Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Pittsburgh

                                                        
 
 
 
 
Study Protocol 
 
 
 
 
 
 
 
 
Official Title: Evaluation of the Efficacy and Mechanisms of a Novel intervention for 
Chronic Pain Tailored to People with HIV (STOMP)  
 
PI: Jessica Merlin, MD, PhD 
 
Study Coordinator: Alissa Eugeni 
 
ClinicalTrials.gov ID (NCT number): NCT03692611 
 
Protocol Date: November, 2019 
 
 
 
 
 
 
 
 
 

 
 
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I. 
STUDY OVERVIEW 
 
Behavioral interventions for chronic pain among people living with HIV (PLWH) are an 
understudied area, with great potential to improve pain and function. Chronic pain is 
an important comorbidity that affects between 30% and 85% of PLWH and is 
associated with greater odds of functional impairment, increased emergency room 
utilization, suboptimal retention in HIV care, and failure to achieve virologic 
suppression. What is not known is how to optimally address chronic pain in this 
population. Opioids are a commonly used treatment for chronic pain, particularly in 
PLWH. Opioid prescribing for chronic pain often does not result in substantial 
improvement in outcomes and contributes to the growing epidemic of opioid addiction 
and overdose. In contrast, behavioral interventions are among the most effective and 
safest treatments for chronic pain in the general population. Pain Self-Management 
(PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves 
pain-related skill acquisition and goal setting. PSM interventions have been promoted 
by the 2016 Department of Health and Human Services National Pain Strategy (DHHS 
NPS) as an effective, scalable approach to chronic pain management. Especially 
given the current opioid crisis, the DHHS NPS underscored the urgent need to develop 
and test PSM interventions tailored to the unique needs of vulnerable populations, 
particularly PLWH, that can be implemented and disseminated nationwide. Until an 
effective and scalable PSM intervention for chronic pain in PLWH is developed, 
reducing the burden of chronic pain safely and effectively in this population will not be 
possible.  
II. 
OBJECTIVES      

 
 
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Our long-term goal is to significantly reduce the burden of chronic pain comorbidity in 
PLWH through the creation of an effective PSM intervention for HIV care settings. Our 
overall objective toward achieving that goal is to evaluate a novel theory-based PSM 
intervention, “Skills TO Manage Pain” (STOMP), that we developed for PLWH. We 
conducted a 44-participant, 2-arm randomized pilot trial of STOMP vs. usual care. 
Findings show that STOMP was feasible, acceptable, and showed preliminary 
evidence of impact on pain and function. Additionally, final analysis of STOMP’s 
cost/QALY was substantially lower than the $50,000 to $100,000/QALY benchmark 
often used to indicate cost-effectiveness. Although based on a pilot trial and, therefore, 
preliminary, these findings are promising, and suggest the importance of cost 
analyses in future STOMP trials. 
 
For this study, we will accomplish our overall objective by focusing on the following 
primary specific aim: 1). Evaluate the efficacy of STOMP, a theory-based intervention 
tailored to improving chronic pain in PLWH. Given the rigorous intervention 
development process and promising pilot trial results, our working hypothesis is that 
STOMP will decrease pain severity and improve function in PLWH. We propose a two-
arm randomized trial of STOMP vs. a usual care comparison condition (N=280).   
We also propose the following secondary aims: 2). Conduct exploratory analyses of 
the impact of STOMP on HIV outcomes associated with chronic pain. Our working 
hypothesis is that STOMP will not only decrease pain severity and improve function, 
but increase retention in HIV primary care and virologic suppression rates.  3. 
Investigate proximal outcomes as potential mediators of STOMP’s impact on chronic 
pain. During our formative work, we incorporated the key SCT constructs of self-

 
 
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efficacy, outcome expectations, and self-regulation into the intervention. Our working 
hypothesis is that these constructs are “proximal outcomes” through which the 
intervention’s impact on pain and function is mediated.         
 
This study will be conducted at the University of Alabama at Birmingham (UAB) and     
the University of North Carolina at Chapel Hill (UNC), two sites within the Center for 
AIDS Research Network of Integrated Clinical Systems (CNICS) cohort. The University 
of Pittsburgh will serve as the lead site and will provide training and oversight. 
 
III. 
STUDY ACTIVITIES 
a) STUDY POPULATION  
A total of 280 participants who are patients at UAB and UNC - enrolled in CNICS, 
experiencing chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least 
moderate pain for at least 3 months) and moderately severe and impairing chronic pain 
(PEG pain questionnaire = average of all three times is 4 or greater).  
 
 
Inclusion Criteria 
1. Enrolled in CNICS 
2. Age ≥ 18 years  
3. English-speaking 
4. Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least 
moderate pain for at least 3 months) 

 
 
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5. Moderately severe and impairing chronic pain (PEG pain questionnaire = average 
of all three items is 4 or greater) 
6. Ability and willingness to attend the group sessions at the date/time specified 
7. No plans for major surgery during the study period that would interfere with study 
procedures. 
 
