The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
Phase: NA
Conditions: Substance Use
Sponsor: Ohio State University

Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project 
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The Substance Abuse Treatment to HIV Care II 
(SAT2HIV-II) Project 
 
Protocol Version 1.1 
 
Funded by the National Institute on Drug Abuse (R01-DA052294) 
 

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TABLE OF CONTENTS 
1 
BACKGROUND & STUDY SYNOPSIS .............................................................................. 3 
1.1 
Background ............................................................................................................ 3 
1.2 
Study synopsis........................................................................................................ 6 
2 
OBJECTIVES & OUTCOMES ............................................................................................ 7 
2.1 
Objectives ............................................................................................................... 7 
2.2 
Implementation outcomes ....................................................................................... 7 
2.3 
Client outcomes ...................................................................................................... 7 
3 
SUBJECT SELECTION ...................................................................................................... 8 
3.1 
HSO staff ................................................................................................................ 8 
3.2 
HSO clients ............................................................................................................. 8 
4 
INFORMED CONSENT ...................................................................................................... 8 
4.1 
HSO staff ................................................................................................................ 8 
4.2 
HSO clients ............................................................................................................. 8 
5 
STUDY PROCEDURES ..................................................................................................... 9 
5.1  
HSO staff ................................................................................................................ 9 
5.2 
HSO clients ........................................................................................................... 10 
6 
RISKS TO PARTICIPANTS .............................................................................................. 10 
6.1 
HSO staff .............................................................................................................. 10 
6.2 
HSO clients ........................................................................................................... 11 
7 
CONFIDENTIALITY OF STUDY-RELATED RECORDS ................................................... 11 
8 
STUDY OVERSIGHT ....................................................................................................... 11 
9 
MONITORING/REPORTING OF DATA AND SAFETY ..................................................... 11 
10 
DATA ANALYSIS PLAN ................................................................................................... 12 
11 
INTENDED USE OF THE DATA ...................................................................................... 13 
12 
LITERATURE CITED ....................................................................................................... 14 
13 
GLOSSARY OF ABBREVIATIONS .................................................................................. 20 
 
 
 
 
 
 

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1 BACKGROUND & STUDY SYNOPSIS 
1.1 
Background 
Addressing Substance Misuse in HIV Service Settings  
The significance of ending the HIV epidemic. In 2019, the Department of 
Health and Human Services launched the Ending the HIV Epidemic initiative with the 
goal of reducing new HIV infection rates by 90% through four key strategies: early 
diagnosis, rapid treatment to reach viral suppression, prevention, and outbreak 
response. Achieving this goal is possible with advances in antiretroviral therapies to 
treat and prevent HIV. Such therapies have significantly improved the quality of life and 
life expectancy of people with HIV (PWH) and have recently been shown to essentially 
eliminate the risk of transmitting HIV to sexual partners among PWH who maintain an 
undetectable viral load. Despite these advances, HIV incidence has remained steady 
since 2013, with approximately 39,000 new infections annually in the United States.1 
Consequently, HIV remains one of the most significant epidemics in the country, with 
1.1 million PWH2 and $20 billion in annual direct health expenditures for prevention and 
care.3 With each new HIV infection having an estimated $400,000 in public health costs, 
new HIV infections cost the nation approximately $1.6 billion each year. Innovative 
strategies that reach the hardest-to-reach populations with the highest rates of 
transmission will help the Ending the HIV Epidemic initiative achieve its goals. 
The significance of addressing substance misuse among PWH. One of the 
most significant barriers to ending the HIV epidemic is substance misuse among PWH 
(misuse of prescription medications, alcohol, or other drugs). Substance misuse among 
PWH has several adverse consequences that increase the risk of HIV transmission, 
including decreased adherence to HIV medications,4-7 poorer viral suppression,8-10 and 
increased incidence of risky sexual behaviors such as condom-less sex with partners 
who are HIV negative or who have an unknown status.11,12 Substance misuse rates are 
significantly higher among PWH than in the general population.13 Recently, Garner and 
colleagues (2019)14 found that use disorders for alcohol, opioid, and methamphetamine 
have the most significant population-level negative impacts for PWH. Few PWH access 
specialty substance misuse treatment services, even when available,15,16 highlighting 
the importance of improving care integration in HIV service settings. If the Ending the 
HIV Epidemic initiative is to achieve its target of 95% of persons with diagnosed HIV 
infection achieving viral suppression, substance misuse among PWH must be 
addressed to help increase engagement in care and subsequently viral suppression. 
Despite the adverse impacts of substance misuse among PWH, research 
addressing substance misuse in HIV service settings has been limited,17-19 with most 
research to date addressing alcohol misuse in HIV primary care settings.17,19,20 
Dr. Garner’s Substance Abuse Treatment to HIV Care (SAT2HIV-I) Project (a dual-
randomized, type 2 effectiveness-implementation hybrid trial) focused on HIV service 
organizations (HSOs) because they are well-positioned to address substance misuse 
among PWH given that (1) HSOs conduct assessments with clients twice per year, 
which provides opportunities to screen for and address substance misuse, and (2) 
relative to time-constrained HIV primary care settings, HSO case management staff 

