trial was conducted at the San Francisco City
and County Jail, San Francisco, Calif. Subjects undergoing therapy for latent
tuberculosis infection who spoke either English or Spanish were randomly allocated
to receive education every 2 weeks while in jail; an incentive if they went
to the San Francisco County Tuberculosis Clinic within 1 month of release;
or usual care. The main outcome measures were completion of a visit to the
tuberculosis clinic within 1 month of release and completion of therapy.
Results Of 558 inmates enrolled, 325 were released before completion of therapy.
Subjects in either intervention group were significantly more likely to complete
a first visit than were control subjects (education group, 37%; incentive
group, 37%; and controls, 24%) (adjusted odds ratio based on pooled results
for the education and incentive groups, 1.85; 95% confidence interval, 1.04-3.28; P = .02). Those in the education group were twice as likely
to complete therapy compared with controls (adjusted odds ratio, 2.2; 95%
confidence interval, 1.04-4.72; P = .04). Of those
who went to the tuberculosis clinic after release, subjects in the education
group were more likely to complete therapy (education group, 65% [24/37];
incentive group, 33% [14/42]; and control group, 48% [12/25]; P = .02).
Conclusions Education or the promise of an incentive improved initial follow-up.
Education was superior to an incentive for the completion of therapy. Fairly
modest strategies provided in jail can improve adherence. Further links between
jail health services and community care should be explored.
INTRODUCTION
TREATMENT OF persons with latent tuberculosis (TB) infection (LTBI)
to prevent progression to disease is a critical component of TB control efforts
in the United States.1-2 The highest
risk for progression is among the recently infected3;
among immigrants from countries with high rates of TB, in particular within
the first 5 years following immigration4-5;
among intravenous injection drug users6-7;
and among persons with clinical conditions such as the human immunodeficiency
virus.8
Correctional facilities have disproportionate numbers of persons with
characteristics associated with developing active TB.9
Inmates are likely to come from racial and ethnic communities, be members
of low-income or homeless populations,1, 10-12
have high rates of injection drug use associated with human immunodeficiency
virus infection, and have limited access to health care.13-16
Jails are the initial intake points for incarceration; persons arrested, awaiting
or on trial, and serving sentences up to 1 year are housed in jails for relatively
short periods and then return to the community.16
In the San Francisco City and County Jail, 27% of inmates during routine screening
had LTBI. Most treated for LTBI (81%) were Latino persons and foreign-born,
with a median of 3 years since immigration.17
Treatment of LTBI has been based on clinical trials of isoniazid in
the 1950s and 1960s, indicating effectiveness in preventing progression to
disease, 3 with evidence of increased efficacy based on length of treatment
and adherence to the treatment regimen.18-19
Poor adherence, defined as taking isoniazid for 3 months or less, has been
associated with a 6-fold increase in risk for subsequent disease compared
with completing more than 3 months of treatment.20
Few studies have focused on inmates and the unique issues of treatment
started in jail with the need for completion in the community. Nolan et al21 reported poor results from an integrated screening
program in a Seattle, Wash, jail combined with community-based directly observed
therapy for LTBI, in which 40.1% were lost to follow-up at release from jail
and only 49.7% completed therapy despite intensive case management. In an
initial study17 in the San Francisco City and
County Jail, less than 3% of inmates released from jail went to the San Francisco
County Tuberculosis Clinic (TB Clinic) after being counseled once in jail,
at the time of medication prescription. In a clinical trial22
in which a consistent single educational session was provided to all inmates
after prescription of therapy for LTBI, the rate was increased to 23.3% in
the education group and 25.8% in a group promised a $5 incentive in addition
to the education. This study builds on the scientific evidence to measure
the effect of education or incentives on initial follow-up and completion
of care among inmates released to the community.
PARTICIPANTS AND METHODS
RESEARCH DESIGN
A randomized controlled trial was designed to study the effects of 2
interventions given to inmates in the San Francisco City and County Jail.
