Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
Phase: NA
Conditions: Hepatitis C Virus (HCV) Infection
Sponsor: University of California, Irvine

 
 
 
 
 
Development of a Community-based HCV Treatment Completion Intervention Among HCV 
Positive Homeless Adults 
 
NCT04513899 
 
Protocol Summary 
 
July 16, 2018 
 
 
 
 
 

Section 4 - Protocol Synopsis 
 
4.1. Brief Summary  
The RCT will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for 
homeless individuals, many who are also drug users. The intervention will be designed during Phase I of the proposal 
(see Research Strategy) using an iterative process between a Community Advisory Board (CAB) and focus groups. The 
CHW/RN intervention will occur over a 2 month (8 week) period. Homeless adults assigned to the CHW/RN HCV 
treatment group will receive culturally-sensitive education, case management, and daily DOT delivery of Mavyret™ 
(pibrentasvir/glecaprevir) by a RN-guided CHW. The CHW will run a brief (20 min) weekly 1:1 education and 20 min 
case management session over the 8 weeks and will deliver all components of the program (which will be developed 
and refined during Phase I). The CHW-RN HCV intervention will be compared to a clinic-based standard of care group 
(cbSOC). Primary outcomes are completion of the DAA treatment (month 2) and SVR12 Cure (month 5). Secondary 
outcomes are improved mental health status, decrease in substance use, and improved access to health care, and 
shelter stability at month 5.

4.2.a. Narrative Study Description 
Our study is a mixed-methods, individually randomized group-treatment trial (IRGT). As detailed in the Research 
Strategy, Phase 1 will implement a novel, community-based approach, which will use a Community Advisory Board 
(CAB) and focus groups, drawn from the community, to help develop and refine an HCV intervention for homeless 
adults. The results of Phase 1 will inform the design of Phase 2, our pilot IRGT, described below. 
After potential participants are identified, screening procedures are completed, and eligibility is confirmed (see 
Research Strategy and Recruitment & Retention (question 4.4. on Study record: PHS Human Subjects and Clinical 
Trials Information form) sections), informed consent will be obtained for interested participants (see question 3.1. 
Protections of Human Subjects section and 2.5 Recruitment & Retention Section). Then, participants will be 
randomized, using computer randomization, into CHW/RN (treatment) group or standard care cbSOC MD/RN (control) 
group, with 54 participants in each group. While about 65%% of the HCV cases are male(98), we will still ensure 
that a sufficient number of women (n=43) are enrolled to evaluate gender differences in intervention effect. To enable 
comparisons, group assignment will be stratified by gender and residence (shelter vs. street). Next, trained staff (see 
below for full details of training and fidelity assurance) will administer a 60-minute questionnaire, with periods of breaks 
and nourishing snacks. The health care providers at the research site (MDs or NPs [under standardized protocols 
supervised by the clinic MD]) will provide the DAA doses which will then be delivered by either the nurse-guided CHW in 
the community or in the clinic setting (in one month supply) by the cbSOC MD/RN. The MDs will provide back-up to the 
RNs.  
Cultural Sensitivity of the Intervention is a Strength. The CAB will discuss how best to communicate results 
of being HCV positive with homeless persons, how to encourage adherence to HCV medication, discuss strategies to 
enhance support offered by the nurse and CHW, and in getting the homeless adults to accept referrals for housing, 
substance use, mental health issues and job skills. In addition, we have now added how we can sensitively use 
technologies to assist in locating our homeless participants for DAA administration. These discussions will be integrated 
into the CHW/RN TBI program and its implementation. Further, by conducting focus groups with homeless adults with a 
history of being diagnosed with HCV and either completing or not completing treatment, a “theater testing approach”(88) 
will be conducted by our study CHW to demonstrate the culturally sensitive program just refined.  As presented in the 
text, this will demonstrate initial encounter, treatment discussion phase, delivery of medication, dealing with emotional, 
physical and life crises, role of nurse-CHW, etc. Rating of acceptability and feasibility will provide further evidence that the 
program is culturally sensitive. 
 
Specific strategies employed by our successful Latina Project Director to deal with common issues faced when providing 
care to low-income Latino community, include:  
1. Begin with an understanding of the barriers to healthcare usually experienced by low-income/homeless minority 
groups via focus group discussions 
2. Language barriers, addressed by ensuring bilingual staff and proper interpretation services 
3. Low health-literacy levels addressed by providing linguistically-appropriate literature on TBI, and TB disease 
prevention; answering all questions in the appropriate language and using vocabulary appropriate to the 
person’s literacy level. 
4. Behavioral Norm differences, addressed by culturally-appropriate education and establishing trust between the 
study team and the participant. 
5. Historic mistrust of healthcare entities within minority communities, addressed by normalizing visits to clinics and 
communication between provider and participant; actively addressing common patient misconceptions about the 
healthcare system and providers.    
6. 
 Specify to participants that the services provided are free of charge; and facilitate needed clinic visits through 
interpretation and transportation. 
 
 
Description of the CHW/RN Intervention. A team of two CHW and a research RN will compose the CHW/RN 
team. In the CHW/RN group, each participant will be assigned to one of two CHW, who will deliver all components of the 
program and assess HCV side effects under the guidance of their RN. Recruitment will be staggered: each CHW may 
be assigned 7-8 participants or 15-16 (total study enrollment) every 2 months until target sample size (n=54 for 
intervention group) is achieved. After the first dose of DAA (see below for rationale of choosing DAA), the CHW will run a 
brief (20 min) weekly 1:1 education and 20 min case management session over the 8 weeks (see details of weekly 
elements below). The CHW will also be involved in facilitating medical, mental health, substance use, social service and 

legal appointments for participants, as well as housing referrals, and accompany the participants to the appointments as 
requested. The CHW will rigorously track participants who have missed a dose, and promote the building of effective 
coping skills, personal assertiveness, self-management, communication, and self-esteem, as well as providing 
knowledge about HCV and prevention of HBV, and HIV. The directly observed treatment (DOT) (on a daily basis) of the 
DAA and the sessions will be delivered in a safe area in the community, mutually agreed upon by the CHW/RN and 
participant. A detailed community resource directory will also be provided. The RN will oversee all components of the 
program, including assessing HCV side effects, referrals, and supporting the CHW in counseling with complex health-
related issues. Even though DAA has been found to have few adverse effects, we will conduct monthly liver function 
tests.  
 
 
 
Weekly sessions will likely include the following elements described below, although modified 
according to results of Phase I CAB and focus group recommendations: 
 
 
In week 1, detailed information about the program will be provided; personal values and goals will be delineated. 
Information will be shared about HCV, its transmission, and risk reduction.  Stigma associated with having HCV will be 
discussed. Culturally-sensitive discussions will be provided throughout about potential barriers to completing treatment, 
seeking health care access, etc. CHW will work early on with their contacts in the community to facilitate securing stable 
housing.     
 
In weeks 2-3. The impact of drug and alcohol use and its role as a risk factor for HCV, HBV and HIV will be 
discussed, as well as gender-specific reasons why people use drugs.  CHW will actively work with participants to 
facilitate their attending outpatient drug and or alcohol substance use programs, if actively using, and to continue their 
work in securing stable housing, job skills, and other goals, with support of the RN.  
 
