Midwest TXTXT Scale up of an Evidence-Based Intervention to Promote HIV Medication Adherence
Phase: NA
Conditions: HIV Infections
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

 
1 
 
PROTOCOL Title: Midwest TXTXT Scale up of an Evidence-Based Intervention to Promote HIV Medication 
Adherence  
 
July 1, 2022 
 
Grant #: U01PS005214 
 
Funding Agency: 
U.S Centers for Disease Control and Prevention 
National Center for HIV, Viral Hepatitis, STD,  and 
TB Prevention 
Division of HIV Prevention 1600 Clifton Road, Mailstop E-45 
Atlanta, GA 30333 
 
Conducted at: 
 
Ann & Robert H. Lurie Children’s Hospital of Chicago 
225 E. Chicago, Box 161 
Chicago IL 
 
Principal Investigator: Amy 
K. Johnson, PhD MSW Senior 
Investigators: 
Robert Garofalo, MD 
Lisa Kuhns, PhD MPH 
 
Co-investigators 
 
Ricardo Rivero, MD 
Corina Wagner, M.Ed., MBA 
Nanette Benbow, MS 
 
Consultants: 
 
N/A 
 
CDC Project Officer: 
 
Kimberly Evans, PhD, MPH 

 
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Table of Contents 
 
 
ABBREVIATIONS AND ACRONYMS............................................................................................................................... 4 
PROTOCOL SUMMARY ................................................................................................................................................. 7 
RESEARCH TEAM .......................................................................................................................................................... 8 
INTRODUCTION.......................................................................................................................................................... 11 
Literature Review....................................................................................................................................................... 11 
Innovation .................................................................................................................................................................. 13 
Conceptual Framework ............................................................................................................................................. 14 
STUDY OBJECTIVES .................................................................................................................................................... 16 
Aim 1 .......................................................................................................................................................................... 16 
Aim 2 .......................................................................................................................................................................... 16 
AIM 1: RESEARCH QUESTION AND OBJECTIVES ........................................................................................................ 17 
RESEARCH DESIGN ..................................................................................................................................................... 17 
METHODS .................................................................................................................................................................. 17 
Audience and Stakeholder Participation ................................................................................................................... 17 
Study Population ....................................................................................................................................................... 17 
Inclusion and Exclusion Criteria ................................................................................................................................. 18 
Procedures for Recruitment and Informed Consent ................................................................................................. 18 
Sampling .................................................................................................................................................................... 22 
Data Analysis Plan and Variables ............................................................................................................................... 24 
AIM 2: RESEARCH QUESTION AND OBJECTIVES ........................................................................................................ 27 
RESEARCH DESIGN ..................................................................................................................................................... 27 
METHODS .................................................................................................................................................................. 27 
Audience and Stakeholder Participation ................................................................................................................... 27 
Study Population ....................................................................................................................................................... 27 
Inclusion and Exclusion Criteria ................................................................................................................................. 27 
Procedures for Recruitment and Informed Consent ................................................................................................. 29 
Sampling .................................................................................................................................................................... 31 
Data Analysis Plan and Variables ............................................................................................................................... 31 
RISKS TO HUMAN PARTICIPANTS .............................................................................................................................. 32 
PROPOSED BENFITS TO PARTICPANTS ...................................................................................................................... 33 
PRIVACY AND CONFIDENTIALITY ............................................................................................................................... 33 
DATA AND SAFETY MONITORING PLAN .................................................................................................................... 35 
IMPORTANCE OF KNOWLEDGE TO BE GAINED ......................................................................................................... 38 
DISSEMINATION AND DATA ACCESS AND MANAGEMENT PLAN .............................................................................. 39 
REFERENCES ............................................................................................................................................................... 40 
APPENDICES ............................................................................................................................................................... 43 
APPENDIX A: TXTXT Intervention Description ........................................................................................................... 44 
Appendix B Training Material .................................................................................................................................... 45 
APPENDIX C Eligibility Screener (Aim 1) ............................................................................................................................ 183 
APPENDIX D Text message tailoring form (Aim 1).............................................................................................................. 192 