The 2 interventions were as follows: (1) education, provided every 2 weeks
while in jail; or (2) the promise of an incentive ($25 equivalent in food
or transportation vouchers) provided at the first visit to the TB Clinic.
A third (control) group received neither intervention. The 2 study outcomes
were as follows: (1) the first visit to the TB Clinic within 1 month after
release from jail and (2) completion of a full course of therapy. The study
design was approved by the institutional review board of The University of
California, San Francisco.
SAMPLE
The target population was jail inmates who were screened by jail medical
personnel and determined to have LTBI, eligible for and agreed to begin therapy
in jail, and released into the community while still undergoing therapy. Those
who went to prison or who remained in custody for the duration of therapy
were not the focus of this study, because they received the entire course
of medication during incarceration. However, because the release date and
destination were unknown at study enrollment, all consecutive eligible inmates
were approached for recruitment and informed consent, many of whom were ultimately
not eligible for the final analytic sample. Sample size calculations indicated
that 86 subjects in each study group would provide sufficient power ( 0.8)
to detect a 20% difference in adherence, based on previous work17, 22
in the jail, between either intervention group and the control group at 
= .05.
Inmates who did not speak Spanish or English or who were determined
by sheriff's personnel to be violent or by Jail Health Services' mental health
staff to have serious psychiatric illness were excluded from the study. Also
excluded were known human immunodeficiency virus–positive inmates under
the care of the Forensic AIDS [Acquired Immunodeficiency Syndrome] Project.
These inmates receive a different treatment for LTBI in jail and intensive
follow-up in the community after release, including additional incentives
to continue care.
STANDARD TB SCREENING AND CARE IN JAIL AND AFTER RELEASE
All decisions on screening, medication prescription or discontinuation,
and monitoring of inmates in jail were made by jail medical personnel. During
the study, the course of therapy provided was 6 months of isoniazid,23 and therapy was observed directly.
We reviewed jail electronic medical records daily and provided standard
information to inmates who began therapy for LTBI. This session, under an
agreement with Jail Health Services, became the usual care for the duration
of the study. Research assistants conducted this one-to-one session based
on Centers for Disease Control and Prevention guidelines24
in English or Spanish, according to inmate preference. The information focused
on LTBI, therapy, adverse effects, availability of free care after release,
and location of, transportation to, and hours of the TB Clinic. The message
concluded with encouragement that completing therapy could eliminate future
risk, with interaction to confirm understanding. Research assistants were
bilingual and bicultural Spanish speakers, without formal health care education,
trained by the project director (E.M.). Once this information was provided
to each inmate, jail pharmacy personnel prepared a 1-month supply of isoniazid
to put in his or her personal belongings at release.
Medication continuation and discontinuation, method of therapy administration,
and completion of therapy for inmates who went to the TB Clinic after release
were determined by TB Clinic clinicians.
STUDY PROTOCOL
Following the informational session provided to all inmates (usual care),
the research assistant determined study eligibility, described the study,
and obtained informed consent. As part of the consent process, inmates were
told that if they completed isoniazid therapy in jail, if isoniazid was discontinued,
or if they were not released to the community, they would no longer be participants
in the study. Enrolled inmates provided baseline data and postrelease contact
information to research assistants using a structured interview in English
or Spanish.
Subjects were then randomized, using ordered sealed envelopes containing
allocation determined by a random numbers table, into 1 of the 3 study groups:
education, incentive, or control. Inmates in the education group were told
they would be visited every 2 weeks for the duration of their jail stay, to
reinforce the initial information and message of the first session. Inmates
in the incentive group were told they would have no further contact with study
personnel in jail and that they would be able to choose a $25 equivalent in
food or transportation vouchers if they went to the TB Clinic within 1 month
of release. Inmates in the control group were told they would have no further
contact with study personnel in jail.