Exclusion Criteria 
1. Do not speak or understand English 
2. Are planning a new pain treatment like surgery 
3. Cannot attend the group sessions 
4. Had previously participated in the pilot study (STOMP)  
5. Unwilling to provide informed consent 
 
We will rely heavily on active recruitment using patients identified as having chronic pain 
on the BCPQ and PEG on CNICS pain Patient Reported Outcome measures.  
Additionally, participants will be recruited via word-of-mouth by clinic staff or providers, 
calls generated from flyer tear-offs and other advertisements placed in the clinic.  
 
b) PRE-SCREENING (phone and then in-person) 
Potential participants will be prescreened over the phone using our prescreening phone 
script once the participating site. A HIPAA waiver will be submitted with the initial 
submission. If the individual passes the telephone prescreen, he or she will be scheduled 
for an in-person pre-screening visit by a member of the STOMP recruitment team. The 
date and time of the pre-screening visit along with the participant contact information and 

 
 
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preferred method of contact will be recorded on the Prescreening Visit Appointment Form. 
Data from the pre-screening phone call and visit appointment forms will be transferred to 
a prescreening excel log for accurate tracking. About 48 hours prior to the in-person 
prescreen visit, a reminder call from the research staff will be made to remind the potential 
participant of the prescreening visit. If the research staff cannot locate the potential 
participant after three attempts, the staff will note an inactive status in the prescreening 
log.  
On the day of the prescreen, the research staff member conducting the prescreen will log 
onto Redcap and establish a unique RedCap instance for this participant and complete 
the prescreen section only. Participants will be required to sign a prescreen consent form 
before the initiation of the session. At the end of the prescreen, the research staff member 
will record the participant’s eligibility on the Prescreening Visit Appointment Form. If the 
participant is eligible for enrollment, a Screening and Enrollment Visit will be scheduled 
and recorded on a Screening and Enrollment Visit form. A separate excel log will collect 
data from the screening and enrollment visit form for tracking purposes. The participant 
will also be thanked and given their $25 incentive. If the participant is not eligible, he or 
she will also be thanked for their time and given a $25 incentive.  
 
 
 
c) SCREENING AND ENROLLMENT 
The Screening and Enrollment Visit will be scheduled approximately 2-4 weeks from the 
date of the pre-screen visit and recorded on a Screening and Enrollment Visit form. 
Participants will receive a reminder call at about a week and 48 hours prior to the 

 
 
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scheduled screening and enrollment visit. At the beginning of the screening and 
enrollment visit, the participant will complete the informed consent process, and then they 
will complete a baseline assessment.  
 
Informed Consent Procedures 
Informed consent will be administered by staff trained in accordance to the University of 
Pittsburgh, the University of Alabama at Birmingham and the University of North Carolina 
at Chapel Hill’s Institutional Review Boards’ guidelines for obtaining informed consent. 
The staff member obtaining consent must verify the following: protocol name, version 
number, dates for use, and institution. The Study team member will also ensure that the 
most recent informed consent is being used for the study. Initial informed consent must 
be completed and documented before any other study related procedures are done. 
Comprehension will be assessed by asking the participant to summarize the study 
activities or some general open ended questions will be asked like what can you tell me 
about this study, can you tell me about how long the study may last, etc. The consent 
process is estimated to take around 30 minutes. Study staff will ensure that the participant 
has signed and dated the consent form including the HIPAA form.  All signed consent 
forms will be stored in locked file cabinets under respective participant files. 
 
Baseline Assessment 
The research staff will then administer the baseline assessment which includes a 
confirmatory set of screening questions via RedCap.  Confirmation of the participant’s 
eligibility will be recorded in RedCap. If a participant is ineligible based on this RedCap 
assessment, they will be given a $50 incentive and thanked for their time, and they will 

 
 
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not be considered to have been enrolled in the study at any point (informed consent is 
asked before this point so that we can use any data generated in published findings).   If 
a participant is eligible, they will also be thanked for coming and given their $50 incentive 
payment for their time. Completion of Baseline assessment will be recorded in excel logs. 
 
RANDOMIZATION 
Our team will utilize a 1:1 ratio for allocation to the STOMP intervention and Usual Care 
(UC) conditions. Our study statistician, Dr. Long, will use SAS to generate the 
randomization scheme stratified by whether the participant is on long-term opioid therapy 
(taking prescribed opioids for at least 3 months) and whether they have chronic multisite 
pain (pain in at least 3 locations or pain all over). Importantly, the PIs and outcomes 
assessors will be blinded to intervention vs. comparison allocation. Participants in the 
intervention and comparison conditions will have full access to all available clinical 
services at their respective sites. 
d) INTERVENTION 
The intervention group will receive “treatment as usual” plus the STOMP behavioral 
intervention. The “treatment as usual” refers to the standard of care that patients receive 
at the UAB and UNC clinics. This standard of care is for patients to discuss chronic pain 
with their providers at their discretion. Although highly variable, providers can 
recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-
pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain.  This 
study will not interfere in any way with usual care. 
 