 
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APPENDIX E Encouraging messages (Aim 1) ...................................................................................................................... 195 
APPENDIX F Measures via CASI (Aim 1) .............................................................................................................................. 197 
APPENDIX G Fidelity Checklist (Aim 1) ............................................................................................................................... 217 
APPENDIX H Recruitment script: Aim 2 TXTXT participants aged 16-35 years (Aim 2) .......................................... 218 
APPENDIX I Recruitment script: Aim 2 TXTXT clinic staff aged 18+ years (Aim 2) .................................................. 219 
APPENDIX J Semi-structured Interview Guide (Aim 2) ............................................................................................................. 220 
APPENDIX K (Aim 2): Standard of care questionnaire ............................................................................................. 231 
APPENDIX L Informed Consent Forms ............................................................................................................................. 232 
APPENDIX M: Cost Analysis Variables (Aim 1) ......................................................................................................... 261 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ABBREVIATIONS AND ACRONYMS 
 
 
AETC = AIDS Education and Training Center AIDS 
= Acquired Immune Deficiency Syndrome ART = 
Antiretroviral Treatment 
CAC = Cluster Auto-Correlation 
 
CDC = Centers for Disease Control and Prevention 
CDPH = Chicago Department of Health 
Ce-PIM = Center for Prevention Intervention Methodology 
CFAR = Center for AIDS Research 
CFIR = Consolidated Framework for Implementation Research 
DEBI = Diffusion of Effective Behavioral Interventions 
EBI = Evidenced Based Interventions 
EMR = Electronic Medical Record 
GEE = Generalized Estimating Equation 
GLM = Generalized Linear Model 
HIPAA = Health Insurance Portability and Accountability Act 
HIV = Human Immunodeficiency Virus 
HRSA = Health Resources and Services Administration 
ICC = Intra-Cluster Correlation 
IS = Implementation Science 
MATEC = Midwest AIDS Education Training Center 
MIT = Massachusetts Institute of Technology 
MPR = Medication Possession Ratio 

 
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MSM = Men Who Have Sex with Men 
 
NHBS = National HIV Behavioral Surveillance System NIAID = 
National Institute of Allergy and Infectious Diseases 
NICHD = National Institute of Child Health and Human Development 
NIDA = National Institute on Drug Abuse 
NIH = National Institutes of Health 
 
NIMH = National Institute of Mental Health 
 
NIMHD = National Institute on Minority Health and Health Disparities 
NINR = National Institute of Nursing Research 
NUCATS = Northwestern University Clinical and Translational Sciences Institute NUFSM = 
Northwestern University, Feinberg School of Medicine 
OR = Odds Ratio 
 
PI = Principal Investigator 
PID= Participant Identification 
PWH = Persons with HIV 
RCT = Randomized Control Trial 
 
RE-AIM = Reach, Effectiveness, Adoption, Implementation, and Maintenance 
SAMHSA = Substance Abuse and Mental Health Services Administration SES 
= Socioeconomic Status 
SD = Standard Deviation SMS 
= Short Message Service US = 
United States 
YLH = Youth Living with HIV 
 
YYALH= Youth and Young Adults Living with HIV 

 
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YMSM = Young Men Who Have Sex with Men

