Latent Tuberculosis Infection3HP-LTBINCT03702049
Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV
A study testing Nurse-led Community Health Worker TBI (RN/CHW TBI) program in people with Latent Tuberculosis Infection, run by University of California, Irvine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- Nurse-led Community Health Worker TBI (RN/CHW TBI) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jan 2019to 4 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles Christian Health Centers (LACHC)
Los Angeles, California, 90013
Union Rescue Mission
Los Angeles, California, 90013
About this study
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.
Read the 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).
- Conditions
- Latent Tuberculosis Infection
- Being tested
- Nurse-led Community Health Worker TBI (RN/CHW TBI) program
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Community Health Worker TBI (RN/CHW TBI) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RN/CHW TBI | Experimental | Nurse-led Community Health Worker TBI (RN/CHW TBI) program Receives: Behavioral: Nurse-led Community Health Worker TBI (RN/CHW TBI) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months (12 weeks)
Secondary outcomes (5)
Drug Use
Assessed by the drug items in the Texas Christian University (TCU) Screen V. Yes/No responses to substance dependency questions and the frequency of drug use based on a 5-point scale from 1 (never) to 5 (daily) will be assessed for each drug used. The total score ranges from 0 - 11; corresponding to the number of symptoms endorsed by the participant and the severity of SUD: mild disorder (2-3 points), moderate disorder (4-5 points), or severe disorder (6 or more points).
Measured: baseline, 3 and 6 months
Alcohol Use
Assessed by the Alcohol items in the Texas Christian University (TCU) Screen V. Problematic use of alcohol was defined as self-identified as being a problem (TCU Item #12) or daily consumption.
Measured: baseline, 3 and 6 months
Depression
Depression will be assessed by the Center for Epidemiological Studies Short Depression Scale Revised (CESD-R-10) is a 10-item measure for depressive symptoms in the past week (endpoints 0=rarely or none of the time; 3=most of the time). Scale range 0-30, with greater values meaning worse depressive symptoms. Responses are summed.
Measured: baseline, 3 and 6 months
Health Care Access
Health Care Access will include number of healthcare visits made
Measured: 3 and 6 months
Shelter Stability - Days Residing in the Shelter
Shelter Factors: Staff will record the type of residence at baseline and follow-up. Shelter Stability will be assessed by the length of time in days residing in the shelter
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start24 Jan 2019
- Primary completion29 May 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Adeline Nyamathi, University of California, Irvine
- Investigators
- Adeline M Nyamathi, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702049
- Sponsor's protocol ID
- 20184698
- Other IDs
- R21MD012696
- Acronym
- 3HP-LTBI
- Status last verified
- Mar 2024
- First submitted
- 8 Oct 2018
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34380979
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV
- ClinicalTrials.gov ID
- NCT03702049
- Acronym / sponsor ID
- 3HP-LTBI / 20184698
- Conditions
- Latent Tuberculosis Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RN/CHW TBI | Experimental | Behavioral: Nurse-led Community Health Worker TBI (RN/CHW TBI) programNurse-led Community Health Worker TBI (RN/CHW TBI) program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led Community Health Worker TBI (RN/CHW TBI) programHomeless 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. | Behavioural | RN/CHW TBI |
Primary outcome
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
5 secondary outcomes
Drug Use
Time frame: baseline, 3 and 6 months
Alcohol Use
Time frame: baseline, 3 and 6 months
Depression
Time frame: baseline, 3 and 6 months
Health Care Access
Time frame: 3 and 6 months
Shelter Stability - Days Residing in the Shelter
Time frame: 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34380979Nyamathi 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.
- Individual participant dataSharing planned: Undecided
Related trials for Latent Tuberculosis Infection
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
RecruitingPhase 2/3
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Tuberculosis, Latent
RecruitingPhase 2
BPaLMZ for TB Meningitis
Tuberculous Meningitis, HIV
Recruiting
Screening With Portable X-rays for Rapid Recognition of TB
Tuberculosis (TB), Tuberculosis Infection, Latent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline M Nyamathi, PhD principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Community Health Worker TBI (RN/CHW TBI) program in people with Latent Tuberculosis Infection, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of TBI Treatment (time frame: 3 months (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.