 
 
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The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 
individual sessions). The sessions will be completed over a period of 12-16 weeks from 
enrollment. The first intervention session will be a group session for all participants 
followed by individual and then alternating group and individual sessions for the rest of 
the intervention. The intervention group will utilize a study manual on pain management 
in which they will use with each session.  
 
Group intervention Sessions 
A total of 6 group sessions will be conducted over a period of 12-16 weeks from study 
enrollment date. These sessions will be led by a peer. A peer is an HIV-infected patient 
of the UAB or UNC clinics living with chronic pain and is a successful self-manager of 
his/her chronic pain. Peers will receive training that will include being a participant in all 
one-on-one sessions, and additional training to co-facilitate the six group sessions with 
the interventionist. Prior to the beginning of the first group session, participants will sign 
an Agreement of Confidentiality. 
 
Participants will receive a reminder call/text approximately 48 hours before the group 
session to remind them of the upcoming session by the peer interventionist. If the 
participants cannot be reached on first contact, the peer interventionist will conduct up to 
three reminder calls or texts before the group session.  Participants will also be notified 
of the upcoming group sessions at the end of each one-on-one intervention.  Group 
sessions will be conducted in designated clinics at UAB and UNC. A sign-in sheet will be 
used to document attendance. Session notes will be used to document any major issues 
presented or any anecdotal nuances identified. The date, start time and end time of the 

 
 
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session will also be documented. Participants will complete an anonymous session 
feedback form at the end of each session. Each session will be audio recorded and 
transcribed later using a third party.  
 
Individual Intervention Sessions 
A total of 6 individual sessions will be conducted over a period of 12-16 weeks from study 
enrollment date.  
 
Each individual intervention session will be scheduled by the staff interventionists 
preferably prior to next group session.  The intervention date and time will be recorded 
on the Individual Intervention Session Form along with the intervention no. and topic. The 
participant will receive a reminder communication about the upcoming session 
approximately 48 hours before the session. An Intervention Session Form will be used to 
record the date, time, length of session, topic covered, homework, next steps, and any 
nuances identified during the session. An adverse event form will be completed if any 
physical, social or psychological issues arise a result of participating in this study and 
warrant immediate attention. The date of the next group session will be announced and 
the date of the next one-on-one session will be recorded at the bottom of the Intervention 
Session Form. Participants will complete a-session feedback form at the end of each 
session. Each session will be audio recorded. Selected sessions will be reviewed by a 
member of the research team not participating in the session for fidelity using the fidelity 
checklist (see Fidelity, below). 
 
Reminder calls 

 
 
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Study staff will conduct up to 3 reminder calls to remind about their upcoming intervention 
session. Please note the purpose of these calls is to remind about appointments but in 
case patient initiates the conversation regarding intervention or other related to the study 
staff will talk to participant regarding intervention.   
 
We will implement a series of best practices if a participant misses a session. This will 
include contacting the participant within a day of the missed session to schedule a make-
up session in-person or by phone depending on the participant’s preference; during that 
session, engaging in problem-solving as to why they missed the session and what 
barriers they envision going forward, and how those barriers might be addressed; and 
allowing participants to phone into group and individual sessions if needed. If there are 
things we can do to help that are reasonable (e.g., more reminders, more transportation 
assistance, or other things), we will provide them. Additionally, if they miss more than one 
visit, they may receive a call asking about their future participation in the study and 
whether, if they are unwilling to participate in intervention sessions, they would be willing 
to just complete outcome assessments. 
Assessments 
All participants in the intervention group will also receive a REDCAP assessment at 
baseline, post-intervention (0-month, after all sessions are completed), and then at 3, 6, 
9 and 12 months post-intervention. The primary outcome will be at 3 months, and a 1-
month window will be allowed after each timepoint for the patient to be contacted and 
assessed. An important medical event form will be administered to each participant at 
post-intervention (0-month) to screen for any unexpected medical incident, the severity 
of the event, its relation to the study, and medical follow-up. Viral load will also be 

 
 
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collected at baseline and at 12 months. At baseline, if a viral load from the prior 6 months 
is available in the medical record, that value will be recorded; otherwise, a viral load will 
be drawn. At 12 months, if a viral load in the prior 3 months is available in the medical 
record, that value will be recorded; otherwise, a viral load will be drawn. We will continue 
to conduct assessments every six months until the end of the study for all participants 
who complete the intervention by the beginning of Year 3. Participants who completed 
the baseline assessment by April 30, 2021 will continue to receive outcome assessments 
until April 2023 for a maximum of 41 months or 3 years. These assessments may be 
conducted by phone, if necessary, or in person. They will also participate in an audio-
recorded in –person qualitative interview at the mid-point and end of the trial which will 
be transcribed using a third party company.   
 
We will also investigate the intervention’s impact on use of prescribed and non-prescribed 
opioids. Study staff will ask at each baseline and outcome assessment (0,3,6,9,12) the 
name of the participants’ pharmacies along with the list of their current medications and 
dosage. Study staff will print out the medication lists and review it against the Opioid 
Medication Resource to identify the prescribed opioids. With written consent and a signed 
release of information from participants, a study staff member will contact the participants’ 
pharmacy (or pharmacies) at the12- month assessment to verify the self-reported 
information provided by the participants in the prior assessments.  The data will be added 
into an excel spreadsheet for collection and analysis.  Participants will receive up to 3 
reminder calls at about a week and 48 hours prior to the next outcome assessment. 
 
Qualitative interviews 

 
 
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Participants assigned to intervention arm, peers and interventionists of the study will be 
interviewed at mid-point of the study and end of the study to provide their feedback on 
the STOMP intervention. These interviews will be audio-recorded and later transcribed 
using third party. Participants will be compensated $50 for each of the qualitative 
interviews.  
 
e) COMPARISON CONDITION 
The comparison group will receive “treatment as usual” as described above.  The 
comparison group will also be provided with the intervention manual, however, no 
additional treatment will be provided to participants allocated to the control group.  
 
 
 
 
Assessments 
The comparison group participants will complete the post-intervention (0-month) follow-
up at the same timing of the intervention group (12 - 16 weeks) after the 1st intervention 
session., and then will complete the outcome assessments (3,6,9,12) as the intervention 
group as described above including the baseline and the 12-month viral load 
assessments, and the important medical event screening at post-intervention. We will 
continue to conduct assessments every six months until the end of the study for all 
participants who complete the baseline assessment by the beginning of Year 3. 
Participants who completed the baseline assessment by April 30, 2021 will continue to 

 
 
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receive outcome assessments until April 2023 for a maximum of 41 months or 3 years. 
These assessments may be conducted by phone, if necessary, or in person.  
We will also investigate the intervention’s impact on use of prescribed and non-prescribed 
opioids. Study staff will ask at each outcome assessment (3,6,9,12) the name of the 
participants’ pharmacies along with the list of their current medications and dosage. Study 
staff will print out the medication lists and review it against the Opioid Medication 
Resource to identify the prescribed opioids. With written consent and a signed release of 
information from participants, a study staff member will contact the participants’ pharmacy 
(or pharmacies) at the12- month assessment to verify the self-reported information 
provided by the participants in the prior assessments.  The data will be added into an 
excel spreadsheet for collection and analysis.    Participants will receive up to 3 reminder 
calls at about a week and 48 hours prior to the next outcome assessment. 
 
 
f) PEER INTERVENTIONISTS  
As a peer interventionist, they will lead the intervention groups.  Having peers 
facilitate the intervention groups fosters relationships with the participants since both 
groups share similar experiences. Peer interventionists will be compensated $500 for 
the initial training time and an additional $1,500 per the intervention block.  
Each participating site will employ up to three peer interventionists for the group 
sessions. Peers should be living with HIV and be good pain self-managers. They 
must be mature, personable, highly responsible, with good communication skills and 
be able to follow rules of confidentiality. Potential peers may be identified by the 

 
 
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healthcare team or self-referrals and will be interviewed by research staff.  They will 
not have contact with external institutions until officially hired.  
During each 16 week cycle, one peer will serve as the lead interventionist and will 
co-facilitate (along with the staff interventionist) a group of ten participants; the other 
two (at sites when more than one peer is hired) will serve as first and second backup. 
The lead and first (active) back-up should attend all 6 group sessions.  The second 
back-up will be utilized in the event a peer decides to drop out of the study.  
Determination of which two peers to start the intervention will be based on their 
scheduling preference. Research staff will conduct periodic check-ins to the active 
and (inactive) back-up to ensure he/she remains engaged in the study. 
Peers will be responsible for the following activities.  
Lead peer 
1. Complete IRB and Good Clinical Practice certification 
 
2. Participate in a 2 day STOMP training on pain self-management on an annual basis 
 
3. Participate in 2 – 5 individual training sessions and 2 mock group sessions with staff 
intervention prior to start of intervention 
4. Co-lead 6 one hour group sessions over a 12 - 16 week period for three years (arrive 
30 minutes before and stay 30 minutes after) and attend weekly debriefing calls  
5. Conduct reminder calls for the group sessions and provide phone-based peer support 
to intervention participants (as needed, during scheduled time)  
6. Lead peer interventionist could work approximately 2 - 5 hours per week during each 
intervention cycle  
First Backup peer 
1. Complete IRB and Good Clinical Practice certification 

 
 
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2. Participate in a 2 day STOMP training on pain self-management on an annual basis 
 