7 
 
 
PROTOCOL SUMMARY 
 
 
In this study we propose to use implementation science (IS) to scale up and evaluate  the 
TXTXT evidence-based intervention (EBI) as an effective strategy to increase ART 
adherence and retention in HIV care, ultimately leading to a suppression of viral load 
among Black/African American, Hispanic/Latino and other racial/ethnic minority youth and 
young adults living with HIV (YYALH) participating in the intervention. We hypothesize that 
those who complete the TXTXT intervention will demonstrate a clinically meaningful 
increase in ART adherence, viral suppression, and sustained retention in care. Additionally, 
we hypothesize that the implementation of TXTXT will reach ≥80% of the intended 
participants, will be fully adopted  by ≥80% of clinic partners, and will achieve ≥90% ratings 
of satisfaction and acceptability. We will use mixed methods to complete our study aims: 1) 
determine the real-world efficacy of a regional scale up of an EBI – TXTXT - among poorly 
adherent racial/ethnicity minority YYALH, aged 16-35 years, on our primary outcomes: 
adherence and viral load suppression at 3-month post initiation of the intervention; and 
secondary  outcome: retention in HIV care at 12-months post baseline, and 2) apply the 
Consolidated Framework for Implementation Research (CFIR) to describe the 
implementation process and identify barriers and facilitators needed to be addressed; and 
measure implementation outcomes of the TXTXT  intervention using the RE-AIM framework 
(Reach, Efficacy, Adoption, Implementation, Maintenance). We will conduct a cluster 
randomized controlled trial to evaluate the intervention effectiveness (i.e., ART adherence, 
viral load suppression) at 3-months post-initiation of the intervention. Twelve clinic sites 
with the ability to enroll up to 50 participants at each site (N=600 participants total) will be 
trained to administer the TXTXT intervention. Sites will be randomized to either start the 
intervention immediately (i.e., intervention arm) or waitlisted to start at 3 months post 
baseline (i.e., comparison arm). In the comparison arm, the study will compare pre-post 
differences in adherence and viral suppression at 6 months post baseline. Last, we will 
evaluate retention in HIV care and sustained impact of the intervention at 12 months post 
baseline for all study participants.  
 
 
 
 

 
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RESEARCH TEAM 
Dr. Amy Johnson, study Principal Investigator (PI) is a junior faculty member in the Division of 
Adolescent Medicine at Lurie Children’s Hospital. Her research, evaluation and service career span a 
decade with established expertise in community-based participatory research and empowerment 
evaluation, specifically with engaging sexual, gender, and racial/ethnic minority youth in research 
and evaluation, as well as in developing and evaluating high-impact interventions for HIV prevention 
and care. 
 
Dr. Johnson will be responsible for all aspects of the scientific integrity, daily operations, and 
implementation of study aims, as well as lead dissemination efforts. Data collection will occur at 
regional  HIV clinic sites and will be submitted directly to Lurie Children’s. Text message data (receipt, 
response)  will be provided by Dimagi Commcare via encrypted data transfer. Dr. Johnson will supervise 
Ms. Cervantes (data manager) in all aspects of data cleaning, storage, and analysis. Dr. Johnson will 
build upon existing research collaborations with multidisciplinary Co-Investigators, Drs Garofalo, 
Kuhns, and Rivero, and Ms. Benbow, Ms. Wagner. Dr. Johnson will convene standing monthly meetings 
with all investigators; and will meet with Dr. Garofalo bi- monthly. 
 
Dr. Robert Garofalo will serve as the primary mentor to this project and will advise on overall study 
implementation; further Dr. Garofalo will provide learning opportunities, support, and critical 
feedback for success. Dr. Garofalo is the Potoski Family Professor of Pediatrics and Preventative 
medicine at Northwestern University’s Feinberg School of Medicine, as well as the Director of the 
Research Center of Excellence for Gender, Sexuality, and HIV Prevention and the Division Chief of 
Adolescent Medicine at Lurie Children’s Hospital. Finally, as Co- Investigator, Dr. Garofalo will 
contribute to the interpretation of findings, aid in the preparation and review of manuscripts and 
conference presentations and assist in the dissemination of study findings. 
 
Dr. Lisa Kuhns, study Co-Investigator (Co-I) is a Research Associate Professor in the Department of 
Pediatrics at the Feinberg School of Medicine and serves as the Associate Director for the Center for 
Gender, Sexuality, and HIV Prevention in the Division of Adolescent Medicine at Lurie Children’s 
Hospital. Dr. Kuhns will serve as a content expert in app development and SMS deployment for HIV 
prevention among adolescents. Dr. Kuhns will attend project meetings, provide critical feedback on 
app development, contribute to the interpretation of findings, aid in the preparation and review of 
manuscripts and conference presentations, and assist in the dissemination of study findings. 
 
