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N/A N=50 Prevention

Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV

Latent Tuberculosis Infection

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Completion of TBI Treatment — 45 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Nurse-led Community Health Worker TBI (RN/CHW TBI) program (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, Irvine
Primary completion
May 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Completion of TBI Treatment
45
SECONDARY
Drug Use
1.98; 1.64; 1.8 0.603
SECONDARY
Alcohol Use
14; 11; 7 0.672
SECONDARY
Depression
9.11; 8.84; 9.4 0.719
SECONDARY
Health Care Access
4.33; 3.18 0.1668
SECONDARY
Shelter Stability - Days Residing in the Shelter
76.8; 82; 74.3 0.9198

Summary

Tuberculosis (TB) is the prototypical disease of poverty as it disproportionately affects marginalized and impoverished communities. In the US, TB rates are unacceptably high among homeless persons who have a 10-fold increase in TB incidence as compared to the general population. In California, the rate of TB is more than twice the national case rate and recent TB outbreaks have been alarming. Among persons with active TB disease, over 10% die during treatment, with mortality being even higher among homeless persons with TB. While TB can be prevented by treating TB infection (TBI) before it develops into infectious, symptomatic disease, individual factors such as high prevalence of psychosocial comorbidities, unstable housing and limited access to care have led to poor adherence and completion of TBI treatment among homeless persons. Given the complex health disparity factors that affect TBI treatment adherence among homeless persons, this study will assess the feasibility of a theoretically-based novel model of care among persons with TBI and complex chronic illnesses. This study will evaluate an innovative, community-based intervention that addresses critical individual level factors which are potential mechanisms that underlie health disparities in completing TBI treatment among the predominantly minority homeless. The study hypothesis is that improving these conditions, and promoting health by focused screening for TBI, and early detection and treatment for these vulnerable adults will improve TB treatment completion and prevent future TB disease. The proposed theoretically-based health promotion intervention focuses on: 1) completion of TBI treatment, 2) reducing substance use; 3) improving mental health; and 4) improving critical social determinants of TB risk (unstable housing and poor health care access) among homeless adults in the highest TB prevalence area in Los Angeles. A total of 76 homeless adults with TBI will receive this program which includes culturally-sensitive education, case management, and directly observed therapy (DOT) delivery of medication among patients who have been prescribed 3HP (12 weeks treatment for latent TB infection) by a medical provider. This study will determine whether this intervention can achieve higher completion rates than the 65% completion rate among homeless persons reported by previous TB programs.

Eligibility Criteria

Inclusion Criteria

  • self-reported homeless adults (past six months);
  • age 18 or older;
  • willing to provide informed consent;
  • positive for TBI
  • reported current or recent substance use (past three years)

Exclusion Criteria

  • screened as having active TB or currently treated for TBI;
  • history of treatment for active TB or TBI;
  • a serum aspartate aminotransferase (AST) level of 3-5 times the upper limit of normal;
  • HIV infected AND receiving antiretroviral therapy (as 3HP is not recommended yet in this group);
  • not able to speak English or Spanish;
  • testing pregnant (as 3HP is not recommended in this group); and
  • judged to be cognitively impaired
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03702049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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