Development of a Behavioral Intervention for Chronic Pain in Individuals With HIV
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Pittsburgh

                                                        
 
 
 
 
                                                                                            
 
Development of a Behavioral Intervention for Chronic Pain in Individuals With HIV  
NCT02824562 
 
 
 
 
STUDY PROTOCOL 
 
 
Version 1.0 
Sep, 2017 
 
 
 
 
 
Send Questions or Comments to: 
Jessica Merlin merlinjs@pitt.edu 
Riddhi Modi rmodi@uabmc.edu 
 
 
 
 
 
 
 
 

 
 
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I. 
STUDY OVERVIEW 
 
Defined as pain lasting longer than three months, chronic pain affects up to 30% of the 
US population. It often occurs in patients with complex chronic illness, including 
medical, psychiatric, and substance use comorbidities. However, chronic pain is not 
simply a symptom of these comorbidities. Its distinct neurobiologic basis and substantial 
impact on physical and emotional function make it a serious illness in itself. In 
recognition of its importance, the Institute of Medicine has called chronic pain a “public 
health crisis,” and identified research on chronic pain, particularly in populations most 
burdened by this condition, to be a priority.  
The burden of chronic pain in HIV-infected patients is substantial. Prevalence estimates 
of chronic pain in HIV-infected patients are as high as 39-85%. Mounting evidence 
suggests that chronic pain in HIV is often associated with psychiatric illness, especially 
mood disorders such as depression, and has serious health consequences, including 
up to 10 times greater odds of functional impairment.  
Non-pharmacologic, behavioral interventions to decrease pain and improve physical 
and emotional function in HIV-infected patients with chronic pain are needed. A 
consensus panel identified pain, physical, and emotional function to be the most 
important outcomes of chronic pain interventions. Commonly used pharmacologic 
therapies, including opioids, often do not result in substantial improvement in these 
outcomes, and carry risks including misuse, abuse, and addiction. In HIV, opioids may 

 
 
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actually be associated with worse pain, and adversely interact with antiretrovirals. 
Behavioral interventions are among the most effective and safe non-pharmacologic 
treatments for chronic pain in the general medical population. 
II. 
OBJECTIVES 
In this study we will conduct a two-arm pilot randomized controlled trial of the chronic 
pain behavioral intervention to investigate feasibility, acceptability, and when possible, 
preliminary impact. 
III. 
STUDY ACTIVITIES 
a) STUDY POPULATION  
A total of 40 patients (up to 60) who are patients at the UAB 1917 clinic, 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. Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least 
moderate pain for at least 3 months) 
4. Moderately severe and impairing chronic pain (PEG pain questionnaire = 
average of all three times is 4 or greater) 
Exclusion Criteria 
1. Do not speak or understand English 
2. Are planning a new pain treatment like surgery 

 
 
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3. Cannot attend the group sessions 
Recruitment of participants will take place in the 1917 clinic. Participants will be 
recruited via word-of-mouth by clinic staff or providers, calls generated from flyer tear-
offs, and responses to the flyer on the TV monitors. 
b) PRE-SCREENING 
Potential participants will be prescreened over the phone using our prescreening phone 
script. 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 
preferred method of contact will be recorded on the Prescreening Visit Appointment 
Form.  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.  
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. At the end of the prescreen, the research tech 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. The participant will also be 
thanked and given their $25 incentive. 
 If the participant is not eligible, he or she will be thanked for their time and give their 
$25 incentive.  
c) SCREENING AND ENROLLMENT 

 
 
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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 
scheduled screening visit. At the beginning of the screening and enrollment visit, the 
participant will complete the informed consent process.  
Informed Consent Procedures 
Informed consent will be administered by staff trained in accordance to the University of 
Alabama at Birmingham 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 

 
 
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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.  
Following completion of the baseline assessment, participants will be thanked for 
coming and given their $50 incentive payment for their time. Completion of Baseline 
assessment will be recorded in excel logs. 
d) RANDOMIZATION 
Our team will utilize a 1:1 ratio for allocation to the treatment and control arms at each 
participating site. The UAB statistician will generate a list of random arm assignments 
for each site. Randomization list will be provided to the study coordinator to create 
sealed envelopes with participant ids on it in chronological order. 
Once the participant completes the enrollment procedures, study staff will open the 
sealed envelope and will show the random arm assignment to participant and record it 
in the excel logs.  
e) ASSIGNMENT OF ARM OF STUDY 
Approximately, 20 intervention arm and 20 control (standard of care) participants will 
be randomly assigned. Recruiting staff and research personnel will be masked to 
treatment arm assignment at the initial study visit. After the initial study visit, study 
coordinator will inform the participant of the follow-up assessments and thank the 
participant for their time. Staff personnel doing the assessment will still be blinded to 
the arm assignment. 
If the participant is randomized to the intervention group, the participant will be informed 
of the next steps which includes the first group session.  If the date of the first group 