3. Participate in 2 – 5 individual training sessions and 2 mock group sessions with staff 
intervention prior to start of intervention 
4. First back-ups will listen to and debrief about audio from group sessions as part of 
their continuous training which will occur monthly 
5. Attend all 6 group sessions  (arrive 30 minutes before and stay 30 minutes after) 
6. First back-ups could work approximately 2 hour per week or less during each 
intervention cycle 
Second Backup peer 
1. Complete IRB and Good Clinical Practice certification 
 
2. Participate in a 2 day STOMP training on pain self-management on an annual basis 
3. Participate in 2 – 5 individual training sessions and 2 mock group sessions with staff 
intervention prior to start of intervention 
4. Second back-ups will listen to and debrief about audio from group sessions as part of 
their continuous training which will occur twice during each 12 – 16 week period 
5. Second back-ups could work approximately 1 hour per week or less during each 
intervention cycle 
Payment Schedule 
1. All peers will be compensated $500 for each annual 2 day STOMP training  
2. The Lead peer will be paid $1,500 for each intervention period in which they serve as 
a lead 
3. First and Second backup peers will be compensated at an hourly rate for study 
activities 

 
 
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RETENTION PROCEDURES 
Several procedures will be implemented to optimize retention and ensure participant 
comfort while participating in both study arms. At all study visits, both intervention and 
follow-up, participants will be offered a beverage and snacks. In addition, for intervention 
group participants only, participants who are in need of transportation will be provided 
transit vouchers to attend intervention group and one-on-one sessions.  (but not outcome 
assessments). In addition, we will have mid-study calls to confirm contact info in the UC 
group.  
If a participant misses a session, study staff will contact the participant within one day of 
the missed session to schedule a make-up session either in-person or by phone based 
on the participant’s preference.  During the make-up session, study staff will engage in 
problem solving skills to address barriers that limited participant’s attendance.  
 
g) FIDELITY ASSESSMENTS 
We will use a structured fidelity assessment tool developed by the study PI and 
psychologist consultant Dr. William Demonte. To assess one-on-one session fidelity 
across interventionists, time, and sites, we will audio record sessions. Initially, we will 
listen to and rate all one-on-one sessions. Once an interventionist completes five 
consecutive sessions with 80% fidelity, we will “certify” the interventionist as having the 
competence necessary to continue to conduct the intervention. Thereafter, a blinded 
assessor with intervention delivery experience trained by Dr. Demonte will review a 10% 
random sample. We will also provide ongoing supervision to prevent interventionist drift. 
We will monitor treatment receipt by using a checklist, which will capture whether 

 
 
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participants have used their tracking logs (which will be photocopied at each session by 
the staff interventionists). Given the less structured format of the group sessions, they 
will be assessed for knowledge sharing between the peers and participants and among 
participants, reflection on one-on-one session content, and fostering social support. 
 
h) COLLECTION OF COST DATA 
Each site will be responsible for tracking the following items in real-time: up-front training 
hours, cost of snacks, travel vouchers and participant manuals.  Individual and group 
sessions will be tracked using the audio-record capability.  
 
i) COLLECTION OF CNICS DATA 
Center for AIDS Research Network of Integrated Clinical Systems  (CNICS) Data:  
CNICS data will be collected from abstractions from site medical record databases in 
collaboration with the CNICS data collection and patient reported outcomes infrastructure. 
Clinical and medical history data will include HIV viral load, CD4+ T-cell counts, co-morbid 
conditions, HIV primary care visit adherence, and medications.  HIV primary care visit 
adherence will be extracted on all HIV care visits from the date of enrollment until the end 
of the study. Data from CNICS Patient Reported Outcomes (PRO) questionnaires 
including assessments of pain will be identified by study code and managed in 
accordance with CNICS electronic storage and data transfer guidelines. 
 
j) TRACKING OF STUDY PATIENTS 
Study staff will use the study’s RedCap database to capture reminder calls, study visits, 
assessments, and intervention activities.  Study staff will use excel logs to capture 

 
 
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prescreening, enrollment, randomization, timeline/window of outcome assessments, 
status of assessments, reminder call status for assessments and pharmacy data.. All 
study staff will be trained in Human Subjects Protections, and this data will be handled 
in accordance with CNICS electronic storage and data transfer guidelines. 
 
Study staff will also review data entered in RedCap on a weekly basis as a quality 
assurance measure. The program manager at the University of Pittsburgh will provide 
oversight of data quality and will conduct monthly audits.  
 
k) MANAGEMENT AND INTEGRATION OF UAB AND UNC SITES 
Study PI Dr. Merlin and Program Director Alissa Eugeni will conduct regular in-person 
visits to each site. Additionally, there will be a weekly video Skype meeting with Dr. Merlin, 
Ms. Eugeni, and local study staff and site PIs at UAB and UNC. The purpose of these 
weekly meetings will be to track progress with study milestones, troubleshoot issues that 
may arise, and discuss any adverse events. 
 
