Feasibility of Screening, Brief Intervention, Referral to Treatment With Peer Navigation (SBIRT-PN) for Underserved HIV+ Adults 50+ in Primary Care Settings.
Phase: NA
Conditions: Substance Use, HIV/AIDS, Older Adults, Behavioral Intervention, Infectious Disease
Sponsor: Florida State University

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
Page 1 of 16 
Revised: December 1, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL TITLE: 
Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary Care 
Settings 
 
PRINCIPAL INVESTIGATOR: 
Dr. Nicole Ennis, Florida State University 
 
NCT03057119 
 
DATE OF DOCUMENT: 
9/26/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
Page 2 of 16 
Revised: December 1, 2018 
 
PROTOCOL TITLE: 
Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary Care Settings  
 
PRINCIPAL INVESTIGATOR: 
Nicole Ennis, PhD 
Department of Behavioral Sciences and Social Medicine 
FSU College of Medicine 
305-467-2121 
nicole.ennis@med.fsu.edu 
VERSION NUMBER/DATE: 
version1/9.26.19 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
9-26-19 
Transfer to RAMP, add a site 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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Table of Contents 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives* .............................................................................................................. 5 
3.0 
Background* ............................................................................................................ 5 
4.0 
Study Endpoints* ..................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 6 
6.0 
Procedures Involved*............................................................................................... 8 
7.0 
Data and Specimen Banking* .................................................................................. 9 
8.0 
Sharing of Results with Subjects* ........................................................................... 9 
9.0 
Study Timelines* ..................................................................................................... 9 
10.0 Inclusion and Exclusion Criteria* ............................................................................ 9 
11.0 Vulnerable Populations* .......................................................................................... 9 
12.0 Local Number of Subjects ..................................................................................... 10 
13.0 Recruitment Methods ............................................................................................. 10 
14.0 Withdrawal of Subjects* ........................................................................................ 10 
15.0 Risks to Subjects* .................................................................................................. 10 
16.0 Potential Benefits to Subjects* .............................................................................. 10 
17.0 Data Management* and Confidentiality ................................................................ 11 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 12 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 12 
20.0 Compensation for Research-Related Injury ........................................................... 12 
21.0 Economic Burden to Subjects ................................................................................ 13 
22.0 Consent Process ..................................................................................................... 13 
23.0 Process to Document Consent in Writing .............................................................. 13 
24.0 Setting .................................................................................................................... 13 
25.0 Resources Available............................................................................................... 13 
26.0 Multi-Site Research* ............................................................................................. 15 
 
 
 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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1.0 
Study Summary 
 
Study Title 
Feasibility of Screening, Brief Intervention for HIV+ Adults 
50+ in Primary Care Settings  
 
Study Design 
We will use a repeated measures randomized control trial 
design to compare patient outcomes at baseline as well as 3 
and 6 months post-intervention.  
Primary Objective 
Feasibility and Acceptability of intervention 
Secondary 
Objective(s) 
Substance misuse 
Research 
Intervention(s)  
Screening, Brief Intervention, Referral to Treatment with 
Peer Navigator (SBIRT-PN) 
Study Population 
HIV+  
Sample Size 
90 
Study Duration for 
individual 
participants 
6 months 
Study Specific 
Abbreviations/ 
Definitions  
SBIRT-PN = Screening, Brief Intervention, Referral to 
Treatment with Peer Navigator 
 
 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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2.0 
Objectives* 
 
In order to develop effective substance use intervention models for HIV care settings the 
specific aims of the current project are: 
 
Aim1: Examine the feasibility of implementing the SBIRT-PN model in Infectious 
Disease-Medical Specialties Clinics in the state of Florida. 
 
H1: We hypothesize that the SBIRT-PN model will demonstrate high feasibility as 
evidenced by at least 80 % of the total N having screenings. 
 
Aim2a: Assess the acceptability of SBIRT-PN. 
 
H2a: We hypothesize that SBIRT-PN will demonstrate high acceptability among 
patients  
enrolled in this condition.   
 
Aim2b: Assess the acceptability of SBIRT-PN among HIV-positive individuals by 
age cohort (younger vs older). 
 
H2b: We hypothesize that SBIRT-PN will demonstrate higher acceptability 
among older HIV-positive patients enrolled in this condition.   
 
Aim3: Assess influence of SBIRT-PN model on treatment engagement and 
substance use compared  to enhanced treatment as usual (TAU). 
 
H3: We hypothesize that those in the SBIRT-PN condition will evidence greater 
treatment engagement and a reduction in substance use.  
 