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may be better able to make time for identifying and addressing substance misuse.21,22 
We believe that to end the HIV epidemic in the United States, we must target missed 
opportunities to address substance misuse within HSOs. Research that focuses on 
improving treatment for substance misuse within HSOs will have significant 
contributions to ending the HIV epidemic. 
The significance of integrating motivational interviewing-based brief 
interventions (MIBIs). Motivational interviewing23 (MI) is effective for reducing 
substance misuse; it has more than 25 years of empirical support.24-27 However, MIBIs 
have only recently been examined in HIV service settings. Aharonovich and colleagues 
(2017)28 found that compared with an educational control, MIBIs delivered in HIV 
primary care settings significantly decreased the frequency and quantity of non-injection 
drug use. Similarly, Satre and colleagues (2019)29 found that MIBIs delivered in primary 
care settings decreased use of illegal drugs and misuse of prescription drugs. Most 
recently, Garner and colleagues (2019)30 found that MIBIs delivered in HSOs 
significantly reduced substance misuse. Thus, research supports the effectiveness of 
MIBIs for addressing substance misuse in HIV service settings. 
Testing Strategies for Implementation and Sustainment 
The significance of testing different strategies using type 3 hybrid trial 
designs. The challenge of implementing evidence-based health interventions (EBHIs) 
in practice settings is well-documented,31-35 with estimates suggesting it takes 
approximately 17 years for 14% of original research to reach patient care.36 
Implementation research aims to improve implementation of EBHIs through “the study 
of methods to promote the adoption and integration of evidence-based practices, 
interventions and policies into routine health care and public health settings.”37 Although 
significant progress has been made, the field of implementation research remains in its 
infancy. Indeed, implementation research has succeeded in generating many 
models/frameworks,38 as well as evidence to better understand key implementation 
barriers.39-41 However, implementation research focused on the development and 
testing of strategies to effectively and cost-effectively address and overcome these 
barriers has been relatively limited. Additionally, Foy and colleagues (2015)42 have 
noted, “If studies evaluating the effects of implementation interventions are to be of 
relevance to policy and practice, they should have end-points related to evidence-based 
processes of care.” Thus, there is a significant need for implementation research that 
tests the effectiveness of implementation strategies in improving implementation 
outcomes and client outcomes, which Curran and colleagues (2012)43 codified as hybrid 
trials. Dr. Garner’s SAT2HIV-I Project, funded by the National Institute on Drug Abuse 
(NIDA), addressed this need by using a dual-randomized type 2 hybrid trial design that 
simultaneously tested the effectiveness of a MIBI to reduce substance misuse and the 
effectiveness of an innovative implementation strategy called Implementation & 
Sustainment Facilitation (ISF).21,22 The SAT2HIV-II Project would address this need by 
using a type 3 effectiveness-implementation hybrid trial design to compare two 
strategies in terms of impact on implementation outcomes (primary aim) and client 
outcomes (secondary aim). This implementation research is especially critical in the 
context of major public health challenges such as substance misuse among PWH. 

