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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702049
Recruitment Status : Active, not recruiting
First Posted : October 10, 2018
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Adeline Nyamathi, University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Latent Tuberculosis Infection Behavioral: Nurse-led Community Health Worker TBI (RN/CHW TBI) program Not Applicable

Detailed Description:

Tuberculosis (TB) is a global public health threat, which is driven by social factors, including poverty, inadequate housing, malnutrition, and substance use. In the United States (US), TB disproportionately impacts homeless populations. When compared to the general population, homeless persons have a 10-fold increase in TB incidence. Lack of stable housing and living in congregate settings are predisposing factors for TB Infection (TBI). Homeless persons who develop active TB disease are also at higher risk of death during TB treatment due to mental illness and substance use. Even one TB case among a homeless person can easily lead to widespread TB transmission due to crowded, poorly ventilated, and congregate living situations. Therefore, an extensive public health response is needed for each case of infectious TB disease that develops among homeless persons.

Given the significant public health impact of TB among homeless persons, development of effective interventions to prevent TB among homeless persons that are theoretically-based and advance science in the area of best adherence strategies to minimize these health disparities can lead to significant benefits for patients and further reduce the disparity in TB rates between homeless and housed persons. While adherence to traditional TBI treatment with 6 to 9 months of isoniazid (INH) has been dismal, over the last few years, a promising treatment option in form of a 12-dose combination therapy (3HP; rifapentine [RPT] plus isoniazid [INH]), delivered once weekly as directly observed therapy (DOT), has achieved treatment completion rates of 82%. However, homeless populations who are at high risk for TBI have complex, multi-dimensional barriers to TBI treatment adherence. Thus, TBI treatment programs in this population have yielded marginal results of 65% completion to date. Among homeless persons, health disparities are accentuated by additional barriers to TBI treatment adherence, including substance use, mental disorders, and unstable housing.

Given the complex factors that affect TBI treatment adherence among homeless persons, the research team developed a theoretically-based novel model of care that has been successfully investigated in other disadvantaged populations. This model involves understanding the behavioral, psychological, and environmental influences on health and developing culturally-tailored interventions to reduce health disparities, and promote health. By engaging nurses, physicians, and community health workers (CHW), the investigators have developed a team-based approach to better understand and support medication adherence by engaging individuals as active partners in managing their own health. This scientific contribution has the potential to be highly significant as new models of care are being proposed to improve timely entry, engagement and retention in care, and supportive services for homeless persons and other vulnerable populations affected by complex health disparities impacting treatment adherence. The pilot study builds on the investigators' extensive three decades of research with homeless persons in improving health, including TBI treatment adherence, HBV vaccination, and adherence to HIV therapy.

This study will assess the impact of the TBI program that the investigators have developed, as a single arm intervention study, among 76 eligible TBI homeless adults on completion of 3HP treatment, decrease in drug and alcohol use, improved access to care and mental health, and shelter stability. Completion of 3HP will be compared to a minimum standard completion rate of 65%. This small pilot will generate the effectiveness data for a future R01 application to evaluate the intervention in a definitive randomized-controlled trial (RCT).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV
Actual Study Start Date : January 24, 2019
Actual Primary Completion Date : May 29, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RN/CHW TBI
Nurse-led Community Health Worker TBI (RN/CHW TBI) program
Behavioral: Nurse-led Community Health Worker TBI (RN/CHW TBI) program
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.




Primary Outcome Measures :
  1. Completion of TBI treatment [ Time Frame: 3 months (12 weeks) ]
    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


Secondary Outcome Measures :
  1. Drug use [ Time Frame: 6 months ]
    Assessed by the drug items in the Texas Christian University (TCU) Screen II. Yes/No to each drug will be assessed for use vs dependency. The total score ranges from 0 - 9; higher scores (> 3) correspond to the Diagnostic and Statistical Manual of Mental Disorders (DSM) drug dependence diagnosis

  2. Alcohol use [ Time Frame: 6 months ]
    Assessed by the alcohol items in the Texas Christian University (TCU) Screen II. Yes/No to each drug will be assessed for use vs dependency. The total score ranges from 0 - 9; higher scores (> 3) correspond to the DSM drug dependence diagnosis

  3. Mental Health Score [ Time Frame: 6 months ]
    Mental Health will be assessed by the Mental Health Inventory (MHI)-5; well-demonstrated reliability for detecting psychological disorders

  4. Health Care Access [ Time Frame: 6 months ]
    Health Care Access will include number of healthcare visits made

  5. Shelter Stability [ Time Frame: 6 months ]
    Shelter Factors: Staff will record the type of residence at baseline and follow-up. Shelter Stability will be assessed by length of time residing in shelter vs elsewhere at 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702049


Locations
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United States, California
Los Angeles Christian Health Centers (LACHC)
Los Angeles, California, United States, 90013
Union Rescue Mission
Los Angeles, California, United States, 90013
Sponsors and Collaborators
University of California, Irvine
University of California, Los Angeles
Investigators
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Principal Investigator: Adeline M Nyamathi, PhD University of California, Irvine
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Responsible Party: Adeline Nyamathi, Founding Dean and Distinguished Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03702049    
Other Study ID Numbers: R21MD012696 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections