Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV
Phase: NA
Conditions: HIV
Sponsor: The Miriam Hospital

 
 
 
Study Name: 
HEALTH IMPROVEMENT PROJECT – PROVIDENCE (HIP-P) 
 
NCT Number: 
NCT02886234 
 
Grant Title: 
MINDFULNESS TRAINING TO IMPROVE ART ADHERENCE AND 
REDUCE RISK BEHAVIOR AMONG PERSONS LIVING WITH HIV 
 
Grant #: 
R34AT008930 
 
Date of Document: 
March 27, 2017 
 
Principal  
Investigators: 
Michael P. Carey, PhD and 
Elena Salmoirago-Blotcher, MD, PhD 
The Miriam Hospital 
Providence, RI 02906 
 
 
 
 
 

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Study 4 Protocol  
Exploratory Clinical Trial 
 
 
CONTENTS 
• 
Protocol 
• 
Appendices 
§ 
Mindfulness Training Protocol 
§ 
Health and Wellness Training Protocol 
§ 
Telephone-based Pill Count Protocol 
§ 
Qualitative Interview Guide  
§ 
Suicide Protocol 
 
 
 
 
 
 

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REVISION HISTORY 
Version Number:   
1.0  
Version Date: 
June 2, 2016 
 
Summary of Revisions Made:  Original Draft  
 
Version Number:  
2.0 
Version Date: 
June 30, 2016 
Summary of Revisions Made: Addition of personnel 
 
Version Number: 
3.0 
Version Date: 
August 25, 2016 
Summary of Revisions Made:  Addition of two personnel (Naomi Krieger and Cynthia Merly) 
and deletion of one (Gloria Mensah) 
 
Version Number: 
4.0 
Version Date: 
October 19, 2016 
Summary of Revisions Made: Addition of one personnel (Abbey Salvas) and deletion of one 
 
(Rebecca Eldridge); Modification to Appendix 4 Qualitative 
 
Interview Scripts 
 
Version Number: 
5.0 
Version Date: 
October 26, 2016 
Summary of Revisions Made    Addition of one personnel (Erin Sharaf); Modification to the 
 
screening questionnaire; Modification to the baseline measures; 
 
Modification to the follow-up measures. 
 
Version Number: 
6.0 
Version Date: 
February 7, 2017 
Summary of Revisions Made    Two recruitment strategies added; Consent modified to add time 
 
limits on completing baseline protocols and coaching sessions; 
 
Two week window for extenuating circumstances added to the 
 
time between completing baseline and starting coaching. 
 
Version Number: 
7.0 
Version Date: 
February 28, 2017 
Summary of Revisions Made    Definition of Project Director (PD) added to list of abbreviations 
 
and defined on the first reference in the text; Clarification of 
 
intervention materials. 
 
 
Version Number: 
8.0 
Version Date: 
March 17, 2017 
Summary of Revisions Made    Addition of one personnel (Dr. Philip Chan). 
 
 
Version Number: 
9.0 
Version Date: 
March 27, 2017 
Summary of Revisions Made    Removal of one personnel (Dr. Aadia Rana). 

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RESEARCH TEAM 
Michael P. Carey, PhD  
 
 
Principal Investigator 
Elena Salmoirago-Blotcher, MD, PhD 
Co-Principal Investigator 
Shira Dunsiger, PhD  
 
 
Co-Investigator/Biostatistician 
 
Rochelle Rosen, PhD   
 
 
Co-Investigator/Qualitative Expert 
Philip Chan, MD 
 
 
 
Co-Investigator/Infectious Disease Physician 
Seth Kalichman, PhD  
 
 
HIV Adherence Expert (Consultant) 
Carla Rich, MA, LMHC 
 
 
Project Director  
Christopher Breault, BS 
 
 
Data System Analyst 
Naomi Krieger, BA 
 
 
 
Research Assistant 
Lauri Klein, LICSW 
 
 
 
Mindfulness Instructor (Consultant) 
Erin Sharaf, MA, PA-C 
 
 
Mindfulness Instructor (Consultant) 
Eugene Dunne, MA 
 
 
 
Health Educator 
Alyssa Norris, MA 
 
 
 
Health Educator 
Moira Kalichman, MSW 
 
 
Assessor (Consultant) 
Brandi Welles  
 
 
 
Assessor (Consultant) 
Cynthia Merly  
 
 
 
Assessor (Consultant) 
Abbey Salvas  
 
 
 
Student Volunteer 
 
 

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1. LIST OF ABBREVIATIONS 
 
 
 
 
 
 
 
AC 
Attention Control 
AE 
Adverse Event 
AIDS 
Acquired Immune Deficiency Syndrome 
ART 
Antiretroviral Therapy 
CBPM 
Centers for Behavioral and Preventive Medicine 
CDC 
Centers for Disease Control and Prevention 
CFAR 
Center for AIDS Research 
Co-I 
Co-Investigator 
CT 
Chlamydia trachomatis 
IMC 
Data Safety Monitoring Committee  
Gc 
Gonorrhea  
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
IRB 
Institutional Review Board 
MBSR 
Mindfulness-Based Stress Reduction 
MT 
Mindfulness Training 
NCCIH 
National Center for Complementary and Integrative Health 
NIH 
National Institutes of Health 
PCP 
Primary Care Provider 
PD 
Project Director 
PLWH 
People living with HIV 
PHI 
Protected Health Information 
PI 
Principal Investigator 
RCT 
Randomized Clinical Trial 
SAE 
Serious Adverse Event 
STI 
Sexually Transmitted Infections 
RA 
Research Assistant 
Trich 
Trichomoniasis 
TMH 
The Miriam Hospital 

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2. BACKGROUND AND RATIONALE 
 
2.1 Background  
Based on estimates from the CDC, 1.2 million persons aged ≥ 13 years are living with 
HIV infection, while incidence rates of new infections reach 50,000 new cases per year.1-4 In 
2012, ~28,000 people were diagnosed with AIDS5 and ~14,000 people with an AIDS diagnosis 
died in 2011.5  
CDC recommendations for people living with HIV (PLWH) include the adoption of safer 
sex practices and strict adherence to antiretroviral therapy (ART) when prescribed.6 Safer sex 
practices such as condom use with all partners and reduction in the number of partners, 
decrease the risk of contracting other sexually transmitted infections (STIs) and HIV super-
infection, and reduce the likelihood of transmitting HIV to an uninfected partner. Adherence to 
ART improves viral suppression, reduces infectiousness and HIV-related morbidities, and 
increases longevity.7-9 Together, safer sex practices and ART adherence improve the health of 
PLWH and reduce the incidence of new HIV infections.10-17  
Despite CDC recommendations, a significant proportion of PLWH still engage in risky 
sexual practices and show sub-optimal ART adherence to ART. For example, 26% to 35% of 
HIV-infected men who have sex with men report recent unprotected anal intercourse.18,19 Risky 
sexual behavior places the infected person at risk for other STIs and for HIV super-infection.20 
Unprotected sex also places partners at risk for HIV infection, fueling the epidemic. Likewise, 
only 30% of PLWH persons adhere to ART to the point of achieving viral suppression.21,22 Sub-
optimal adherence to ART compromises individual health, increases health care costs, and can 
lead to the development of ART-resistant strains of HIV.9,23 Thus, poor adherence to CDC 
recommendations adversely affects both an individual’s and the population’s health. 
Among the multiple barriers to adherence to CDC recommendations24 patient-related 
factors such as stress, depression, and poor impulse control have been the most difficult to 
modify. PLWH are exposed to considerable stress due to poverty25 and/or discrimination due to 
minority social status.26-29 Further, HIV remains highly stigmatized, further exacerbating stress 
levels. It is not surprising, given this stressful context, that many PLWH report elevated levels of 
depression.30-34 In the absence of strong coping skills, stress and depression can enhance 
impulsivity in vulnerable persons,35 who then cope maladaptively (i.e., by using alcohol and 
other drugs, engaging in risky sex).36-46 Depression and stress have also been associated with 
poor ART adherence24,47-57 and risky sexual behavior.58-62 Thus, stressful life circumstances, 
depression, and impulsivity conspire to undermine adherence to CDC recommendations.24,48,63-
73 
2.2 Study Rationale 
Mindfulness training can reduce perceived stress, depression, and impulsivity. 
Mindfulness has been defined as the act of paying attention to the present moment’s experience 
in an intentional and non-judgmental way.36-38 While mindfulness is a fundamental ability of the 
mind, studies have shown that mindfulness levels increase with training, thus showing that 
mindfulness is also a teachable skill.74 The best known program is Mindfulness Based Stress 
Reduction (MBSR),75 which offers training in traditional mindfulness meditation adapted to a 
non-Buddhist, clinical context. The MBSR program has been shown to be effective in reducing 
anxiety, depression, and a variety of physical symptoms in many medical conditions76-78 
including cancer,79-82 chronic pain,83,84 rheumatoid arthritis,85 and fibromyalgia.86 
Current evidence suggests the efficacy of mindfulness training (MT) on the aforementioned 
barriers to adherence in the HIV context. First, MT improves depressive symptoms and 
perceived stress, with moderate to large effect sizes. Hofman et al.87 reviewed 39 studies where 

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patients received MT for a range of psychiatric or medical conditions and reported that MT led to 
robust and sustained improvements in mood symptoms (Hedge’s g = 0.95). The Campbell 
Collaboration88 reviewed 31 RCTs, and found medium-sized post-intervention effects for 
depression (g=0.54) and for stress/distress (g=0.56). Goyal et al.89 included 47 randomized 
clinical trials and found improvements in depression at 8 weeks that lasted up to 6 months. The 
most recent meta-analytic study90 isolated results from 12 studies that included only participants 
diagnosed with a current episode of a depressive or anxiety disorder, and found significant 
benefits on depressive symptom severity for MT relative to controls. 
Furthermore, by emphasizing the intentional and non-judgmental acceptance of any 
thought, feeling, or sensation arising in the field of consciousness, MT cultivates qualities that 
are the very opposite of impulsivity. Indeed, observational evidence suggests a possible effect 
of MT on impulsivity.91 Dispositional mindfulness (i.e., the capacity that individuals have to be 
mindful prior to training)92,93 has been associated with lower impulsivity and better self-control.94 
Higher dispositional mindfulness has been associated with reduced binge eating episodes and 
better sleep quality as well as with healthier dietary habits among students.95,96 
Prior studies among PLWH. Although mindfulness-based approaches are increasing used 
by PLWH,97-99 MT has not been well studied in the context of HIV. We found only 8 published 
studies100-107 and one unpublished study108-110 of mindfulness-based interventions with PLWH. 
Our review, as well as previous reviews,111,112 suggests that MT reduces distress and promotes 
more adaptive coping in PLWH. The only study assessing the effect of MT on ART adherence 
did not show improvements; however, adherence was only a secondary outcome, only self-
report measures of adherence were used, and low ART adherence was not an inclusion 
criterion.104 No study has investigated the effect of MT on safer sex practices, and most studies 
suffer from methodological limitations (e.g., small samples, recruitment of low risk participants 
leading to possible ceiling effects on the outcomes). A particularly important limitation is that 
PLWH may have not received an adequate dose of MT due to low class attendance and high 
attrition in prior studies of group-based MT.103,107  
Conceptual model. Stress, depression, and impulsivity are associated with poor adherence 
to ART and risky sex among PLWH. Previous research with patients having various chronic 
illnesses, including HIV, shows that MT reduces distress and symptoms of depression. There is 
also observational evidence that MT may improve impulsivity. Building upon this empirical 
evidence as well as theories of 
mindfulness,113,114 we propose 
a model to guide the proposed 
R34 research and a future 
RCT. Figure 1 shows our 
expectation that a MT 
intervention will reduce stress, 
depressive symptoms, and 
impulsivity, which will improve 
safer sex practices and ART 
adherence. We will explore 
these relationships in the proposed R34 research. For the future RCT, we will also investigate 
the longer-term hypotheses, i.e., that improved adherence to ART and safer sex will improve 
CD4 counts, reduce viral load, and reduce incident STIs. Key to these hypotheses is 
confirmation that patients receive an adequate dose of the MT intervention. 
Rationale for the proposed research. The proposed research is needed (1) to adapt a 
previously developed phone-delivered mindfulness intervention to assure that it will deliver an 
adequate dose of MT for PLWH; (2) to refine the evaluation protocol; (3) to develop a 
comparison condition that controls for the time and attention patients receive in the MT 
intervention; and (4) to pilot-test the interventions and assessment protocols for feasibility and 

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acceptability. After this R34, we envision a R01-supported RCT to evaluate the efficacy of MT 
on adherence and safer sex among PLWH. This large RCT will advance the field and will have 
the following strengths: intervention mapping based on a conceptual model; provision of an 
adequate dose of MT; implementation of MT by skilled instructors following a detailed manual; 
separate instructors to avoid contamination across conditions; confirmation of intervention 
fidelity; measurement of psychological (e.g., depression), behavioral (e.g., ART adherence, 
risky sex), and biomedical (e.g., VL, STIs) outcomes; testing of hypothesized mediators and 
moderators; use of computerized assessments to minimize demand. These strengths will 
greatly enhance the quality of the research and permit stronger inferences to be drawn about 
the key hypotheses, namely: (1) MT will reduce perceived stress, depressive symptoms, and 
impulsivity, which (2) will improve ART adherence and increase safer sexual practices, which 
will in turn (3) improve CD4 counts and reduce VL, and (4) reduce the incidence of STIs. If 
effective, these hypothesized changes can also reduce HIV-related premature morbidity. 
3. AIMS 
This protocol seeks to satisfy Aim 4 of our R34 grant, namely: 
 
Pilot test both interventions as well as the evaluation protocol for feasibility and 
acceptability (Study 4). PLWH (n=50) will be recruited and randomly assigned to MT 
(n=25) or to the control intervention (n=25), and assessed at baseline, post-
intervention (3 months since baseline), and follow-up (5 months since baseline). The 
primary outcomes will be feasibility and acceptability. The secondary outcomes will 
include ART adherence and risky sex behaviors as well as possible mediators (i.e., 
depression, perceived stress, impulsivity) that will be included in full mediation 
analyses in the future RCT. 
 
4. SAFETY ASSESSMENT 
 
4.1. Overview 
Overall, this is a low risk study. The attention control intervention and mindfulness training are 
low-risk, behavioral interventions. Thus, we anticipate that patients will incur minimal risks due 
to their participation in this study.  
 
4.2. Protection Against Possible Risks  
 
Possible risks during the study involve:  
a. Emotional discomfort during mindfulness practice  
b. Breach of confidentiality 
c. Minor side effects from venipuncture for assessments of viral load 
d. Depression and Suicidality 
The level of risk for each of these events is minimal.  
a. Emotional discomfort during mindfulness practice: Psychological distress during 
mindfulness practice is mild, of short duration, and rarely occurs in absence of ongoing serious 
psychiatric conditions; participants with suicidal ideation and ongoing psychosis will be excluded 
from participation in the study. In case a patient presents signs of severe psychological 
discomfort during or between sessions, he/she will be excused from participating in the 
mindfulness intervention. The mindfulness instructor will actively inquire at each phone session 
about psychological side effects that might occur during the session or during individual 
practice. Mindfulness instructors are experienced and trained on how to help individuals 

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presenting such issues. Participants will also be instructed to contact the Project Director (PD) 
should any discomfort arise during the training.  
b. Breach of confidentiality: The likelihood of loss of privacy or confidentiality is rare and its 
impact on participants is likely to be minimal. Risks to privacy and confidentiality associated with 
this study will be described in the consent form along with our procedures to minimize this risk. 
Participant confidentiality will be maintained through a number of strategies. Each participant 
will be assigned a unique study identification number. The only individuals who will have access 
to participants’ identifiers will be the PD, assessors, mindfulness instructors, and health 
educators. Mindfulness instructors and health educators must have access to participant 
identifiers in order to call the participants for their weekly sessions. Assessors will have access 
to participant identifiers in order to call the participants for their monthly pill counts.  Assessors, 
mindfulness instructors, and health educators are all trained and experienced in following 
research protocols and participant confidentiality.  Audio recordings of mindfulness and health 
education sessions will be reviewed promptly to ensure treatment fidelity and then destroyed. 
Checklists and paper records of the treatment fidelity review will not include identifying 
information but will be stored and handled using the same methods as with other paper data. 
Audio recordings of interviews will be summarized without participant identifiers and then 
destroyed following analysis.  
 
Protection of study data will be assured by the use of locked files and password-protected 
computer databases with access available only to the study personnel. Biospecimens will be 
labeled only with the collection date and an anonymous numerical code; no identifiable patient 
information will be present on the samples. The PD will be responsible for collecting, handling 
and bringing the samples to the designated lab for analysis; no other personnel will have access 
to these samples.  
c. Side effects from the venipuncture. Blood samples will be taken by venipuncture by IC 
phlebotomists.  Venipuncture is a procedure commonly performed in general medical care 
which involves inserting a needle into a vein in the arm and withdrawing a sample of blood. 
Participants may experience mild discomfort associated with blood sample collection, including 
pain during blood drawing and subsequent bruising. In very rare circumstances participants may 
experience fainting or local infection. These risks will be minimized by having an experienced 
certified phlebotomist performing the venipuncture.  
d. Depression and suicidality. Although participants with suicidality will be excluded from the 
study, depression is common among PLWH and suicidal ideation could emerge during the 
course of the study. The PD will calculate depression scores on the study questionnaire 
immediately after survey completion at each data collection point. If scores indicate that severe 
depressive symptoms are reported and/or if suicidal ideation is reported or if the PD has reason 
to be concerned about the welfare of the participant then the PD will follow the suicide protocol 
(Appendix 5). The PD, Carla Rich, a licensed mental health counselor; will either directly 
conduct an assessment of suicidality risk, or she will arrange for the PI, Dr. Carey, a licensed 
psychologist, to conduct an assessment of suicidality risk.  If neither of these persons are 
available, a licensed clinical psychologist who works full-time at the Immunology Center will be 
contacted to conduct an assessment of suicidality risk.  If the licensed psychologist is not 
available other providers in the Clinic are likely to be available. If none of these options were 
available, the participant can be escorted to The Miriam Hospital Emergency Room. 
A protocol for the assessment and management of suicidality risk is included in 
Appendix 5 of this application. 
 
4.3. Expected Benefits 

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The proposed research may result in direct benefits to participants and we expect that these 
benefits will outweigh the minor risk associated with participating in this research study. 
Individuals who complete the mindfulness training may experience reduced levels of distress, 
depression, and impulsivity; and an improved quality of life. Individuals who complete the 
general health intervention may improve their health behaviors. The magnitude of the benefits 
may be mild to moderate, and such benefits may last for the duration of the intervention and 
likely for the following months. Participants may also benefit from receiving additional medical 
assessments (e.g., sexually transmitted infection testing). By participating in the research, 
participants will also benefit from knowing they may ultimately be helping others to reduce their 
risk behavior, adhere better to their HIV treatments, and improve their health. 
4.4. Data Safety and Monitoring Plan 
Several different entities will safeguard the participants’ safety and the integrity and quality of 
the data. 
 
1. Institutional Review Board (IRB) at The Miriam Hospital: The study will be submitted 
for approval and meet all IRB requirements and directions.  
 
2. PIs (Drs. Carey and Salmoirago-Blotcher) will closely supervise all study activities on a 
day-to-day basis. They will meet weekly with the Project Director, Carla Rich and other study 
personnel to monitor recruitment procedures, accrual and retention, side effects, and data 
integrity in order to take the necessary measures in a timely fashion.  
 
3. Independent Monitoring Committee (IMC): Consistent with NIH guidelines for smaller 
studies (see: http://nccam.nih.gov/grants/policies/data-safety-monitoring) an IMC will be 
responsible for monitoring the safety of participants and the validity and integrity of the data. 
IMC members will include experts in HIV/AIDS, mindfulness, and statistics; members will be 
approved by the Program Officer of the NIH funding Institute (NCCIH). The IMC will meet yearly, 
either in person or via conference call. However, the IMC will convene on a more frequent (i.e., 
ad hoc) basis when immediate study concerns arise. At both scheduled and ad hoc meetings, 
they will review adverse events, re-evaluate measures for the protection of human subjects if 
needed, and re-assess the risk/benefit ratio of the study. A report will be compiled after each 
meeting and will include (a) a list of adverse and serious adverse events classified by severity 
and likelihood of being related to the study intervention; (b) whether adverse event rates are 
consistent with pre-study assumptions; (c) rates and reasons for study withdrawal; (d) whether 
all participants met entry criteria; (e) whether continuation of the study is justified. Summary 
reports of IMC meetings will be sent to the PI, the IRB and to the funding NIH agency and 
included in the annual NIH report (non-competing continuation grant) for the project. 
Study safety and progress will be monitored according to the schedule outlined in the table 
below (and more frequently, if needed).  
Table 1. 
 
Frequency of 
data collection 
Frequency of 
data review 
Data type 
PD 
PIs 
IMC 
Accrual, retention and attrition  
Weekly 
Every 2 weeks 
Yearly 
Adverse events * 
Weekly 
Weekly 
Yearly 
Participants’ compliance  
to the intervention protocol 
Weekly 
Every 2 weeks 
Yearly 
Providers’ compliance  
to intervention protocol 
Weekly 
Every 2 weeks 
Yearly 
Missing data/data integrity 
Weekly 
Every 2 weeks 
Yearly 
* Please note: serious adverse events will be reported within 24 hours to the IMC, IRB, 

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4.5. Adverse Events and Serious Adverse Events  
a. Definition. An adverse event (AE) is defined as any untoward medical occurrence in a 
participant temporally associated with participation in the clinical study. An adverse finding 
can include a sign, symptom, abnormal assessment (laboratory test value, vital signs, 
electrocardiogram finding, etc.) or any combination of these. A Serious Adverse Event (SAE) 
is any adverse event that results in one or more of the following outcomes: 
• Death 
• A life-threatening event 
• Inpatient hospitalization or prolongation of existing hospitalization  
• A persistent or significant disability/incapacity 
• Important medical event based upon appropriate medical judgment 
Note: A birth defect is a highly unlikely event considering our study intervention. This 
outcome has been excluded. 
 
b. Classification of AE Severity. AEs will be labeled according to severity, which is based on 
their impact on the patient. An AE will be termed ‘mild’ if it does not have a major impact on 
the patient, ‘moderate’ if it causes the patient some minor inconvenience and ‘severe’ if it 
causes a substantial disruption to the patient’s wellbeing. 
 
c. AE Attribution Scale. AEs will be categorized according to the likelihood that they are related 
to the study intervention. Specifically, they will be labeled either definitely, probably, possibly 
or unrelated to the study intervention. The determination of whether an AE is related to the 
study intervention will be made by the PD. If relatedness is unclear, the PD will seek the 
guidance of the PI.  
 
Reportable and non-reportable events. The IRB at TMH requires reporting of all SAEs as well 
as of those AEs that are unanticipated and related to the study protocol or procedures (that is, 
they are “unlikely”, “possibly”, “probably” or “definitely” related). Unanticipated AEs are events, 
signs and symptoms that are not listed as risks on the consent form. Please note that AEs that 
are either anticipated or are “definitely not” related to the intervention procedures are not 
reportable to the IRB at TMH. 
 
4.6. AE Reporting Procedures and Follow-Up 
 
All reportable AEs (see 4.5. for definition) will be reported by the PIs to the Institutional Review 
Board (IRB) at TMH. Serious adverse events (SAEs) are reported to the IRB within 24 hours as 
described below (“SAE reporting”). All other reportable adverse events will be reported during 
the routine annual continuation reports to the IRB. In addition, all AEs (reportable and non-
reportable) will be provided to the Chair of the IMC prior to each IMC meeting and to the NCCIH 
program officer, annually. 
 
All intervention visits (mindfulness and control sessions) and follow-up assessments will include 
proactive assessments of potential adverse events. The PD will record all AEs and SAEs in a 
secure database using the format in the example below: 
 
 
 
 
and to the sponsor (NIH) in accordance with their requirements. 

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Subject 
Identifier 
AE 
Onset 
AE 
End 
AE 
Code 
Severity 
SAE? 
(y/n) 
Relatedness 
Action 
Taken 
Outcome 
Comments 
Subj001 
11/1/
15 
 
 
1 
 
2 
1 
1 
Subject felt 
anxious 
during MT; 
resolved 
within 15 
minutes 
 
Subj002 
 
 
 
 
 
 
 
 
 
Subj003 
12/18
/15 
 
 
3 
 
0 
4 
4 
Subject fell 
while hiking; 
broke leg; 
withdrew 
from study 
Severity of AE: 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Life threatening 
or disabling 
 
Relatedness to 
intervention: 
0 = Definitely 
unrelated 
1 = Unlikely 
2 = Possibly related 
3 = Probably related 
4 = Definitely related 
Action Taken: 
0 = None 
1 = Intervention modification 
2 = Medical intervention 
(specify in comments) 
3 = Hospitalization 
4 = Intervention 
discontinued 
5 = Other (specify in 
comments) 
Outcome: 
1 = Resolved 
2 = Recovered 
with minor 
sequelae 
3 = Recovered 
with major 
sequelae 
4 = Continuing 
treatment 
5 = Condition 
worsening 
6 = Subject death  
 
Participants will be asked about all AEs at each intervention session and at each follow up 
assessment. AEs will be recorded on the AE log. The PD will report all AEs to the PIs as soon 
as possible. All AEs will be assessed to determine their classification and whether they meet 
criteria for an SAE. The PD will refer participants to their own physician for assistance with 
adverse symptoms. Each week the PIs will review AE reports from the previous week for events 
that were reported as new or continuing, and will follow all AEs to the point of a satisfactory 
resolution. The PIs will be available at all times to discuss other adverse symptoms with the PD 
and the study participants.  
 
SAE Reporting. SAEs that are unanticipated, serious, and/or possibly related to the study 
intervention will be reported to the IMC, the IRB at TMH, and to the sponsor (NIH) in 
accordance with their requirements.  
• 
Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Officer within 7 days. Other serious and unexpected AEs related to the 
intervention will be reported to the Program Official within 15 days.  
• 
Anticipated or unrelated SAEs will be handled in a less urgent manner but will be 
reported to the Independent Monitor(s), IRB, GCRC/CTSA, NCCIH, and other oversight 

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organizations in accordance with their requirements. In the annual AE summary, the 
Independent Monitor(s) Report will state that they have reviewed all AE reports. 
Stopping rules. Considering the low-risk of this study, stopping rules have not been established.  
However, the IMC will closely monitor the risk/benefit ratio and the progress of the study and 
should issues in accrual, retention, data quality or safety arise, will take prompt action including 
considering the interruption of the study. Given the low risk of this study, no interim analyses are 
proposed. 
4.7. Monitoring of Study Progress (see also Table 1 in 4.4.) 
Accrual, retention. Review of the number of screened and eligible participants/month, accrual 
rates, adherence to inclusion/exclusion criteria will occur weekly. This will help evaluate the 
adequacy of the eligibility criteria and of the recruitment procedures and to address concerns in 
a timely fashion. 
Compliance with the intervention protocol. Protocol compliance will be assessed in an ongoing 
fashion. Participants’ compliance will be monitored by the instructors and PD and will involve 
tracking of the number of session attended and of the total time of individual mindfulness 
practice. Instructors’ compliance will be supervised by Dr. Salmoirago-Blotcher according to the 
Treatment Fidelity Workgroup guidelines. At the end of each intervention session the instructor 
will complete a checklist in which duration and delivery of the intervention as specified in the 
intervention script will be evaluated, as well as the patient’s level of engagement during the 
session. In order to monitor the consistency of the delivery of the intervention, each session will 
be digitally recorded. Ten percent of all recorded sessions will be randomly reviewed.  
Data accuracy.The PD and data manager , in collaboration with the data analyst, will be 
responsible for tracking participants to ensure that all data are collected in a timely and efficient 
fashion; for developing and generating monitoring reports; for providing timely and relevant 
feedback to project staff and leadership regarding the accuracy and precision of data. The 
following data verification procedures are planned:  
Research Electronic Data capture (REDCap) technology will be used for direct data entry during 
the interviews.  REDCap employs automatic checks for values that are out of range or represent 
errors of logic. Outliers will be corrected with verification from participants.  
Calculations (i.e., from self-report measures, when necessary) will be independently performed 
by two different persons and any invalid score (i.e. scores that differ between the two people) 
will be recalculated. 
5. ELIGIBILITY  
 
5.1. Population  
 
This study will enroll 50 HIV+ adult outpatients (25 per condition). The sample will be 
representative of the demography of the HIV epidemic and of the clinic outpatient population (n 
= 1614 outpatients with 70% male and 30% female; 60% White, 30% African American; 10% 
other/mixed; 25% Hispanic). We expect no difficulties recruiting 50 patients for this research. 
 
5.2. Participant Source 
 
Participants will be recruited from the Immunology Clinic (IC) at The Miriam Hospital (TMH) in 
Providence, RI. The Immunology Center is an urban HIV-clinic that provides comprehensive 
primary and specialty care for over 1,600 HIV-infected patients. It is the largest HIV clinic in 
Rhode Island with patients also referred from western Connecticut and southern 
Massachusetts. An average of 300-400 HIV-infected patients are seen in the clinic per month. 

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The Immunology Center is located at 1125 North Main St., Providence, RI. The clinic occupies 
the first floor. The second floor, designed to support clinical research, has exam and interview 
rooms dedicated to clinical research. Co-I Dr. Philip Chan, who is also a clinic treatment 
provider, will act as a liaison between the study and the clinic. 
  
Vulnerable populations. This study will not recruit individuals from the traditionally vulnerable 
populations (i.e., adults unable to consent, infants, children, teenagers or pregnant women). 
However, the PIs and the research team recognize that HIV-infected persons are vulnerable 
because of their disease status and because the disease disproportionately affects individuals 
with a range of vulnerability characteristics—including racial/ethnic minorities, women, and/or 
injecting drug users—not necessarily specified in the current definition and categories. 
Therefore, we will uphold the highest standards to protect study participants. 
 
An overriding concern in HIV research is confidentiality and privacy because breaches of 
confidentiality could have adverse consequences. Therefore, as described in this protocol (and 
in our research application and other study communications), we will establish procedures that 
ensure that our study guards and protects participants' confidentiality. We will adopt standard 
protections, including as the following: (a) where identifiers are not required, they will not to be 
recorded; (b) if identifiers are recorded, they will be separated, to the greatest extent possible, 
from data and securely stored, with linkage restored only if necessary to conduct the research; 
(c) potential participants will be given a fair and clear explanation of how information about them 
will be handled, including whether and how the information will be recorded in their medical 
records; (d) we will seek and obtain a Federal Certificate of Confidentiality so that we can resist 
attempts to force disclosure of participants’ research records; and (e) information that is 
recorded (e.g., focus group discussions) will have all identifying information removed from 
transcripts, and the source materials will be destroyed once transcripts are prepared and 
checked for accuracy. 
 
Assessments for Study 4 will be collected at baseline, at completion of intervention sessions 
(post-intervention), and approximately 3 months after completion of intervention sessions (3 
month follow-up). In addition, we will conduct monthly telephone calls for the unannounced pill 
counts, to be used as a measure of medication adherence. The entire duration of the study is 
projected to be 2 years. Each individual will be involved for about 6 months from enrollment with 
the maximum individual involvement to be 7.5 months in cases where the participant’s 
intervention start date is delayed due to extenuating circumstances (e.g., death in the family or 
hospitalization).  
 
5.3. Inclusion Criteria 
 
Participants must meet all of the following inclusion criteria to participate in this study: 
1. Age ≥18 years  
2. HIV infection  
3. Sub-optimal adherence to ART (Less than “always” taking ART medication and/or VL 
>20 copies/mL);  
4. Psychological distress (PHQ-4 score ≥ 2);  
5. Access to a telephone or cell phone 
5.4. Exclusion Criteria 
Participants meeting any of the following criteria will be excluded from participating in this study: 
1. Inability or unwillingness to give informed consent 
2. Cognitive impairment 
3. Non-English speaking 

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4. Enrollment in another ongoing behavioral research project 
5. Prior formal training in MBSR or active practice of mindfulness, meditation, or related 
mind-body techniques in the past year 
6. Severe hearing impairment not allowing phone delivery  
7. Suicidal ideation  
8. Psychosis (e.g., diagnosis of a severe and persistent mental disorder) 
9. Planning to move out of the area within the study period 
10. Health care provider (i.e. physician, nurse, or mental health professional) at the 
Immunology Clinic recommends patient should not be approached for the study 
 
6. ENROLLMENT 
 
6.1. Recruitment Processes 
Participants will be recruited from patients receiving care at the Immunology Center at The 
Miriam Hospital. Dr. Philip Chan, a Co-Investigator on the project who is also a clinic treatment 
provider, will act as a liaison between the study and the clinic. The Immunology Center is an 
enthusiastic supporter of clinical research. 
Study 4 will rely on four methods of recruitment: (1) patients from the clinic, using a patient 
database query and in person recruitment, (2) direct referral from clinic providers (e.g., research 
nurses, physicians, mental health professionals) at the Immunology Center followed up by in 
person recruitment, (3) recruitment letter, and (4) phone recruitment.  
(1) Direct appeal to patients in person: The Immunology Center Database (ICDB) will be 
queried to identify all patients who have had a detectable HIV-1 Plasma viral load within the 
past 12 months, are 18 years of age or older, and have an upcoming appointment within the 
next 3 months. The PD will review the IC appointment list on a daily basis to assess which 
patients from the ICDB query are coming in for an appointment.  The PD will review the 
eligibility with the participant’s HIV provider. If considered eligible by the HIV provider, the PD 
will approach the patient at their scheduled appointment. 
(2) Physician referral: The PD will share some eligibility criteria with clinic providers from the IC 
through the use of a flyer which can be emailed or hand delivered.  The PD will ask for referrals 
from the clinic providers.  The PD will check the IC appointment list to assess the patient’s next 
clinic visit.  The patient will be approached in person at their scheduled appointment. 
(3) Direct appeal to patients by Letter: The Immunology Center Database (ICDB) will be 
queried to identify all patients who have had a detectable HIV-1 Plasma viral load within the 
past 12 months and are 18 years of age or older. The PD will review the eligibility with the 
participant’s HIV provider.  The PD will ask the HIV provider if contacting the participant via 
letter is appropriate.  If the HIV provider provides permission the PD will mail the recruitment 
letter. 
(4) Direct appeal to patients by phone:  If no response is received within two week of mailing 
the letter (see #3), the PD will ask the HIV provider if contacting the participant via phone is 
appropriate.  If the HIV provider provides permission for phone contact the PD will call the 
participant following the phone recruitment script. 
If a participant is found ineligible or refuses to be screened and/or participate at any of above 
the four recruitment methods he or she will not be contacted again for the life of the study. 
 
6.2. Screening and Consenting Procedures 
 

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For recruitment methods (1) and (2) the PD will meet individually with referred patients in a 
private room at the Immunology Center. For recruitment methods (3) and (4) the PD will screen 
the participant via telephone.  The PD will summarize the study and its requirements and 
enquire whether the patient is still interested. If the patient is interested, the PD will explain the 
need to collect some preliminary information to determine whether he/she is eligible to 
participate. A screening script and screening instrument will be used to standardize this phase 
of screening. Patients meeting initial eligibility criteria will receive a thorough explanation of the 
study design, including what they will be expected to do if they join the study as well as detailed 
information regarding risks and benefits. All questions answered to the patient’s satisfaction and 
understanding.  
Once informed consent procedures are completed, the PD will complete screening 
assessments to confirm the participant’s eligibility for the study (see 8.2 for a detailed 
description of screening assessments).  
Participants who are eligible and agree to participate will proceed to the completion of all 
baseline measures, with the exception of baseline objective assessments of ART adherence.  
Screen failures 
 
Filemaker Pro will be used for tracking all participants for Study 4 who expressed interest in 
participating and were screened for eligibility. We will collect data from all individuals assessed 
for eligibility (i.e., individuals who consented but then resulted non-eligible at the completion of 
the screening process) so that we can provide a complete Consort diagram and description of 
the recruitment process both for publication purposes and as an indicator of future 
generalizability of the study. We estimate that 70% of screened participants will be eligible for 
this study. 
 
Screening window 
  
We will make every effort to minimize the time between the completion of all screening 
procedures and the beginning of the intervention in Study 4 (max, 8 weeks).  
 
Randomization 
 
After all baseline assessments have been completed, the PD will randomly assign participants 
(1:1 ratio) to the MT or AC condition using a randomization schedule generated by the study 
biostatistician, Dr. Dunsiger. The schedule will be generated using a permuted block 
randomization procedure with small, random-sized blocks. The allocation table will be password 
protected and saved to the CBPM secure drive. The unit of randomization will be the individual 
patient. We do not anticipate contamination between MT and AC, as patients will likely have no 
chance to exchange experiences about the interventions and instructors delivering the MT 
intervention will be different from those delivering the AC intervention.  
Participants will be given the option to pick up intervention materials in person after 
randomization occurs or to have the materials mailed to them.  Intervention materials for the MT 
condition consist of a compact disc with audio recordings of the mindfulness instructor’s voice 
as well as a box of raisins to be used during mindfulness sessions and daily practice.  Scripts of 
these recordings are located in Appendix 1 of this protocol.  The compact disc doesn’t contain 
the name of the study nor any identifying information about the study or the participant.  
Intervention materials for the AC condition consist of a packet of material pertaining to the 
session topics (i.e. nutrition, sleep) that is available to the public on the internet.  These 
materials were chosen from websites such as the Centers for Disease Control and the 

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American Heart Association.  Intervention materials for both MT and AC condition do not 
mention HIV or HIV status.   
 
6.3. Retention Plan 
Patients will be asked to provide two different telephone numbers (home and mobile phone 
number) and an email address. Participants will be asked to provide contact information for two 
locators to be used in the event that contact is lost with the participant.  Locators will not be 
given information about the nature of the research study.  The study tracking system will identify 
participants due for a visit. We will send mail/email reminders or phone messages to remind 
patients of their follow-up appointments. Participants who wish to drop out of the study will be 
queried as to their reasons for doing so and every attempt will be made to address their 
concerns. In addition, we will provide monetary compensation to patients for their time and 
expenses. Participants will receive $40 cash for the baseline assessment, $40 cash for the post-
intervention assessment, $50 cash for the follow-up assessment and $10 cash each for the pill 
count telephone calls (seven total) for a total of $200. 
 
If a participant does not complete all of the baseline procedures (including the two pill counts) 
within 60 days of enrollment, then he or she will be considered lost to follow-up.   
 
If a participant does not complete two intervention weeks in a row he or she may be withdrawn 
from the intervention portion of the study per PD and PI discretion. These participants would still 
be contacted for pill count assessments and follow-up assessments.   
 
7. DESIGN AND DRAFT PROCEDURES  
 
This is a pilot, Phase 2, behavioral randomized controlled trial, which is primarily designed to 
determine the feasibility and patient acceptability of mindfulness training for improving 
adherence to ART and promoting safer sex practices among persons living with HIV (PLWH). 
As a secondary purpose, we will obtain preliminary estimates of efficacy of MT on two clinically 
relevant outcomes (namely, actual adherence to ART and adoption of safer sexual practices) 
and the hypothesized mediators (i.e., mindfulness, depression, perceived stress, impulsivity). 
7.1. Study Outcomes  
Primary outcomes: feasibility and acceptability. 
 
Feasibility: Key metrics will include the number of screened, eligible, consented and randomized 
participants; retention rates; session attendance; and individual mindfulness practice. We will 
consider either condition feasible under the following conditions:  
 
1) If we achieve retention rates of 80% at the final follow-up visit  
2) If patients attend at least 70% of the planned sessions  
3) If patients report to have completed 70% of the assigned individual home practice 
exercises 
4) Intervention session calls lasting approximately 20 minutes 
5) Fewer than three rescheduled intervention calls 
 
Acceptability: We will assess the following domains:  
 
1) Participants’ experience in the study (qualitative data collection) 

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2) Participants’ ratings of the interventions on a satisfaction survey. The intervention will be 
considered acceptable if ≥80% of participants responds that they are at least somewhat 
satisfied with the intervention.  
 
Secondary outcomes:  
Preliminary estimates of effect size of mindfulness training vs. attention control on changes from 
baseline ART adherence, risky sex behaviors as well as on hypothesized mediators (i.e., 
mindfulness, depression, perceived stress, and impulsivity) will be assessed. We expect that the 
mindfulness training condition will achieve larger positive changes in ART adherence and risky 
sexual behaviors compared to the attention control condition. 
 
 
 
 
7.2. Design Overview 
 
Participants (n = 50; 25 per condition) will be assessed (i.e., baseline), randomized to 
intervention (i.e., 8 weekly phone-delivered sessions of mindfulness training or the attention 
control intervention), and reassessed at the end of the intervention (i.e., post-intervention), and 
at 3 month post-intervention follow-up.  
7.3. Study Interventions  
Intervention setting. Intervention sessions for both conditions will be individually delivered over 
the phone. Prior to the beginning of the intervention instructors will contact participants to set up 
the best time to deliver the intervention.  
 
Session frequency. Participants in both conditions will receive a 30-minute phone call session 
once a week for 8 weeks.  
Mindfulness training (MT). The intervention protocol is based on the MT protocol pilot-tested in 
our preliminary work120 (see Appendix 1 for a script of each session). This intervention maintains 
the basic components of Mindfulness Based Stress Reduction (MBSR)75 but has been 
streamlined to distill the active ingredients for phone delivery. The MT intervention involves 
training in the following practices: (1) Awareness of breath, a technique in which trainees learn 
to attend to the sensations associated with breathing; and (2) Body scan, a technique based on 
the cultivation of attention to bodily sensations that would normally go unnoticed. Later, 
participants are gradually trained to (3) direct their attention to simple activities of daily life and 
(4) to become aware of their own thoughts and emotions. Only at the final session they (5) 
practice “open awareness” – a technique by which the participant is invited to direct his/her 
attention to any event arising in their field of experience at a given moment, whatever it may be, 
e.g., a physical sensation, sound, emotion, or thought.  
Individual home practice. In addition to the weekly training session, participants will practice 
mindfulness techniques for 15 minutes daily on their own with the guidance of a digitally 
recorded, standardized guided mindfulness practice containing the techniques learned with the 
instructor. The mindfulness practice digital recording will be provided in different formats (CD or 
MP3 file) depending on the participant’s preference. (Please see Appendix 1 for a detailed script 
of the CD/MP3 recording).  
MT instructors. MT instructors will be graduates from the teachers’ training program at the 
University of Massachusetts Center for Mindfulness with ≥ 5 years teaching experience. To 
ensure consistency of delivery, each patient will be trained by the same instructor throughout 
the intervention. Instructors will receive 3-hour training session in the delivery of the MT 
intervention, self-recording and fidelity checks, protocols, and reporting. Supervision will be 

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provided during regular conference calls. These calls will be scheduled weekly during the first 
month, biweekly during the second month, and monthly thereafter. Additional ad hoc calls will 
be scheduled if needed. The calls will be led by Dr. Elena Salmoirago-Blotcher, and will involve 
discussion of issues that arise during MT sessions. 
Attention control (AC) condition. The AC condition is an active, structurally equivalent, 
intervention to control for the time and attention received in the MT condition.  The content of 
the AC intervention was developed using participants’ feedback from the Study 1-3 focus 
groups and will include health topics suggested by the focus groups including: Sleep, Nutrition, 
Sun Safety, Physical Activity, and Home and Travel Safety (see Appendix 2 for a script of each 
session). 
Individual home practice. Each health topic has an associated daily practice activity to control 
for the time patients in the MT intervention spend practicing mindfulness exercises on their own 
(15 minutes daily). (See Appendix 2 for an explanation of daily practice for the AC condition). 
AC instructors. Instructors will be clinical psychology residents with ≥ 5 years of experience.  To 
ensure consistency of delivery, each patient will be trained by the same instructor throughout 
the intervention. Instructors will receive undergo training in the delivery of the general health 
intervention. Supervision will be provided during regular conference calls. These calls will be 
scheduled weekly during the first month, biweekly during the second month, and monthly 
thereafter. Additional ad hoc calls will be scheduled if needed. The calls will be led by Carla 
Rich, and will involve discussion of issues that arise during AC sessions. 
 
7.4. Concomitant Interventions  
 
Allowed Interventions: Participants are allowed to continue ALL the medications and follow all 
behavioral recommendations prescribed by their care providers. We will monitor all medications 
used and control for these in data analyses. 
 
Prohibited Interventions: Yoga, stress reduction, or other mind-body training.  
  
7.5. Treatment Fidelity 
To ensure that interventions are delivered with fidelity, we will have developed, a protocol, 
manual, and script of each session. The script will not be used verbatim but instructors will be 
trained to follow the sequence indicated in the Session Guides. As noted earlier, to avoid 
contamination, different instructors will deliver the MT and AC interventions. Assessments of 
treatment fidelity will be conducted following the guidelines developed by the Treatment Fidelity 
Workgroup.121,122 We will create checklists of essential intervention components for the MT and 
AC. At the end of each session instructors will complete the auditor checklist corresponding to 
that session. Instructors will also digitally record each session. We will audit 10% of all 
recordings using the checklist to ensure that the interventions are being delivered as intended.  
 
7.6. Blinding 
This is a phase 2 pilot study testing the feasibility of a behavioral intervention; participants will 
not be blinded. 
Blinded personnel:  
• 
Principal Investigators and all Co-Investigators  
• 
Data management and data analysis personnel  
• 
MT and AC instructors will be blinded to the study outcomes. 
 
Non-blinded personnel:  
• 
Project Director. Blinding the PD would be impractical given that she will be randomizing the 
patients to either condition. The impact of un-blinding the PD will be minimal because study 

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surveys are completed electronically by participants and the PD will NOT be involved in data 
analysis. 
 
8. STUDY ASSESSMENTS  
 
Overview 
 
Table 8.2 provides the schedule of study assessments for this pilot RCT. All assessments will 
be conducted in-person. The PD will be responsible for data collection; see section 7.6 for 
blinding consideration. Because not all participants can be reached for assessments on their 
due date, windows have been established to determine when to record a protocol violation or 
consider assessments missing (Table 8.1). 
 
 
 
Table 8.1 
Assessment 
Window 
Baseline 
Within 60 days from screening visit 
 Post-Intervention 
Within 2 weeks of final intervention session  
Follow-up 
12 weeks (+/- 2) after completing final intervention session  
All visits will be conducted at the Immunology Center (described earlier). 
 
Table 8.2 Schedule of Study Assessments 
Assessment 
S 
BL 
At 
each 
sessio
n 
Post FU 
Screening 
HIV infection status 
X 
 
 
 
 
ART adherence 
X 
 
 
 
 
Viral load 
X 
 
 
 
 
Psychological distress 
X 
 
 
 
 
Sexual risk behavior (past 3 months) 
X 
 
 
 
 
Prior mind-body training  
X 
 
 
 
 
Hearing impairment 
X 
 
 
 
 
Suicidal ideation 
X 
 
 
 
 
Telephone Access 
X 
 
 
 
 
Literacy 
X 
 
 
 
 
Feasibility and Acceptability 
n of screened individuals 
X 
 
 
 
n eligible  
X 
 
 
 
n enrolled 
X 
 
 
 
n refusing to participate 
X 
 
 
 
Reasons for refusing participation  
X 
 
 
 
n of dropouts and lost to follow-up 
X 
X 
X 
Reason(s) for dropping out 
X 
X 
X 
Sessions attendance (both conditions) 
X 
 
 
Individual home practice (both conditions) 
X 
X 
X 
Acceptability Survey/ Satisfaction scale 
 
 
 
X 
X 
Qualitative Interview 
 
X 
X 
Efficacy 

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ART adherence: self-reported measure  
 
X 
 
X 
X 
ART adherence: objective measure (unannounced pill count) 
 
 X* 
 
X 
X 
Viral load (ART adherence biomarker) 
 
X 
 
X 
X 
Sexual risk: Self-report  
 
X 
 
X 
X 
STI  (sexual risk biomarker) 
 
X 
 
 
X 
Mediators 
Mindfulness 
 
X 
 
X 
X 
Depression 
 
X 
 
x 
X 
Anxiety 
 
X 
 
X 
X 
Perceived stress 
 
X 
 
x 
X 
Impulsivity 
 
X 
 
x 
x 
Moderators and Descriptors 
Demographic characteristics  
 
X 
 
 
 
Perceived physical health 
 
X 
 
X 
X 
Medical history; medications 
 
X 
 
 
X 
Social support 
 
X 
 
 
 
Sleep 
 
X 
 
X 
X 
Alcohol use 
 
X 
 
X 
X 
Other Drug Use 
 
X 
 
X 
X 
Smoking 
 
X 
 
X 
X 
Nutrition/Eating  
 
X 
 
X 
X 
Food Security 
 
X 
 
X 
X 
S = screening; BL = baseline; post = post-intervention; FU = follow-up. * Scheduled within one 
week of the baseline. 
8.2. Screening Assessments 
These evaluations occur to determine if the Immunology Center patient is eligible for the study. 
• 
HIV infection status will be obtained from the medical record. 
• 
ART Adherence will be assessed using self-report and viral load: participants who are less 
than 100% adherent during the past six months and/or those with a viral load (obtained from 
the medical record) > 20 copies/mL will be eligible. 
• 
Psychologically distress will be measured using the PHQ-4115; only individuals scoring ≥ 2 
on the PHQ-4 will be included in the study. 
• 
Recent sexual risk behavior assessed with self-report. 
• 
Prior training in mindfulness, meditation, or related mind-body techniques will be assessed 
using self-report. 
• 
Severe hearing impairment not allowing phone delivery will be self-reported and 
corroborated by the PD. 
• 
Telephone access will be assessed by self-report. 
• 
Literacy will be assessed by the SILS. 
• 
Suicidal ideation will be assessed by questions on recent suicidal thoughts and plans.  
Individuals endorsing 1 or more of these items will be assessed further by use of the suicide 
protocol (Appendix 5).  
• 
Additional foil questions about other health factors (e.g., smoking, alcohol use) will be 
included to decrease the likelihood of potential participants figuring out eligibility criteria.  

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8.3. Baseline Assessments 
FEASIBILITY 
To assess feasibility the following will be recorded: number of screened, eligible, consented and 
randomized participants; number of patients who refuse participation and reasons for refusal.  
 
EFFICACY OUTCOMES 
1. Medication Adherence 
Consistent with NIH (e.g., PA-14-335)124 and expert recommendations,125-128 we will employ a 
multi-modal assessment of medication adherence: self-reported ART adherence, objectively 
reported ART adherence, and a biological health-related indicator (viral load). 
• 
Self-report: we will use the Wilson 3 item Self-Report Adherence measure, a recently 
developed and validated 3-item measure.130  
 
• 
Objective: phone-based unannounced pill counts.131-133 Unannounced phone-based pill 
counts are reliable and valid.132-136 Field studies show high concordance between phone-
based and home-based number of pills counted (Spearman’s rho = .995, p < .001) and 
percentage of pills taken (r = .997, p < .001).132 Concordance between participants defined 
as 90% adherent to their medications by the phone count and home count was 95%, Kappa 
coefficient = .995. Adherence determined by unannounced cell phone-based pill counts also 
corresponds with VLs at a similar magnitude observed between unannounced home-based 
pill counts and VL.131 Use of a phone-based method has the additional advantage of being 
consistent with the phone-based MT intervention we are evaluating. A detailed protocol for 
the phone-based unannounced pill count protocol can be found in Appendix 3. This protocol 
has been provided by Dr. Kalichman, our consultant. 
 
• 
Biological indicator: Viral load: Although not a direct measure of adherence, VL is closely 
aligned with adherence.137-139 Participants will provide blood specimens for performing VL 
lab work. Samples will be collected using standard phlebotomy and processed at Lifespan 
laboratories. 
 
2. Sexual Risk Behavior 
Also consistent with the NIH Consensus Panel and recommendations from HIV prevention 
experts, we will employ a multi-modal assessment of sexual risk behavior with self-report, 
medical chart review, and laboratory testing. 
• 
Self-report: This information will be collected using a self-reported survey developed 
according to standard strategies.140-143 We will collect information using items that we have 
used in previous studies,144-147 namely, number of male and female sexual partners; number 
of occasions of protected and unprotected oral, anal, and vaginal sex; partner type and 
partner serostatus over previous 3 months.  
 
• 
Medical chart review for clinical diagnosis of STI: This information will be collected from 
medical, consistent with current guidelines148 and prior work.145,149 This information is 
necessary to capture STIs that have been treated between visits150 because successfully 
treated bacterial infections will not be detected with laboratory testing.  
 
• 
Laboratory-diagnosed STI: this data will be collected as a proxy of risk sexual behavior. We 
will collect blood, urine, rectal, and pharyngeal specimens, and test these using at Lifespan 
laboratories using standard processing methods.  STI testing will be supervised by Co-I 
Chan, an infectious disease physician. Detailed procedures about specimen collection and 

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lab testing will be included in the Manual of Procedures. We will collect:  
o Urine specimens for urethral (men) and cervical (women) Gc, CT, and 
Trichomoniasis  
o Pharyngeal swabs for Gc.  
o Rectal swabs for Gc and CT. 
Laboratory results will be reviewed by the Dr. Chan and the PD.  If there is a positive test the 
participant and his or her Immunology Center provider will be notified.  The Immunology Center 
provider will advise the participant on treatment options (if applicable). If the STI is reportable, it 
will be reported to the Health Department as required by law. 
 
 
MODERATORS AND PARTICIPANT DESCRIPTORS 
 
Research suggests a number of person factors that may be associated with adherence to ART 
and safer sex. We will seek to balance comprehensiveness of the data set with participant 
burden. We will look for precise measures of constructs with the fewest items that yield reliable 
and valid estimates of the constructs. 
• 
Demographic characteristics (e.g., sex assigned at birth, gender identity, age, race/ethnicity, 
relationship and employment status, income, educational attainment) will be assessed using 
standard questions developed in previous research with this population.  
 
• 
Perceived physical health will be assessed with a single item from the Medical Outcomes 
Study General Health Survey.154,155  
 
• 
Medical history will be obtained from patient’s medical record, and will include: date of initial 
HIV diagnosis, likely mode of contracting HIV, length of time since initiating ART, VL and 
CD4 counts, adherence to medical appointments (# of missed appointments, if any), AIDS 
diagnosis (yes/no, date), number of HIV-related hospitalizations, medical and psychiatric 
comorbidities and current medications. Our hospital system now maintains an electronic 
medical record, and data will be corroborated as appropriate. 
• 
Social support will be measured using 12 items from the Medical Outcomes Study Social 
Support Survey, a 19 item survey used to measure how perceive social support (i.e., family, 
friends, and significant other).  
• 
Sleep will be measured using the Pittsburgh Sleep Quality Index, a 7 item measure. 
• 
Alcohol use will be assessed with the Alcohol Use Disorders Identification Test (AUDIT),163 
widely used in healthcare settings; scores of ≥8 indicate hazardous drinking, and scores ≥16 
suggest alcohol use disorder; and PhenX Measures for Lifetime Use, 30-Day Frequency, 
and Maximum Drink in 24 Hours.  
• 
Other drug use will be measured with the PhenX Substances-Lifetime Use, Substances-30 
Day Frequency and DAST-10. 
• 
Smoking will be measured with questions about lifetime smoking and past 30 days. 
• 
Food Security will be measured using the U.S. Household Food Security Survey, a 6 item 
index. 
MEDIATORS 
• 
Mindfulness will be assessed with the FFMQ-15, a measure of trait (dispositional) 
mindfulness comprised of 15 items. 
 
• 
Depression will be assessed using the PHQ-9. 
 

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• 
Anxiety will be assessed using the GAD-7. 
 
• 
Perceived Stress will be measured with the 4-item Perceived Stress Scale (PSS),117,175 
which assesses the degree to which participants perceive circumstances as stressful in the 
last month. Higher scores indicate greater levels of perceived stress. 
 
• 
Impulsivity. The Barratt Impulsiveness Scale (BIS-11)176,177 has 5 factors (attention, motor, 
self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 
is widely used.  
 
8.4. Post-Intervention and Follow-up Assessments 
Two additional assessments will take place (a) post-intervention (within two weeks of finishing 
the program) and (b) at 3 months post-intervention (within 12 weeks (+/- 2 weeks) after finishing 
the program): 
• 
Feasibility 
o Retention rates; drop-out counts and reason for dropping out will be maintained by 
the RA. 
o Adherence to Mindfulness Training and Health Coaching 
§ 
Session attendance will be recorded at each session by the instructor using 
an attendance log.  
§ 
Individual practice at home will be self-reported during each session. 
• 
Acceptability 
o Satisfaction Survey178 reporting how informative, interesting, and helpful the MT was; 
how likely they are to continue practicing after the training; whether they would 
recommend it to other PLWH; and whether they have suggestions for how we might 
improve it. Participants will rate the interventions on a scale from 0 to 6.  
 
• 
Qualitative data collection  
o At each assessment, participants will be asked to participate in an interview to solicit 
information about their experiences. They will be asked open-ended questions about 
their experiences.  The semi-structured qualitative interview guide can be found in 
Appendix 4. 
 
• 
Efficacy (measures described at Baseline) 
o Adherence to ART 
§ 
Self-reported adherence 
§ 
Unannounced pill counts 
§ 
Viral Load 
o Sexual Risk  
§ 
Self-report of risk behavior 
§ 
STI (chart diagnosis) 
§ 
STI (lab-diagnosed) 
• 
Moderators (measures described at Baseline) 
o Perceived health 
o Sleep 
o Alcohol Use 
o Substance Use 
o Smoking 
• 
Mediators (measures described at Baseline)  
o Mindfulness  

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o Depression 
o Perceived stress 
o Impulsivity 
o Anxiety 
 
9. DATA COLLECTION 
 
9.1. Data Sources 
With participant consent, information about concurrent medical conditions and history as well as 
current medications will be collected from electronic medical records.  
 
9.2. Data Safety  
 
Electronic data will be stored in password protected data files accessible only to authorized 
project personnel including the PIs, Data Systems Analyst, Statistician and the PD. All data files 
will be automatically backed up daily. Paper data will be stored in locked file cabinets. Data 
containing identifiers (e.g., name, address, phone number of participants) will be stored on 
password-protected secure servers separately from de-identified study data (e.g., surveys, 
screeners).  
 
9.3. Data Collection 
 
The PD will collect data via in-person interviews at each assessment. Electronic data capture 
technology will be used for direct data entry during the interviews; clinical data will be entered by 
the PD from the abstraction forms into electronic version of the abstraction forms. Any ambiguity 
in the response to a question will be brought to the attention of the Data Systems Analyst for 
clarification. If the Data Systems Analyst is unsure how to code the response, the matter will be 
brought to the attention of the PI.  
 
9.4. Qualitative Data Collection 
 
Data from qualitative interviews will be collected using audiotapes and observer/interviewer 
notes. Audio recordings will be analyzed using a framework matrix and will be reviewed by 
study staff.  At the conclusion of the study recordings will be destroyed.  
 
10. DATA MANAGEMENT 
 
10.1. Tracking Systems 
 
Prior to beginning participant recruitment; the Data Systems Analyst will develop a tracking 
system using Filemaker software. The tracking system will help the PD in ensuring that all 
procedures are followed, interventions are adhered to, and assessments administered in a 
timely fashion. The tracking system will include all steps included within the Recruitment, 
Treatment and Follow up phases of participant participation in the trial.  
 
10.2. Data Entry and Storage 
 
Our major data management and analysis needs for the proposed project can be met by using 
a Pentium-based microcomputer. The data systems analyst will conduct data management 
under the supervision of the study biostatistician and the PIs. De-identified data will be exported 
directly into study datasets. Depending upon the analytic question, either STATA 14 (Stata 

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Corporation) or SAS statistical software will be used for analyses, as determined by the study 
biostatistician, Dr. Dunsiger. 
 
Electronic data will be stored in password protected data files accessible only to authorized 
project personnel including the PIs, Data Systems Analyst, Statisticians and PD. All data files 
will be automatically backed up daily. Paper data will be stored in locked file cabinets. Data 
containing identifiers (e.g., name, address, phone number of participants from ACCESS files) 
will be stored on password-protected secure servers separately from de-identified study data 
(e.g., surveys, screeners).  
 
The Data Systems Analyst will work with project statistician Dr. Dunsiger and the PIs to ensure 
that data are cleaned prior to analysis. When ready for analysis, he will provide a STATA 
database of collected data to the statistician.  
 
11. QUALITY CONTROL AND QUALITY ASSURANCE 
 
11.1. Treatment Fidelity  
 
Procedures are described in section 7.5.  
 
 
11.2. Training 
 
All staff involved in data collection will be trained and certified regarding their competence. This 
includes training on administration and scoring of all questionnaires as well as on reviewing 
assessment instruments immediately for omissions. When information is missing or incomplete, 
the PD will contact participants to obtain the necessary information. A manual of operations will 
be developed during the study start-up period that explicitly describes the specific procedures 
related to data collection and quality assurance. At study beginning, the first 10 participants will 
have their data audited to make sure there are not any systematic problems with regards to 
entry. This preliminary audit process will reveal any possible problems at the onset as opposed 
to the end of the study, which would result in more work cleaning the data.  
Staff will receive extensive training in maintaining patient confidentiality, supervised by Dr. 
Carey, a licensed clinical psychologist with 30 years of research and clinical experience in 
sexual health, HIV, substance use, and related socially sensitive topics. Training will focus on 
procedures for making sure data are not accessed by individuals outside of the research team, 
keeping identifying information separate from data, and not disclosing participant information or 
participant names to individuals outside of the research team. Staff will be assigned readings 
about confidentiality and research ethics; readings will be discussed with Dr. Carey. All staff will 
complete on-line NIH- and Hospital-based ethics training. Staff will also receive extensive 
confidentiality training, which will involve reading, online videos and other training materials, and 
discussing scenarios in which confidentiality could be breached. Staff will be required to sign an 
agreement to keep all patient information confidential. In addition, staff will receive training in 
duty to warn and duty to report child abuse. They will be told to immediately contact one of the 
investigators if a participant threatens to hurt him/herself or someone else, or if a participant 
reports child abuse. 
Staff will also receive training in study policies and procedures, the need for clinical sensitivity in 
working with patients, gender and developmental sensitivity, and cultural and sexual orientation 
competence. Staff will role play recruitment and assessment sessions with the investigators, to 
demonstrate competence with the study protocol. When hiring project staff, we will recruit 
individuals with previous research experience who demonstrate a good understanding of the 
importance of participant confidentiality and research ethics, and evince personal integrity. We, 

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and the Miriam Hospital Human Resources Department, will check personal and professional 
references to be sure that all research staff have high personal standards regarding 
confidentiality and clinical sensitivity, as well as an ability to maintain the scientific 
responsibilities entrusted to them. 
 
11.3. Data Monitoring 
 
With supervision from the PIs and the Study Biostatistician (Dr. Dunsiger), the Data Systems 
Analysts (Chris Breault) will ensure that entered data accurately represent data collected. He 
will conduct error-checking procedures quarterly on all data to ensure their accuracy. Data entry 
systems developed using Access will include appropriate skip patterns and parameter limits to 
ensure that data are entered accurately (e.g., item response formats from 1-5 will not permit 
entry of other numbers). Data entry systems will be tested to ensure that these constraints are 
working correctly prior to entering real data. Microsoft ACCESS employs automatic checks for 
values that are out of range or represent errors of logic. Outliers will be corrected if possible with 
verification from participants. 
 
Quantitative data will be cleaned prior to analysis and then made available to the study 
statisticians for analysis. Dr. Dunsiger will be primarily responsible for the final outcome 
analyses and will assist in the preparation of manuscripts and reports.  
 
11.4. Metrics 
Direct entry of study data into electronic forms by the study participant and automatic parameter 
limits and error-checking procedures embedded into the Access system eliminate the need for 
re-entry of data and cross-referencing with paper copies, as well as auditing procedures. See 
Section 11.3 for data monitoring procedures.  
  
11.5. Protocol Deviations 
 
A minor protocol deviation is defined as an accidental and unintentional change, or 
non-compliance with the IRB approved research protocol that does not increase risk or 
decrease benefit or does not have a significant effect on the participant's rights, safety or 
welfare; and/or on the integrity of the data; for example, the need to reschedule a visit because 
the participant is traveling, or a follow up visit that occurred outside the protocol required time 
frame because of the participant’s schedule. A major protocol violation is a divergence from the 
protocol that materially (a) reduces the quality or completeness of the data, (b) makes the 
Informed Consent Form inaccurate, or (c) impacts a participant’s safety, rights, or welfare. 
Examples include: inadequate or delinquent informed consent; enrollment of non-eligible 
individuals; unreported or misreported serious adverse events; breaking of the blind; use of 
prohibited interventions; incorrectly collected or missing tests; multiple visits missed or visits 
outside permissible windows; intentional deviation from protocol, Good Clinical Practice, or 
regulations by study personnel.  
 
Capture, documentation, and review. All protocol deviations will be captured using a protocol 
deviations tracking log as they occur. The PI will sign each form after it has been completed or 
immediately prior to a monitoring visit. If it has been signed with fewer than five deviations 
entered into it, the next identified deviation will be reported on a new page to ensure that all 
deviations have been reviewed by the PI. Pages will be numbered and stored in reverse 
chronological order in the study Regulatory Binder. At the conclusion of the study, the final page 
of the log will be identified by checking the box in the footer. ALL protocol deviations will be 
reviewed by the PI at weekly study staff meetings; SAE reporting procedures will be followed 
(see 4.5 and 4.6) if a protocol deviation results in a SAE.  

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Reporting. Minor protocol deviations will be included in IMC reports and in the TMH IRB 
continuing review application. Major protocol violations will be reported to the TMH IRB and to 
the NCCIH Program Officer.  
 
Please note that retention, attendance are feasibility outcomes; consequently dropouts, 
missing session, and missing self-reported practice will not be considered protocol 
deviations. This information will be collected and monitored (as aggregate data and 
without breaking the PI blind status).  
Protocol amendments. Please also not that given the pilot nature of this study, we may need to 
amend the original protocol in response to feasibility issues (e.g., if we realize that our eligibility 
criteria are too strict, unnecessary and negatively affect recruitment). If needed, we will submit 
an amended protocol to NCCIH for approval in the following cases: any change that may affect 
patient safety (e.g., change in eligibility criteria; change in risk, regardless of whether risk is 
increased or decreased); any change that changes scientific intent or study design, or affects 
human subject protection; addition/deletion of a site; addition/deletion of key study personnel; 
change of institution for key study personnel; change in enrollment targets. Amendments will 
also be submitted to the IRB in accordance with IRB policies at TMH.  
 
 
12. STATISTICAL CONSIDERATIONS 
 
12.1. Preliminary Analyses 
 
Expertise. Co-Investigator Dr. Shira Dunsiger, Ph.D., is a biostatistician who has extensive 
research experience in the context of behavioral medicine research, including research. She is 
familiar with the challenges associated with the analyses of count data, missing data, 
longitudinal data, and has used SAS, Stata, and other statistical packages for more than a 
decade. She will be responsible for the analysis of all quantitative data. 
 
Preliminary analyses will examine comparability of participants in the MT and AC groups at 
baseline on demographic and other characteristics using Fisher or t-tests depending on the 
specific variable characteristics (categorical or continuous). We will examine the distributional 
properties of continuous variables to determine if normalizing transformations should be applied 
before conducting further analyses. If group differences are found for any variables, we will 
evaluate them and statistically control them in outcome analyses (e.g., employing them as 
covariates in analyses to control for their effects on the outcomes).  
 
12.2. Primary Outcomes: Feasibility and Acceptability 
Because this is a pilot study, analyses are not powered to detect treatment effects nor to 
formally test mediation or moderation. Any formal statistical testing will be only exploratory.  
 
Feasibility. To determine feasibility of conducting a RCT, we will calculate the percentage of 
individuals who were: eligible; consented; accepted randomization; and returned for the post-
intervention and 3-month follow-up. Based on our recent trials (R01-MH068171), we expect 
≥80% of all patients to return for the 3-month follow-up and will conclude the intervention is 
feasible if the follow-up rate is at least 80%. To determine feasibility of the MT and AC 
interventions, we will calculate the percentage of individuals who attended their intervention 
sessions. Based on previous research, we predict that ≥ 70% of those assigned to a MT will 
complete all intervention sessions. 
 

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Acceptability. To determine the acceptability of the interventions, we will calculate means for the 
satisfaction surveys, and inspect responses. The intervention will be considered acceptable if 
≥80% of participants respond that they are satisfied with the intervention. We will also collect 
metrics (e.g., duration of calls, number of cancelled sessions). We will construe as evidence of 
acceptability, patients completing all ≥7 sessions, with call durations averaging 20 minutes per 
call, and with fewer than 3 rescheduled sessions. 
 
12.3. Secondary Outcomes  
Preliminary estimates of efficacy. We will examine the within- and between-group effects on 
both efficacy outcomes (i.e., sexual risk, ART adherence) and potential mediators (mindfulness, 
perceived stress, depression, impulsivity, alcohol use). We will use intent-to-treat analyses, as 
well as per-protocol analyses to fully understand the data we obtain from this exploratory clinical 
trial. We predict an intervention condition x time interaction such that, relative to AC recipients, 
MT recipients will increase mindfulness and adherence, and decrease perceived stress, 
depression, impulsivity, and sexual risk behavior over time. We do not expect to see changes in 
VL or STIs at the follow-up, because this is too brief an interval to expect changes. Using a 
series of longitudinal mixed effects models, we will simultaneously regress outcomes (efficacy 
measures and mediators) at end of intervention and follow-up, on condition (MT vs. AC), time, 
condition x time, baseline value of the outcome and potential confounders of the intervention 
effect (including variables not balanced by randomization). Models will include a subject-specific 
intercept to account for within-subject correlation in the outcome over time. Modeling will be 
done using a likelihood-based approach and thus will make use of all available data (on the 
intent-to-treat sample) to produce consistent estimates of the regression parameters. Models 
require specification of the distribution of the outcome and will be adapted for continuous, 
binary, and count variables. Models will allow us to estimate the average change over time 
within condition for efficacy outcomes and potential mediators, as well as estimate the effect 
size with respect to between group effects. 
 
12.4. Qualitative Analyses  
 
Audio recordings of the patients’ interviews will be reviewed and summarized in a framework 
matrix.  Dr. Rosen and a second rater will listen to and summarize the audios.  NVivo software 
will be used to manage the framework matrix and the audio. Throughout the coding and 
analysis process, categories and subcategories will be compared and revised as new 
information is considered or as the team comes to new understandings of the data.  
12.6. Sample Size 
Because effect size estimates based on small samples have large SDs and wide confidence 
intervals (CIs),184 we will use these pilot data only to gauge whether MT effects are encouraging, 
to examine distribution of the outcomes, and to inform future analytic approaches. The choice of 
the proposed sample size (n = 50 – 25 participants per condition) was based on practical 
considerations.  
 
12.7. Missing Data 
 
As noted earlier, the primary analysis will be performed according to the intention to treat 
approach. Withdrawals will be asked to complete follow-up assessments and home visits or 
phone interviews will be arranged if necessary. If we encounter substantial missing data, 
possible options will include using accepted statistical methods (e.g., use of complete data only, 
use of multiple imputation, use of modified weights and model-based procedures).  
 

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13. REGULATORY REQUIREMENTS 
 
13.1 Institutional Review Board (IRB) Review  
This protocol and any subsequent modifications will be reviewed and approved by the IRB at 
TMH responsible for oversight of the study.  
 
13.2 Informed Consent and HIPAA 
Consent will be obtained at the screening visit. Individuals will provide written consent using an 
IRB approved consent form. In addition to describing the study and the participant’s involvement 
in detail, the consent form also emphasizes that participation is voluntary, that consent may be 
withdrawn at any time, and that participants may withdraw from the study verbally or in writing 
by contacting the study RA and/or the PIs. Participants are given ample opportunity to ask 
questions before providing consent. Contact information for the PIs as well as the IRB (for 
complaints) is provided in the consent form. Signed informed consent forms will be kept in 
locked filing cabinets separate from all data. Participants will receive a copy of the consent and 
HIPAA document for their records.  
13.3 
Participant Confidentiality  
Protection of Participant Privacy: All phone contacts with the participants will take place in a 
private, locked office and will be conducted by the PD who has been trained and certified in the 
protection of human subjects in research trials and HIPAA requirements according to TMH 
policies. Individuals who are interested in the study will provide Contact Information (e.g., name, 
address, phone, email) and will be scheduled for a screening visit (screening visit 1) to learn 
more about the study requirements and procedures, and to sign written informed consent as 
approved by TMH Institutional Review Board (IRB).  
 
In addition, because of the potentially sensitive nature of the data we are collecting, we will 
apply for a Certificate of Confidentiality for this study to ensure that participants’ data cannot 
be subpoenaed with a court order. We have successfully obtained Certificates of Confidentiality 
for other, similar research projects. 
 
Because some of the qualitative assessments involve participation in focus groups with multiple 
participants, it is impossible to guarantee privacy of information that is shared in a group format. 
However, at the beginning of each focus group, a statement will be read to participants 
regarding maintaining the privacy of information shared in the group. In addition, participants will 
be reminded of these instructions and to respect each other’s privacy and not repeat information 
shared with the group outside of the study setting at the start of each focus group.  
 
Data Safety 
 
• 
Participants will be identified with a randomly generated identification code unique to the 
participant and all personal identifiers will be removed from the study questionnaires and 
from datasets. Electronic communication with outside collaborators will involve only 
unidentifiable information. AE reports and annual summaries will not include participant-
identifiable material.  
• 
Data collected for screening (i.e. reasons for ineligibility and refusal) and tracking reasons 
(Filemaker data base) that contain identifiers will be stored into a password-protected 
server separate from other study data and will be destroyed at study completion. This 
Filemaker database is password accessible only to the PD, the data systems analyst, and 
the PI. 

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• 
Signed consent forms will be stored in locked filing cabinets separate from all other study 
data. 
• 
Audio files from qualitative data collection will have no identifiers and will be destroyed 
following approval of the summarization.  
• 
Patients will be informed in the consent form that the instructors’ voice during mindfulness 
sessions will be digitally recorded for assessments of treatment fidelity and digital 
recordings will be treated as explained above for focus groups recordings.  
• 
All copies of de-identified study questionnaires (paper and/or electronic) will be destroyed 
at the earlier of two dates: 1) seven years after the end of the study; 2) after the manuscript 
based on the work is published. 
 
13.4. Study Discontinuation  
 
The study may be discontinued by the IRB, the NCCIH, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected.  
 
13.5. Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to participants or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria: 
• Unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; 
• Related or possibly related to participation in the research (in the guidance document, 
possibly related means there is a reasonable possibility that the incident, experience, 
or outcome may have been caused by the procedures involved in the research); and 
• Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
An incident, experience, or outcome that meets the three criteria above generally will warrant 
consideration of substantive changes in order to protect the safety, welfare, or rights of 
participants or others.  
 
Procedures for handling the reporting of adverse events and serious adverse events to the 
Institutional Review Board at The Miriam Hospital, NCCIH and the Data Safety and Monitoring 
Committee are detailed in the DSM plan and in section 4.4 of this protocol.  
 

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APPENDICES 
 
 
 
DESCRIPTION 
1 Protocol for Mindfulness Training  
2 Protocol for Health Coaching 
3 Protocol for Telephone-Based Pill Count  
4 Qualitative Interview Guide 
5 Suicide Protocol  
 
 
 

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182. Saldaña J. The coding manual for qualitative researchers (No. 14): Sage; 2012. 
183. Guest G, MacQueen KM, E. NE. Applied thematic analysis: Sage; 2011. 
184. Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of 
pilot studies to guide power calculations for study proposals. Archives of General 
Psychiatry 2006;63:484-9. 
185. Kalichman SC, Simbayi LC, Cloete A, Mthembu PP, Mkhonta RN, Ginindza T. Measuring 
AIDS stigmas in people living with HIV/AIDS: the Internalized AIDS-Related Stigma Scale. 
AIDS Care. 2009;21:87-93. PMID: 19085224 
186. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy 
questionnaire. J Beh Ther Exp Psychiat, 2000, 31: 73-86. PMID: 11132119 

Mindfulness Training for PLWH 
Study 4 Protocol Version 7.1                    27 March 2017  
Page 44 
 
 
Appendix 1 
Study 4  
Mindfulness Training Materials 
 
 
 
Sources: 
Salmoirago-Blotcher E, Crawford SL, Carmody J, et al. Phone-delivered mindfulness training for patients with 
implantable cardioverter defibrillators: results of a pilot randomized controlled trial. Ann Behav Med. 
2013; 46: 243-250. PMID: 23605175; PMCID: PMC3758416. 
Salmoirago-Blotcher E, Carmody J, Yeh G, Crawford S, Rosenthal L, Ockene I. Design and methods for a pilot 
study of a phone-delivered, mindfulness-based intervention in patients with implantable cardioverter 
defibrillators. Evid Based Complement Alternat Med. 2012; 2012: 972106. PMID: 22536294; PMCID: 
PMC3320061. 
 
 
CONTENTS 
• 
Mindfulness Training Intervention Overview 
• 
Mindfulness intervention outline 
• 
CD/MP3 Script / Body Scan 
• 
CD/MP3 Script / Awareness of Breath Exercise 
 
 

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MINDFULNESS INTERVENTION OVERVIEW 
 
   
 
 
 
Session 
1 
Session 
2 
Session 
3 
Session 
4 
Session 
5 
Session 
6 
Session 
7 
Session 
8 
Awareness of breath 
X 
X 
X 
X 
X 
X 
X 
X 
Body scan 
 
 
X 
X 
X 
X 
X 
X 
Attention to daily experience 
exercise 
 
X 
 
X 
 
 
 
 
Awareness of sounds 
exercise 
 
 
 
 
X 
 
 
X 
Awareness of emotions 
exercise 
 
 
 
 
 
X 
 
X 
Awareness  of thoughts 
exercise 
 
 
 
 
 
 
X 
X 
Open awareness exercise 
 
 
 
 
 
 
 
X 
 
 
 

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MINDFULNESS INTERVENTION OUTLINE (MT condition) 
Source: Salmoirago-Blotcher E, Crawford SL, Carmody J, et al. Ann Behav Med. 2013. 
Schedule: 1 session once a week for 8 weeks; duration of each session: 30 minutes  
 
Session 1:  Awareness of Breath (AOB) 
• 
Introduction to intervention (and what we will be doing over next 8 weeks)  
 
 
(10’) 
 
 
 
 
 
 
 
• 
Exercise: direct the attention to the bodily sensations associated with breathing (AOB) 
 
(10’) 
 
• 
Feedback from participant      
 
 
 
 
 
 
             
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Participant encouraged to practice AOB exercise during the following week  
 
 
 
with aid of study CD - track 1 once a day; confirm next meeting  
 
      Session 2: AOB/Attention to Daily Experience 
• 
Questions and answers related to practice in previous week  
 
 
 
 
(10’)  
Ask family member to get small raisin box (provided) 
 
 
• 
Exercise: direct the attention to the bodily sensations associated with breathing (AOB) 
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Attention to daily experience: exercise of paying attention to everyday activity (eating a raisin) 
(5’) 
 
• 
Feedback from participant 
 
 
 
 
 
 
 
 
 
(5’) 
 
 
 
 
 
 
 
 
 
 
 
• 
Participant encouraged to practice AOB exercise during the following week  
 
 
 
with aid of study CD - track 1 once a day; confirm next meeting  
 
Session 3: AOB/BodyScan 
• 
Questions and answers related to practice in previous week 
 
 
 
 
(10’) 
 
• 
Body scan exercise: participant is invited to sit in comfortable chair.  
 
 
 
(10’) 
Participant is instructed to move his/her awareness to different  
parts of the body in a systematic way, beginning with the toes and progressing to  
the top of the head, noticing whatever sensations happen to be present in that  
part of the body at that moment. End with short AOB exercise. 
 
 
 
 
 
 
            
• 
Feedback from participant  
 
 
 
 
 
 
 
 
 
(10’)  
 
• 
Participant encouraged to practice Body Scan exercise during the following week  
 
 
 
with aid of study CD - track 2 once a day; confirm next meeting  
       
Session 4: AOB/Body Scan/Attention to Daily Experience 
• 
Questions and answers related to practice in previous week  
 
 
 
 
(10’)  
Ask relative to get a glass of water or other non-alcoholic drink that participant likes 
 
• 
Short AOB exercise, followed by Body Scan exercise  
 
 
 
 
 
(10’) 
 
• 
Attention to daily experience: drinking exercise.  
 
 
 
 
 
 
(5’) 
 
• 
Feedback from participant 
 
 
 
 
 
 
 
 
 
(5’) 
 

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• 
Participant is instructed to practice attention to daily activities (i.e., drinking, eating, walking), throughout 
the day; practice Body Scan exercise during the following week with aid of study CD - track 2 at least 
once a day; confirm next meeting 
 
 
 
Session 5: AOB/Body Scan/Sounds 
• 
Questions and answers related to practice in previous week  
 
 
 
 
(10’)  
 
• 
Short AOB, short body scan, followed by awareness of sounds exercise          
 
 
(10’) 
(explain what observing means: the sound, the reactions to the sound, memories, associations  
with the sound). 
 
• 
Feedback from participant  
 
 
 
 
 
 
 
 
 
(10’) 
 
• 
Participant is instructed to practice attention to daily activities throughout the day and particularly to 
sounds. Participant is encouraged to practice AOB exercise OR Body Scan during the following week 
with aid of study CD - tracks 1 or 2 once a day; confirm next meeting  
 
Session 6: AOB/Body Scan/Emotions 
• 
Questions and answers related to practice in previous week 
 
 
  
 
(10’)  
 
• 
Short AOB, short Body Scan followed by awareness of emotions exercise  
 
 
(10’) 
 
• 
Feedback from participant  
 
 
 
 
 
 
 
   
 
(10’) 
 
• 
Participant is instructed to practice attention to daily activities throughout the day and particularly to  
emotions. Participant instructed to practice using study CD once a day (either track). Confirm next 
meeting. 
 
Session 7: AOB/Body Scan/Thoughts 
• 
Questions and answers related to practice in previous week 
 
 
 
 
 (10’)  
 
• 
Short AOB, short body scan followed by awareness of emotions exercise   
 
 
 (10’) 
 
• 
Feedback from participant  
 
 
 
 
 
 
 
  
  
 (10’) 
 
• 
Participant is instructed to practice attention to daily activities throughout the day and particularly to 
thoughts (pleasant and unpleasant ones). Participant instructed to practice using study CD once a day 
(either track) or without CD once a day.  Confirm next meeting. 
 
 Session 8: AOB/Body Scan/ Sounds/Emotions/Thoughts/Open Awareness 
• 
Questions and answers related to practice in previous week 
 
 
 
 
 (10’)  
 
• 
Awareness of breathing exercise, body scan, sounds, emotions, thoughts   
 
 
 (15’) 
and open awareness.(During open awareness exercise, participant is instructed to just notice where the 
attention goes when it is not directed on a specific object. 
 
• 
Feedback from participant  
 
 
 
 
 
 
 
 
  
(5’) 
 
• 
Participant is encouraged to practice attention to daily activities throughout the day and to bring this skill 
to all their experiences (pleasant and unpleasant ones). Instruct participant to keep practicing with or  
without CD for at least 15’ a day. Thank participant. 