In weeks 4-6, CHW will continue facilitating stable housing opportunities, reducing drug and alcohol use, and 
seeking health care access, etc. Basic problem solving in relation to reducing risk will include:  a) identifying triggers that 
could increase use of substances; b) identifying a goal/outcome that will reduce or avoid risk; c) identifying potential steps 
to reach the goal of reducing/avoiding risk; d) evaluation of usefulness of steps discussed; and e) planning how to act on 
the best solution. Coping scenarios will provide examples of positively dealing with situations that place individuals at risk 
for on-going drug use. The importance of positive social relationships will be discussed in supporting compliance with 
HCV treatment. The CHW will also facilitate referrals to community agencies. The intervention will be gender-sensitive; 
for example, women may be engaged in discussing empowerment and the impact of depression on risk behaviors, while 
men may be engaged in discussions on risk behaviors.   
 
In weeks 7-8, continued discussions on problem-solving skills related to HCV/HIV risk reduction. Participants 
placed in stable housing will be assessed to determine new needs relative to maintaining housing security, employment 
opportunities, etc. An incentive of $10 will be provided after each week, totaling $80 for the 8-week period. 
 
 
 
Fidelity of Program Implementation. During Phase 1, after the intervention is refined, the CAB will work on 
developing the protocols and manuals and process measures to strengthen the fidelity of the program. A Program 
Manual will standardize training; an operations manual will outline study constructs, measures and timeframes for data 
collection, recruitment and randomization.  
 
Process Measures. Process logs will be designed to ensure fidelity and include: 1) attendance and content log 
of educational sessions; 2) medication completion log; 3) lab results log; and 5) referral attendance.   
Training of CHW/RN. The CHW and RNs will undergo special training to present the CAB/FGS designed 
intervention. Mock sessions will be held with the two CHW and RN by the MPIs and the Project Coordinator (PC) to 
assess their skills in presenting the intervention.  After each mock session, the MPIs and PC will provide feedback on 
how well they functioned.  This process will continue until all skills are optimal.   
The CHW and RNs will be trained as extended care providers by Los Angeles County experts in the field of 
HCV, following their structured teaching protocol. The CHW/RN staff will also be trained by experts in drug and alcohol 
addiction and mental health to supplement their knowledge of key resources in the community and become competent 
facilitators of risk reduction. They will be trained to deal with reactions of individuals who are determined to be HCV, HIV 
or HBV positive, in communication skills, and in providing psychosocial support. The Partnership for Health approach, to 
adherence (designated by the CDC as a good-evidence model) will be followed, which focuses on strengthening the 
client/provider relationship (109).  
   
The CHW will meet with the RN twice weekly and receive support with the education sessions, implementing the 
program, delivering the DAA, and in organizing the paperwork. CHW will be trained to fill out logs that record any side 
effects relative to the doses received and will receive oversight for monitoring any medication side effects on RedCap. All 
medical concerns will be reported to the HCV treating physician.  Adverse events with DAA (<5%) may include fatigue, 

headache, nausea, diarrhea, and insomnia(108).  
Statistical considerations. One challenge is the likelihood that participants may interact with each other post-
randomization, given that participants are drawn from the same community (Skid Row). Upon enrollment, CHW/RNs will 
explain to participants in the intervention group the value of waiting until study completion to discuss details of the 
intervention with others in the community. We acknowledge that while this may increase internal validity of our study, it 
may also inflate type 2 error, given that drawing support from others in their social circle may be a related benefit to our 
community-based approach that could increase adherence, bolster commitment, and thus enhance treatment effects.  
Moreover, there may be variability in outcomes at the level of the intervention administrators and over time given 
staggered recruitment every 2 months. Indeed, CHW may become more skilled over time. These potential sources of 
bias will be examined by testing the intraclass correlation (ICC) within administrators at baseline, month 2, and 5 month 
follow-up and over recruitment schedule, following recommendations for IRCT(110) . Values closer to 0 indicate that the 
particular administrator or recruitment period did not account for variability in the results (i.e., independence was 
achieved) (111).  This will help control for type 1 error. High ICCs will be accounted for in statistical analysis via the 
implementation of mixed-models that can include this clustering as a random effect and intervention group as the fixed 
effect (110, 111). Due to the pilot nature of this proposal, randomization across CHW/RNs will not occur prior to 
administration of the intervention; however, potential administrator effects, although we believe unlikely, will be 
accounted for in subsequent R01 design.  
See section 4.4. Statistical Design section for full details of the analytic strategy.  
 
The Clinic-based Standard of Care (cbSOC) Program (control group). This program will be delivered by a 
clinic-based MD or clinic-based NP at the clinic site. ES will be hired and trained to do the interviewing/survey 
administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the 
education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 
week program. Usual care will include: 1) HCV pre-treatment education; 2) one month supply of DAA; 3) monitoring 
adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided 
over standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, 
or accompaniment to needed services.  
 
 
ADMINISTRATION AND DOCUMENTATION OF THE HCV MEDICATION.  
Administration: A recommended dosage of three tablets of Mavyret™ (total daily dose: glecaprevir 300 mg and 
pibrentasvir 120 mg) taken orally once daily with food for 8 weeks for Treatment-Naïve Patients (all HCV genotypes 1, 2, 
3, 4, 5, or 6) with no cirrhosis will be prescribed by clinic-based MD or clinic-based NP for both the groups. Each 
Mavyret™ tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. The tablets are pink, oblong-shaped, film-
coated, and debossed with “NXT” on one side.  
The cbSOC Program (control group) will receive the medication on a monthly basis from the clinic MD or NP. 
For the intervention group (CHW/RN) the dose will be delivered/administered by CHW/RN on a daily basis after 
prescription.   
 
Documentation of all client notes on referrals made and appointments kept will be captured on REDCap by 
enabling signatures on the tablets for both the participant as well as the research staff administering the dose. This 
process will not only capture signatures but also date / time stamp the process thereby maintaining the fidelity of the 
program. 
 
Missed Doses.  Interruptions in HCV dosing will be assessed individually, with a focus on resuming the 
schedule. If a dose of Mavyret™ missed and it is: 
• 
Less than 18 hours from the time Mavyret™ was due, then the participant will be advised to take the missed 
dose with food as soon as possible. They can then take their next dose at your usual time. 
• 
More than 18 hours from the time Mavyret™ was due, then the participant will be advised to not take the 
missed dose. They can then take their next dose as usual with food. 
 
Medication Adherence. We will use pill count to measure adherence in both groups. The total number of missed 
doses will be divided by the total number of doses for this measure. This will be repeated by the evaluation staff who will 
conduct follow-up at month 2 to view any remaining pills in the pill bottle and will be documented on RedCap.  
In addition, for the intervention group (CHW/RN), the daily DOT delivery of Mavyret™ pills administered by CHW 
will be documented on RedCap tablet each time s/he observes the participant swallow a pill. For the cbSOC Program 

(control group), the clinic based MD/NP will conduct a pill count monthly, based on the medications left in the pill bottle 
each month the participant is scheduled to pick up the next supply. 
 
INSTRUMENTS AND MEASUREMENTS.  Data will be obtained at baseline, 2- and 5-month assessments. All 
measures have been utilized with homeless populations previously and have supported psychometrics(112, 113).   
 