 
 
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session has been established, the participant will be informed of the date and time. If it 
has not been scheduled, the participant will be informed that s/he will receive a call 
within the next two weeks informing his/her with the date and the time of the first group 
session 
f) INTERVENTION 
This 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 session for the rest of 
the sessions.  
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 1917 Clinic living with chronic pain, who has completed all ten of the one-on-
one sessions offered, received training to co-facilitate the six group sessions with the 
interventionist, and is successfully self-managing his/her chronic pain. 
Participants will receive a reminder call/text approximately 48 hours before the group 
session to remind them of the upcoming 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 UAB 1917 clinic building or the Bevill Biomedical Research Building 
(BBRB). 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 session will also be documented. Participants will 

 
 
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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 interventions 
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 an anonymous session feedback 
form at the end of each session. Each session will be audio recorded and later 
transcribed using a third party. 
Each session will be reviewed by a member of the research team not participating in the 
session for fidelity using the fidelity checklist. 
Reminder calls 
Study staff will conduct up to 5 reminder calls to remind about their upcoming 
intervention session. Please note the purpose of these calls is to remind about 

 
 
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appointments but in case patient initiates the conversation regarding intervention or 
other related to the study staff will talk to participant regarding intervention.   
If a participant misses a session, they will receive up to 5 reminder calls asking why and 
what we can do to help. 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. 
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 willing to just complete outcome assessments. 
Assessments 
All participants in the intervention group will also receive a baseline, post-intervention 
(after all sessions are completed), and at about 3 months (1 month leeway) 
assessment. These may be conducted by phone 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. 
Qualitative interviews 
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.  
g) CONTROL 
The control group will receive “treatment as usual”.  The “treatment as usual” or control 
arm refers to the standard of care that patients receive at the UAB 1917 clinic. This 
standard of care is for patients to discuss chronic pain with their providers at their 

 
 
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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. No additional treatment will be provided to 
participants allocated to the control group. The control group participants will complete 
the baseline assessment and around 12 week follow-up (1 month leeway) assessment. 
h) 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. 120 minutes 
each 
Maximum of on average 
every other week 
Group sessions 
(intervention group only) 
6 sessions, up to 120 
approx minutes each 
Maximum of on average 
every other week 
Questionnaire 
assessments – see 
attached 
Approx 30 minutes 
Baseline, end of intervention, 
and 3 months after 
intervention 
Qualitative interviews 
(intervention group only) 
Approx up to 120 
minutes 
Midpoint and end of trial 
Phone calls (intervention 
group only) 
Approx up to 30 
minutes 
Average of once weekly 
 

 
 
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h) SUMMARY OF COMPENSATION 
Intervention group 
In person for Prescreen 
 
 
$25 
Screening/Enrolment visit  
 
$50 
Mid-point qualitative interview 
 
$50 
End of study qualitative interview  
$50 
Post intervention follow up  
 
$50 
3 month follow up 
 
 
 
$100 
 
Control group 
In person for Prescreen 
 
 
$25 
Screening/Enrolment visit  
 
$50 
12 week assessment 
 
 
$50 
3 month follow up 
 
 
 
$100 
Offer parking vouchers/coffee vouchers/bus tickets etc. as required to the participants if 
that is the standard practice followed over at the clinic.  
IV. 
DATA COLLECTION AND MANAGEMENT 
All study documentation will be kept in locked file cabinets in BBRB or CCB in study 
personnel’s offices. RedCap database can only be accessed by STOMP personnel 
using a UAB computer or encrypted laptop. 
V. 
DATA ANALYSIS 
Outcomes were reported as means and standard deviations for continuous 
variables, and frequencies and percentages for categorical variables. T-tests 
were used to compare change scores for continuous variables and Fisher’s exact 

 
 
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tests were used to compare percentages. Interviews were analyzed thematically 
by two independent coders. Discrepancies were reconciled, a code book was 
created, and the lead analyst coded the remaining transcripts with continued 
input from the other coder. Representative quotes are presented for themes that 
helped us understand why and how the intervention could work.   
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.  Providers for the patient may be informed about the same. 
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: 
Jessica Merlin 
 
 
 
Principal Investigator 
 
 
 
 
Research Team: 
Riddhi Modi  
 
 
Coordinator 
Chastity McDavid 
 
 
Coordinator 
Sally Shurbaji 
 
 
Interventionist 
King, Kiko S.  
 
 
Interventionist 
Banasiewicz, Mary K 
 
Research Technician 
Hutchins Katelin K  
 
Research Technician 
Megan Couture 
 
 
Research Technician