3.0 
Background* 
Substance use science-to-service gap needs to close for the underserved aging 
with HIV. Many effective interventions do not translate into meaningful outcomes that 
improve patient care. Therefore, NIDA and the Office of AIDS Research have prioritized 
research that promotes the uptake of evidence-based interventions into real-world 
settings. In order to provide effective patient-centered care, effective interventions need 
to reach those in need. In particular, substance use interventions have lagged in moving 
from the bench (research labs) to the community (real-world settings).  Extant literature 
suggests that peer navigators may improve treatment engagement among substance 
users and thereby has the potential to improve the effectiveness of SBIRT in this 
population in particular. 
 
 
Florida provides the opportunity to implement substance use interventions 
among older HIV-positive adults. In Florida 42% of people living with HIV are aged 50 
years and older compared to 31% in the rest of the United States. While cART has 
transformed HIV into a manageable chronic condition, leading to a large population 
aging with the disease, people aging with HIV continue to engage in high risk behaviors. 
At this stage in the HIV epidemic, we must use available evidence-based tools to meet 
the needs of those aging with HIV.  Older adults living with HIV misuse alcohol and illicit 
drugs at rates higher than the general population. In addition, HIV+ adults aged 50 years 
and older are likely to be frailer than their chronological age indicates due to their 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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disease status, which makes them more vulnerable to the consequences of substance 
misuse (i.e., greater intoxication even with lower levels of consumption). Further, 
substance misuse is associated with decreased medication adherence, decreased 
engagement in HIV care, more medical co-morbidities, higher rates of depression, and 
poorer quality of life. Extant research suggests depression and pain are considered 
motivators of misuse and may make patients less responsive to interventions. 
Importantly, depressive symptoms among older, chronically ill populations are 
associated with transition from informal community-based care by family and friends to 
institutionalization. Therefore, studies located in Florida provide an opportunity to 
examine how primary care health systems can adopt interventions to reach this 
population and remain effective.    
 
 
 Determine best methods for improving uptake of substance use interventions in 
real-world settings While the primary care setting presents an opportunity to address 
substance misuse among older HIV-positive adults, barriers exist at multiple levels in the 
public health sector. Extant literature indicates that underserved adults aging with HIV 
need substance use intervention on a broad scale. However, to be effective we need to 
improve our understanding of the mediators and moderators of effective delivery of 
substance use interventions in this population. A study that implements SBIRT-PN and 
then examines the barriers to uptake will provide data needed to implement evidence-
based substance use interventions in public health settings while creating sustainable 
interventions that the community can maintain 
. 
4.0 
Study Endpoints* 
 
Primary Outcome 
 
Feasibility Calculation. Feasibility is defined as the extent to which the intervention can 
be successfully used or carried out within the UF Health Infectious Disease-Medical 
Specialties Clinic. Therefore, we will calculate feasibility using the following steps (see 
link to method for calculation below):  
• 
Step 1: Enumerating all potential participants in target population. The target 
population will be defined as all patients seen by Dr. Janelle seen during study 
period.  
• 
Step 2: Quantify Exclusions. List reasons for and number of exclusions. 
• 
Step 3: Quantify missed cases. List number of lost cases or missed due to lack 
of staff resources, etc.  
• 
Step 4: Quantify Eligible Participants. List number of known eligible participants 
who were offered participation.  
• 
Step 5: Quantify number of Patients Reached. Divide number of participants 
enrolled to determine percent participation.  
• 
Step 6: Report most common reasons for declining participation. 
 
http://re-aim.org/resources-and-tools/calculations/calculating-and-reporting-on-reach/ 
 
 
Acceptability Questionnaire. This 10-item questionnaire (1 = not acceptable to 5 = highly 
acceptable) queries the participant on the acceptability of the program. Item content 
includes the following: 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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1. Program was a good use of my time 
2. Program was helpful 
3. Program will be useful in my daily  
4. Likeability of interventionist 
5. Clinical skill of interventionist 
6. Likeability of assessor 
7. Ease of participation in assessments  
8. Ease of participation in intervention 
9. Interactions with program staff 
10. Overall rating.  
 
To examine ratings of acceptability, we will use the overall acceptability score and 
percentage of acceptability. Overall acceptability will be assessed by summing ratings 
from the 10-item questionnaire to provide a total intervention acceptability score for the 
intervention, such that acceptability scores for the intervention could range from 10 (low 
acceptability) to 50 (high acceptability). The intervention will be considered to have 
acceptability if 80% of the participants rank the intervention as acceptable (i.e., 4 or 
higher) on 80% or more of the scale items. We will then examine each question of the 
Acceptability Questionnaire separately to determine strengths and weaknesses of the 
intervention. 
 