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Consistent with NIH’s encouragement to consider approaches previously used, 
we propose that the current control condition be the strategy found to be most effective 
as part of the SAT2HIV-I Project. Thus, the control condition will couple the staff-
focused Addiction Technology Transfer Center (ATTC) strategy and the team-focused 
ISF strategy, which was found to be more effective than the ATTC strategy alone.30 
Consistent with the landmark research of Miller and colleagues (2004),44 which provided 
the most rigorous support for the ATTC strategy in preparing staff to implement MIBIs, 
Dr. Garner and colleagues (2019)30 found that ISF significantly improved 
implementation effectiveness (i.e., the consistency and quality of MIBI implementation). 
These results advanced implementation research on the effectiveness of facilitation 
(i.e., a process of interactive problem solving and support that occurs in a context of a 
recognized need for improvement and a supportive interpersonal relationship).45-48 
Although ISF improved implementation effectiveness beyond the ATTC strategy, our 
results suggested that room for improvement remained, especially with regard to 
sustainment.30 Indeed, even the ATTC+ISF strategy did not appear to be sufficient for 
MIBI sustainment, with only about one-third of HSOs reporting MIBI sustainment at 
follow-up. Thus, we believe building on the promising results of the SAT2HIV-I Project is 
the next logical step in advancing this area of implementation research. 
The significance of testing Pay For Performance (P4P) as an effective 
adjunct to the ATTC+ISF strategy. P4P (i.e., providing monetary bonuses for 
achieving predefined performance targets) has been recommended as a promising 
strategy to improve the quality of care and address the research-to-practice gap.49-51 In 
2008, the National Institute on Alcohol Abuse and Alcoholism funded Dr. Garner and his 
research team to conduct a type 3 hybrid trial to test the effectiveness of using P4P to 
improve implementation outcomes and client outcomes within community-based 
substance use treatment organizations implementing an EBHI for adolescent substance 
use.52 More specifically, the P4P strategy was tested as an adjunct to a multifaceted 
strategy similar to the ATTC strategy.53 As described by Garner and colleagues 
(2012),54 P4P was found to have a significant impact on implementation outcomes and 
client outcomes. As such, we hypothesize that the P4P strategy (i.e., ATTC+ISF+P4P 
strategy) will improve implementation outcomes and client outcomes beyond the 
ATTC+ISF strategy. Additionally, we hypothesize that the P4P strategy will significantly 
improve sustainment by offering organizations monetary bonuses for developing a 
sustainment plan. Thus, the proposed implementation research is significant because it 
will test the effectiveness of the P4P strategy as an adjunct to ATTC+ISF strategy, 
which may affect how the Health Resources and Services Administration (HRSA) funds 
the AIDS Education and Training Center (AETC) to support future HRSA-funded 
initiatives focused on improving the integration of MIBIs into HIV service settings. 
Identifying Implementation Strategies’ Mechanisms of Change 
Beyond understanding whether or not implementation strategies are effective, it 
is important that implementation research seeks to better understand why and how 
implementation strategies work (i.e., what the mechanisms of change are).55 Thus, our 
research will seek to advance implementation research by examining the extent to 
which implementation climate (i.e., the extent to which the innovation is expected, 