For those in the incentive group who went to the TB Clinic within 1
month of release, clinic personnel contacted research assistants who met the
subject at the clinic or arranged another time to meet. Research assistants
then provided them the choice of a $25 equivalent in food or transportation
vouchers. Follow-up interviews among all released to the community were conducted
with those who could be located. This interview occurred after the first outcome
(visit to the TB Clinic 1 month after release) was ascertained.
DATA
At enrollment, structured interviews were used to gather sociodemographic
information (age, sex, educational level, marital status, previous time in
jail or prison, and employment before jail), ethnicity and culture (country
of birth, time since immigration, and preferred language), health status (alcohol
or other drug problem using the CAGE questions, modified to include other
drugs and alcohol [CAGE is a questionnaire for alcoholism evaluation: C, Have
you ever felt the need to cut down on your drinking?
A, Have you ever felt annoyed by criticism of your
drinking? G, Have you ever felt guilty about your
drinking? E, Have you ever taken a drink {eye opener}
first thing in the morning?],25 and self-rated
health using the Medical Outcomes Survey 5-point scale from poor to excellent26), and health care information (having a regular place
to go for health care, number of visits in the past 12 months, medical insurance,
and history of treatment with isoniazid). Housing in the month before jail
was asked about in detail and then dichotomized into stable (own apartment
or house, hotel, or house or apartment of friends or relatives) vs unstable
(park or street; car, truck, or van; shelter; or positive answer to "in the
month before coming to jail, did you spend any night on the street or in a
shelter, in other words, homeless?"). Medication and health care attitudes
and intent to complete therapy were asked in a series of questions used in
previous studies27 among the homeless. The
presence of social support, by family or friends, for adherence to therapy
was asked in a series of questions with Likert scale responses from "absolutely
yes" to "definitely no."
Jail records were used to monitor isoniazid therapy, length of jail
stay, and disposition to the community. We were unable to determine whether
inmates had the 1-monthsupply of isoniazid at release, as the sheriff's personnel
were not always able to put it in the inmate's property and there were no
records of this.
Records from the TB Clinic were used to determine outcomes (first visit
to the clinic within 1 month after release and completion of therapy for LTBI
among those who went to the clinic), with a follow-up record review until
determination of completion was made by TB Clinic clinicians. The first outcome
was recorded "yes" if there was a clinic record indicating that the person
had come to the clinic to see a clinician within the first month of release
from jail. The second outcome was recorded "yes" if the clinician indicated
completion of therapy in the medical record. Medical record review was performed
by personnel who did not have access to study group assignment.
STATISTICAL ANALYSIS
Standard methods were used to examine the sample and the distribution
of known and suspected predictors of adherence. Any variables disproportionately
distributed by study group were identified for inclusion in subsequent regression
analyses. Both outcomes were analyzed by intent to treat for the analytic
sample of those released while still taking isoniazid. A conditional analysis
was also performed on the second outcome, completion of therapy for LTBI,
for the subset of those who made the first visit to the TB Clinic and in whom
medications were not discontinued because of adverse effects.
An ordered categorical variable was made to describe time in the United
States, with 3 categories: born in the United States; foreign birth, with
longer than 5 years spent in the United States; and foreign birth, with 5
years or less spent in the United States. The dichotomy of foreign-born to
longer than 5 years vs 5 years or less spent in the United States was based
on the work of McKenna et al4 indicating the
highest risk for conversion to active TB in the 5 years since immigration.
Group status and other covariates were tested against the 2 outcome
measures using  2 and t tests or Mann-Whitney
tests. Using significant variables from bivariate analyses ( = .10),
we built a separate logistic regression model for each outcome, to assess
the effect of group status while adjusting for multiple covariates. For the
categorical variable, time in the United States (born in the United States,
immigration >5 years ago, and immigration  5 years ago), 2 indicator variables
were created to assess the independent contribution of each of the 2 foreign-birth
categories compared with the reference group, those born in the United States.28 Final statistical models predicting the 2 outcomes
were generated, with adjusted odds ratios and 95% confidence intervals.