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BODY SCAN CD SCRIPT– ~15 Minutes 
In this recording you are beginning the practice of the body scan.  This practice is to develop and 
increase your ability to pay deliberate, careful attention. So remember that each time you take the few minutes 
to practice this you are taking a powerful and active role in improving your health and well-being.  
Do the body scan either lying or your bed or sitting in an easy chair. Dress in loose, comfortable clothes 
and try to arrange not to be interrupted by friends, family, or phone calls. It’s most helpful to see this as a time 
for self care - a time to give yourself unconditional attention. Try to stay awake and alert - If you find yourself 
repeatedly falling asleep, experiment with changing your position to one in which you can remain awake.  
We will be bringing awareness to areas of the body in a systematic way. As we go along use the 
instructions for guidance, simply doing what it says to do. There is no right or wrong way to feel while you do 
this exercise. Just allow yourself to be exactly as you are, accepting whatever you notice is happening in 
yourself.  
And now bringing your attention to the breath - becoming aware of the flow of the breath into and out of 
the body. You may feel it at the chest or the abdomen, or the flow of air at the nostrils. Not trying to change it in 
any way - just letting your attention rest lightly upon the sensations of your breathing. [PAUSE 5 SECONDS]  
And now bringing your awareness to the abdomen and following the movement of your abdomen with the in-
breath and the out-breath [PAUSE 5 SECONDS] On the in-breath the belly expands as the diaphragm muscle 
presses down, creating more space for the air and lungs. Noticing the flow of this movement with the breath – 
the belly expanding and then lowering with the out-breath [PAUSE 15 SECONDS]  
Now letting the breath fade into the background as you take your attention and direct it through other 
areas of the body. So for now, take your attention to both feet and narrowing your focus to sense all of the 
toes, perhaps being aware of the skin of the toes - perhaps aware of the pads of the toes - perhaps aware of 
the spaces between the toes [PAUSE 7 SECONDS]. 
Moving attention now from the toes to the rest of the feet - aware of any sensations here [PAUSE 2 
SECONDS].  The soles and the tops of the feet, the heels - using your attention to explore deeply, noticing 
what’s there for you right now. Perhaps there is a sensation of temperature - coolness or warmth - or lightness, 
or heaviness, moisture. Exploring the skin perhaps, or maybe exploring very deeply into the feet, aware of the 
bones, the muscles. Whatever sensations happen to be present in the feet. If you have no sensation there, 
being simply aware of that fact [PAUSE 12 SECONDS].  
 Bringing attention now up to the ankles and the lower legs - to the bones and tendons passing through 
the ankles. Aware of the large calf muscles and the shinbones - exploring the density or thickness of the lower 
legs, and whatever sensations are present in the knees [PAUSE 12 SECONDS]. 
Moving now to the thighs and the hamstrings and the hips - perhaps noticing the large muscles of this 
area - feeling the support on which you’re lying, feeling the contact that the thighs and hamstrings are making 
here - perhaps aware of the touch of clothing, pulsation of circulation. Perhaps sensing no feeling at all, and 
just aware of that [PAUSE 10 SECONDS]. 
Now, bringing attention to the buttocks and the pelvis. Perhaps aware of the muscles here - the contact 
with the supporting surface. Perhaps sensing any feelings in the intestines, the lower abdomen. Then bringing 
the attention to the upper abdomen and stomach area - aware of any sensations in that area including no 
sensations if that is the case [PAUSE 10 SECONDS].  
Now bringing your attention around to the lower back.  Many of us hold tension in the lower back, so 
allowing this area to ease with deep attention. Noticing the muscles, the contact that the back makes with the 
surface you’re lying or sitting on - noticing being held by that support [PAUSE 2 SECONDS]. Then bringing 
attention to the upper back - aware of the spine - aware of the all of the nerves encased in the spine and 
branching out to all parts of the body [PAUSE 2 SECONDS]. Aware of the muscles of the back - muscles 
which hold us upright [PAUSE 5 SECONDS].  
Aware now of the very bottom of the rib cage and in back, the ribs attaching to the spinal column and 
moving awareness into the area of the chest - deeply exploring here, bringing a very gentle attention [PAUSE 
2 SECONDS]. You may be aware of the diaphragm gently moving with the in- and out-breath - feeling the 
movement of the back with each in-breath and each out-breath.  Aware of the muscles of the chest region and 
the skin - sensing the movement of the ribcage opening to the volume of fresh air being brought into the body, 

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and what is no longer needed flowing out on the out breath [PAUSE 2 SECONDS]. Aware of the area of the 
heart and the lungs - the lungs filling with fresh oxygen with each in breath, delivering vitality to the blood - 
perhaps feeling the beating of the heart as it delivers fresh blood around the body [PAUSE 5 SECONDS].  
Remember, if any sensation or area is too uncomfortable at any time, you can always override the 
instructions and come back to the sensations of the abdomen moving with the breath. Simply paying attention 
to the breathing until the mind settles again [PAUSE 10 SECONDS]. 
Now bringing the attention down both arms to the hands and fingers - aware of any sensations here - 
perhaps noticing moisture, or coolness, or warmth - aware of the skin of the palms, the back of the hands 
[PAUSE 10 SECONDS].   
And moving attention now to the wrists and forearms - the delicate skin on the underside of the wrist, 
and the bones and muscles in the lower arms, the elbows [PAUSE 5 SECONDS]. Exploring the upper arms, 
perhaps aware of the triceps and biceps muscles, aware of the bones inside the arms - the arm bones resting 
in the shoulder sockets - the arm pits. Aware of any sensations at all in this area, including no sensation if that 
is the case [PAUSE 5 SECONDS]. 
And now coming to the shoulders and the tops of the shoulders. Here is another area that many of us 
hold tensions - exploring in detail all parts of the shoulders. Allowing our attention to be like a light fingertip 
massage, releasing any tightness as it moves. Breathing deeply in, and on the out-breath letting any tightness 
and congestion simply flow away [PAUSE 10 SECONDS].   
Aware now of the neck and the throat - aware of the ability to speak and to swallow, perhaps feeling the 
breath moving in the trachea. Noticing the muscles of the neck, the strong muscles that hold up the head, and 
the place where the spinal column meets the skull bones [PAUSE 8 SECONDS].  
And moving your attention up to the head, aware of the skull, or any sensations of the head being 
supported [PAUSE 2 SECONDS]  And bringing attention now to the forehead - aware of any sensations in this 
area - moving attention from one temple across the forehead to the other, allowing the forehead to smooth with 
your attention [PAUSE 10 SECONDS].   
Aware of the eyelids and the eyeballs resting in their sockets [PAUSE 5 SECONDS] - the area of the 
nose. Perhaps feeling the coolness of the incoming breath in the nostrils, and noticing slight warmth on the 
outgoing breath [PAUSE 10 SECONDS]. Bringing your attention now to the cheeks and the muscles of the 
face that give expression to our many emotions. Aware of the jaw and the muscles of the jaw [PAUSE 5 
SECONDS] - allowing the jaw to be completely slack and at ease [PAUSE 5 SECONDS]. Aware of the ears - 
the ability to hear at this moment [PAUSE 5 SECONDS].  Aware now of the mouth and the lips, the inside of 
the mouth, the tongue [PAUSE 5 SECONDS]. Breathing deeply, bringing the freshness of this breath to all 
parts of the head - and breathing out, releasing any tightness, any tensions - letting go of all congestion 
[PAUSE 10 SECONDS]. 
Now bringing the attention back to the sensations of the breath and allowing the breath to bring fresh 
energy through every part of the body, right down to the feet. Feeling the freshness in lower legs, the upper 
legs, the torso, the hands, arms, shoulders and head - and releasing any tension or congestion on the out-
breath [PAUSE 15 SECONDS].  
And now gently beginning to move the toes and fingers, the hands and feet - beginning to move and 
stretch. Moving in any way that feels comfortable for you right now - giving yourself plenty of time to do this. 
Knowing that by allowing yourself to be as you are you are inviting a sense of openness and presence to 
whatever is happening in your daily life and in this way you are supporting your health and wellbeing.  
 
AWARENESS OF BREATH EXERCISE CD SCRIPT  ~15 Minutes 
 
In this exercise we will be building your attentional skills. We will be learning to use attention to bring 
increased awareness to everyday experiences - experiences that may have become so familiar we are 
perhaps no longer aware of them. So sitting in a comfortable chair just allow the body to become still - feeling 
the support of the floor and the chair and settling in to this stable seat. The back is straight without being stiff - 
the posture is relaxed yet awake and dignified. 
And now just becoming aware of your breathing - aware of the movement of the breath as it flows in 
and out of the body. Not controlling it in any way. Just allowing it to be as it is. Simply aware of the sensations - 
how it feels.  You may notice the sensations at the belly - sensing the belly expanding as you breathe in and 

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flattening as you breathe out - just allowing your attention to ride gently on the sensations of each breath. This 
is not thinking about breathing, but feeling it directly - the best you can. [PAUSE 15 SECONDS]   
Just allowing the breath to breathe itself – giving it your full care and attention. Being there for the entire 
cycle of the breath - noticing the very beginning of the in-breath and following that breath as it enters the body, 
filling the lungs and expanding the abdomen, then as it comes to a tiny moment of stillness before it turns 
around and makes its journey out of the body. Just noticing this process - letting your attention rest lightly on 
the sensations. [PAUSE 25 SECONDS] 
You may notice that from time to time that the attention will wander off – perhaps to memories, 
fantasies, judgments, worries or regrets. Or it may move to anticipation of the future - planning, wishing or 
concerns. As soon as you become aware that the attention has moved off to other things gently bring it back to 
the sensations of the breath - escorting it with a gentle firmness. No need to give yourself a hard time about it, 
it’s the habit of the mind to wander. This is simply about bringing your attention back to the breath each time 
you notice it has wandered - once again aligning the attention with “this” breath in “this” moment. One breath 
following the next - noticing the movement in your body with each breath [PAUSE 25 SECONDS]  
Bringing your attention to the breath in this way can be a powerful anchor to this present moment. This 
is a place you can return to whenever you become distracted, preoccupied or anxious – simply returning your 
awareness to the breath in this way and returning to this state of awake stillness [PAUSE 25 SECONDS]. 
You may find as you observe the breath that other sensations in your body come into your field of 
awareness - perhaps discomfort or perhaps restlessness or distress. These sensations may be more focused 
and intense from time to time. Just be aware of the body sitting - being present to whatever sensations or 
feelings may emerge, perhaps lingering, changing in intensity and passing away. Simply being here as you are 
in this moment - aware of the flow of the breath and whatever feelings happen to present themselves [PAUSE 
25 SECONDS]. 
Now for the next couple of minutes, experimenting with expanding the field of your attention to include 
any sound that may be present. Not stretching to reach out for the sounds but just allowing them to reach the 
ear - aware also of the silence between the sounds.  Notice any tendency to judge the sounds - to like them or 
dislike them - just noticing this if it is present without trying to change it, and returning to simply being with 
hearing - embracing sounds as they occur moment to moment. You might notice the difference between the 
sound sensation reaching the ear, and the mind’s naming and identifying the sound [PAUSE 10 SECONDS]  
If the attention wanders off, simply coming back to whatever sounds are occurring now - alert, alive, receiving 
sounds in stillness. [PAUSE 25 SECONDS]  
At times, strong emotions may dominate the attention making it more difficult to focus. If a strong 
emotion emerges you may choose to investigate it, noticing its exact qualities. What are its qualities? Perhaps 
it is throbbing or pulsing? Not trying to change it or struggle with it, just noticing it with gentleness, kindness 
and patience. As these emotions subside, returning the attention again to the breath moving in and out of the 
body [PAUSE 25 SECONDS] 
And now for the next few minutes we will be focusing attention on becoming aware of any thoughts that 
may be present in the mind. There may be big attention-getting thoughts, or quite subtle barely noticeable 
thoughts. Or there may be anxious thoughts – thoughts of memories, pressures, concerns or obligations. Or 
there may be fantasy thoughts - desires, likes, dislikes, plans. Just allowing whatever thoughts happen to be 
present without trying to change them. Just noticing them as thoughts, without engaging with whatever it is 
they are about. Allowing the thoughts to be like clouds, drifting through a vast, spacious sky – you are just 
being witness to the thoughts [PAUSE 20 SECONDS]  
You may be finding your mind is quite busy and there are many thoughts, or perhaps it happens to be 
relatively quiet and there are few thoughts. It doesn’t matter - just let it be as it is. It doesn’t have to be a 
problem if it is busy – that’s just the way it happens to be right now - just notice that it is busy [PAUSE 20 
SECONDS] 
If you find yourself carried away by a stream of thoughts or if the thoughts are too distressing or 
unsettling - there is no need to struggle with the thoughts. As soon as you recognize if they are too unsettling 
you can re-anchor your attention in the awareness of the breath - coming now to “this” breath. When you feel 
steady again, if you choose to you can return to witnessing the thoughts arising in the mind or simply stay with 
the breath [PAUSE 30 SECONDS]. 

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And now for the time remaining, letting go of any particular focus of attention and allowing yourself to 
simply be here, fully present. Aware of the breath moving - sensations in the body - sounds - thoughts and 
emotions coming and going - allowing it all to be as it is. Just be witnessing it all as it unfolds. Complete, as 
you are right now.  PAUSE 25 SECONDS. 
And now as the recording comes to an end, once again narrowing your attention to the breath - this 
breath - your attention riding on the flow of the breath - fully present with each in-breath and with each out-
breath. Nothing you need to do - just being fully present with the breath flowing into and out of the body 
[PAUSE 15 SECONDS]  
You might now want to congratulate yourself for taking the time and the energy to do this and form an 
intention to make the time to do this on a regular basis. Deepening your ability to be fully present and allowing 
the benefits of this practice to flow into the experience of your daily life. 
 
 
 

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Appendix 2 
Study 4  
Health Coaching  
Training Materials 
 
 
 
 
 
CONTENTS 
• 
Health Coaching Overview 
• 
Health Coaching outline 
 
 

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HEALTH COACHING OVERVIEW 
 
   
 
 
 
Session 
1 
Session 
2 
Session 
3 
Session 
4 
Session 
5 
Session 
6 
Session 
7 
Session 
8 
Sleep 
X 
 
 
 
 
 
 
 
Nutrition 
 
X 
x 
x 
x 
 
 
 
Sun Safety 
 
 
 
 
 
X 
 
 
Physical Activity 
 
 
 
 
 
 
X 
 
Home and Travel Safety 
 
 
 
 
 
 
 
X 
 
 
 

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HEALTH COACHING OUTLINE (HC condition) 
 
Source:  
Schedule: 1 session once a week for 8 weeks; duration of each session: 30 minutes  
 
Session 1:  Tips for a Good Night’s Sleep 
• 
Questions and answers related to material discussed in the last session 
 
 
 
 
(5’) 
 
 
 
 
 
 
 
• 
Assess participant’s current sleep habits; Tips for sound sleep; Assess barriers to implementing healthy  
sleep tips  
 
 
 
 
 
 
 
 
 
 
 
(10’) 
 
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Explanation of daily practice (Sleep Diary); Participant encouraged to complete daily practice;  
confirm next meeting  
 
 
 
 
 
 
 
 
 
 
(5’) 
 
Session 2:  Eating to Feel Well 
• 
Questions and answers related to material discussed in the last session 
 
 
 
 
(5’) 
 
 
 
 
 
 
 
• 
Foods to Feel Better; Benefits of Fruits and Vegetables, Strategies to add more fruits and vegetables to 
diet 
(10’) 
 
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Explanation of daily practice (Trying new fruits/vegetables, Reading); Participant encouraged to complete  
daily practice; confirm next meeting  
 
 
 
 
 
 
 
 
 (5’) 
 
Session 3:  Healthy Choices When Eating Out 
• 
Questions and answers related to material discussed in the last session 
 
 
 
 
(5’) 
 
 
 
 
 
 
 
• 
Fast food choices; Bodega choices; Soup kitchen choices; Restaurant choices 
 
 
 
(10’) 
 
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Explanation of daily practice (Reading, Daily Effort to make healthy choices when eating out); Participant 
encouraged to complete daily practice; confirm next meeting   
 
 
 
 
(5’) 
 
Session 4:  Reading Food Labels 
• 
Questions and answers related to material discussed in the last session 
 
 
 
 
(5’) 
 
 
 
 
 
 
 
• 
Nutrition Facts; Serving Size; % Daily Value; Measurements  
 
 
 
 
(10’) 
 
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 

Mindfulness Training for PLWH 
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• 
Explanation of daily practice (Reading labels at home and grocery story; making grocery choices based on  
labels); Participant encouraged to complete daily practice; confirm next meeting  
 
 
 
(5’) 
 
Session 5:  Smart Snacking 
• 
Questions and answers related to material discussed in the last session 
 
 
 
 
(5’) 
 
 
 
 
 
 
 
• 
Assess participant’s current snacking behaviors; Healthy snacking options; More filing food choices 
 
(10’) 
 
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Explanation of daily practice (Daily effort to making healthier snack choices); Participant encouraged to  
complete daily practice; confirm next meeting   
 
 
 
 
 
 
(5’) 
 
Session 6:  Sun safety 
• 
Questions and answers related to material discussed in the last session 
 
 
 
 
(5’) 
 
• 
Importance of sun exposure; vitamin D; type of UV light; safe sun practices; importance of maintaining  
adequate hydration  
 
 
 
 
 
 
 
 
 
 
(10’) 
 
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Explanation of daily practice (Reading); Participant encouraged to complete daily practice; confirm next  
meeting   
 