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supported, and rewarded)56 mediates the implementation condition to outcome 
relationship. We focus on implementation climate for several reasons. First, numerous 
implementation researchers have hypothesized implementation climate as the key 
construct that may explain the impact of implementation strategies on implementation 
effectiveness.57-61 Second, implementation climate is one of the few constructs that has 
a psychometrically sound and pragmatic measure available.62 Third and most 
importantly, the P4P strategy is specifically designed to enhance the dimension of 
implementation climate that may not be addressed by the ISF strategy (i.e., reward). 
Thus, this exploratory aim will help advance knowledge by improving understanding 
regarding the extent to which implementation climate is a key mechanism of change. 
Public Health Relevance 
There is an urgent public health need to end the HIV epidemic and more broadly 
to identify effective strategies to overcome (not just understand) barriers to 
implementing and sustaining EBHIs in practice settings. The proposed MIBI for 
substance misuse has been shown to be effective for reducing substance misuse. 
Additionally, the ATTC+ISF strategy has been shown to be an effective strategy for 
implementing this MIBI within HSOs. However, even with the ATTC+ISF strategy, room 
for improvement remains, especially regarding sustainment. Given P4P has been 
shown to be highly effective, it may be an effective adjunct to the ATTC+ISF strategy 
(i.e., ATTC+ISF+P4P strategy > ATTC+ISF strategy). However, due to the strength of 
the research design (i.e., a 30-site, cluster-randomized, type 3 hybrid trial), we believe 
implementation research will be advanced significantly even if our hypothesis is not 
supported (i.e., if the ATTC+ISF+P4P strategy is not able to significantly improve 
implementation outcomes or client outcomes beyond the ATTC+ISF strategy). 
1.2 
Study synopsis 
The SAT2HIV-II Project is a prospective 30-site cluster-randomized type 3 hybrid 
trial that is regulated by the Department of Health and Human Services and focused on 
testing the effectiveness of a Pay For Performance (P4P) strategy as an adjunct to the 
multifaceted ATTC+ISF strategy, which Garner et al. (2020) found to be the most 
effective strategy for integrating a MIBI for substance misuse into HSOs. The control 
condition, which will be provided to all participating HSOs, consists of the following for 
MIBI staff: 1) a 5-hour online introduction to MI course, 2) three 4-hour virtual training 
workshops that are focused on the MIBI, 3) standardized feedback reports regarding the 
fidelity with which each MIBI was implemented, 4) monthly 30-60-minute virtual group 
consultation calls with an MI expert regarding how to improve fidelity, and 5) monthly 
30-60-minute virtual ISF team meetings with an implementation expert. In addition to 
these strategies, MIBI staff at HSOs randomized to the experimental condition will have 
the opportunity to earn a $10 bonus for each MIBI implemented, as well as an additional 
$10 bonus for each MIBI that is rated as meeting or exceeding the quality benchmark 
(i.e., 80th percentile fidelity score from the SAT2HIV-I Project). For leadership staff at all 
participating HSOs regardless of condition, participation consists of monthly 30-60-
minute virtual ISF team meetings with an implementation expert. Other procedures that 
are included for research purposes only are online surveys with consenting staff and 
client participants.  

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2 OBJECTIVES & OUTCOMES 
2.1 
Objectives 
The objective of the SAT2HIV-II Project is to test the effectiveness of P4P in 
improving implementation, sustainment, and client outcomes. Specific aims and 
hypotheses are: 
Primary aim: Test the impact of ATTC+ISF+P4P on implementation outcomes. 
Primary hypothesis: Relative to ATTC+ISF, ATTC+ISF+P4P will achieve 
significant improvements in staff-level measures of MIBI implementation consistency, 
MIBI implementation quality, MIBI sustainment consistency, and MIBI sustainment 
quality. 
Secondary aim: Test the impact of ATTC+ISF+P4P on client outcomes.  
Secondary hypothesis: Relative to ATTC+ISF, ATTC+ISF+P4P will achieve 
significant reductions in client-level measures of substance use, anxiety symptoms, and 
depression symptoms. 
Exploratory aim: Test the extent to which implementation climate mediates the 
implementation condition to outcome relationship.  
Exploratory hypothesis: Implementation climate will partially mediate the 
relationship between implementation condition and each of the outcomes in the primary 
and secondary aims. 
2.2 
Implementation outcomes 
The SAT2HIV-II Project’s four implementation outcomes are: 
MIBI implementation consistency: The cumulative number of MIBIs that each 
MIBI staff member implemented during the implementation phase.  
MIBI implementation quality: The cumulative sum quality score that each MIBI 
staff member demonstrated during the implementation phase. Each MIBI session will be 
rated using the Lyssn Platform and the Independent Tape Rater Scale.63  
MIBI sustainment consistency: The cumulative number of MIBIs that each MIBI 
staff member implemented during the sustainment phase.  
MIBI sustainment quality: The cumulative sum quality score that each MIBI staff 
member demonstrated during the sustainment phase. Only the Lyssn Platform will be 
used to rate each MIBI session during the sustainment phase. 
2.3 
Client outcomes 
The SAT2HIV-II Project’s three client outcomes are: 
Days using primary substance: The number of days clients used their primary 
substance (i.e., the substance the client identified a willingness to talk about during the 
MIBI) during the past 28 days, collected via the Addiction Severity Index—Lite.64 