I. 
Socio-Demographic information will include variables such as site, age, birth date, gender, race/ethnicity, 
education, religion, employment, relationship status, country of birth, history of incarceration, homelessness and 
substance use, pregnancy status (if female), etc. The Locator Guide will record name and address of the 
participant, hangout locations, etc. (assessed at baseline, 2-month, and 5-month; race and age assessed only 
at baseline).   
II. 
Brief HCV, HBV, and HIV-Related Health History will be assessed by 5 items covering prior hepatitis/HIV test 
results, date, history of liver disease, and history of completed treatment for HCV, HBV or HIV and assess for 
symptoms of cirrhosis at baseline.  
III. 
Drug and Alcohol Use vs Dependency During the Past 2-3 months, will be assessed by the Texas 
Christian University (TCU) Screen II(114, 115) at Baseline, 2- and 5-month follow up. 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.   
IV. 
Mental Health will be assessed by the MHI-5 at Baseline, 2- and 5-month follow up.; well-demonstrated 
reliability for detecting psychological disorders(116) with reliabilities of .77 and .71 for women/men, 
respectively(117).   
V. 
HCV. HCV status will be assessed by the research RN, using the OraQuick HCV Rapid Antibody Test 
(OraSure Tech.), a rapid assay for the presumptive detection of HCV antibody in fingerstick capillary blood, with 
sensitivity and specificity similar to FDA-approved assays.  A reactive result will be confirmed by collecting blood 
from a subsequent venipuncture for testing for HCV RNA in blood, by polymerase chain reaction (PCR) as a 
marker for HCV viremia(118).. 75% of those screened HCV AB+ will be HCV RNA+. HCV RNA by PCR will be 
tested at Baseline and 5-month follow up. 
VI. 
HBV status will be assessed by the HBsAg test if found to be HCV RNA + at baseline. We anticipate that 5-10% 
will be found confirmed HBsAg+ who will be excluded from the study.   
VII. 
HIV. Tested via Alere Determine™ HIV-1/2 Ag/Ab Combo with confirmation for those not previously tested or 
have no validation(103, 104). Results will be obtained within 20-30 minutes at baseline.  
VIII. 
Cirrhosis and Decompensation testing will be conducted by the APRI Score (Hepatic Function Panel and 
CBC and Platelet Count, respectively every month if found to be HCV RNA+. Those with Cirrhosis and 
Decompensation will be excluded and referred to a hepatologist.  
IX. 
SVR12. Tested at 5-month follow up (12 weeks after treatment completion) by HCV PCR RNA as a marker for 
HCV viremia(118)..  
X. 
Medication Adherence. We will use pill count to measure adherence in both groups. The total number of 
missed doses will be divided by the total number of doses for this measure. This will be repeated by the 
evaluation staff who will conduct follow-up at month 2 to view any remaining pills in the pill bottle and will be 
documented on RedCap.  
In addition, for the intervention group (CHW/RN), the daily DOT delivery of Mavyret™ pills administered 
by CHW will be documented on RedCap tablet each time s/he observes the participant swallow a pill. For the 
cbSOC Program (control group), the clinic based MD/NP will conduct a pill count monthly, based on the 
medications left in the pill bottle each month the participant is scheduled to pick up the next supply. 
 
Primary and secondary outcome variables are described in question 4.3 Outcome Measures (Study record: 
PHS Human Subjects and Clinical Trials Information form). 
 
 
 
 

4.2.b. Primary Purpose 
 
 
 
Treatment 
4.2.c. Interventions 
Intervention Type 
Behavioral (e.g., Psychotherapy, Lifestyle Counseling) 
Name 
Community Health Worker/Registered Nurse (CHW/RN) Intervention 
Description 
We plan to deliver care within a multidisciplinary team trained in HCV assessment and 
treatment. A team of two CHW and a research RN will compose the CHW/RN team. In the 
CHW/RN group, each participant will be assigned to one of two CHW, who will deliver all 
components of the program including daily DOT delivery of Mavyret™ and assess HCV side 
effects under the guidance of their RN. Recruitment will be staggered: each CHW may be 
assigned 7-8 participants or 15-16 (total study enrollment) every 2 months until target sample 
size (n=54 for intervention group) is achieved. After the first dose of DAA (see below for 
rationale of choosing DAA), the CHW will run a brief (20 min) weekly 1:1 education and 20 
min case management session over the 8 weeks (see details of weekly elements below). The 
CHW will also be involved in facilitating medical, mental health, substance use, social service, 
legal appointments for participants, housing referrals, and accompany the participants to the 
appointments. 
 
Intervention Type 
Behavioral (e.g., Psychotherapy, Lifestyle Counseling) 
Name 
clinic-based Standard of Care (cbSOC) program 
Description 
This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. ES 
will be hired and trained to do the interviewing/survey administration and follow-ups at the 
clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education 
and monitoring of these participants who will interact with the clinic-based-MD and/or NP 
monthly over the 8 week program. Usual care will include: 1) HCV pre-treatment education; 2) 
one month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on 
HCV.  Referral to drug/alcohol and housing programs will be provided over standard of care. 
The cbSOC participants will not receive the community delivery of the DAA, or case 
management, or accompaniment to needed services. Outreach to find patients lost to follow-
up will be conducted by the clinics’ outreach teams. 
 
 
 
4.2.d. Study Phase 
 
 
Other  
 
 
 
N/A 
 
Is this an NIH-defined Phase III clinical trial? No 
 
4.2.e. Intervention Model 
 
Parallel 
4.2.f. Masking   
 
Yes 
Participant  
 
Care Provider   
Investigator  
 
Outcomes Assessor 
4.2.g. Allocation 
 
 
Randomized 
 
4.3. Outcome Measures 
Name 
Completion of HCV treatment and SVR12 

Type 
Primary 
Time Frame 
2 month follow up and 5 month follow up 
Brief Description 
Completion of HCV treatment of a 7 day per week x 8 week treatment of DAA as measured 
by the CHW/RN daily or pill count by the cbSOC RN monthly and SVR12 Cure (HCV RNA < 
25 IC/ml, detectable or undetectable) as tested at 5-month follow up (12 weeks after treatment 
completion) by HCV PCR RNA as a marker for HCV viremia(118)  
Name 
Drug and Alcohol Use 
Type 
Secondary 
Time Frame 
2 month follow up and 5 month follow up 
Brief Description 
Drug and Alcohol Use vs Dependency During the Past 2-3 months, will be assessed by the 
Texas Christian University (TCU) Screen II (115,116) at baseline, 2- and 5-month follow up. 
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.   
Name 
Mental Health 
Type 
Secondary 
Time Frame 
2 month follow up and 5 month follow up 
Brief Description 
Mental Health will be assessed by the MHI-5 at Baseline, 2- and 5-month follow up.; well-
demonstrated reliability for detecting psychological disorders(116) with reliabilities of .77 and .71 
for women/men, respectively(117).   
Name 
Shelter Factors 
Type 
Secondary 
Time Frame 
5 month follow up 
Brief Description 
Shelter Stability will be assessed by length of time residing in shelter vs elsewhere at 5 
months 
Name 
Health Care Access 
Type 
Secondary 
Time Frame 
2 month follow up and 5 month follow up 
Brief Description 
Health Care Access will include number of healthcare visits made and purpose during the 
duration of the intervention 
Name 
 
Type 
 
Time Frame 
 
Brief Description 
 
Name 
 
Type 
 
Time Frame 
 
Brief Description 
 
Name 
 
Type 
 
Time Frame 
 
Brief Description 
 
Name 
 
Type 
 
Time Frame 
 
Brief Description 
 
Name 
 
Type 
 
Time Frame 
 
Brief Description 
 
 
 
 

