A Randomized Controlled Trial of Two Treatment Programs for Homeless Adults with Latent Tuberculosis Infection

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A Randomized Controlled Trial of Two Treatment
Programs for Homeless Adults with Latent
Tuberculosis Infection

• Adeline Nyamathi, ANP, PhD, FAAN
• Audrienne H. Moseley Endowed Chair
• in Community Health Research
• Professor and Dean for Academic Affairs
• UCLA School of Nursing

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Problem

• TB Homeless at higher risk
• Compromised immune system from drug
• use, overcrowding and poor nutrition
• Little access to health and social services
• Poor adherence to preventive health
• LTBI treatment shown to reduce risk of
  progression to active TB by 64 to 93 (ATS,
  2000)
• LTBI completion rates among the homeless have
  ranged from 19 to 44 (Tulsky et al., 2000)

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Specific Aims

• To compare the effectiveness of a
  theoretically-based comprehensive intervention
  program employing nurse case management against a
  control program with standard care on LTBI
  treatment completion in a homeless population.

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Study Design

• Prospective, two-group, site randomized design
• Age 18-55, or over 55 with reported risk
  activation factors for TB
• Homeless the previous night
• Denied previous LTBI treatment

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Positive TB Skin Test

• Induration gt 10 mm in HIV seronegative
  individuals
• Induration gt 5 mm in HIV seropositive individuals

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Comprehensive Health Seeking and Coping
Paradigm (Nyamathi, 1989)
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Intervention - 1
NCMI The intervention components, delivered in
a culturally competent and tailored manner by
assigned nurses and outreach workers during five
weekly sessions include 1) TB and HIV risk
reduction education 2) Social and cognitive
problem-solving training pertinent to the
implementation of behavior change
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Intervention - 2
NCMI (continued) 3) Training in behavioral,
self-management,and communications skill
competencies necessary for risk reduction change
for TB and HIV 4) Development of relationships,
activities and social networks conducive to
maintaining reductions in risk behavior 5)
Administer DOT biweekly for 52 doses 6)
Provide a 5 incentive
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Intervention - 3

• Traditional Program Interact biweekly with the
  UCLA research nurse and outreach workers
  stationed at the Satellite Clinic who
• Provide a 20-minute education program
• administer DOT biweekly x 52 doses and
• 3) Provide a 5 incentive

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Assessments

• TB completion by logs
• Drug and Alcohol Use by TCU Drug History Form
  (Simpson Chatam, 1995)
• Social Support- 18 item RAND Medical Outcomes
  Study (Sherbourne Stewart, 1991) (Cronbachs
  alpha .91-97)
• Depressive Symptoms (CES-D)
• (Radloff, 1977)
• Psychological Well-Being RAND Mental Health

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• Baseline and Six-Month Follow-up
• 98
• Importance of Tracking

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Assumptions

• Participants confidentiality is ALWAYS kept
• Use of locator guide
• Approved photo
• Check prison and jail rosters
• Participants specific requests about who to
  contact who NOT to contact are ALWAYS honored

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Persistence!

• Tracking, locating, and eventually completing a
  follow-up interview is ALL about persistence
• Track daily, track often
• Always assume that you WILL find the person
• And NEVER give up!

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Results

• Using intent to treat analysis, 62 of
  intervention participants completed 6 months of
  LTBI treatment with INH, compared to 39 of
  controls.

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SociodemographicsCharacteristics by Group

• NCMI (n 283) Traditional (n 237)
• Average age 41.5 years
• Mean education 12 years
• Gender NCMI Traditional
• Male 87.3 70.5
• Female 12.7 29.5

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SociodemographicsCharacteristics by Group

• African American 81
• White 7.3
• Hispanic 9.4

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Behavioral Characteristics

• Social Support Mean 49.1
• Depressive Symptoms 17.8
• Psychological Well Being 65.0

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BehavioralCharacteristics by Group
NCMI (n 283)
Traditional (n 237)
13.8 7.2 66.4
27.4 16.5 58.7
Lifetime IDU Current IDU Current non
injection drugs
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Behavioral Characteristics

• Daily alcohol use 16
• Daily drug use 22
• Years smoked 15

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Behavioral Characteristics

• Intent to adhere 83.6
• Wanted to take INH 81.1
• Medical Discharge 14.2

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Compliance Status by Group
NCM (n 283)
Traditional (n 237)
Completed Treatment Yes Intention to
Treat
72 60