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Anxiety: The sum of the 7 items included in the Generalized Anxiety Disorder 
(GAD-7) instrument.65 Bahorik and colleagues (2016)66 found reductions in substance 
use to be associated with reductions in anxiety as measured by the GAD-7. 
Depression: The sum of the 8 items included in the Patient Health Questionnaire 
(PHQ-8) instrument.67 Bahorik and colleagues (2016)66 found reductions in substance 
use to be associated with reductions in depression. 
3 SUBJECT SELECTION 
Consistent with the goal of the funding opportunity, subjects for the SAT2HIV-II 
Project are limited to those from HSOs supported by HRSA Ryan White funding. Below 
are descriptions regarding the selection of HSO staff and client participants, the latter of 
which are considered a vulnerable population due to having HIV. 
3.1 
HSO staff 
Each collaborating HSO will select their staff to be invited to participate as part of 
the project. Staff may participate as leadership staff or as MIBI staff.  
3.2 
HSO clients  
All HSO clients who have been diagnosed with HIV and are 18 years of age or 
older will be invited to participate in the project.  
4 INFORMED CONSENT 
4.1 
HSO staff 
 
A participation agreement, memorandum of understanding, and/or subgrant will 
be executed between RTI International and each of the project’s collaborating HSOs. 
Each collaborating HSO will select staff to be invited to participate in the project, and all 
staff must give their informed consent to participate. The project’s RTI-based research 
staff will send each identified staff member an email with a link to the online informed 
consent. Both the email and the informed consent will emphasize that participation in 
the project is voluntary and to contact Dr. Garner by phone (919-597-5159) or email 
(bgarner@rti.org) if they have any questions or concerns.  
4.2 
HSO clients  
During the project’s implementation phase, we will seek to inform all HSO clients 
who have been diagnosed with HIV and are 18 years of age or older about the research 
project. A copy of the project’s participant recruitment flyer will be included as part of the 
collaborating HSOs’ pre-appointment paperwork and posted on the HSOs’ bulletin 
boards and websites. Interested individuals may access the online informed consent via 
their own internet-capable device or, as described on the recruitment flyer, they may 
request to use one of the project’s electronic tablets. As noted on the recruitment flyer 
and in the informed consent, individuals may call the project’s toll-free number (to be 
determined) or email the project’s email address (sat2hiv@rti.org) with any questions or 
concerns they have about the project, both of which are monitored by the project’s RTI-
based research staff. 

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5 STUDY PROCEDURES 
5.1  
HSO staff 
The expected duration of participation for each HSO staff participant is 19 
months. Organized chronologically, below are the study procedures. All online staff 
surveys will be programmed using Voxco.  
Complete baseline staff survey. During month 1, all consenting staff participants 
will be emailed a unique link to the project’s online baseline staff survey, which will take 
about 25 minutes to complete. Each staff participant who completes the baseline staff 
survey will receive $25 as compensation. 
Complete online introduction to motivational interviewing course. During month 1, 
all MIBI staff participants will be emailed a link to the project’s 5-hour online introduction 
to motivational interviewing course.  
Participate in virtual motivational interviewing training workshop. During month 2, 
all MIBI staff participants will be emailed a Zoom training link and passcode for each of 
the project’s three 4-hour motivational interviewing training workshops.   
Complete follow-up staff survey. During month 2, after the training workshops, all 
MIBI staff participants will be emailed a unique link to the project’s online follow-up staff 
survey, which will take about 25 minutes to complete. Each staff participant who 
completes the follow-up staff survey will receive $25 as compensation. 
Submit recording of MIBI roleplay session. Beginning in month 2, after the 
completion of the project’s second motivational interviewing workshop training, all MIBI 
staff participants will be asked to submit a recording of their MIBI roleplay session that 
will be conducted with one of their organization’s other MIBI staff participants. 
Submit recordings of MIBI sessions with client participants. After demonstrating 
proficiency via a MIBI roleplay session, all MIBI staff participants will be asked to submit 
a recording for each MIBI session they implement with a client participant. 
Review standardized motivational interviewing fidelity feedback reports. Each 
MIBI session recording will be rated for fidelity, and MIBI staff participants will be asked 
to review each fidelity feedback report. 
Participate in MIBI consultation meetings. Beginning in month 3, all MIBI staff 
participants will be asked to participate in monthly 30-60-minute virtual group 
consultation meetings with an MI expert. 
Participate in ISF meetings. Beginning in month 1, all staff participants will be 
asked to participate in monthly 30-60-minute virtual ISF team meetings with an 
implementation expert. 
Complete follow-up staff surveys. At months 7, 13, and 19, all staff participants 
will be emailed a unique link to the project’s online follow-up staff survey, which will take 
about 25 minutes to complete. Each staff participant will receive $25 as compensation 
for each follow-up staff survey completed. 