4.4. Statistical Design and Power 
Based upon our prior studies, (3, 16), we conservatively anticipate that 25% of 460 persons screened (n = 115) will 
be eligible and willing to undergo ongoing testing for HCV. Allowing for a 94% approval by the physician for HCV 
treatment, we estimate 108 will be enrolled in the study. Using the intention to treat approach, patients lost to follow-up 
within the 3 month follow-up will be categorized as not having achieved the primary outcome of SVR12 (87). We assumed 
55% SVR12 in real-world conditions under cbSOC (10% higher than found among substance-using patients for an 
earlier DAA). The sample size of 108 would give us 80% power at alpha of 5% to detect an improvement of 80% SVR 
12 in the CHW/RN arm. This approach will generate preliminary estimates of SVR12 for both arms and help inform a 
future RCT.  
Statistical analysis. Initial analysis will include descriptive statistics. We will then screen for outliers and 
deviations from normality; results will be considered in subsequent analyses. Patterns of missing data will be examined 
using logistic regression (0=missing; 1=complete) and will be reported in results. As based on our prior research, we 
expect very little missing data on key independent variables(3, 16). Missing data on independent variables or continuous 
dependent variables may be imputed using multiple imputation and related methods as appropriate (119) and intention-to-
treat approach will be implemented for SRV12 (120); complete case analysis will be utilized for secondary variables (e.g., 
mental health, stable housing). Reliability for computed scores will be assessed using Cronbach’s alpha. 
Next, a series of t-tests and chi-squares will examine differences between groups (CHW/RN vs. standard care). 
Then, for each dependent variable of interest, key predictors and covariates will be examined using a series of t-tests, 
chi-squares, and ordinary least squares (for continuous outcomes) and logistic (for dichotomous outcomes) bivariate 
regression models. 
Dependent variables at 2- and 5-month assessments will be examined using mixed effects models to account 
for both fixed (e.g., treatment group) and random (e.g., treatment administrator) effects. For dichotomous outcomes (e.g., 
yes/no SVR12), risk ratios will be examined using a Poisson distribution with robust variance, which tends to generate 
more appropriate effect size estimates than a logit-based approach (121). Covariates that are statistically significant or 
theoretically-relevant will be accounted for in final models using a hierarchical variable entry strategy.   
Further analyses will explore potential mediators and moderators to build a basis for development of process 
models and a larger RCT. In addition, mediation analysis will serve as evaluation of the extent to which the CHSCP and 
other related models, such as BMVP, explain the observed mechanisms of action. We will use structural equation 
modeling (SEM) to conduct path analysis of variables informed by the CHSCP (122). This approach will allow the 
estimation of the direct, indirect, and total effects of the intervention on SVR12 through multiple hypothesized mediators. 
Possible mediators of the effectiveness of the intervention include housing stability and social support, which may affect 
SVR12. We will model SVR12 as a categorical endogenous variable within the SEM framework using probit estimation. 
Standardize coefficients, standard errors, and 95% confidence intervals will be estimated for each path. The fit of the 
model will be evaluated by evaluating the chi-square statistic and the Standardized Root Mean Square Residual. The 
CALIS procedure in SAS v. 9.4 will be used to perform this analysis with p < .05 considered statistically significant for 
two-sided tests. 
 
 
 
 
 

4.5. Subject Participation Duration:   
 
5-6 months 
 
4.6. Will the study use an FDA-regulated intervention? 
 
 No 
4.6.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug 
(IND)/Investigational Device Exemption (IDE) status 
 

4.7. Dissemination Plan 
The Investigators are committed to the open and timely dissemination of research outcomes. The MPIs ensure that they 
will follow all the required NIH Policy on Dissemination of NIH-funded Clinical Trial Information. Plans for disseminating 
the findings of this research as follows: 
1. Clinicaltrials.gov: The study will be registered on Clinicaltrials.gov website once the proposed grant application is 
funded and no later than 21 calendar days after the enrollment of the first participant. The summary of results will 
also be submitted to the website no later than one year after the trial's primary completion date. University of 
California Irvine (UCI) and the investigators will make sure that all the regulatory requirements are met. UCI 
Office of Research has an internal policy in place to ensures that clinical trials registration and results reporting 
occur in compliance with policy requirements and can be found on this link: 
https://www.research.uci.edu/compliance/human-research-protections/researchers/guidelines-for-registering-in-
a-clinicaltrialsgov-registry.html#nih  
2. Informed consent documents: As per the policy the informed consent documents will include the following 
specific statement relating to posting of clinical trial information at ClinicalTrials.gov 
 
In the UCI IRB consent form in the section “WHO WILL HAVE ACCESS TO MY STUDY DATA?” we will 
include the following statement (This statement must be included verbatim): 
 
“ClinicalTrials.gov is a Web site that provides information about clinical trials.  A description of this clinical trial 
will be available on http://www.clinicaltrials.gov as required by U.S. Law.  This Web site will not include 
information that can identify you.  At most, the Web site will include a summary of the results. You can 
search this Web site at any time.” 
 
3. The results will be disseminated through publications in interdisciplinary journals and presentations at 
professional national or international conferences in a timely fashion. The strategies for dissemination of results 
will be discussed at quarterly meetings with the research team. The strategies will include 1) determining the 
best, currently available method of sharing data among all investigators; 2) submitting abstracts to appropriate 
professional conferences for presentation of results; 3) identifying manuscripts, journals, authors, and timeline for 
publications that address the study’s specific aims; and 4) determining appropriate secondary data analyses.  
 
4. NIH Public access policy: The investigators will submit all the final peer-reviewed journal manuscripts that arise 
from this proposal to PubMed Central immediately upon acceptance for publication. 
 
5. We know that research is most effectively disseminated using multiple vehicles, ideally with face-to-face 
interaction. So, in addition to the above, dissemination activities will also include:  
a. Interactive Workshops: For the workshop, we will invite contributors, including key regional stakeholders 
and community health clinics, as well as national policy makers to discuss their program and policy 
implications.  
b. Academic and other centers: We will work with our local Academic Network as well as other 
organizations, which will also be promoting the dissemination of research to non-academic audiences, 
who will advise and support dissemination to the public. Additionally information will be collected and 
networks established throughout this study to further inform and strengthen the strategy. 
 
 