RESULTS
SAMPLE CHARACTERISTICS
Eligibility determination and recruitment from March 1, 1998, through
May 31, 1999, and flow of subjects through the study are shown in Figure 1. Of the 558 subjects enrolled, 510
continued to take isoniazid and 62 (12%) of these 510 finished therapy while
in jail. Nearly three quarters (325 [73%]) of the 448 who continued to take
isoniazid in jail were released before completion, after an average of 48.6
days (median, 34 days) of a 6-month course of isoniazid. These 325 subjects
composed the analytic sample for determining study outcomes. There were no
significant differences in subjects by study group, in either the 558 enrolled
or the 325 released from jail. Sample characteristics are shown in Table 1.
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Flow of study participants through the randomized controlled trial.
AIDS indicates acquired immunodeficiency syndrome; TB Clinic, San Francisco
County Tuberculosis Clinic, San Francisco, Calif.
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Table 1. Characteristic of 325 Subjects Released From Jail, by Study
Group*
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A problem with alcohol or other drugs was reported by 55% of subjects,
but 81% answered yes to 1 or more of the questions that composed the CAGE
measure, modified to reflect a problem with alcohol or other drugs.25 One third (33%) of the subjects reported that they
would have support for taking isoniazid after release, from a spouse or steady
partner, family, or friends. Nearly all subjects (98%) believed taking isoniazid
was good, stated they would definitely go to the TB Clinic (84%), and reported
they would definitely complete therapy for LTBI (81%).
OUTCOMES
Completion of the First Visit to the TB Clinic
One third of the 325 subjects (107 [33%]) completed the first visit
to the TB Clinic after release from jail. Rates of completing a first visit
in the education group (37%) and the incentive group (37%), when pooled, were
significantly different from the rate in the control group (24%) (P = .02, 2 test).
Other variables significant in bivariate analyses predicting completion
of a first visit were older age (mean, 33.4 vs 29.8 years) (P = .10), more years of education (mean, 10.5 vs 8.9 years) (P = .001), having unstable housing (P = .02), and being seen more often by a physician or nurse practitioner
in the past 12 months (mean, 1.9 vs 1.2 times) (P
= .02). Language preference (Spanish vs English) was highly correlated with
being Latino (Cohen  , 0.90, P<.001) and
foreign birth (Cohen , 0.68, P<.001), and
all were inversely associated with going to the TB Clinic. Language was chosen
for inclusion in the model because it has support as a surrogate measure for
acculturation, with validity as a measure of cultural integration29 and relevance to health behaviors.30
Time in the United States was strongly associated with going to the TB Clinic:
42% of those born in the United States, 39% of those foreign-born who immigrated
more than 5 years before jail, and 12% of recent immigrants (5 years)
completed the first visit (P.001). The logistic
regression model controlling for these covariates is presented in Table 2.
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Table 2. Characteristics Associated With Completion of the First Visit
to the TB Clinic Among 325 Subjects Released From Jail, by Logistic Regression
Analysis*
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Number of Educational Sessions and Time in Jail.
Subjects randomized into the education group understood that they would
receive educational sessions every 2 weeks in jail. Nearly one third (32 [30%])
were released before any session occurred. The distribution of rates of completion
of the first visit to the TB Clinic, by the number of educational sessions
received, is shown in Table 3.
Even among those who did not stay long enough to have the promised session,
the rate of completion was 38% (12 of 32 subjects). We examined, however,
whether less time in jail, while not statistically significant (P = .42) in the overall analysis, could explain this observation. In
a post hoc analysis, we compared subjects in all 3 groups who were in jail
as long as those in the education group who did not go to any session. There
were no statistically significant (P = .59) differences
by study group, indicating that this observation may have been due to the
proximity of the usual care to release.