Dr. Rivero, study Co-Investigator (Co-I), has been the Executive Director of MATEC for 17 years and 
currently serves as a member of the National Alliance of HIV Education and Workforce Development. 
His work has focused on HIV within the Latinx community. 

 
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Ms. Wagner, study Co-Investigator (Co-I), is currently the Research and Evaluation Manager for 
MATEC and oversees evaluation in addition to lending technical assistance and capacity building to 
the AETC. 
 
Dr. Rivero and Ms. Wagner will oversee the TXTXT training, capacity building and technical 
assistance provided to HIV clinics across years 1-3 of the grant. Dr. Johnson will work with Dr. 
Rivero and Ms. Wagner to evaluate the implementation of TXTXT and engagement of clinic sites. 
A project coordinator will be hired and will report directly to Ms. Wagner. 
 
Ms. Benbow, study Co-Investigator (Co-I) is current faculty at Northwestern University. Ms. 
Benbow also previously served as the Deputy Commissioner of the Chicago Department of Public 
Health. Additionally, she has worked collaboratively with MATEC for 20 years. Ms. Benbow will 
assist with cost analysis and sustainability planning by providing expertise to assist with the 
identification of barriers and facilitators and implementation outcomes to implement and scale-up 
the  TXTXT intervention, as well as assess sustainability of the intervention. She will contribute to 
the oversight of the project, provide insight into implementation in a public health context, and 
provide input on dissemination products and manuscripts. 
 
Kalob Gossett, research coordinator, will assist Dr. Johnson and Ms. Wagner with day-to-day study 
activities, coordinate communication with clinic sites, provide technical assistance to clinic sites, 
oversee data collection, assist with data management and data quality queries, and will attend all 
project meetings. 
 
Marbella Cervantes, study data manager, will oversee data collection systems, data management, 
data quality, and assist Dr. Johnson with initial and interim analysis. 
 
Table 1. Research and Collaborator Team 
 
Name 
Role 
Institution 
Amy K Johnson, PhD 
Principal Investigator, lead 
study & analyses; 
oversee data security 
Lurie Children’s Hospital 
Robert Garofalo, MD 
Senior Investigator, primary 
mentor; support PI on 
project activities 
Lurie Children’s Hospital 
Lisa Kuhns, PhD 
Co-Investigator, content area 
expert- mHealth 
Lurie Children’s Hospital 
Ricardo Rivera, MD 
Co-Investigator, oversee 
TA/CBA for TXTXT 
MATEC- UIC 
Corina Wagner, M.Ed., MBA 
Co-Investigator, oversee 
TA/CBA for TXTXT 
MATEC-UIC 

 
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Nanette Benbow, MS 
Co-Investigator, content area 
expert – implementation 
science 
Northwestern University 
Kalob Gossett, MHA 
Research Coordinator, 
oversee day-to-day 
activities, clinic 
engagement/communication 
MATEC- UIC 
Marbella Cervantes, MS 
Data Manager, data 
collection/data 
management 
Lurie Children’s Hospital 
 
 
 
 

 
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INTRODUCTION 
 
Literature Review 
In the United States, at the end of 2019, there were an estimated 1.2 million people living with 
HIV.1 Of those people, approximately 87% are aware of their status.1 There are approximately 
48,000 youth (aged 13-24) living with HIV, with 86% aware of their status.1 Overall, 66.8% of 
young people aged 13 and older reach viral suppression within 6 months of HIV diagnosis.1 
Among young people, those who have the lowest rates of viral suppression include those who 
identify as Native Indian/Alaska Native (52.9%), Black/African American (62.9%), and Native 
Hawaiian/Other Pacific Islander (66.7%). Meanwhile, youth with the highest rates of viral 
suppression include those who identify as Multiple Races (69.3%), White (68.3%), 
Hispanic/Latino (71.0%) and Asian (76.7%).1 New diagnoses have been decreasing since 2015, 
with 36,801 recorded in 2019.1 Men who have sex with men (MSM) represent 69% of new HIV 
diagnoses in the United States and 6 dependent areas in 2019.1 In terms of diagnoses by race 
and ethnicity, Black and African American people accounted for 45% and Latino people 
accounted for 21.5% of all new HIV diagnoses in 2019.1 
 