REFERENCES 
 
1. 
Centers for Disease Control and Prevention. Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the 
Prevention, Care & Treatment of Viral Hepatitis. 2011. Available at: https://www.hhs.gov/sites/default/files/action-
plan-viral-hepatitis-2011.pdf (last accessed Feburary 2018). 
2. 
Denniston MM, Jiles RB, Drobeniuc J, Klevens RM, Ward JW, McQuillan GM, Holmberg SD. Chronic hepatitis 
C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern 
Med. 2014;160(5):293-300. PMCID: Pmc4562398. 
3. 
Gelberg L, Robertson MJ, Arangua L, Leake BD, Sumner G, Moe A, Andersen RM, Morgenstern H, Nyamathi 
A. Prevalence, distribution, and correlates of hepatitis C virus infection among homeless adults in los angeles. 
Public Health Rep. 2012;127(4):407-21. PMCID: 3366378. 
4. 
Hajarizadeh B, Grebely J, Dore GJ. Epidemiology and natural history of HCV infection. Nat Rev Gastroenterol 
Hepatol. 2013;10(9):553-62. 
5. 
Navaneethan U, Kemmer N, Neff GW. Predicting the probable outcome of treatment in HCV patients. Therap 
Adv Gastroenterol. 2009;2(5):287-302. PMCID: Pmc3002533. 
6. 
de Vos AS, Prins M, Kretzschmar ME. Hepatitis C virus treatment as prevention among injecting drug users: 
who should we cure first? Addiction. 2015;110(6):975-83. 
7. 
Hellard M, Rolls DA, Sacks-Davis R, Robins G, Pattison P, Higgs P, Aitken C, McBryde E. The impact of 
injecting networks on hepatitis C transmission and treatment in people who inject drugs. Hepatology. 
2014;60(6):1861-70. 
8. 
World Health Organization. Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C 
Infection. Geneva: 2014. Available at: http://www.who.int/hiv/pub/hepatitis/hepatitis-c-guidelines/en/ (last 
accessed Feburary 2018). 
9. 
Mehta SH, Genberg BL, Astemborski J, Kavasery R, Kirk GD, Vlahov D, Strathdee SA, Thomas DL. Limited 
uptake of hepatitis C treatment among injection drug users. J Community Health. 2008;33(3):126-33. PMCID: 
Pmc3800027. 
10. 
Grebely J, Genoway KA, Raffa JD, Dhadwal G, Rajan T, Showler G, Kalousek K, Duncan F, Tyndall MW, 
Fraser C, Conway B, Fischer B. Barriers associated with the treatment of hepatitis C virus infection among illicit 
drug users. Drug Alcohol Depend. 2008;93(1-2):141-7. 
11. 
Treloar C, Rhodes T. The lived experience of hepatitis C and its treatment among injecting drug users: 
qualitative synthesis. Qual Health Res. 2009;19(9):1321-34. 
12. 
Grebely J, Robaeys G, Bruggmann P, Aghemo A, Backmund M, Bruneau J, Byrne J, Dalgard O, Feld JJ, 
Hellard M, Hickman M, Kautz A, Litwin A, Lloyd AR, Mauss S, Prins M, Swan T, Schaefer M, Taylor LE, Dore 
GJ. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Int J 
Drug Policy. 2015;26(10):1028-38. 
13. 
Ho CJ, Preston C, Fredericks K, Doorley SL, Kramer RJ, Kwan L, Kamal A. A unique model for treating chronic 
hepatitis C in patients with psychiatric disorders, substance abuse, and/or housing instability. J Addict Med. 
2013;7(5):320-4. 
14. 
Crawford S, Bath N. Peer support models for people with a history of injecting drug use undertaking assessment 
and treatment for hepatitis C virus infection. Clin Infect Dis. 2013;57 Suppl 2:S75-9. 
15. 
Ingram M, Schachter KA, Sabo SJ, Reinschmidt KM, Gomez S, De Zapien JG, Carvajal SC. A community 
health worker intervention to address the social determinants of health through policy change. J Prim Prev. 
2014;35(2):119-23. 
16. 
Nyamathi AM, Dixon EL, Robbins W, Smith C, Wiley D, Leake B, Longshore D, Gelberg L. Risk factors for 
hepatitis C virus infection among homeless adults. J Gen Intern Med. 2002;17(2):134-43. PMCID: 
PMC1495011. 
17. 
Nyamathi A, Dixon EL, Wiley D, Christiani A, Lowe A. Hepatitis C virus infection among homeless men referred 
from a community clinic. West J Nurs Res. 2006;28(4):475-88. 
18. 
Stein JA, Nyamathi A. Correlates of hepatitis C virus infection in homeless men: a latent variable approach. Drug 
Alcohol Depend. 2004;75(1):89-95. 
19. 
Nyamathi A, Robbins WA, Fahey JL, Wiley D, Pekler VA, Longshore D, Robins TA, Singh J, Saab S. Presence 
and predictors of hepatitis C virus RNA in the semen of homeless men. Biol Res Nurs. 2002;4(1):22-30. 
20. 
Nyamathi A, Liu Y, Marfisee M, Shoptaw S, Gregerson P, Saab S, Leake B, Tyler D, Gelberg L. Effects of a 
nurse-managed program on hepatitis A and B vaccine completion among homeless adults. Nurs Res. 
2009;58(1):13-22. PMCID: 3076026. 

21. 
Nyamathi A, Reback CJ, Shoptaw S, Salem BE, Zhang S, Yadav K. Impact of Tailored Interventions to Reduce 
Drug Use and Sexual Risk Behaviors Among Homeless Gay and Bisexual Men. Am J Mens Health. 
2017;11(2):208-220. PMCID: PMC5675281. 
22. 
Rongey C, Gelberg L, Ryan G, Gregerson P. Hepatitis C treatment intervention in a homeless, illicit drug using 
population: A feasibility study. Hepatology. 2008;48(4):793A. 
23. 
Pedroso J, Rongey C, Gelberg L. To treat or not to treat: Bias and barriers to Hepatitis C care among the 
homeless of skid row. Journal of Investigative Medicine. 2007;55(1):S92. 
24. 
Gelberg L, Altman L. Hepatitis C "SCAN-ECHO" (Specialty Care Access Network - Extension for Community 
Health Outcomes). VA Central Office of Speciality Care Transformation; 2015. 
25. 
U.S. Food and Drug Administration. FDA approves first combination pill to treat hepatitis C. 2014. Available at: 
https://www.hhs.gov/hepatitis/blog/2014/10/14/fda-approves-first-combination-pill-to-treat-hepatitis-
c.html?language=es (last accessed Feburary 2018). 
26. 
Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch 
P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds 
WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P. Ledipasvir and sofosbuvir for untreated HCV genotype 1 
infection. N Engl J Med. 2014;370(20):1889-98. 
27. 
Bruggmann P, Litwin AH. Models of care for the management of hepatitis C virus among people who inject 
drugs: one size does not fit all. Clin Infect Dis. 2013;57 Suppl 2:S56-61. 
28. 
Yau AH, Yoshida EM. Hepatitis C drugs: the end of the pegylated interferon era and the emergence of all-oral 
interferon-free antiviral regimens: a concise review. Can J Gastroenterol Hepatol. 2014;28(8):445-51. PMCID: 
Pmc4210236. 
29. 
Fattovich G, Giustina G, Favarato S, Ruol A. A survey of adverse events in 11,241 patients with chronic viral 
hepatitis treated with alfa interferon. J Hepatol. 1996;24(1):38-47. 
30. 
McHutchison JG, Manns M, Patel K, Poynard T, Lindsay KL, Trepo C, Dienstag J, Lee WM, Mak C, Garaud JJ, 
Albrecht JK. Adherence to combination therapy enhances sustained response in genotype-1-infected patients 
with chronic hepatitis C. Gastroenterology. 2002;123(4):1061-9. 
31. 
Manns MP, Wedemeyer H, Cornberg M. Treating viral hepatitis C: efficacy, side effects, and complications. Gut. 
2006;55(9):1350-9. PMCID: Pmc1860034. 
32. 
Beiser M. Enhancing hepatitis c care for people experiencing homelessness: A patient-centered primary care 
approach.  National Health Care for the Homeless Council Annual Meeting; New Orleans, 2014. 
33. 
Nyamathi A, Flaskerud JH, Leake B, Dixon EL, Lu A. Evaluating the impact of peer, nurse case-managed, and 
standard HIV risk-reduction programs on psychosocial and health-promoting behavioral outcomes among 
homeless women. Res Nurs Health. 2001;24(5):410-22. 
34. 
Nyamathi A, Slagle A, Thomas A, Hudson A, Kahilifard F, Avila G, Orser J, Cuchilla M. Art messaging to engage 
homeless young adults. Prog Community Health Partnersh. 2011;5(1):9-18. PMCID: PMC3792012. 
35. 
Nyamathi A, Salem B, Marshall L, Idemundia F, Mata R, Khalilifard F, Farabee D, Leake B. Substance use 
trends among younger vs. older homeless parolees. J Addict Dis. 2014;33(2):124-33. PMCID: Pmc4096302. 
36. 
Martinson NA, Barnes GL, Moulton LH, Msandiwa R, Hausler H, Ram M, McIntyre JA, Gray GE, Chaisson RE. 
New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med. 2011;365(1):11-20. PMCID: 
Pmc3407678. 
37. 
Nyamathi A. Comprehensive health seeking and coping paradigm. J Adv Nurs. 1989;14(4):281-90. 
38. 
Nyamathi A, Stein JA, Schumann A, Tyler D. Latent variable assessment of outcomes in a nurse-managed 
intervention to increase latent tuberculosis treatment completion in homeless adults. Health Psychol. 
2007;26(1):68-76. 
39. 
Nyamathi A, Christiani A, Nahid P, Gregerson P, Leake B. A randomized controlled trial of two treatment 
programs for homeless adults with latent tuberculosis infection. Int J Tuberc Lung Dis. 2006;10(7):775-82. 
40. 
Mengistu Z, Chere A. Adherence to antiretroviral therapy and its associated factors among people living with 
HIV/AIDS in Addis Ababa, Ethiopia. Ethiop Med J. 2012;50(4):355-61. 
41. 
Nel A, Kagee A. The relationship between depression, anxiety and medication adherence among patients 
receiving antiretroviral treatment in South Africa. AIDS Care. 2013;25(8):948-55. 
42. 
Rotheram-Borus MJ, Swendeman D, Chovnick G. The past, present, and future of HIV prevention: integrating 
behavioral, biomedical, and structural intervention strategies for the next generation of HIV prevention. Annu Rev 
Clin Psychol. 2009;5:143-67. PMCID: Pmc2864227. 
43. 
Noel RJ, Jr., Rivera-Amill V, Buch S, Kumar A. Opiates, immune system, acquired immunodeficiency syndrome, 
and nonhuman primate model. J Neurovirol. 2008;14(4):279-85. PMCID: Pmc4086310. 