Secondary Outcomes 
 
Substance Use Treatment Engagement:  Participants will self-report if they obtained 
formal substance use treatment (i.e., any services sought to address substance use 
from individual therapy to 12 step fellowships). We will request treatment facility 
information and permission to verify treatment. Once treatment has been verified, 
treatment engagement will be coded as 0= no formal treatment 1= formal treatment 
engagement  
 
Substance use NIDA STTR Drug and Alcohol Use Measure: A standard measure from 
the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used. It will 
assess quantity and frequency of types of substances used in the prior 30 days.  
 
Biologically Confirmed Drug Use: A CLIA 12-Panel Instant Drug Test Cup 
(CLIAwaivedTM, San Diego, CA), which tests for the presence of 12 common substances 
in the urine will be used. 
 
5.0 
Study Intervention 
Intervention Procedures: The 30 minute intervention session will cover the 
following content: 1) Psycho-educational content (5 minutes): The interventionist 
will discuss substance use and misuse, HIV, and the interaction of aging and 
substance use (e.g. greater intoxication effects with lower amounts). 2) 
Readiness Assessment (10 minutes): The interventionist will give the patient 
feedback on their NM-ASSIST score and assess the patient’s readiness to 
change based on Prochaska’s stages of change. 3) Goal-Setting (5 minutes): 
The interventionist will use motivational interviewing techniques to identify the 
patients’ most salient reasons for addressing substance use issues. 4) Identifying 
and prioritizing needs (5 minutes): The interventionist will use problem-solving 
techniques to help patients identify which services may best help them work 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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towards their goals. Services will include (but are not limited to) emergency crisis 
services, counseling to deal with substance use, referral to local self-help groups 
(Alcoholics Anonymous, Narcotics Anonymous, etc.), legal assistance, faith-
based counseling, or mental health counseling. 5) Assignment of Peer Navigator 
and Session wrap (5 minutes): The interventionist will use a referral resource 
guide to provide the contact information of agency representatives and help the 
patient formulate a plan for follow-up. 
6.0 
Procedures Involved* 
 
Recruitment/Sampling: Patients will be recruited using convenience sampling 
technique from HIV primary care clinics with whom the PI works regularly: the Columbia 
County Department of Health (Lake City, FL)  and the CAN Community Health Clinic 
(Jacksonville, FL) 
 
 
Preliminary Screen: Patients will be prescreened for eligibility using a 
computerized screening tool, NIDA Modified Alcohol, Smoking, Substance Involvement 
Screening Test [NM-ASSIST], to assess substance misuse risk level.  All clinic patients 
will have the opportunity to complete the substance use screening assessment after 
checking in for their appointment. All who score moderate and above on the alcohol or 
illicit substance portion of the NM-ASSIST and meet eligibility criteria will be referred to 
the study. We will train all recruiters (clinic staff) to provide an extensive explanation of 
why we are offering these services, as the patients may not perceive themselves as 
having a substance misuse issue.  
 
 
Baseline Assessment Procedures: 
Following a successful initial screen, study 
staff will explain the procedures of the study and obtain informed consent.  All study 
activities will be conducted in a private room in the clinic.  The research assistant (RA) 
performing the assessment will verify the patient’s complete understanding of the 
informed consent form and all study procedures. Following informed consent, patients 
will complete the baseline assessment. The baseline assessment will consist of urine 
drug screen and a series of research questionnaires delivered on a mobile device. The 
research questionnaires include information on: substance use, substance use 
treatment, HIV treatment engagement, depression, and pain. The assessment is 
relatively brief in order to maximize willingness to participate and decrease patient 
burden. The assessment will take approximately 30 minutes to complete. The 
questionnaires will be given in a computerized. The iPad/tablet will use REDCap survey 
software, which provides direct, encrypted transfer of information via internet to a secure 
study server.  
 
  
 
Three and Six Month Follow-Up Assessment: Participants will be contacted three 
and six months post-intervention to schedule an in-person follow-up assessment. We will 
evaluate substance use treatment engagement post intervention and substance use 
(self-report and urine toxicology analysis). Participants will be compensated $30 for each 
  
Randomization: We will use Block random assignment (blocks of 4 by each 
recruitment site) to ensure equal numbers are assigned to each condition by site. 
Randomization should create groups with equal characteristics with respect to disease 
related and medical variables.  However, we will assess for baseline differences prior to 
conducting any analyses and control as necessary.  