Black and Latino youth experience disproportionate rates of HIV compared to white youth. 
Accounting for only 14% of the US population, Black youth accounted for 51% of new HIV 
diagnoses in 2019, with Hispanic/Latino youth accounting for 30%.1 Youth living with HIV (YLH) are 
also  more likely to be racial/ethnic minorities. Young Black and Latino men who have sex with 
men (MSM) in the U.S. bear the disproportionate burden of HIV infection. HIV incidence is highest 
among young MSM (YMSM) aged 13-24 years, particularly Black and Latino YMSM. 
 
Rates of infection among Black MSM are particularly relevant to the epidemiology of HIV in the 
Midwest, the region which has the second-highest rate of new HIV infections in Black residents, 
representing 47% of all new regional infections (Figure 1).1 Despite the Midwest’s relatively low 
national standing in terms of new diagnoses (only 7% of all new diagnoses of infections nationwide 
in 2019), there is an evident need for a more comprehensive approach to eliminating racial 
disparities in HIV infection in this region.1 Rates of diagnoses in the Midwest decreased from 2015 
to 2019 in addition to decreases in the South, Northeast, and West regions as well as 6 U.S. 
dependent areas (American Samoa, Guam, Northern Mariana Island, Puerto Rico, Republic of Palau, 
& U.S. Virgin Islands).1 The Midwest region also contains several urban poverty areas sampled by 
the National HIV Behavioral Surveillance System (NHBS), including Chicago, Detroit, and St. Louis, 
which found very high prevalence rates of HIV among heterosexuals and an inverse relationship 
between HIV prevalence rates and socioeconomic status (SES). 2 
 
In addition to disproportionate risk for HIV infection, MSM and other YLH are less likely to be adherent 
to antiretroviral therapy (ART).3 Low adherence is problematic because ART suppresses viral load and 
results in better long-term health.4 A secondary benefit of viral suppression is that it prevents onward 
transmission, as people who are virally suppressed are extremely unlikely to transmit HIV.5 

 
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The effort to identify 
individuals with HIV infection, 
link and keep them engaged in 
care, support adherence to 
ART and suppress viral 
replication is known as the “HIV 
care continuum”.6 This project 
focuses on adherence to ART, 
a step in the HIV care 
continuum that has not  
been prioritized among youth 
and young adults to the same 
degree as earlier steps in the 
continuum. Correlates  of ART 
adherence among youth 
include key psychosocial 
factors, such as co-morbid 
mental illness, substance use 
and HIV-related stigma, among 
other factors.7 Youth and young adults living with HIV (YYALH) are more likely to disengage from care, delay 
initiation of ART, and have lower rates of virologic suppression compared to adult populations.8-16 
However, the most frequently cited reason for non-adherence among  YLH is 
simply forgetting. In a study of youth living with HIV, (aged 12-24 years; n=217), 
74% reported the reason for missing doses was that they “forgot”.17 These 
findings underscore the need for implementation of reminder interventions, 
including novel and proven effective intervention strategies such as the TXTXT 
intervention described herein. 
 