 
 
 
 
 
 
 
 
 
 
(5’) 
 
Session 7:  Physical Activity 
• 
Questions and answers related to material discussed in the last session 
 
 
 
 
(5’) 
 
 
 
 
 
 
 
• 
Assess current level of physical activity; Benefits of physical activity; Safe stretching; 
 Walking; 
Importance  
of Posture 
 
 
 
 
 
 
 
 
 
 
 
 
(10’) 
 
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Explanation of daily practice (Reading on physical activity; Implementing physical activity); Participant  
encouraged to complete daily practice; confirm next meeting   
 
 
 
 
(5’) 
 
       Session 8: Healthy homes & Safety While Traveling  
• 
Questions and answers related to material discussed in the last session   
 
 
 
 
(5’)  
 
 
• 
Tips for a healthy home: chemicals (including drugs); noise protection;  carbon monoxide, radon, lead, 
ozone;    

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drinking water and hand hygiene.  Tip for safety while traveling: Seatbelts, airbags, children in car.  Bus  
safety, safety while waiting for the bus, crosswalks, 
 
 
 
 
 
 
 
(10’)  
 
• 
Instructor asks participant for any comments or questions they may have related to the material discussed
 
(10’) 
 
 
 
 
 
 
 
 
 
 
 
• 
Explanation of daily practice (Reading); Participant encouraged to complete daily practice; confirm next  
meeting   
 
 
 
 
 
 
 
 
 
 
 
(5’) 
 
 
 
 
 
 
 

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Appendix 3 
 
Study 4  
 
Unannounced Telephone-based  
Pill Count Protocol 
 
 
 
 
 
 
Sources: 
Fredericksen R, Feldman BJ, Brown T, et al. Unannounced telephone-based pill counts: a valid and feasible 
method for monitoring adherence. AIDS Behav. 2014; 18: 2265-2273. PMID: 25331265. 
Kalichman SC, Amaral CM, Stearns H, et al. Adherence to antiretroviral therapy assessed by unannounced pill 
counts conducted by telephone. J Gen Intern Med. 2007; 22: 1003-1006. PMID: 17390095; PMCID: 
PMC2219717. 
Kalichman SC, Amaral CM, Cherry C, et al. Monitoring medication adherence by unannounced pill counts 
conducted by telephone: reliability and criterion-related validity. HIV Clin Trials. 2008; 9: 298-308. 
PMID: 18977718; PMCID: PMC2937191. 
Kalichman SC, Amaral C, Swetsze C, et al. Monthly unannounced pill counts for monitoring HIV treatment 
adherence: tests for self-monitoring and reactivity effects. HIV Clin Trials. 2010; 11: 325-331. PMID: 
21239360. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Phone Assessment Training 
 
Prior to coming in for the pill count training, the participant is instructed to bring all of their pill form medications-
ARV and Non-ARV. If the participant is currently out of medications and has not refilled the prescriptions, ask 
the participant to bring in the empty bottles in order that the prescription information may be gathered. If the 
participant has forgotten the medication, they are asked to go home and get their medications prior to 
beginning the pill count training. 
 
The purpose of the in person pill count training is to introduce the pill counting procedure; but it is also a 
valuable opportunity for the pill counter to gain some information before the phone 0 interview. This needs to 
be individualized, and the pill counter needs to work to sensitively find out how much of this information each 
patient will be able to give.  
 
During the pill count training the participant will meet the Interviewer and will be walked through the 
assessment protocol. All of the steps of the phone assessment will be part of this initial meeting. The outline for 
the assessment training sessions is as follows: 
 
The Pill Counter meets and greets the participant. 
 
Explain the phone pill counts and why we are doing them: 
 
“A pill counter will call you several times during the study to talk to you for the study. The call will be done on 
the phone while you are home. On the phone calls, the pill counter will ask you to count your medications and 
tell her how many you have received and what you have left.  It is very important we receive accurate 
information.” 
 
Prior to beginning the practice pill count, review the sample pharmacy label with the patient. With the 
Consultant’s assistance, the TMH pill counter will highlight the pertinent information that will be used each 
month.  
 
Run through a practice pill count using the pills that have been brought in for the baseline assessment. 
 
BE SURE TO EMPHASIZE THE IMPORTANCE OF HAVING ALL MEDICATIONS OUT FOR THE PHONE 
CALL.  
 
The Pill Counter will run through 3 sample question to demonstrate each type of response. Mention that the 
caller will also ask some questions about how the participant has been feeling and related issues. 
 
Phone Assessment Training 
 
1. Review the reason for the medication assessment: to learn how people are using their medications so 
that we can development better health programs.  
 
2. Provide Health and Assessment Kit. 
 
Contents:  
 
 
The Pill Tray 
 
Pill Knife 
 
 
Hand Wipes 
 
 
3. Explain the pill count protocol. Use the Pill Counting Demo Kit to demonstrate how to count pills.  
 

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4. Practice a pill count with the Interviewer present. Pour the pills onto the pill tray. Instruct the participant 
to count their pills out loud by using the pill knife and sliding the pills into the valley of the pill tray. After 
all of the pills are counted have the participant put the pills back in the medication bottle and count the 
pills a second time. If the participant does not have medications to count, use the candy (Skittle, Tic 
Tacs, etc.). 
 
5. Review protocol – answer questions – trouble shoot – problem solve 
 
The Intake Interview is completed….participant given… 
 
 
Copy of consent form 
 
Take Home Kit 
 
Incentive Payment  
 
Phone Assessments and Pill Count  
 
Time 0 Phone Assessment 
 
Ideally participants are called within 3 days of Initial Intake for their Time 0 phone call. 
Materials Needed for Phone Assessments 
Previous Call Information Sheet 
Assessment Form 
Phone Tracking Sheet-(log of participants contacted with their participant ID)  
Timing of interviews  
Each month, the participant receives an unannounced call that includes a pill count and interview. Ideally, 
participants should be called within 3 days of the Initial Intake.  
Calls should occur in 28-day intervals, +/- 7 days; in other words, participants should be called 21-35 days from 
their last phone call.  
While interviews are ideally conducted every 21-35 days, they can be conducted 14-42 days from the date of 
last call if necessary.  
Beyond this time span, the visit is considered a missed call and should be entered as a dummy record in the 
database.  
If you do get off schedule with a participant’s calls (for example, you couldn’t call them until the end of the 
previous window), you should aim to get them back on schedule during the next month.  
You should always try to maintain the 28-day (+/- 7 days) interval between calls.  
The Tracking system will generate weekly schedules for phone interviews. Weekly schedules will include all 
participants due for visits within the 14 day window with the target date for the call.  
Phone Interviews should not be scheduled with the participant. It is helpful to know the best times to call a 
participant and when he or she is likely to be out. 

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Ø If the interviewer calls the participant, but they are not able to take the call (they’re too busy, etc.), then 
tell them that it’s not a problem and you will call back later. 
If participants call and ask to schedule a call because they need the money or will not be available, then we 
reiterate the fact that all calls are unannounced.  
It can feel uncomfortable at times when the participant asks when you are calling and you cannot tell them. 
Simply explain that the way the project was designed was to have these types of calls and it actually makes it 
easier on everyone because then nobody’s daily routine is disturbed by waiting around. If they say they would 
feel bad if you call when they are not around, you could say, “It’s no problem if you’re not home. People often 
aren’t home when I call them, but I’m not wasting time because I can just call someone else and try again later 
or another day.”  
During the Interview 
Before starting the interview it is good to review your notes from the last call and Intake Interview Survey. The 
Tracking Sheet and Phone Assessment Booklets have all of the necessary data you will need to collect during 
the call. While the tracking sheet and assessment booklet has all the information you will need, here are some 
key points to keep in mind: 
Ø It is crucial to be sure that all of the participant’s pill bottles are in front of the participant on the 
phone and that they get an accurate pill count. Sometimes a participant will not immediately have all 
of their pill bottles. Ask them if they have any other bottles, or pills in other containers, anywhere in their 
home. Use the information in the Intake Survey to help with this. Check the Rx dates of the bottles to 
the Rx dates recorded in the booklet to make sure that all bottles are accounted for. 
Ø To instruct participants in the phone assessment you should include the following:  
1. Find a comfortable place with a flat surface where you can spread out your pill bottles in front of 
you.  
2. Get all of the bottles together and group them so that all of the medications are separate. Guide 
the grouping from the medication list in the Intake Interview Survey. Example, have all Combivir 
grouped in one area, then all of your Kaletra in another area…etc.  
3. Use an alcohol wipe to clean your pill tray and pill knife before starting. 
4. Select one drug to count first. Be sure that all of the medications are present for the count. 
a. Select one bottle to count. 
b. Collect Label information from the bottle. 
c. Pour mediations from a bottle into the Medications Cup. 
d. Pour medications from the cup on to the pill tray – this is especially for large pills. Small pills 
or small numbers of pills may be poured directly onto the tray. 
f. Have participant count the pills out loud and replace in the bottle. 
g. Tell interviewer the count. 
h. REPEAT STEPS c thru g for second confirming count – bottle by bottle.  
Ø It is important to document all the bottles that are present during a call. The bottle information table is a 
tool for interviewers to keep track of bottles they have counted. Note the distinction between “Pills per 
Bottle” and “Refill Amount.” For example, a participant might have received a refill of 240 RIT, which are 

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given to him in 2 bottles with 120 pills in each; in this case, “pills per bottle” is 120 and “refill amount” is 
240—this is so that later you will recognize that the participant has 2 new bottles for RIT.  
Ø It is very important to figure out whether or not the participant got a refill and, if so, how many since the 
last phone assessment. Look at the Rx info from the previous assessment booklet to see if the Rx label 
is the same or not. Also, remember that a participant may have received more than one refill between 
calls. 
Ø Always have the participant count pills twice to verify that they have the correct number. Make sure to 
write the date of the bottle above each column in the pill count table.  
Ø Do a quick check of the pill count, prior pill count and dispensed to see if it makes sense – that way if it 
does not make sense you have participant look for other bottles or get more information while you still 
have the participant on the phone.  
Ø If the participant has changed regimens, you should have them count all old and new meds and find out 
from the participant what date (and dose) the old meds were stopped and the new ones were started.  
Ø Tell participant they will be paid at the next in person visit.  If the participant would like to be paid 
sooner arrange for an in person payment.  
Ø Verify participant locator information. 
Ø Provide reminder for next study activity and remind them of any upcoming intervention sessions or 
office assessments. 
Pill Boxes/Medisets/Blister Packs 
BE VERY CAREFUL WHEN COUNTING PILL BOXES AND MEDISETS 
Some of our participants will be using Medisets dispensed by pharmacies or agencies. You need to handle 
these pill counts differently to obtain accurate data. Please refer to the “Medisets method” document. Medisets 
filled by the participant can be treated like any other pill count. Have the participant open each compartment 
and count by the pill. Go by color or shape or size. Count twice.  
Blister packs are dispensed for the entire month.  
 
Ask  
 
-if all of the medications are dispensed in blister packs 
 
-Do they have a.m. and p.m. doses 
 
-What medications are in each pack 
 
-Do they have pills from the blister pack that they do not take anymore 
Change in Regimen Between Calls  
Sometimes a participant will start a new regimen between visits. Often you will be able to determine the exact 
date and dose (am/pm) that the old pills were stopped and the new pills were started. These dates can be 
entered into the “start date” and “stop date” fields of the database, allowing the database to correctly arrive at 
an adherence calculation. In this situation, the Pill Count Summary is “1. All Pill Counts obtained,” and the 
Regimen Summary is “2. Change of ARVs prescribed.” Note that the “stop date” for a med is the first day a 

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participant did not take the med, not the last day she did take it. If you are not able to determine the start/stop 
dates, the visit is coded as “6. New Baseline after missed visit/no pill count.” 
Special circumstances 
 
If the participant is in jail, prison, or the hospital: If the participant will be out of jail or the hospital soon 
(before their 42-day maximum visit window has passed), it is usually best to wait until they return home to 
conduct the interview. This is so that you can get a pill count, since the participant almost never has their own 
meds with them in the institutional setting. In this case, conduct the pill count as usual but be sure to find out 
the exact dates they were in jail or the hospital. You can then figure out the number of doses of meds they had 
dispensed in the institutional setting and add this number to the dispensed column in the grid. You would code 
this visit as “1. All Pill Counts Obtained.” However, we only do this if the participant has received meds in the 
institutional setting for fewer than 14 days, or less than half the time period between visits (whichever is 
smaller). Beyond that, we consider the participant as not responsible for his own meds for that visit period. In 
this case, dispensed is –9 and the visit code is “3. No Pill Count.”  
 
If you cannot wait until after the participant has returned home, you can often conduct the self-report portion of 
the visit while they are in the hospital or at jail. In this case, the visit code is “3. No Pill Count” and you should 
mark an X in the pill count column. If the participant has returned home by the time of the next visit, you can 
often compute a 2-month adherence percentage by changing the start date and adjusting dispensed to 
account for meds given while in the hospital or jail.  
Do not follow a participant if they have not done their baseline. They are dropped from the study. 
If a participant has been randomized/baselined they should remain in the study. 
If a participant moves and has done their baseline, they may continue to participate in the study by doing the 
monthly pill counts. 
Avoid Performing Any Intervention 
Because our study aims to gain an accurate picture of participants’ adherence, we are not allowed to intervene 
in ways that would affect how they take their medication. For example, you should not praise a participant for 
improved adherence, suggest that participants use a Medisets, pick up meds for a participant, etc. Participants 
develop close relationships with us, but we must remember that we are researchers and not nurses, 
caretakers, or social workers. You might feel uncomfortable with some participants’ requests or expectations of 
you; you should always feel free to talk with Seth or other project managers about the situation. 
In some situations, intervention is permissible and important.  
For example:  
1. At Intake the participant doesn’t understand their regimen; their self-report of how many pills they 
are supposed to take might be different from what is instructed on the Rx label. In this case, we 
should ask if they are aware that their routine is different from what their prescription says. We 
should tell them about the discrepancy and recommend that they talk to their doctor.  
2. If the Rx is written or filled incorrectly, then we should inform the participant and call the pharmacy. 
If a participant’s Medisets has been filled incorrectly by an agency, we should tell them and talk to 
their nurse at the agency.  
3. If the participant’s life is in jeopardy (for example, in cases of domestic violence), we may intervene 
in some ways. These extreme cases should be discussed with the Project Management 
immediately.  

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4. If it is apparent that the participant is mis-dosing, get the participant to call their doctor to fix the 
problem. Call back within two days and check in with the participant to assure that they contacted 
their doctor.  
  
Pill Count Notes: 
A. Help the participant group their pills together and set up tray. There are instructions on how to do this 
on page 4 of the assessment. If this is not done correctly participant might not report all of the 
medication they have.  
B. Large pills can be difficult for the participant to count. It is helpful to dump them all in tumbler cup 
initially and then dump a few at a time onto the pill tray. After those have been counted you should have 
them put back into the bottle and then have more from the tumbler dumped onto the tray.  
C. It is very important for the participants to count each medication twice. 
D. Participants should count their medications out loud and the pill counter should make sure they are 
counting accurately.  
E. Do refrigerated drugs first and then have them put them back in the fridge. 
F. Work on one prescription at a time – Obtain bottle information and then count the medication. 
G. Participants often think that you are only interested in their open bottles. Make sure they have all sealed 
bottles and pill boxes or other containers in front of them. 
H. If a participant was not taking prescriptions in the previous call make sure that you ask them if they 
have begun taking pills. If they were taking pills make sure you ask them if they have changed their 
regiment. 
I. If participant is not taking pills they are only asked the questions on pages 1, 2, 11, 12, 13, 14, 15 and 
16. 
J. If they lose the pill tray? Call the Share Project, let them know that they will need a new one and have 
the participant pick it up. Ask Share Project to let you know when person has picked up their new 
assessment kit. 
K. Participants who are not taking ARVs, but are taking non-ARVs they are not asked the questions on 
page 11.  
L. If the participant asks to set up an appointment? We don’t set up appointments because it would 
inconvenience you. “We don’t want you sitting around waiting for me to call. I don’t mind calling and if I 
call at a bad time, please tell me and I will call another time. I don’t mind doing that.” 
M. Pill counters do not track ARV’s that are in liquid form. 
 
During the assessment you should have the following in front of you: 
1. Tracker sheet – 1 page. 
2. Intake Interview Form = Refer to pages 3, 4, 5 & 7. 
3. Last Monthly Assessment Booklet = Refer to page 8 = previous pill count. 
4. Blank Monthly Assessment Booklet for this call. – It saves some time if you fill in some of the answers 
ahead of time. That would be name of medication; pharmacy used, and set up the pill box form if they 
are using a pill box.  
 

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Telephone Pill Count Script 
1. Insert Reminder Notes Here 
 
2. Introduction – Hi, is ________there? Hi, this is _______ from HIP-Providence. I am calling to do your 
monthly assessment. Is this a good time for you to do an assessment? 
 