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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.  
7.0 
Data and Specimen Banking* 
N/A. 
8.0 
Sharing of Results with Subjects* 
N/A. 
9.0 
Study Timelines* 
 
10.0 Subject Population* 
 
Participants will be 90 patients recruited through DOH Columbia County and CAN 
Community Health.   
 
Study inclusion criteria includes that patients must be:  
1. HIV-positive (seropositive confirmed by medical records). 
2. Arrive for a clinic visit with an HIV physician. 
3. Have a substance misuse screening score indicating moderate or high risk.  
 
 
Persons will be ineligible if they:  
1. are unable to interview and consent in English 
2. unwilling or unable to participate in follow up 
3. currently in addiction treatment 
4. have a medical marijuana prescription 
 
11.0 Vulnerable Populations* 
N/A. 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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12.0 Local Number of Subjects 
N= 90 
13.0 Recruitment Methods 
We will recruit participants from patients attending the primary care clinic 
for routine medical appointments. Patients will be prescreened for 
eligibility using a computerized screening tool, NIDA Modified Alcohol, 
Smoking, Substance Involvement Screening Test [NM-ASSIST], to assess 
substance misuse risk level.  All clinic patients will have the opportunity to 
complete the substance use screening assessment after checking in for 
their appointment. All who score moderate and above on the alcohol or 
illicit substance portion of the NM-ASSIST and meet eligibility criteria will 
be referred to the study. We will train all recruiters (clinic staff) to provide 
an extensive explanation of why we are offering these services, as the 
patients may not perceive themselves as having a substance misuse 
issue) 
Participants will be compensated $30 for each assessment which includes 
the baseline visit and two follow up visits for a total of $90 of 
compensation throughout the entire six month study period 
 
14.0 Withdrawal of Subjects* 
Participants may be withdrawn from the study without consent for the following reasons: 
• 
Participants who tell us that they are going to hurt him or herself or someone 
else will be withdrawn from the study.  These participants will be referred to 
community based agencies that provide counseling and treatment services.   
• 
The Principal Investigator can withdraw participants from this study for 
unanticipated reasons.   
 
15.0 Risks to Subjects* 
 
Possible Discomforts and Risks: Questions may be unpleasant or difficult for 
participants to answer. Additionally, despite taking appropriate steps to safeguard 
collected information, there is a slight risk that participant information could be 
revealed accidentally or inappropriately. This release of information may upset a 
participant or even affect their insurability or employability. A Certificate of 
Confidentiality will be obtained from the National Institute of Drug Abuse to assist 
us in protecting participant information. 
 
16.0 Potential Benefits to Subjects* 
 
Participants may benefit from information about substance misuse and how it 
could negatively affect their mental and physical health. 
 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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Participants may also benefit from tips and strategies that decrease substance 
misuse 
 
17.0 Data Management* and Confidentiality 
Analysis Plan  
 
Aim 1: Feasibility will be calculated as described above. The model will be 
considered feasible if 80% of the target population has been reached. 
 
Aim 2: Acceptability scores will be calculated for all participants as listed above to 
determine overall acceptability of the SBIRT model. Sub analyses will be 
conducted for disease type and HIV x age using calculations listed above. 
Acceptability will be examined by disease type HIV vs. non-HIV. Acceptability will 
also be examined for HIV only by younger (<49) versus older >50). 
 
 
Aim 3: This pilot is a randomized two groups (SBIRT-PN vs. TAU) with repeated 
measures (baseline and 3 and 6-month follow-ups) design. We will clean the 
data, examine variable distributions, compute descriptive statistics, examine 
outliers, and examine the effectiveness of randomization prior to analyses of 
specific aims to ensure the underlying assumptions of normality and equal 
variance have not been violated. Before testing each secondary outcome, we will 
examine whether intervention and control group participants differ on potential 
confounding variables at study entry. We will control for a variable if it differs by 
condition on the outcome variable being tested in that analysis at p < .05. Using 
chi-square (or t-test for continuous variables) we will examine the associations 
between the dependent variables and relevant demographic variables. All 
analyses will employ an intent-to-treat approach.  
 