44. 
Pellegrino TC, Dunn KL, Bayer BM. Mechanisms of cocaine-induced decreases in immune cell function. Int 
Immunopharmacol. 2001;1(4):665-75. 
45. 
Rehm J, Samokhvalov AV, Neuman MG, Room R, Parry C, Lonnroth K, Patra J, Poznyak V, Popova S. The 
association between alcohol use, alcohol use disorders and tuberculosis (TB). A systematic review. BMC Public 
Health. 2009;9:450. PMCID: Pmc2796667. 
46. 
Wei G, Moss J, Yuan CS. Opioid-induced immunosuppression: is it centrally mediated or peripherally mediated? 
Biochem Pharmacol. 2003;65(11):1761-6. 
47. 
Nyamathi AM, Stein JA, Dixon E, Longshore D, Galaif E. Predicting positive attitudes about quitting drug and 
alcohol use among homeless women. Psychol Addict Behav. 2003;17(1):32-41. 
48. 
Jaffe A, Shoptaw S, Stein J, Reback CJ, Rotheram-Fuller E. Depression ratings, reported sexual risk behaviors, 
and methamphetamine use: latent growth curve models of positive change among gay and bisexual men in an 
outpatient treatment program. Exp Clin Psychopharmacol. 2007;15(3):301-7. 
49. 
Cooper CL. Now Is the Time to Quickly Eliminate Barriers Along the Hepatitis C Cascade of Care. J Infect Dis. 
2018;217(12):1858-60. 
50. 
Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical 
care use and outcomes for homeless people. Health Serv Res. 2000;34(6):1273-302. PMCID: Pmc1089079. 
51. 
Soriano V, Fernandez-Montero JV, de Mendoza C, Benitez-Gutierrez L, Pena JM, Arias A, Barreiro P. 
Treatment of hepatitis C with new fixed dose combinations. Expert Opin Pharmacother. 2017;18(12):1235-42. 
52. 
Soriano V, Gallego L. Viral hepatitis: Treating hepatitis C in injection drug users. Nat Rev Gastroenterol Hepatol. 
2013;10(10):568-9. 
53. 
Nyamathi A, Flaskerud J, Keenan C, Leake B. Effectiveness of a specialized vs. traditional AIDS education 
program attended by homeless and drug-addicted women alone or with supportive persons. AIDS Educ Prev. 
1998;10(5):433-46. 
54. 
Nyamathi A, Nandy K, Greengold B, Marfisee M, Khalilifard F, Cohen A, Leake B. Effectiveness of intervention 
on improvement of drug use among methadone maintained adults. J Addict Dis. 2011;30(1):6-16. PMCID: 
3077081. 
55. 
Nyamathi A, Shoptaw S, Cohen A, Greengold B, Nyamathi K, Marfisee M, de Castro V, Khalilifard F, George D, 
Leake B. Effect of motivational interviewing on reduction of alcohol use. Drug Alcohol Depend. 2009;107(1):23-
30. PMCID: 3383096. 
56. 
Greengold B, Nyamathi A, Kominski G, Wiley D, Lewis MA, Hodge F, Singer M, Spiegel B. Cost-effectiveness 
analysis of behavioral interventions to improve vaccination compliance in homeless adults. Vaccine. 
2009;27(5):718-25. PMCID: 2772200. 
57. 
Jones T, Nyamathi A, Giger JN, Jacobsen SJ. Antibody response to hepatitis B vaccination in urban, homeless 
adults. J Natl Black Nurses Assoc. 2007;18(1):1-7. 
58. 
Nyamathi A, Sinha K, Greengold B, Cohen A, Marfisee M. Predictors of HAV/HBV vaccination completion 
among methadone maintenance clients. Res Nurs Health. 2010;33(2):120-32. PMCID: 3253736. 
59. 
Nyamathi A, Nahid P, Berg J, Burrage J, Christiani A, Aqtash S, Morisky D, Leake B. Efficacy of nurse case-
managed intervention for latent tuberculosis among homeless subsamples. Nurs Res. 2008;57(1):33-9. PMCID: 
PMC3100804. 
60. 
Nyamathi A, Leake B, Albarran C, Zhang S, Hall E, Farabee D, Marlow E, Marfisee M, Khalilifard F, Faucette M. 
Correlates of depressive symptoms among homeless men on parole. Issues Ment Health Nurs. 2011;32(8):501-
11. PMCID: 3359372. 
61. 
Nyamathi A, Salem BES, Farabee D, Hall E, Zhang S, Khalilifard F, Faucette M, Leake B. Predictors of high 
level of hostility among Homeless Men on Parole. J Offender Rehabil. 2014;53:95-115. PMCID: PMC4114043. 
62. 
Salem BE, Nyamathi A, Idemundia F, Slaughter R, Ames M. At a Crossroads: Reentry Challenges and 
Healthcare Needs among Homeless Female Ex-Offenders. Journal of Forensic Nursing. 2013;9(1):14-22. 
PMCID: 3783031. 
63. 
Nyamathi A, Marlow, E., Zhang, S., Hall, E., Farabee, D., Marfisee, M., Khalilifard, F., Faucette, M., & Leake, B. 
Correlates of serious violent crime for recently released parolees with a history of homelessness. Violence & 
Victims. 2012;27(5):793-810. PMCID: PMC3629810. 
64. 
Nyamathi AM, Zhang SX, Wall S, Hall EA, Salem BE, Farabee D, Faucette M, Yadav K. Drug Use and Multiple 
Sex Partners Among Homeless Ex-Offenders: Secondary Findings From an Experimental Study. Nurs Res. 
2016;65(3):179-90. PMCID: Pmc4856526. 
65. 
Nyamathi A, Ekstrand M, Zolt-Gilburne J, Ganguly K, Sinha S, Ramakrishnan P, Suresh P, Marfisee M, Leake 
B. Correlates of Stigma among Rural Indian Women Living with HIV/AIDS. AIDS Behav. 2011. PMCID: 
3549011. 