46 40
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Associations by Treatment Completion
Completers (n 266)
Non-Completers (n 254)
M 42.5
M 40.5
Age
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Associations by Treatment Completion
Completers (n 266)
Non-Completers (n 254)
86.8 5.6 6.4 83.8 16.7
74.8 9.1 12.6
74.8 25.2
Ethnicity Black White Hispanic Recruit ER
Shelter Drug Recov
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Key Characteristics Treatment Completion

Social Support Depr. Sym Psych. Well Being
Mean 49 Mean 18 Mean 65

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Associations of Key Characteristics Treatment
Completion
Completers (n 266)
Non-Completers (n 254)
Lifetime IDU IDU Non-injection drugs
N 44 16.5 25 9.4 167 62.8
N 60 23.6 34 13.6 160
63.0
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Associations of Key Characteristics Treatment
Completion
Completers (n 266)
Non-Completers (n 254)
Daily Alcohol Use Daily Serious Drugs
N 34 12.8 44 16.6
N 49 19.3 66 26.3
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Logistic Regression Results for Completion of
LTBI Treatment
Adjusted Odds Ratio
95 CI
P Value
NCMI Group Age Black Sex
2.25 1.03 1.70 1.08
1.55-3.28 1.002-1.05 1.02-2.84 0.67-1.75
.001 .034 .042 .758
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Logistic Regression Results for Completion of
LTBI Treatment
Adjusted Odds Ratio
95 CI
P Value
Hospitalized Past 6 Months Daily Alcohol Use
0.52 0.59
0.27-1.01 0.36-0.98
.055 .043
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Efficacy of Intervention Using Adjusted Odds
Ratios and 95 CIs

• Males
• Females
• Black
• Veteran
• Daily ETOH
• Fair/Poor Health
• Homeless Shelter
• Distressed

• 2.51 (1.60, 3.93)
• 5.80 (1.72, 19.57)
• 2.60 (1.69, 4.02)
• 4.34 (0.87, 21.73)
• 10.41 (2.48, 43.68)
• 3.27 (1.30, 8.25)
• 5.10 (1.79, 14.52)
• 2.76 (2.00, 6.37)

• 2.51 (1.60, 3.93)
• 5.80 (1.72, 19.57)
• 2.60 (1.69, 4.02)
• 4.34 (0.87, 21.73)
• 10.41 (2.48, 43.68)
• 3.27 (1.30, 8.25)
• 5.10 (1.79, 14.52)
• 2.76 (2.00, 6.37)

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Summary
Findings to date indicate that 72 of homeless
persons in the NCM program have
completed treatment for LTBI while 46 of the
Traditional group have completed treatment for
LTBI.
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Conclusions - 1
Completers were more likely to be older, African
American and recruited from a homeless shelter.
Non completers were more likely to be Hispanic,
and have used lifetime injection drugs, drink
alcohol daily, or use serious drugs daily.
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Conclusions - 2
Strategies utilized by nurses and outreach
workers in the NCM program including case
management, incentives for enhancing compliance
and relocating clients to return for DOT are
helpful. Compliance to a medication regimen
among homeless populations at risk for HIV is
possible with effective strategies.
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Publications

• Nyamathi A., Christiani, A., Nahid, P., Strehlow,
  A., Gregerson, P., Morisky, D., Leake, B.
  (2006). A Randomized Controlled Trial of Two
  Treatment Programs for Homeless Adults with
  Latent Tuberculosis Infection. IJTLD, 10, 775-82.
• Schumann, A., Nyamathi, A., Stein, J. (2007).
  HIV Risk Reduction in Nurse Case managed TB and
  HIV Intervention among Homeless Adults. J Hlth
  Psy, 12, 833-843.
• Nyamathi, A., Stein, J. A., Schumann, A., Tyler,
  D. (2007). Latent Variable Assessment of Outcomes
  in a Nurse Case Managed Intervention to Increase
  Latent Tuberculosis Treatment Completion in
  Homeless Adults. Health Psychology, 26, 68-76.
• Nyamathi, A., Nahid, P., Berg, J., Christiani,
  A., Aqtash, S., Morisky, D., Leake, B. (in
  press). Efficacy of a Nurse Case Managed Program
  Among Subgroups of Homeless Adults. Nursing
  Research