Our first step will be to see if the intervention influenced formal engagement in 
substance use treatment. Using chi-square analyses we will examine group 
difference on engagement in formal treatment (0=no treatment/1=treatment 
confirmed). To test the remainder of the hypothesis, analyses will rely on mixed 
model repeated measures ANOVA since the relatively small sample size is likely 
to prohibit more sophisticated statistical modeling. Hypotheses testing rely on 
inspection of F values and associated p values. A mixed model ANOVA is used 
to test for differences between two or more independent groups while subjecting 
participants to repeated measures. In the current analyses the fixed effect will be 
group condition (SBIRT-PN or TAU) and the random effect will be number of 
drug use days in the past 3 and 6 months. 
 
Missing Data. We will handle missing data values with a 3-step process. First, 
the dropout rates will be compared across the groups with chi-square analyses to 
assess systematic differences due to condition. Second, demographic and 
dependent variables will be examined for their relationship to dropout. Those 
variables related to dropout status will be used to impute missing values for use 
in the analyses described (via SPSS Missing Items Analysis). Finally, 
comparison of the completers vs. imputation analyses will yield an additional 
estimate of the effect of dropouts on hypothesis tests. 
 
Confidentiality Safeguards 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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To ensure confidentiality, all information will be coded so that it cannot be 
associated with any individual. A master sheet, with individual names and their 
respective code numbers will be kept in a locked file that can be accessed only 
under supervision of the PI. All data entered into the computerized database will 
be identifiable by subject code number only. No one outside of the lead research 
team will have access to records identifying participants' names at any time. The 
information gathered will be used only for scientific, educational, or instructional 
purposes. 
 
 
Data Safeguards 
Any computer files with identifying data, such as subject logs needed to match 
data to names over time, will be protected by multiple passwords.  During the 
analysis of the data, all identifying information with the exception of the subject 
identification number is removed from the data. 
  
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
N/A 
19.0 Provisions to Protect the Privacy Interests of Subjects 
To ensure confidentiality, all information will be coded so that it cannot be 
associated with any individual. A master sheet, with individual names and 
their respective code numbers will be kept in a locked file that can be 
accessed only under supervision of the PI. All data entered into the 
computerized database will be identifiable by subject code number only. 
No one outside of the lead research team will have access to records 
identifying participants' names at any time. The information gathered will 
be used only for scientific, educational, or instructional purposes. 
Any computer files with identifying data, such as subject logs needed to match 
data to names over time, will be protected by multiple passwords.  During the 
analysis of the data, all identifying information with the exception of the subject 
identification number is removed from the data. 
  
Discomfort with Procedures or Disclosure Safeguards 
During the course of participation in the research, a participant may have 
questions about the assessment procedure. A project staff member or 
interventionist will be available to answer questions. To prevent discomfort or 
embarrassment, staff are trained in building rapport and skillful interviewing. 
Participants are informed prior to the assessment that they may choose to skip 
any questions or procedures they find uncomfortable. If any individual becomes 
overly distressed or distraught, the assessment will be stopped immediately and 
a staff clinician will talk privately with the affected individual(s) and appropriate 
referrals will be made, as needed. 
 
20.0 Compensation for Research-Related Injury 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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N/A 
21.0 Economic Burden to Subjects 
       N/A 
22.0 Consent Process 
 
All participants will be required to read detailed consent forms prior to participation.  
Then the Research Assistant who will be consenting the participant will address all of the 
major details of the study.  Before signing, participants will be given the opportunity to 
ask any questions they may have about the study. Participants are advised of the 
voluntary nature of participation and of their right to withdraw from the project at any time 
and their right to require that information about themselves be removed from data 
analysis. Each study participant receives a verbal and written description of the study. 
Non-English Speaking Subjects 
• 
N/A 
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception) 
• 
N/A 
Subjects who are not yet adults (infants, children, teenagers) 
• 
N/A 
Cognitively Impaired Adults 
• 
N/A 
Adults Unable to Consent 
o 
N/A 
23.0 Process to Document Consent in Writing 
 
Participants will sign an IRB approved informed consent document.  Before signing, 
participants will be given the opportunity to ask any questions they may have about the 
study. Participants are advised of the voluntary nature of participation and of their right to 
withdraw from the project at any time.  
 
24.0 Setting 
 
Recruitment/Sampling: Patients will be recruited using convenience sampling 
technique from HIV primary care clinics with whom the PI works regularly: the Columbia 
County Department of Health (Lake City, FL)  and the CAN Community Health Clinic 

PROTOCOL TITLE: Feasibility of Brief Intervention for HIV+ Adults 50+ in Primary 
Care Settings 
 
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(Jacksonville, FL).  The PI has dedicated space in these locations to conduct all study 
activities. 
 
