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

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)

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.

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

Positive TB Skin Test Induration > 10 mm in HIV seronegative individuals Induration > 5 mm in HIV seropositive individuals

Comprehensive Health Seeking and Coping Paradigm (Nyamathi, 1989)

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

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

Intervention - 3 Traditional Program: Interact biweekly with the UCLA research nurse and outreach workers stationed at the Satellite Clinic who: 1)Provide a 20-minute education program; 2)administer DOT biweekly x 52 doses; and 3) Provide a $5 incentive

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) (Cronbach’s alpha.91-97) Depressive Symptoms (CES-D) (Radloff, 1977) Psychological Well-Being RAND Mental Health

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

Assumptions Participant’s confidentiality is ALWAYS kept Use of locator guide Approved photo Check prison and jail rosters Participant’s specific requests about who to contact & who NOT to contact are ALWAYS honored

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!

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

Sociodemographics Characteristics by Group NCMI (n = 283) Traditional (n = 237) Average age 41.5 years Mean education 12 years Gender*: NCMI Traditional % % Male Female

Sociodemographics Characteristics by Group African American: 81% White: 7.3% Hispanic: 9.4%

Behavioral Characteristics Social Support Mean: 49.1 Depressive Symptoms: 17.8 Psychological Well Being: 65.0

Behavioral Characteristics by Group Lifetime IDU*** Current IDU*** Current non injection drugs NCMI (n = 283) Traditional (n = 237) % %

Behavioral Characteristics Daily alcohol use: 16% Daily drug use: 22% Years smoked: 15

Behavioral Characteristics Intent to adhere: 83.6% Wanted to take INH 81.1% Medical Discharge: 14.2%

Compliance Status by Group NCM (n = 283) Traditional (n = 237) Completed Treatment*** Yes Intention to Treat *** % 72% 60% % 46% 40%

Associations by Treatment Completion Age** Completers (n = 266) Non-Completers (n = 254) M 42.5 M 40.5

Associations by Treatment Completion Ethnicity** Black White Hispanic Recruit*** ER Shelter Drug Recov Completers (n = 266) Non-Completers (n = 254) % %

Key Characteristics & Treatment Completion Social Support: Depr. Sym Psych. Well Being Mean: 49 Mean: 18 Mean: 65

Associations of Key Characteristics & Treatment Completion Lifetime IDU IDU Non-injection drugs Completers (n = 266) Non-Completers (n = 254) N % N % *

Associations of Key Characteristics & Treatment Completion Daily Alcohol Use Daily Serious Drugs Completers (n = 266) Non-Completers (n = 254) N % N % * **

Logistic Regression Results for Completion of LTBI Treatment NCMI Group Age Black Sex Adjusted Odds Ratio 95% CI P Value

Logistic Regression Results for Completion of LTBI Treatment Hospitalized Past 6 Months Daily Alcohol Use Adjusted Odds Ratio 95 % CI P Value

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) (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) (2.48, 43.68) 3.27 (1.30, 8.25) 5.10 (1.79, 14.52) 2.76 (2.00, 6.37)

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.

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.

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.

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, 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, 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, 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