l) Assessment Table  
 
STOMP 
 
Data Collection 
Instrument  
Pre-
Baseline 
(1) 
Baseline 
(2) 
0 
Month 
Post 
(3) 
3 
Month 
Post 
(4) 
6 
 Month 
Post 
(5) 
9 
 Month 
Post 
(6) 
12 
Month 
Post 
(7) 
LT 
Assessment(s)
(8) 
SECTION I 
 
 
 
 
SECTION II 
 
 
 
 
SECTION III 
 
  
 
 
 
 
 
 

 
 
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SECTION IV 
 
 
 
 
 
 
 
 
SECTION V 
 
 
 
 
 
 
 
 
SECTION VI 
 
 
 
 
 
 
 
 
SECTION VII 
 
 
 
 
 
 
 
 
 
m) SNAP SHOT OF STUDY ACTIVITIES 
Procedure 
Length of Time 
Required of 
Participants 
Frequency of Repetition 
Individual sessions 
(intervention group only) 
6 sessions, up to 
approx. 60 
minutes each 
Maximum of on average every 
other week 
Group sessions 
(intervention group only) 
6 sessions, up to 
approx. 60 
minutes each 
Maximum of on average every 
other week 
REDCAP assessments – 
see attached  
Approx 30 
minutes 
Baseline, (0-month), 3,6,9 and 12 
months after intervention, and 
every 6 months until the end of the 
study for all participants who 

 
 
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complete the intervention by the 
start of Y3 
Mid-study calls  
(comparison group) 
Approx 5 min 
 8 weeks after the beginning of the 
intervention   
Viral load assessment 
Approx 15 
minutes 
Baseline and 12 month 
assessment visit 
Qualitative interviews 
(peers, intervention 
group only) 
Approx up to 
120 minutes 
 
After 6 sessions are completed 
and after all 12 sessions are 
completed 
Pre-screen reminder 
calls 
Approx 5 
minutes 
48 hours before pre-screening in-
person visit 
One-on-one and group 
reminder calls (peers, 
intervention group only) 
Approx 5 
minutes 
Up to three reminder calls before 
the scheduled intervention date 
Reminder calls at 
0,3,6,9, 12 month-
assessments, and every 
6 months thereafter, if 
applicable 
Approx 5 
minutes 
Up to three reminder calls,, 1 week 
prior to and 48 hours prior to 
scheduled assessment date. 
 
 
n) SUMMARY OF COMPENSATION 
Intervention group 

 
 
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In person for Prescreen 
 
 
 
$25  
Screening/Enrollment (Baseline) visit 
 
$50 
Mid-point qualitative interview 
 
 
$50 
End of study qualitative interview  
 
$50 
0, 3, 6, 9 and 12-month assessments 
 
$50 each 
Longer term assessments (18, 24, 30, 36,41)   $50 each 
Control group 
In person for Prescreen 
 
 
 
$25 
Screening/Enrollment (Baseline) visit 
 
$50 
0, 3, 6, 9 and 12-month assessments 
 
$50 
Longer term assessments(18, 24, 30, 36,41) 
$50 each 
 
IV. 
DATA COLLECTION AND MANAGEMENT 
All study documentation will be kept in locked file cabinets in in study personnel’s offices 
at UAB and UNC. RedCap database can only be accessed by STOMP personnel using 
UAB and UNC computers or encrypted laptops. 
 
V. 
DATA ANALYSIS 
A separate document will be submitted by the PI of the study for the statistical analysis 
plan.  
 
VI. 
CRISIS PROTOCOL 
As a general note, referrals can be made for crisis consultation at any time.  The research 
staff will document the findings of his/her evaluation and the course of action taken.  

 
 
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Providers for the patient may be informed about the same. If it becomes apparent during 
data collection that a patient is in danger, is suffering, or is at risk for developing a clinically 
relevant physical or mental health condition (e.g., depression, suicide, self-injurious 
behaviors), relevant staff in the local clinic (e.g., professional mental health counselors, 
social workers, and nurses/providers) will be notified and standard procedures already in 
places in each clinic for ensuring the physical and mental wee-being of patients will be 
followed (e.g., intervening and/or providing appropriate referral, as indicated).  
 
VII. 
PROTECTION OF HUMAN SUBJECTS 
Our team has devised a comprehensive plan for ensuring protection of human subjects 
throughout the course of the proposed study. We will utilize an English-language consent 
form with common phrasing that describes that no special privileges or considerations will 
be conferred as a result of study participation, and that access to medical care will not be 
affected by the potential participant’s decision to enroll in the study. The procedures listed 
in the following sections detail procedures that have been approved and utilized during 
recent years of clinical and behavioral trials at each site for collaborative research that 
utilizes sensitive information from participants. Our team will make every effort to protect 
all participants’ confidential and private information in order to minimize possible study-
associated risks.  
 
All findings related to this research will be available and provided to study participants in 
accordance with standard practices. Clinical and measurement data used for research 
studies will be released only in de-identified fashion. 
 