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5.2 
HSO clients 
The expected duration of participation for each HSO client participant is about 1 
day if the MIBI is not recommended based on their answers on the initial assessment or 
about 5 weeks if the MIBI is recommended. All online client assessments will be 
programmed using Voxco. For all online client assessments, client participants will 
access them either via a unique link that is emailed to them or by entering a unique 
participant ID that is emailed to them. 
Complete initial assessment. All consenting client participants will be asked to 
complete an online initial client assessment, which will take about 10 minutes to 
complete. Each client participant who completes the initial client assessment will receive 
$10 as compensation. 
Participate in a MIBI session. Client participants for whom the MIBI is 
recommended will be asked to participate in a 15-30-minute MIBI session with one of 
the project’s trained MIBI staff, which will be recorded for quality assurance purposes. 
Complete pre-MIBI assessment. Client participants who participate in a MIBI 
session will be asked to complete an online pre-MIBI client assessment, which will take 
about 20 minutes to complete, immediately prior to receiving the MIBI session. Each 
client participant who completes the pre-MIBI client assessment will receive $20 as 
compensation. 
Complete post-MIBI assessment. Immediately after receiving the MIBI session, 
client participants will be asked to complete an online post-MIBI client assessment, 
which will take about 10 minutes to complete. Each client participant who completes the 
post-MIBI client assessment will receive $10 as compensation. 
Complete 4-week follow-up assessment. Four weeks after receiving the MIBI 
session, client participants will be asked to complete an online follow-up client 
assessment, which will take about 10 minutes to complete. Each client participant who 
completes the follow-up client assessment will receive $10 as compensation. Client 
participants who complete the follow-up client assessment within 24 hours of being 
emailed their unique link will receive $10 in bonus compensation. Client participants 
who complete the follow-up client assessment within 48 hours of being emailed their 
unique link will receive $5 in bonus compensation. 
6 RISKS TO PARTICIPANTS 
6.1 
HSO staff 
The risks of participating in the research itself are considered minimal. 
Additionally, participating does not include any physical risks. One potential risk is 
breach of confidentiality, such that unauthorized persons could get access to personal 
or study-related information. Another potential risk is that staff could feel uncomfortable 
or anxious about answering some survey questions or having MIBI session recordings 
rated for fidelity. 

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6.2 
HSO clients 
The risks of participating in the research itself are considered minimal. 
Additionally, participating does not include any physical risks. One potential risk is 
breach of confidentiality, such that unauthorized persons could get access to personal 
or study-related information. Another potential risk is that clients could feel 
uncomfortable or anxious about answering some survey questions or having their MIBI 
session recorded. 
7 CONFIDENTIALITY OF STUDY-RELATED RECORDS 
The study will be made available for monitoring, auditing, IRB review, and 
regulatory inspection by providing direct access to study-related source data. Study-
related records identifying research participants will be kept confidential (i.e., will only be 
accessible to the project’s authorized research staff) and, to the extent permitted by 
applicable laws and/or regulations, will not be made publicly available. All study-related 
records identifying research participants will be destroyed at the end of the study. 
Recordings of the MIBI sessions will be stored on a HIPAA-compliant cloud managed 
by Lyssn, with a back-up copy saved on RTI International’s enhanced security network 
server. Recordings of the MIBI sessions will be stored for the duration of the project and 
destroyed at the end of the project. 
8 STUDY OVERSIGHT 
Oversight of the study will be the responsibility of the Principal Investigator, 
including the identification of any conditions that may require premature termination.  
The study will be made available for monitoring, auditing, IRB review, and regulatory 
inspection by providing direct access to study-related source data.  
9 MONITORING/REPORTING OF DATA AND SAFETY 
Responsibility. The research is believed to pose minimal risk to study 
participants. The Principal Investigator of the research will be responsible for executing 
the project’s data and safety monitoring plan, which will (1) ensure the integrity and 
security of study data, (2) safeguard the confidentiality of participant data, (3) monitor 
participant experiences in the study for evidence of potential danger or abuse of the 
participants or threat of harm by the participants to themselves or to others, and 
(4) monitor data for possible adverse effects (AEs) of the study and take steps to 
remedy any that are found.  
Data to be collected and monitored. Staff participant data to be collected are 
staff surveys and digital audio recordings of MIBI staff participants delivering the MIBI. 
Client participant data to be collected are client assessments and digital audio 
recordings of MIBI sessions. The staff survey data, client assessment data, and MIBI 
session fidelity data will be monitored monthly by the data analysis team.  
Safety monitoring. An AE is any untoward or unfavorable medical occurrence in 
a human subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 