66. 
Nyamathi A, Ekstrand M, Salem BE, Sinha S, Ganguly KK, Leake B. Impact of Asha Intervention on Stigma 
Among Rural Indian Women With AIDS. West J Nurs Res. 2013. PMCID: 3725982. 
67. 
Stein JA, Andersen RM, Robertson M, Gelberg L. Impact of hepatitis B and C infection on health services 
utilization in homeless adults: a test of the Gelberg-Andersen Behavioral Model for Vulnerable Populations. 
Health Psychol. 2012;31(1):20-30. PMCID: 3235541. 
68. 
Strehlow AJ, Robertson MJ, Zerger S, Rongey C, Arangua L, Farrell E, O'Sullivan A, Gelberg L. Hepatitis C 
among clients of health care for the homeless primary care clinics. J Health Care Poor Underserved. 
2012;23(2):811-33. PMCID: Pmc3786672. 
69. 
Gelberg L, Linn LS. Assessing the physical health of homeless adults. Jama. 1989;262(14):1973-9. 
70. 
Gelberg L, Linn LS, Leake BD. Mental health, alcohol and drug use, and criminal history among homeless 
adults. Am J Psychiatry. 1988;145(2):191-6. 
71. 
Linn LS, Gelberg L, Leake B. Substance abuse and mental health status of homeless and domiciled low-income 
users of a medical clinic. Hosp Community Psychiatry. 1990;41(3):306-10. 
72. 
Gelberg L, Leake BD. Substance use among impoverished medical patients: the effect of housing status and 
other factors. Med Care. 1993;31(9):757-66. 
73. 
Gelberg L, Andersen RM, Afifi AA, Leake BD, Arangua L, Vahidi M, Singleton K, Yacenda-Murphy J, Shoptaw 
S, Fleming MF, Baumeister SE. Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial 
of a primary care-based multi-component brief intervention to reduce risky drug use. Addiction. 
2015;110(11):1777-90. PMCID: PMC4948983. 
74. 
Baumeister SE, Gelberg L, Leake BD, Yacenda-Murphy J, Vahidi M, Andersen RM. Effect of a primary care 
based brief intervention trial among risky drug users on health-related quality of life. Drug Alcohol Depend. 
2014;142:254-61. PMCID: Pmc4127148. 
75. 
Padwa H, Ni YM, Barth-Rogers Y, Arangua L, Andersen R, Gelberg L. Barriers to drug use behavior change 
among primary care patients in urban United States community health centers. Subst Use Misuse. 
2014;49(6):743-51. PMCID: Pmc4026246. 
76. 
McCarthy WJ, Gelberg L. Is MyPlate.gov Approach to Helping Overweight Patients Lose Weight More Patient-
Centered. Patient Centered Outcome Research Institute. Available at: https://www.pcori.org/research-
results/2013/myplategov-approach-helping-overweight-patients-lose-weight-more-patient (last accessed 
Feburary 2018). 
77. 
Saab S, Greenberg A, Li E, Bau SN, Durazo F, El-Kabany M, Han S, Busuttil RW. Sofosbuvir and simeprevir is 
effective for recurrent hepatitis C in liver transplant recipients. Liver Int. 2015;35(11):2442-7. 
78. 
Saab S, Jimenez M, Bau S, Goo T, Zhao D, Durazo F, Han S, El Kabany M, Kaldas F, Tong MJ, Busuttil RW. 
Treating fibrosing cholestatic hepatitis C with sofosbuvir and ribavirin: a matched analysis. Clin Transplant. 
2015;29(9):813-9. 
79. 
Saab S, Park SH, Mizokami M, Omata M, Mangia A, Eggleton E, Zhu Y, Knox SJ, Pang P, Subramanian M, 
Kowdley K, Afdhal NH. Safety and Efficacy of Ledipasvir/Sofosbuvir for the Treatment of Genotype 1 Hepatitis C 
in Subjects Aged 65 Years or Older. Hepatology. 2016;63(4):1112-9. 
80. 
Saab S, Rheem J, Sundaram V. Hepatitis C Infection in the Elderly. Dig Dis Sci. 2015;60(11):3170-80. 
81. 
Nyamathi A, Salem, B., Meyer, V., Ganguly, K., Sinha, S., Ramakrishnan, P. Impact of an ASHA intervention on 
depressive symptoms among rural women living with AIDS in India:  Comparison of the ASHA life and usual 
care program. AIDS Educ Prev. 2012;24(3):280-93. PMCID: 3677948. 
82. 
Nyamathi A, Ekstrand M, Salem BE, Sinha S, Ganguly K, James C, Leake B, Marfisee M. Impact of an ASHA 
intervention on stigma and avoidant coping among rural women living with AIDS in India. West J Nurs Res. 
2013;35(7): 867–883. PMCID: PMC3725982. 
83. 
Nyamathi A, Hanson AY, Salem BE, Sinha S, Ganguly K, Leake B, Yadav K, Marfisee M. Impact of a rural 
village women (ASHA) intervention on adherence to antiretroviral therapy in southern india. Nurs Res. 
2012;61:353-62. PMCID: PMC3509934. 
84. 
Nyamathi A, Salem BE, Farabee D, Hall E, Zhang S, Faucette M, Bond D, Yadav K. Impact of an intervention 
for recently released homeless offenders on self-reported re-arrest at 6 and 12 months. J Addict Dis. 2017: 
36(1):60-71. PMCID: PMC5567829. 
85. 
Oakes K. MyPlate as effective as calorie counting after 12 months. Clinical Endocrinology News. 2017. Available 
at: https://www.mdedge.com/clinicalendocrinologynews/article/155087/obesity/myplate-effective-calorie-
counting-after-12-months (last accessed Feburary 2018). 
86. 
Necessary Relief: The Stewart B. McKinney Homeless Assistance Act. Washington, D.C.: National Coalition for 
the Homeless; 1988. 