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Table 3. Completion of the First Visit to the TB Clinic by the Number
of Educational Sessions Provided, in 107 Subjects Randomized to the Education
Group*
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Follow-up Effect.
We observed an effect of the interview conducted in the community after
release, after the first outcome had been ascertained. For subjects who had
not completed a visit to the TB Clinic, this interview seemed to serve as
a reminder. Completion rates were boosted nearly equally in each study group,
to 48% in the education group, 46% in the incentive group, and 31% in the
control group, following this interview.
Completion of Therapy for LTBI
For the intent-to-treat analysis of subjects released from jail, rates
of completion were 23% (24/106) in the education group, 12% (14/113) in the
incentive group, and 12% (12/103) in the control group. Medications were discontinued
because of adverse effects in 3 subjects, all of whom were in the education
group. Those in the education group were more than twice as likely to complete
therapy as were those in the control group (adjusted odds ratio, 2.2; 95%
confidence interval, 1.04-4.72; P = .04), whereas
those in the incentive group did not differ from the controls (adjusted odds
ratio, 1.07; 95% confidence interval, 0.47-2.40). No other variables were
statistically significant ( = .05) in predicting completion of therapy.
For the conditional analysis of the 104 subjects who went to the TB
Clinic within 1 month and in whom medications were not discontinued, 50 (48%)
completed isoniazid therapy, 65% (24/37) in the education group, 33% (14/42)
in the incentive group, and 48% (12/25) in the control group. In a logistic
regression model intervention, group overall remained statistically significant
(P = .01) while controlling for the influence of
variables identified in bivariate analyses (Table 4). Having stable housing before jail predicted completion
of therapy (adjusted odds ratio, 2.94; 95% confidence interval, 1.01-8.58; P = .05), the opposite finding from that seen in predicting
completion of the first outcome, first visit to the TB Clinic.
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Table 4. Conditional Analysis of Characteristics Associated With Completion
of Therapy Among 104 Subjects Who Went to the TB Clinic After Release From
Jail and in Whom Isoniazid Was Not Discontinued, by Logistic Regression*
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COMMENT
Substantial improvements can be made, in linking released inmates to
postrelease care and in completion of therapy, with modest interventions conducted
in the jail setting.17, 22 Provision
of standard education or the promise of an incentive significantly improved
follow-up after release. In agreement with others,22, 27, 31-33
we found that an incentive influenced short-term outcomes, equal to the effect
of education, but was less important in predicting therapy completion. Our
finding that the influence of education persists over time is encouraging,
and further work should focus on the role of a postrelease reinforcement,
based on our anecdotal observation of a follow-up effect among nonadherent
subjects.
Nolan et al21 concluded that TB screening
of asymptomatic inmates is not a good use of funds for TB control because
of poor completion of therapy in released inmates. Our completion rate among
those who went to the TB Clinic within 1 month of release (48%) is remarkably
similar to the overall completion rate among the nonrandomized subjects in
their intensive program to link inmates to appropriate community care (50%).21 Our conclusions, however, differ. The reality of
the completion rates that are not as high as one would expect should not result
in a conclusion to abandon initiation of treatment of LTBI in jail inmates.
Rather, in this population with high rates of recidivism, linking jail
health services to community care is critical to maximize the effect of resources
used to screen and treat persons with LTBI inside and outside jail.
Results of this study do, however, provide strong evidence that the
initiation of therapy for LTBI in jail must include strategies to ensure follow-up
after release. Our findings that nearly one quarter of inmates had been taking
isoniazid before and that three quarters were released after a median 34 days
of therapy should raise serious questions about the value of starting therapy
in jail without such strategies. New recommendations for short-course therapy
may not solve the problem.2 Rifampin and pyrazinamide,
given daily for 2 months, may be too expensive for jail health care budgets,
which must pay for the care and the close clinical monitoring of inmates without
reimbursement from public or private insurance. In San Francisco, the cost
of isoniazid is $0.07 per day, compared with $4.54 per day for the 2-drug
regimen. Furthermore, on average, our subjects were released before a 2-month
regimen could be completed, and close monitoring for adverse effects mandates
postrelease care.34 The recently revised recommendations
for isoniazid therapy from 6 to 9 months2 exacerbate
the problem of follow-up.