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participation in the research, whether or not considered related to the subject’s 
participation in the research. A serious adverse event (SAE) is one that meets one or 
more of the following criteria: (1) results in death, (2) is life-threatening (places the 
subject at immediate risk of death from the event as it occurred), (3) results in inpatient 
hospitalization or prolongation of existing hospitalization, or (4) results in a persistent or 
significant disability or incapacity. All research staff will be trained to identify and report 
AEs and SAEs. Any AE or SAE will be reported to the PI within 24 hours. The PI will 
record all reported events with start dates occurring from when informed consent is 
obtained through 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day 
of study participation. Events will be followed for outcome information until resolution or 
stabilization. When reporting an AE or SAE, the following will be reported: (1) research 
protocol information (e.g., title, investigator’s name, and IRB number); (2) a detailed 
description of the adverse event, incident, experience, or outcome; and (3) a description 
of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the AE or SAE. Additionally, to satisfy the requirement for 
prompt reporting, we will report unanticipated problems using the following timeline:  
• Unanticipated problems that are SAEs will be reported to the IRB within 1 
week of the PI becoming aware of the event.  
• Any other unanticipated problem will be reported to the IRB within 2 weeks of 
the PI becoming aware of the problem.  
• IRB actions (e.g., approval, violations) will be reported to NIDA as part of the 
annual progress reports. 
10 DATA ANALYSIS PLAN 
All analyses will follow the intent-to-treat principle and will be conducted using R, 
SAS, or Mplus. The distribution of each outcome will be examined before analysis. If a 
distribution exhibits sufficient nonnormality, we will consider other distributions as an 
alternative to the normal distribution. Doing so will yield more accurate standard errors 
and p-values. To assess whether distributional choices were appropriate, we will 
conduct residual diagnostics. Before fitting mixed effects regression models, we will 
examine variance partitioning between the levels. Intraclass correlations (ICCs) will be 
estimated and included in publications. Organized by aim, below are descriptions of the 
sample size, missing data, power, and analysis plan.  
Primary Aim. Analyses on the impact of the P4P strategy (i.e., ATTC+ISF+P4P 
compared to ATTC+ISF) on staff-level outcomes will be analyzed using a three-level 
mixed-effects regression model (repeated-measures t nested in staff s nested in 
organization o) with an appropriate distributional assumption. The primary predictor will 
be the P4P indicator (an organization-level predictor), and its estimated effect is 𝜷𝟐. 
Random intercepts 𝜷𝟎𝒔𝒐 will adjust for organization differences. Random slopes 𝜷𝟏𝒔𝒐 
allow for change over time. The basic reduced form of the model is 𝒚𝒕𝒔𝒐= 𝜷𝟎𝒔𝒐+
𝜷𝟏𝒔𝒐𝑻𝒊𝒎𝒆+ 𝜷𝟐𝑷𝟒𝑷+ 𝜺𝒕𝒔𝒐. This model will be generalized with a link function if the 
outcome 𝒚𝒕𝒔𝒐 is nonnormal. Model comparisons will be used to select an appropriate 
trajectory shape (e.g., linear, quadratic) for the Time variable. A sensitivity analysis will 