3. What is your Date of Birth? 
 _________/______________/___________ 
 
 
 
 
 
Month  
Day 
 
Year 
 
4. Where were you born? or, What is your Mother’s name? 
 
5. Please get your Pills 
 
6. While you wait: 
 
DATE _________/______________/___________ 
 
 
 
Month  
Day 
 
 
Year 
 
Call Start Time ____________AM / PM 
 
Interviewer Initials ___________ 
 
Phone Contacted On (circle one): Home Personal Cell Other_______ 
 
6. Many people with HIV have many pills to take at different times during the day. Some find it hard to 
always remember their pills, for example… 
 
• 
Some people get busy and forget to carry their pills with them. 
 
• 
Some people find it hard to take their pills according to instructions, such as “with food”, “on an empty 
stomach”, “every 8 hrs.”, or with plenty of liquids”.  
 
• 
Some people decide to skip pills to avoid side effects or simply just don’t want to take their meds that 
particular day. 
 
I just want to remind you that the reason why we do these home assessments is because we want to 
understand what people with HIV are really doing with their pills. Please tell us what you are actually 
doing. Don’t worry about telling us that you missed or stopped your meds. We need to know what is 
really happening, not what you think we want to hear. If we don’t know all of the good and bad aspects 
to taking meds, then we won’t be able to help others in the future. 
 
7. Verify where the participant keeps their medication. 
 
See INTAKE SURVEY- BE SURE TO MAKE ANY CHANGES TO WHERE MEDS ARE KEPT DIRECTLY TO 
THE INTAKE SURVEY 
 
8. Verify the current drug regimen by asking about the drugs taken at last home assessment. Write the 
current regimen below. 
 
FOR EACH PRESCRIPTION FROM INTAKE SURVEY, ASK: 
• 
Are you still taking [MED]? IF SO, ASK: How many doses per day? How many pills per dose? 
(Compare with cover sheet. Record changes in Table) 

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• 
Have you stopped taking any HIV meds since our last call? 
 Yes / No (Record stop date in Table) 
 
• 
Have you been prescribed any new HIV meds since the last call? 
 Yes / No. (Record new drugs and dosage information in Table) 
 
Current PRESCRIPTION DRUGS (Compare to Last Assessment) 
 
 
 
Medication 
 
 
Dose/Times 
 
1. ______________________ ____________________ 
 
 
2. ______________________ _____________________ 
 
 
3. ______________________ _____________________ 
 
 
4. ______________________ _____________________ 
 
 
5. ______________________ _____________________ 
 
 
6. ______________________ _____________________ 
 
9. Additional Information about Current Medications. 
 
Keeps meds in bottles  
 
Yes 
 
No 
 
 
Uses a Pill Box / Mediset  
 
Yes 
 
No 
Carries doses  
 
 
Yes 
 
No 
Gets meds in blister packs 
 
Yes 
 
No 
-If yes, Do you have all of these pills with you. 
10.  
To instruct participants in the phone assessment you should include the following:  
1. Find a comfortable place with a flat surface where you can spread out your pill bottles in front of you.  
2. Lay out the pill try, tumbler, and pill knife. 
3. Get all of the bottles together and group them so that all of the medications are separate. Guide the 
grouping from the medication list in the Intake Interview Survey. Example, have all Combivir grouped in 
one area, then all of your Kaletra in another area…etc.  
4. Use an alcohol wipe to clean your pill tray and pill knife before starting. 
5. Select one drug to count first. Be sure that all of the medications are present for the count. 
a.  Select one bottle to count. 
b.  Collect Label information from the bottle. 
c.  Pour mediations from a bottle into the Medications Cup. 
d.  Pour medications from the cup on to the pill tray – this is especially for large pills. Small pills or 
small numbers of pills may be poured directly onto the tray. 
f.  Have participant count the pills and replace in the bottle. Ask the participant to count out loud. 
g.  Repeat Pill Count 
h.  REPEAT STEPS c thru g for second confirming count – bottle by bottle 
 

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References 
 
1. 
Kalichman SC, Amaral CM, Stearns H, et al. Adherence to antiretroviral therapy assessed by 
unannounced pill counts conducted by telephone. J Gen Intern Med. 2007; 22: 1003-1006. PMID: 
17390095; PMCID: PMC2219717. 
2. 
Kalichman SC, Amaral CM, Cherry C, et al. Monitoring medication adherence by unannounced pill 
counts conducted by telephone: reliability and criterion-related validity. HIV Clin Trials. 2008; 9: 298-
308. PMID: 18977718; PMCID: PMC2937191. 
3. 
Kalichman SC, Amaral C, Swetsze C, et al. Monthly unannounced pill counts for monitoring HIV 
treatment adherence: tests for self-monitoring and reactivity effects. HIV Clin Trials. 2010; 11: 325-331. 
PMID: 21239360. 
4. 
Fredericksen R, Feldman BJ, Brown T, et al. Unannounced telephone-based pill counts: a valid and 
feasible method for monitoring adherence. AIDS Behav. 2014; 18: 2265-2273. PMID: 25331265. 
 

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Appendix 4 
 
Study 4  
 
Qualitative Interview Scripts 
 
 
 
 
 
 
 
 

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OBJECTIVES 
1. To obtain patient feedback on the Mindfulness-based Instruction 
2. To obtain patient feedback on the Health Promotion curriculum  
3. To obtain patient feedback on the study protocols  
4. To use this data to inform refinements for our R01 
 
INTRODUCTION  
 
This agenda is intended to guide interviewers through the key content areas of data collection for this project, 
ensuring that the same content is discussed in each interview.  While the agenda is used to guide the discussion, 
it is not a rigid script that will be adhered to verbatim.  This ensures that the facilitators gather data on the 
same topics in each interview, while also allowing them the flexibility to adapt and clarify questions to suit the 
needs and experiences of individual participants.  Similarly, questions need not be asked in this particular 
order.  Rather, the facilitators will adapt the conversation as needed according to the narrative within each 
interview, pursuing both the a priori research topics as well as any emergent relevant themes that evolve from 
the conversation.  
 
Good afternoon and welcome to our session. My name is Name of Interviewer and I work at The Miriam 
Hospital.  
  
Thank you for taking the time out of your busy schedules. We would like to get your feedback about the Health 
Improvement Project in which you are taking part. Your input will be very important to help us see if we can 
improve the program for future studies. There are no right or wrong answers, just differing points of view. We 
are very interested in hearing a range of views. Please feel free to share your point of view especially if it 
differs from what others have said.  
 
Before we begin, let me suggest some things that will make our discussion more productive. We are tape 
recording the session because we don’t want to miss any of your comments. Please speak up so tape recorder 
can hear you. Everything said here is confidential. 
 
My role here is to ask questions and listen. Let’s begin. 
 
Mindfulness-Based Training -- Coach-led Sessions 
Let’s start by thinking about the mindfulness-based training sessions you had with the coach 
who called you once a week on the phone. 
1. What was most helpful about the sessions on mindfulness-based training? Why?  
2. What was least helpful about the sessions? Why? How would you recommend we 
improve the mindfulness-based training sessions? 
3. What did you helpful or not helpful about the mindfulness instructor? Why? How might 
the instructor have improved? 
4. Overall, how can we make the mindfulness-based training sessions more interesting for 
other patients? 
5. Can you tell me how you felt about your instructor?  Alt: do you have any feedback about 
your instructor?  
There were many exercises you did during the mindfulness-based training sessions. These 
included exercises about the awareness of breath, the raisin exercise, sensations, body 
movement, sounds, emotions, thoughts, and open awareness.  
6. Which of the exercises was the most helpful? Why?  
7. Which of the exercises was the least helpful? Why? How would you recommend we 
improve these exercises? 
 
 

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Mindfulness-Based Training – Individual Practice At Home 
Think about the digital or MP3 recordings you used to practice at home, on your own. 
1. What was most helpful about practicing at home? Why? 
2. What was least helpful? Why? How would you suggest we improve the at home practice 
for other patients? 
Now consider the two separate tracks: tracks 1 and 2.  
1. What was most helpful about track 1? What was not helpful about track 1? Why? How 
might we improve this track? 
2. What was most helpful about track 2? What was not helpful about track 2? Why? How 
might we improve this track? 
Mindfulness-Based Training Program Overall  
Please consider the mindfulness-based training program overall. 
1. Are there any other aspects of the program you found particularly helpful or not helpful? 
2. What changes would you recommend we make to this program to make it more 
interesting for other patients? 
3. Which mindfulness technique(s) do you use the most? Why? 
Health Coaching Sessions  
Please think about the 8 Health Coaching sessions you had. 
1. What was the most helpful about the Health Promotion sessions? Which topics did you 
like the best? Why? 
2. What was the least helpful about the sessions? How would you recommend we improve 
the lessons? Why? Are their topics that we did not include that you wish we had? 
3. Show the packet. What was most helpful about the packet? Why? What would you 
suggest we change to make it more useful and interesting for patients?  
4. Any other thoughts about the 8 Health Coaching sessions that will help us improve 
them? 
Study Procedures 
The last thing we would like to ask you about is your experience in participating in the study.  
1. How might we improve the way you were recruited in the study? 
2. How would you recommend we improve the way we asked you to consent to be in the 
study? 
3. How could we improve the process for completing study assessments at the 
Immunology Center? This included completing the computerized survey and giving 
biological samples. 
4. How could we improve the completion of the pill count interviews by phone?  
5. What would you recommend be done differently to make it easier to participate in this 
study in the future? 
6. Did you have any thoughts about the pill counting exercise?  Was it clear?  Did you learn 
anything from it—if so, what?  Is there anything we can do to improve the pill counting?  
For participants who did not complete the study 
We’d like to understand why you chose not to finish the formal part of the research study 
participation.  Knowing this can help us improve experiences for other participants. 
1. Why did you not finish the study? 
2. Is there anything we could have done to have kept you involved in the study? 
Final Thoughts 
Is there anything we did not discuss that you would like to share with us? 
THANK YOU so much for taking the time to meet with us and share your experience with the 
study! We will use your feedback to see how we can improve the program for other patients in 
the future.  
 
 

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Question for participants at the 3-month follow-up 
We have a few open ended questions to ask you about your experiences since the study ended.  
1. Can you tell me what has changed in your life since you finished the research study? 
2. For smokers: has there been any change in your smoking habits? 
3. Can you tell me in your own words, what did you think the study was about? 
Mindfulness-Based Training Participants 
1. How are you using the mindfulness skills you learned in the study? 
a. What practices are you using?  
b. When are you practicing?  Daily? 
c. Are you using any of the audios? Which ones? 
d. Are you practicing on your own?   
2. Now that you have participated in the study, what does mindfulness mean to you 
Health Promotion Participants 
1. Are you using any of the skills you learned in the study? 
a. What skills are you using?  
b. Have you changed any specific behaviors?  Which ones? Why? 

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Appendix 5 
 
Study 4  
 
Suicide Assessment Protocol 
 
 
 
 
 

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Assessment of Suicide Ideation and Vulnerability 
 
If any patient, at any time,  
• 
endorses items assessing suicidal thoughts and plans during the past two weeks, or  
• 
reports significant depression on the screening or computer-assisted self-interview questions (score > 
15 on the PHQ-9), or  
• 
appears severely distressed during any in-person session (i.e., screening, baseline, or follow-up; as 
determined by recruiter judgment), or  
• 
reports suicidal thoughts at any time to PD or Instructor, initiate a “distress check” to assess suicidality. 
This check must be conducted in a sensitive and caring way. For example, you can say to the 
participant the following:  “I would like to check in with you about how this experience was for you. I 
asked a lot of questions, and want to check in to ask how are you doing?” 
 
 
If participant says he/she is okay and does not meet any of the above criteria for enacting the suicide 
safety protocol, no further intervention will be taken. 
 
 
However, if participant says she/he is upset, then the PD or Instructor will say: “It is not uncommon for 
people to feel upset or emotional after answering questions like this (or, talking about  experiences like this). 
We do ask many personal questions. It is also not uncommon for people to have thoughts of hurting 
themselves. Have you had thoughts of actually hurting yourself?” 
 
 
If participant has not had any thoughts of hurting herself and does not meet any of the criteria above for 
enacting the suicide safety protocol, then we will remind patients of the resources available for counseling 
within the Immunology Center. We will also give everyone a list of local agencies that provide counseling 
services, and say: “You may find it helpful to contact one of these agencies to set up an appointment to talk to 
someone about the feelings that were raised today. Also, if you are ever in crisis or need to talk to someone 
immediately, you can call the Immunology Center.” 
 
 
If participant has had thoughts of hurting herself or meets any of the above criteria for enacting the suicide 
safety protocol, then we will start suicide safety protocol, described next. 
Script to Screen for Suicidal Concerns 
If suicidal thoughts or severe distress are reported at screening or during any intervention or assessment 
session, the PD or Instructor will start the suicide safety protocol.  
The PD and Instructors will be trained to use the following script. If indicated (as outlined earlier), they will ask:  
“I’d like to ask you a few additional questions, because I am concerned for your well-being and safety. 
1. Have you ever attempted to harm yourself in the past? 
 
NO 
YES 
 
2. Have you thought about how you might actually hurt yourself?   
NO 
YES  à  [How? ___] 
 
3. There’s an important difference between having a thought and acting on a thought. How likely do 
you think it is that you will act on these thoughts about hurting yourself for ending your life some 
time over the next month? 
 
a. Not at all likely 
________ 
 
b. Somewhat likely 
________ 
 
c. Very likely  
________ 
 
 

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4. Is there anything that would prevent or keep you from harming yourself? 
 
NO 
 
YES  à  [What?  ____________________________________] 
Scoring: 
1. 
Minimal Risk: no shaded items 
2. 
Lower Risk: item 1 or 2 (or both) is shaded; neither item 3 nor 4 is shaded 
3. 
Higher Risk: item 3 or 4 (or both) is shaded 
Safety Protocol 
1. If the patient falls into the minimal risk category, no further action will be taken. The PD or Instructor can 
say something like this:  
Thank you for being open with me. We provide everyone with this list of counseling centers. You may 
find it helpful to contact one of these agencies to set up an appointment to talk to someone about the 
feelings that were raised today. Also, if you are ever in crisis or need to talk to someone immediately, 
you can call The Immunology Center. 
2. If the patient falls into the lower risk category, the PD or Instructor will work on developing a safety plan 
with the patient (described below).  The PD or instructor can say something like this:  
Thank you for being open with me. We provide everyone with this list of counseling centers. You may 
find it helpful to contact one of these agencies to set up an appointment to talk to someone about the 
feelings that were raised today. Also, if you are ever in crisis or need to talk to someone immediately, 
you can call The Immunology Center. I’d also like to work with you to develop a plan to make sure you 
are safe. [see Safety Plan] 
 
Safety Plan (see: http://www.suicidesafetyplan.com/Training.html) 
What can you do, on your own, if you become suicidal, to help yourself not to act on your thoughts or 
urges? 
Who or what social settings help you take your mind off your problems at least for a little while? Who 
helps you feel better when you socialize with them? 
Among your family or friends, who do you think you could contact for help during a crisis? Who is 
supportive of you and who do you feel that you can talk with when you’re under stress? 
Who are the mental health professionals that we should identify to be on your safety plan? 
How will you know when this safety plan should be used? What do you experience when you start to 
think about suicide or feel extremely depressed? 
3. If the patient falls into the higher risk category, the PD or Instructor can say something like this:   
Thank you for being open with me. I would like to help support you. Given your situation, it seems best 
to have someone with more experience than me [ supervisor, and/or the community mobile crisis team]  
talk with you.  
[If in person] I need to make a quick call and then I will sit with you until they arrive.  
[If on the telephone] I am going to make a quick phone call from another line.  I will stay on the line with 
you until we have someone arrive. 
Order of which supervisor to contact: 1) Contact Carla Rich (licensed mental health clinician), 2) Dr. Carey 
(clinical psychologist, PI), 3) a licensed clinical psychologist at the Immunology Center clinical psychologist, or 
3) another clinic provider at the Immunology Clinic (in that order, depending on immediate availability).  The 
supervisor contacted will work with Immunology Center staff to call community mobile crisis team and wait with 
patient until crisis team arrives. 
 

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During Phone-based Sessions 
 
If suicidal thoughts or severe distress are reported during the intervention, the Instructor will follow the 
suicide safety protocol. If the patient falls into the minimal risk category, no further action will be taken. If the 
patient falls into the lower risk category, the Instructor will work on developing a safety plan with the patient. If 
the patient falls into the higher risk category, the Instructor will contact the crisis team and continue to talk to 
the patient on the phone. 
 
 
References 
 
1. 
Broadhead WE, Leon AC, Weissman MM, et al. Development and validation of the SDDS-PC screen 
for multiple mental disorders in primary care. Arch Fam Med. 1995; 4: 211-219. PMID: 7881602. 
2. 
Olfson M, Weissman MM, Leon AC, Sheehan DV, Farber L. Suicidal ideation in primary care. J Gen 
Intern Med. 1996; 11: 447-453. PMID: 88

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