25.0 Resources Available 
 
Since SBIRT is intended to be a universal intervention within a targeted setting, all 
adults (18+) who are being seen in clinic will be screened using validated screening 
instruments as part of routine care. Scores and the nature of the follow up (i.e., 
referred to brief intervention or no intervention needed) will be documented in the 
electronic medical record. We will train all recruiters and clinic staff to provide an 
extensive explanation of why we are offering these services, as the patients may 
not perceive themselves as having a substance misuse issue.  
 
Universal Screening Procedures 
Screening is intended to identify individuals at varying levels of risk associated 
with the use of alcohol and/or drugs. It is not intended to provide a formal 
diagnosis (which is the function of clinical assessment), but rather to provide 
guidance for deciding which level of intervention may be needed to address the 
identified level of risk. The ASSIST is an eight-item instrument developed by the 
World Health Organization (WHO) to screen for hazardous, harmful, and 
dependent use of alcohol, tobacco, and drugs. The ASSIST typically takes about 
5-10 minutes to administer, although it can take longer depending on the number 
of drugs used over the lifetime. For each drug endorsed, questions are asked 
about frequency of use, problems related to use, dependence indicators, and 
injection drug use in the three months prior to the current administration of the 
instrument. Following ASSIST administration, separate risk scores are 
calculated, with scores falling within a low-, moderate-, or high-risk range. Table 
1 shows the risk-level scores for alcohol and drugs and the indicated intervention 
for each risk level, as specified in the WHO brief intervention manual. We will use 
a computer based version of the ASSIST to make the screening faster to 
administer and score (see link below). 
 
https://www.drugabuse.gov/nmassist/ 
 
 
Table 1 ASSIST risk scores and level of intervention 
 
ASSIST Alcohol 
Score 
Assist Drug 
Score 
Intervention 
Low Risk 
0 – 10 
0 – 3 
Feedback on ASSIST 
score, literature 
Moderate 
Risk 
11 – 26  
4 – 26 
Feedback on ASSIST 
score, literature, brief 
intervention 
High Risk 
27+ 
27+ 
Feedback on ASSIST 
score, literature, brief 
intervention, referral to 
treatment 

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Retention 
 
Attrition is a significant concern in an implementation trial. First, we will develop a 
strong collaborative relationship between participants and members of the 
research team. This is a critical component of our retention strategy, beginning at 
the moment of first contact between the recruiter and potential participant. Second, 
we will ensure that participants understand that they are making a contribution and 
that their efforts have the potential to improve other people’s experiences. 
Participants will receive study newsletters and flyers containing useful and 
pertinent information on wellness management and other related resources and 
local events. Finally, we will obtain secondary contact information and will use 
multiple communication channels (email, phone, text messaging, social media) to 
maintain contact with study participants. We have budgeted research staff time for 
tracking and follow-up of participants. One RA will dedicate 20% time to patient 
tracking during recruitment and follow up phase. Based on our prior work using 
these strategies with this patient population, we anticipate a 10% dropout rate with 
a maximum dropout rate of 20% by time 3. 
 
Follow-up visits will be scheduled 4-6 weeks in advance of the next study 
appointment. Participants will then be contacted with assessment visit reminders 
within the week before their 3-month and 6-month visits. If participants cannot be 
reached by phone, a voicemail will be left listing the day and time of the scheduled 
visit along with instructions to call and reschedule if the participant is no longer 
available at the scheduled day and time. Participants who do not attend their 
assessment visit will be called 15 minutes after the anticipated start time of the visit 
and asked to reschedule. If the participant does not answer the phone, a voicemail 
will be left and an email sent asking the participant to call our study staff to 
reschedule their visit. Participants will be contacted up to 5 times to reschedule. 
Participants who cannot be reached will be sent a registered letter through the 
USPS reminding them of the final assessment visit and asking them to contact 
study staff to schedule. We will also use clinical schedules from our research 
partner clinics to monitor for participant return visits to clinic and use these visits 
as an opportunity to reengage with study participants. We will continuously review 
and examine our retention strategies to ensure that they meet participant approval 
and are maximally effective. 
 
26.0 Multi-Site Research* 
 
+++Per NIH policy research funded via Career Development Awards, such as the 
current study are NOT subject to the NIH single IRB policy due to the scope of the 
research award. The current research is funded via a career development award from 
NIDA under grant 1K23DA039769-04. 
 
 
See section C item 6 in the link below. 
 

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https://grants.nih.gov/grants/policy/faq_single_IRB_policy_research.htm#5180