87. 
Woodrell C, Weiss J, Branch A, Gardenier D, Krauskopf K, Kil N, Paredes H, Bichoupan K, Sigel K. Primary 
Care-Based Hepatitis C Treatment Outcomes With First-Generation Direct-Acting Agents. J Addict Med. 
2015;9(5):405-10. PMCID: PMC4672248. 
88. 
Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV 
Interventions. J Acquir Immune Defic Syndr. 2008;47 Suppl 1:S40-6. 
89. 
Feeley N, Cossette S, Cote J, Heon M, Stremler R, Martorella G, Purden M. The importance of piloting an RCT 
intervention. Can J Nurs Res. 2009;41(2):85-99. 
90. 
Judge KS, Yarry SJ, Orsulic-Jeras S. Acceptability and feasibility results of a strength-based skills training 
program for dementia caregiving dyads. Gerontologist. 2010;50(3):408-17. PMCID: Pmc2867494. 
91. 
Nyamathi AM, William RR, Ganguly KK, Sinha S, Heravian A, Albarran CR, Thomas A, Greengold B, Ekstrand 
M, Ramakrishna P, Rao PR. Perceptions of Women Living with AIDS in Rural India Related to the Engagement 
of HIV-Trained Accredited Social Health Activists for Care and Support. J HIV AIDS Soc Serv. 2010;9(4):385-
404. PMCID: 3038639. 
92. 
Nyamathi AM, Sinha S, Ganguly KK, William RR, Heravian A, Ramakrishnan P, Greengold B, Ekstrand M, Rao 
PV. Challenges experienced by rural women in India living with AIDS and implications for the delivery of 
HIV/AIDS care. Health Care Women Int. 2011;32(4):300-13. PMCID: 3475645. 
93. 
Hudson AL, Nyamathi A, Slagle A, Greengold B, Griffin DK, Khalilifard F, Gedzoff D, Reid C. The power of the 
drug, nature of support, and their impact on homeless youth. J Addict Dis. 2009;28(4):356-65. PMCID: 2953560. 
94. 
Downe-Warmboldt B. Content analysis: Method, application and issues. Health Care for Women International. 
1992;13:313-21. 
95. 
Lincoln YS, Guba EG. Naturalistic Inquiry. Newbury Park, CA: Sage; 1985. Available at: 
https://us.sagepub.com/en-us/nam/naturalistic-inquiry/book842 (last accessed Feburary 2018). 
96. 
Centers for Disease Control and Prevention. Viral Hepatitis Surveillance. United States, 2015. Available at: 
https://www.cdc.gov/hepatitis/statistics/2015surveillance/pdfs/2015hepsurveillancerpt.pdf (last accessed 
Feburary 2018). 
97. 
Edlin BR, Eckhardt BJ, Shu MA, Holmberg SD, Swan T. Toward a more accurate estimate of the prevalence of 
hepatitis C in the United States. Hepatology. 2015;62(5):1353-63. PMCID: PMC4751870. 
98. 
California Department of Public Health. Los Angeles County – Chronic Hepatitis C. Cases and Rates of Newly 
Reported Cases, 2011-2015. Available at: 
https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/Converted_LosAngeles_HCV.
pdf (last accessed Feburary 2018). 
99. 
American Association for the Study of Liver Diseases. HCV Guidance: Recommendations for Testing, 
Managing, and Treating Hepatitis C 2015. Available at: http://www.hcvguidelines.org/ (last accessed Feburary 
2018). 
100. 
European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2015. 
Journal of Hepatology. 2015;63:199-236. 
101. 
Hoben J. Review of Stewart B. McKinney Homeless Assistance Programs Administered by HUD. In: 
Development USDoHaU. Washington, D.C.1995. 
102. 
NIDA. Prevalence of drug use in the Washington D.C. metropolitan area homeless and transient population. 
Rockville, MD: Department of Health and Human Services; 1993. 
103. 
Masciotra S, Luo W, Youngpairoj AS, Kennedy MS, Wells S, Ambrose K, Sprinkle P, Owen SM. Performance of 
the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US 
and HIV-2 infected individuals from Ivory Coast. J Clin Virol. 2013;58 Suppl 1:e54-8. 
104. 
Rosenberg NE, Kamanga G, Phiri S, Nsona D, Pettifor A, Rutstein SE, Kamwendo D, Hoffman IF, Keating M, 
Brown LB, Ndalama B, Fiscus SA, Congdon S, Cohen MS, Miller WC. Detection of acute HIV infection: a field 
evaluation of the determine(R) HIV-1/2 Ag/Ab combo test. J Infect Dis. 2012;205(4):528-34. PMCID: 
Pmc3318673. 
105. 
Anglin MD, Danila B, Tyan T, Mantius K. Staying in Touch:  A Fieldwork Manual of Tracking Procedures for 
Locating Substance Abusers for Follow-up Studies. Washington, D.C.: National Evaluation Data and Technical 
Assistance Center (NEDTAC); 1996. 
106. 
Hall E, Zuniga R, Cartier J, Anglin MD, Danila B, Ryan R, Mantius K. Staying in Touch: Fieldwork Manual of 
Tracking Procedures for Locating Substance Abusers in Follow-up Studies. 2nd ed. Los Angeles, CA: UCLA 
Integrated Substance Abuse Programs; 2003. 
107. 
Nyamathi AM, Shin SS, Smeltzer J, Salem BE, Yadav K, Ekstrand ML, Turner SF, Faucette M. Achieving Drug 
and Alcohol Abstinence Among Recently Incarcerated Homeless Women: A Randomized Controlled Trial 

Comparing Dialectical Behavioral Therapy-Case Management With a Health Promotion Program. Nurs Res. 
2017;66(6):432-41. PMCID: PMC5679786. 
108. 
Gilead Sciences. Highlights of Prescribing Information for Harvoni. Gilead Sciences; 2015. 
https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf (last accessed 
Feburary 2018). 
109. 
Milam J, Richardson JL, McCutchan A, Stoyanoff S, Weiss J, Kemper C, Larsen RA, Hollander H, Weismuller P, 
Bolan R. Effect of a brief antiretroviral adherence intervention delivered by HIV care providers. J Acquir Immune 
Defic Syndr. 2005;40(3):356-63. 
110. 
Roberts C, Roberts SA. Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials. 
2005;2(2):152-62. 
111. 
Kahan BC, Morris TP. Assessing potential sources of clustering in individually randomised trials. BMC Med Res 
Methodol. 2013;13:58. PMCID: PMC3643875. 
112. 
Nyamathi AM, Reback CJ, Shoptaw S, Salem BE, Zhang S, Farabee D, Khalilifard F. Impact of Community-
Based Programs on Incarceration Outcomes Among Gay and Bisexual Stimulant-Using Homeless Adults. 
Community Ment Health J. 2016;52(8):1037-1042. PMCID: PMC4490143. 
113. 
Nyamathi A, Branson, C., Idemundia, F., Reback, C., Shoptaw, S., Marfisee, M., Keenan, C., Khalilifard, F., & 
Liu, Y., Yadav, K. Correlates of depressed mood among young stimulant-using homeless gay and bisexual men. 
Issues in Mental Health Nursing. 2012;33:641-9. PMCID: 3624023. 
114. 
Simpson D, Knight K. TCU data collection forms for correctional residential treatment. Fort Worth, Texas: Texas 
Christian University, Institute of Behavioral Research; 1998. 
115. 
Knight K, Simpson DD, Hiller ML. Screening and Referral for Substance-Abuse Treatment in the Criminal 
Justice System. New York: Springer; 2002. 259-72 p. 
116. 
Berwick DM, Murphy JM, Goldman PA, Ware JE, Jr., Barsky AJ, Weinstein MC. Performance of a five-item 
mental health screening test. Med Care. 1991;29(2):169-76. 
117. 
Leake B, Nyamathi A, Gelberg L. Reliability, validity, and composition of a subset of the Centers for Disease 
Control and Prevention acquired immunodeficiency syndrome knowledge questionnaire in a sample of 
homeless and impoverished adults. Med Care. 1997;35(8):747-55. 
118. 
Centers for Disease Control and Prevention. Testing for HCV Infection: An Update of Guidance for Clinicians 
and Laboratorians. Morbidity and Mortality Weekly Report, 2013. Available at: 
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6218a5.htm (last accessed Feburary 2018). 
119. 
Li P, Stuart EA, Allison DB. Multiple Imputation: A Flexible Tool for Handling Missing Data. JAMA. 
2015;314(18):1966-7. PMCID: PMC4638176. 
120. 
Little R, Kang S. Intention-to-treat analysis with treatment discontinuation and missing data in clinical trials. Stat 
Med. 2015;34(16):2381-90. 
121. 
Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 
2004;159(7):702-6. 
122. 
Bryan A, Schmiege SJ, Broaddus MR. Mediational analysis in HIV/AIDS research: estimating multivariate path 
analytic models in a structural equation modeling framework. AIDS Behav. 2007;11(3):365-83.