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be conducted for each outcome by adding potential staff-level confounders (e.g., sex, 
race) to the model.  
Secondary Aim. Analyses on the impact of the P4P strategy (i.e., 
ATTC+ISF+P4P compared to ATTC+ISF) on client-level outcomes will be analyzed 
using a three-level mixed-effects regression model (clients c nested in staff s nested in 
organization o), with an appropriate distributional assumption. The primary predictor will 
be organizational-level condition assignment (ATTC+ISF+P4P condition = 1; ATTC+ISF 
condition = 0), and its estimated effect is 𝜷𝟐. Random intercepts 𝜷𝟎𝒔𝒐 will adjust for 
organization and staff differences. Random intercepts will adjust for organization and 
staff effects on the relationship between baseline client outcomes and the follow-up 
outcome 𝜷𝟏𝒔𝒐. The basic reduced form of the model is 𝒚𝒄𝒔𝒐(𝒇𝒐𝒍𝒍𝒐𝒘−𝒖𝒑) = 𝜷𝟎𝒔𝒐+
𝜷𝟏𝒔𝒐𝒚𝒄𝒔𝒐(𝒃𝒂𝒔𝒆𝒍𝒊𝒏𝒆) + 𝜷𝟐𝑷𝟒𝑷+ 𝜺𝒄𝒔𝒐. A sensitivity analysis will be conducted for each 
outcome by adding potential staff-level and client-level confounders (e.g., sex, race) to 
the model. 
Exploratory Aim. For the exploratory aim, we will use the staff-level data and 
client-level data used above, as well as the average implementation climate score for 
each MIBI staff member (i.e., the hypothesized mediator). We will apply a Baron-and-
Kenny-style mediation approach, which uses centering within context and includes a 
group mean at level three. Step 1 is that the outcome will be regressed on the condition 
variable (ATTC+ISF+P4P condition = 1; ATTC+ISF condition = 0) in a multilevel 
regression. Step 2 is that the outcome will be predicted by both condition and the group 
mean-centered mediator (i.e., implementation climate) in a multilevel regression. Step 3 
is that the mediational effect will be calculated by subtracting the estimated coefficient 
associated with condition in Step 2 from the estimated coefficient associated with 
condition in Step 1. This method will allow the between-group mediation effect to be 
partitioned from the within-group mediation effect, which is important because between-
group mediation is the effect of interest. Significance of the mediation effect will be 
calculated using the Freedman and Schatzkin t statistic. 
11 INTENDED USE OF THE DATA 
 
The data collected as part of this research is primarily intended to help improve 
generalizability of knowledge about how best to improve integration of care for HIV and 
substance misuse within HIV service settings. The data is also intended to help 
contribute to generalizable knowledge about how to reduce the research-to-practice 
gap, which is a significant problem across numerous areas of health. 
 
 

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symptom improvement among psychiatry patients: A longitudinal study. Journal of 
Affective Disorders, 206, 169-173. http://dx.doi.org/10.1016/j.jad.2016.07.039 
67. 
Kroenke, K., Strine, T. W., Spitzer, R. L., Williams, J. B., Berry, J. T., & Mokdad, A. H. 
(2009). The PHQ-8 as a measure of current depression in the general population. 
Journal of affective disorders, 114(1-3), 163-173. 
https://doi.org/10.1016/j.jad.2008.06.026  
 
 

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13 GLOSSARY OF ABBREVIATIONS 
AE ..................... Adverse effect 
AETC ................ AIDS Education and Training Center 
AIDS ................. Acquired immunodeficiency syndrome 
ATTC ................ Addiction Technology Transfer Center 
EBHI ................. Evidence-based health intervention 
GAD-7 ............... Generalized Anxiety Disorder-7 instrument 
HIPAA ............... Health Insurance Portability and Accountability Act 
HIV .................... Human immunodeficiency virus 
HRSA ................ Health Resources and Services Administration  
HSO .................. HIV service organization 
ICC .................... Intraclass correlation 
ID ...................... Identifier 
IRB .................... Institutional review board 
ISF .................... Implementation and Sustainment Facilitation 
MI ...................... Motivational interviewing 
MIBI .................. Motivational interviewing-based brief intervention 
NIDA ................. National Institute on Drug Abuse 
P4P ................... Pay for performance 
PHQ-9 ............... Patient Health Questionnaire-9 instrument 
PI ...................... Principal investigator 
PWH ................. People with HIV 
RTI .................... Research Triangle Institute 
SAE ................... Serious adverse event 
SAS ................... Statistical Analysis System 
SAT2HIV-I ......... Substance Abuse Treatment to HIV Care I Project 
SAT2HIV-II ........ Substance Abuse Treatment to HIV Care II Project