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

NCT03702049 | Completed Results DMC

• 2 other identifiers: 20184698R21MD012696
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Latent Tuberculosis Infection

Outcome Measures

Primary Outcomes (1)

• Completion of TBI Treatment

  Completion of TBI Treatment will be measured at 3 month follow-up by 90% completion of medication (at least 11/12 doses) consumed over a 12 week period

  3 months (12 weeks)

Secondary Outcomes (5)

• Drug Use

  baseline, 3 and 6 months

• Alcohol Use

  baseline, 3 and 6 months

• Depression

  baseline, 3 and 6 months

• Health Care Access

  3 and 6 months

• Shelter Stability - Days Residing in the Shelter

  3 and 6 months

Study Arms (1)

RN/CHW TBI

EXPERIMENTAL

Nurse-led Community Health Worker TBI (RN/CHW TBI) program

Behavioral: Nurse-led Community Health Worker TBI (RN/CHW TBI) program

Interventions

Nurse-led Community Health Worker TBI (RN/CHW TBI) program BEHAVIORAL

Homeless adults with TBI will be assigned to 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. For this research, 3HP will be delivered to homeless persons infected with TB on a weekly basis by CHW under the guidance of their RN. The RN/CHW team will also provide case management, including health education and referrals for social services.

RN/CHW TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, Los Angeles: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Los Angeles Christian Health Centers (LACHC)

Los Angeles, California, 90013, United States

Location

Union Rescue Mission

Los Angeles, California, 90013, United States

Location

Related Publications (1)

• Nyamathi A, Salem BE, Shin SS, Jones AA, Garfin DR, Yadav K, Chang AH, White K, Morisky D. Effect of a Nurse-Led Community Health Worker Intervention on Latent Tuberculosis Medication Completion Among Homeless Adults. Nurs Res. 2021 Nov-Dec 01;70(6):433-442. doi: 10.1097/NNR.0000000000000545.

  PMID: 34380979 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Results Point of Contact

• Title: Adeline M Nyamathi
• Organization: University of California, Irvine, Sue & Bill Gross School of Nursing

anyamath@hs.uci.edu

(949) 824-8932

Study Officials

• Adeline M Nyamathi, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Dean and Distinguished Professor

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: January 24, 2019
• Primary Completion: May 29, 2020
• Study Completion: September 4, 2020
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Locations

US (2)