 
 
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In addition, all study personnel are required to renew Human Subjects trainings annually, 
or in accordance with their site regulatory mandates.  
 
VIII. 
KEY PERSONNEL AND ROLES 
Principal Investigators: 
Jessie Merlin 
 
Principal Investigator     
 
University of Pittsburgh 
Jane Liebschutz  
Co-Investigator    
 
 
University of Pittsburgh 
Michael Saag                  Co-Investigator    
 
 
University of Alabama at Birmingham 
Michael Mugavero          Co-Investigator     
 
 
University of Alabama at Birmingham 
Dustin Long 
 
Co-Investigator    
 
 
University of Alabama at Birmingham 
Olivio Clay                     Co-Investigator    
 
 
University of Alabama at Birmingham 
Sonia Napravnik 
Co-Investigator    
 
             University of North Carolina at Chapel Hill  
Amy Durr 
             Co-Investigator                                       University of North Carolina at Chapel Hill 
Claire Farel 
             Co-Investigator                                       University of North Carolina at Chapel Hill
 
 
 
Research Team: 
Bernadette Johnson             Program Director 
     
            University of Alabama at Birmingham 
Tammi Thomas     
     Coordinator, Outcome Assessor,         University of Alabama at Birmingham                              
                                             2nd B/U Interventionist                        
 
Kiko S. King 
 
      Interventionist                            
 University of Alabama at Birmingham 
Nashira Brown        
      1st B/U Interventionist               
 University of Alabama at Birmingham       
Mark Butler 
 
      Recruiter                               
 University of Alabama at Birmingham 
D’Netria Jackson 
      Outcomes Assessor          
 
 University of Alabama at Birmingham 
Alfredo Guzman 
      Informatics Director            
 University of Alabama at Birmingham 
Satinder Kaur                    Programmer 
     
 
 University of Alabama at Birmingham 

 
 
25 
 
Suneetha Thogaripally         Data Analyst 
 
            University of Alabama at Birmingham 
Chastity McDavid 
      Qualitative Interviewer             
 University of Alabama at Birmingham 
TBD 
 
 
      Research Staff   
 
              University of North Carolina at Chapel Hill 
Kuo-Ping Li 
 
      Data Manager UNC                           University of North Carolina at Chapel Hill 
Alissa Eugeni        
      Project Manager                                  University of Pittsburgh 
 
 

© 2024 American Medical Association. All rights reserved. 
Statistical Analysis Plan 
Study Design & Objectives.  Our overall objective is to evaluate a novel theory-based PSM 
intervention, “Skills TO Manage Pain” (STOMP) developed for people with HIV (PWH). The 
design of the proposed study is a multicenter parallel-group individually randomized group 
clinical trial. The primate outcome is to evaluate the efficacy of STOMP, a theory-based 
intervention tailored to improving chronic pain in PWH immediately post intervention. The 
secondary outcomes are to investigate additional pain outcomes and proximal outcomes as 
potential mediators of STOMP’s impact on chronic pain immediately post intervention and at 3 
months.  
The study will be conducted at 2 institutions in the United States (University of Alabama at 
Birmingham (UAB) and University of North Carolina at Chapel Hill (UNC)), and we will enroll 
adult patients, ages >18 years of age, consented to participate in the CFAR Network of 
Integrated Clinical Systems (CNICS), English-speaking, having at least moderate chronic pain, 
ability and willingness to attend the group sessions at the date/time specified, and no plans for 
major surgery during the study period that would interfere with study procedures. 
The primary hypothesis is STOMP will decrease pain severity and improve function (as 
measured by BPI-total) in PWH. To test this hypothesis, we propose a two-arm randomized trial 
of STOMP vs. an enhanced usual care comparison condition.  Our primary outcome will be Brief 
Pain Inventory (BPI)-Total score and will be measured at baseline and immediately post-
intervention (~12 weeks after first intervention session). Our secondary outcomes will be 
changes in additional pain scales (PEG and BPI subscales of BPI-pain severity and BPI- 
interference), pain self-efficacy questionnaire (PSEQ), Patient Health Questionnaire (PHQ-8), 
and pain catastrophizing scale (PCS) between groups immediately post intervention. We will 
examine sustained differences in primary and secondary outcomes at 3 months post intervention.  
Sample Size Calculation. Our primary outcome is the BPI-Total score as described above. 
Given that 20 participants progress through the study at a time, our total sample size should be 
divisible by 20. A sample size of 210 will provide 85% power to detect a difference of 1 on a 10 
point scale with at standard deviation of 2.4 assuming a two-sample t-test with equal variance. 
The IMMPACT guidelines suggest that a change of 1 on the BPI is a minimum clinically 
significant difference. Additionally, the difference we found in our pilot trial was 1 (SD=2.4). 
Therefore, a sample size of 210 is sufficient to detect this effect size. To become divisible by 20 
and allow for 25% dropout (slightly more than in the pilot trial) we will recruit 280 participants 
With our anticipated sample size, we will be able to estimate a margin-of-error of 1.5 percentage 
points for 95% intervals. For secondary outcomes, we can detect an effect size of 0.4, a medium 
effect, for continuous measures and a difference of proportions between 7.5% and 17% for 
binary measures, each with 85% power.  
Interim & Final Analyses.  We will not have any planned interim looks for stopping for 
efficacy, although safety and tolerability data will be monitored by the study DSMB at each 
meeting. The final analyses will be conducted once study follow-up is complete, after all data is 