Findings from this study differ from the literature in that few of the
factors traditionally associated with nonadherence influenced the outcomes
of this study. Such general factors include homelessness; substance abuse;
lack of family or social support; migrant status; unemployment or low income;
low education and minority status35-40;
age and male sex,37-38 which have
been inconsistent predictors36-37,40;
and specifically related to TB, no prior medication use, knowledge, and beliefs
about medications, cultural factors, and limited access to care.38, 41-48
Incarcerated persons share many of the factors identified as barriers, but
in this study, time in the United States and stable housing were the only
important additional predictors of adherence. Foreign-born subjects in the
United States for 5 years or less, identified as being at highest risk for
disease progression,4-5 were one
third as likely to go to the clinic after release, but were just as likely
to finish medication if they made the postrelease visit to the TB Clinic.
This warrants further study to determine if those who are the least acculturated
are initially lost to the system, but once engaged in care, follow through
to completion.41 Another difference was that
unstable housing predicted the first visit to the TB Clinic, while stable
housing predicted therapy completion in those who went to the TB Clinic. The
former may be explained by multiple messages regarding TB provided in homeless
shelters and clinics serving the homeless; the latter may reflect consistency
with adherence literature,35, 40
pointing to social support and additional resources among the stably housed.
Limitations to the study include selection for English- or Spanish-speaking
inmates, to the exclusion of inmates who were non–English-speaking Asian/Pacific
Islanders. Data from the city and county of San Francisco indicate that more
than half treated for LTBI from 1997 to 1998 were Asian/Pacific Islanders
(Masae Kawamura, MD, unpublished data, 1997-1998). In the jail, both groups
have a high prevalence of LTBI (Asian/Pacific Islanders, 51.1%; and Latino
persons, 26.7%). But only 5.2% of annual jail bookings in 1998 were Asian/Pacific
Islanders, whereas Latino persons composed 17.7% of the bookings.49 The multiple cultural and language groups implied
in the category Asian/Pacific Islanders were beyond our scope and resources,
although this is clearly a group that warrants further study. Subjects in
this study are representative of inmates in the San Francisco City and County
Jail with LTBI who speak English or Spanish, and the results are generalizable
to areas with high immigration rates from Latin American countries. Based
on extrapolation from 1993 to 1998 data, current estimates are that more than
half of the persons with active TB in the United States are foreign-born5; addressing LTBI in foreign-born persons is a necessary
corollary to other active TB control efforts and should be culturally appropriate
and tailored to local needs.50
AUTHOR INFORMATION
Accepted for publication September 6, 2001.
This study was supported by grant R01 NR04456 from the National Institute
of Nursing Research, National Institutes of Health, Bethesda, Md.
Corresponding author and reprints: Mary Castle White, MPH, PhD, FAAN,
Department of Community Health Systems, School of Nursing, The University
of California, San Francisco, 2 Koret Way, Campus Box 0608, San Francisco,
CA 94143-0608 (e-mail: mcwhite{at}itsa.ucsf.edu).
From the Department of Community Health Systems, School of Nursing
(Drs White, Portillo, and Menendez), and the Department of Medicine, School
of Medicine, Positive Health Program (Dr Tulsky), The University of California,
San Francisco; Jail Health Services, San Francisco City and County Department
of Public Health, San Francisco, Calif (Dr Goldenson); and Tuberculosis Clinic
and the Department of Public Health, San Francisco General Hospital Medical
Center, San Francisco (Dr Kawamura).
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