Trial Outcomes & Findings for Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV (NCT NCT03702049)

NCT ID: NCT03702049

Last Updated: 2024-04-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 3 months (12 weeks)
• Results posted on: 2024-04-18

Participant Flow

466 were screened. Of these, 250 were determined as not meeting inclusion criteria as follows: PPD negative (n=178); QFT negative (n=18); Previous LTBI tx completion (n=22); Moved out of state (n=2); CXR positive (n=1); HIV positive (n=1); Not homeless (n=8); Did not have mental illness, substance use or medical care while homeless (n=12); Not willing to take blood test (n=3); Not willing to take medication (n=5); Declined to participate (n=13); and Failed to return (n=153).

Participant milestones

Measure	RN/CHW TBI This is a single-arm trial with all participants assigned to receive the multi-component intervention, including the 3HP medication.
Overall Study STARTED	50
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	RN/CHW TBI This is a single-arm trial with all participants assigned to receive the multi-component intervention, including the 3HP medication.
Overall Study Lost to Follow-up	4
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	RN/CHW TBI n=50 Participants Nurse-led Community Health Worker TBI (RN/CHW TBI) program 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.
Age, Continuous	53.7 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months (12 weeks)

Population: Participants with 3 month follow-up visit completed

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

Outcome measures

Measure

RN/CHW TBI n=49 Participants Nurse-led Community Health Worker TBI (RN/CHW TBI) program 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.

Completion of TBI Treatment

45 Participants

SECONDARY outcome

Timeframe: baseline, 3 and 6 months

Population: Participants who completed 6 months of follow-up

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).

Outcome measures

Measure	RN/CHW TBI n=45 Participants Nurse-led Community Health Worker TBI (RN/CHW TBI) program 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.
Drug Use Baseline	1.98 score on a scale Standard Deviation 3.02
Drug Use 3 month	1.64 score on a scale Standard Deviation 2.84
Drug Use 6 month	1.8 score on a scale Standard Deviation 3.47

SECONDARY outcome

Timeframe: baseline, 3 and 6 months

Population: Participants who completed 6 months of follow-up

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.

Outcome measures

Measure	RN/CHW TBI n=45 Participants Nurse-led Community Health Worker TBI (RN/CHW TBI) program 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.
Alcohol Use Baseline	14 Participants
Alcohol Use 3 month	11 Participants
Alcohol Use 6 month	7 Participants

SECONDARY outcome

Timeframe: baseline, 3 and 6 months

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.

Outcome measures

Measure	RN/CHW TBI n=45 Participants Nurse-led Community Health Worker TBI (RN/CHW TBI) program 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.
Depression 3 month	8.84 score on a scale Standard Deviation 4.82
Depression 6 month	9.4 score on a scale Standard Deviation 5.3
Depression Baseline	9.11 score on a scale Standard Deviation 6.07

SECONDARY outcome

Timeframe: 3 and 6 months

Health Care Access will include number of healthcare visits made

Outcome measures

Measure	RN/CHW TBI n=45 Participants Nurse-led Community Health Worker TBI (RN/CHW TBI) program 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.
Health Care Access 3 month	4.33 Visits Standard Deviation 2.27
Health Care Access 6 month	3.18 Visits Standard Deviation 2.66

SECONDARY outcome

Timeframe: 3 and 6 months

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

Outcome measures

Measure	RN/CHW TBI n=45 Participants Nurse-led Community Health Worker TBI (RN/CHW TBI) program 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.
Shelter Stability - Days Residing in the Shelter Baseline	76.8 days Standard Deviation 59.9
Shelter Stability - Days Residing in the Shelter 3 month	82 days Standard Deviation 16.8
Shelter Stability - Days Residing in the Shelter 6 month	74.3 days Standard Deviation 24.6

Adverse Events

RN/CHW TBI

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	RN/CHW TBI n=50 participants at risk This is a single-arm trial with all participants assigned to receive the multi-component intervention, including the 3HP medication.
Metabolism and nutrition disorders Loss of apetite	6.0% 3/50 • Number of events 3 • 3 months Adverse effects were typical side effects of the prescribed medication
Metabolism and nutrition disorders Unexplained anorexia	6.0% 3/50 • Number of events 3 • 3 months Adverse effects were typical side effects of the prescribed medication
Gastrointestinal disorders Abdominal pain	6.0% 3/50 • Number of events 3 • 3 months Adverse effects were typical side effects of the prescribed medication
Gastrointestinal disorders Nausea	10.0% 5/50 • Number of events 5 • 3 months Adverse effects were typical side effects of the prescribed medication
General disorders Easy Bruising or Bleeding	6.0% 3/50 • Number of events 3 • 3 months Adverse effects were typical side effects of the prescribed medication

Additional Information

Adeline M Nyamathi

University of California, Irvine, Sue & Bill Gross School of Nursing

Phone: (949) 824-8932

Email: anyamath@hs.uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place