 
 
 
 
© 2024 American Medical Association. All rights reserved. 
cleaned, and once the study database is locked. We anticipate database lock will happen by 
February 2024 with completion of primary analyses occurring by March of the same year. 
 
 
Analysis Sets. The full analysis set will be based on an intention-to-treat (ITT) analysis with a 
per-protocol (PP) sensitivity analyses. The ITT analysis set will comprise all participants who 
have been randomized to either study arm, regardless of length of follow-up or actual 
intervention received.  
 
Endpoint and Covariates 
 
Our primary outcome will be the Brief Pain Inventory (BPI)-Total score, a commonly used 
composite measure of pain severity and the impact of pain on an individual’s function. The BPI 
asks 11 questions about pain severity (pain at its worst, least, average, and right now) and the 
interference of pain in several aspects of patients’ lives (activity, mood, walking ability, work, 
relations with other people, sleep, and enjoyment of life) on a scale of 0 (no pain/does not 
interfere) to 10 (pain as bad as you imagine/completely interferes). The BPI-Total score is the 
average score across all 11 questions. 
 
 
There were no covariates included in our models, only time and treatment group indicator.  We 
used linear mixed effects models which do not require adjustment for baseline as a fixed effect as 
it is included as an outcome.  This allows for estimation of treatment effects at all follow-up 
times that takes into account any baseline differences between groups.  
 
Handling of Missing Values. As a preventive measure, we will make every attempt to document 
all reasons for missing data. In addition, baseline characteristics will be compared between 
participants who do and do not withdraw from the study as a way to assess the impact of missing 
information and attrition. We will also compare the rates of lost-to-follow-up (LTF) between 
study arms. 
 
Our general assumption will be that missing data is of the Missing at Random (MAR) 
mechanism. In this case, the use of linear mixed models for the primary analysis will be 
sufficient in reducing the impact that missing data has on biasing the primary results. 
Additionally, we will conduct a sensitivity analysis using multiple imputation via chained 
equations (MICE) to see how robust the overall inferences are.  
 
 
Statistical Analyses.  
The primary outcome – BPI-Total score – and the other secondary outcomes will be assessed as 
continuous variables. Linear mixed effects models will be performed to test differences between 
intervention and control conditions at the immediate post intervention and at 3 months. Models 
will include random effects for participant and therapy group.  Therapy group is an identifier of 
the group of 20 that were randomized to create a STOMP group of 10.  Fixed effects will be 
STOMP indicator, time and STOMP by time interaction.  The primary hypothesis will be tested 
using the least squared means of each group at each time.  We will check distributional 

 
 
 
 
© 2024 American Medical Association. All rights reserved. 
assumptions for these models using residual analysis including studentized residuals for 
individual observations, PRESS residuals which are composite residuals across an individual in 
longitudinal analysis, and Cook’s distance. In compiling our analysis set, we will use an 
Intention to Treat (ITT) approach. We chose ITT for two reasons: 1) it fully exploits the benefits 
of balancing through randomization by including all patients who are randomized in the analysis; 
2) it is a more “real-world” assessment of the intervention’s impact as it allows for incomplete 
adherence and includes participants who may unintentionally cross over from the control to the 
intervention condition. Each of these issues can be handled well within the linear mixed models 
that will allow investigators to plot model-predicted trajectories for individuals with incomplete 
data. An additional advantage of linear mixed models is that they do not assume that the time 
between assessments is fixed and data for individuals who miss a time point can still be included. 
However, as this is the first efficacy trial to investigate STOMP, we will also conduct a per-
protocol/as treated sensitivity analysis to understand the impact of the intervention without these 
complicating factors and adjust for differences by site. As a sensitivity analysis, missing data will 
be examined using multiple imputation methods. Specifically, multiple imputation using chained 
equations will be performed using previous baseline outcome data.  Data will be imputed 
separately for each treatment group to improve efficiency and reduce bias in the treatment effect 
estimate.1 Response to treatment defined by a reduction of at least 30% BPI Total score will be 
compared between groups using generalized linear mixed models with binary outcome using the 
same model effects and random components as the primary analysis.   
 
Reference 
1. 
Sullivan TR, White IR, Salter AB, Ryan P, Lee KJ. Should multiple imputation be the 
method of choice for handling missing data in randomized trials? Stat Methods Med Res. Sep 
2018;27(9):2610-2626. doi:10.1177/0962280216683570