The TXTXT intervention 18 will be adapted, pilot-tested, and scaled up in this project (Appendix A-
https://www.cdc.gov/hiv/pdf/research/interventionresearch/compendium/ma/cdc-hiv-text- 
messaging-txtxt-good-ma.pdf.). TXTXT uses a two-way daily text reminder and response system 
designed by Dr. Garofalo and colleagues, to improve ART adherence for 16-29 years old U.S. 
adolescents and young adults.18 Both HRSA and the CDC have designated TXTXT as an effective 
HIV treatment intervention for ART adherence.19 While the original TXTXT intervention focused 
exclusively on ART adherence, for the purposes of the proposed study, we will adapt the 
intervention to deliver SMS text reminders not only for ART adherence, but also to focus on 
critical aspects of retention in care (e.g., clinic appointment and pharmacy refill reminders) as our 
primary outcome; viral suppression, is influenced by both. Further, we have expanded the age 
range up to 35 years to include young adults who often struggle with adherence as they transition 
into adulthood and face other developmental milestones.  
 

 
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Given the potential to accelerate progress towards no new HIV infections, the United States is at a 
critical point in the epidemic to support persons with HIV (PWH), particularly racial/ethnic minority 
youth, in achieving and sustaining viral suppression. 20 Deaths among PWH have decreased, 
resulting  in an increasing prevalence; therefore, disparities in ART adherence in racial/ethnic 
minority youth must be the continued focus of these efforts in order to promote viral suppression 
and prevent onward  transmission.16,18,21,22 Evidence-based interventions for these youth across the 
HIV care continuum should be scaled up and widely disseminated to increase access to effective 
strategies. 
 
The proposed implementation science research project “Midwest TXTXT” will focus on the Ending the HIV 
Epidemic Initiative Treating people with HIV rapidly and effectively to reach sustained viral suppression by 
delivering an evidence-based intervention to improve ART adherence, retention in care and sustained viral 
suppression among racial/ethnic minority youth, inclusive of young gay, bisexual and other MSM, young 
cisgender women and young transgender women across multiple sites.20 
 
 
Justification of the Study  
 
The goal of the proposed project is to implement a scaled-up version of the existing TXTXT EBI in an 
effort to increase the rate of viral suppression among YYALH aged 16-35 years through medication 
adherence and retention in HIV medical care. In addition to disproportionate risk for HIV infection, racial 
and ethnic minority YYALH are less likely to be adherent to antiretroviral therapy (ART).3 The most 
frequently cited reason for non-adherence among YYALH is simply forgetting .17 The results of this 
study, if the adapted intervention proves to be an impactful and acceptable innovation, will be used to 
scale up this intervention further so that it can be used as a practical and sustainable tool at the 
regional level within clinic settings in the United States.  
 
Innovation 
 
This study is innovative for the following reasons: 
 
1. 
Scale-up and adaptation of a medication adherence intervention developed specifically 
for YYALH, only one of two such EBIs in the CDC Compendium: In addition to the TXTXT 
intervention there is only one other intervention in the CDC Compendium that has been 
developed for youth, adolescents, or young adults (Red Carpet program). See  
https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html 
Of note, the Red Carpet program is a structural intervention that was evaluated in 
an international setting for YLH and consisted of fast tracked peer navigation to 
support linkage to and retention in care.  
2. 
Leverage of collaboration with a systems-level HIV/AIDS service partner, MATEC, to 
promote medication adherence among racial/ethnic minority youth, who have the lowest 
rates of viral suppression: This widescale implementation of an EBI in conjunction with an 
already existing HIV service infrastructure is a novel approach to HIV care. 

 
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3. 
Systems-level Implementation Science Approach: Implementing this EBI at the systems-
level or regional scale with MATEC has the possibility of broadening the reach of such an 
intervention. 
4. 
Targeting a diverse set of clinics who partner with MATEC across the Midwest region 
who serve Black and Latinx youth with poor adherence: This initiative will allow us to test 
the intervention throughout MATEC’s network of clinics but also allow us to compare 
different types of clinics within the network (i.e., Ryan White Care Act clinics versus non-
Care Act clinics). 
 
 
Conceptual Framework 
 
Implementation Science  
 
Implementation Science is a critical new area of HIV prevention and intervention science which 
provides the frameworks and methods to effectively translate evidence to practice in the next era of 
HIV prevention intervention for public health impact.23 As articulated by the CDC, a set of lessons 
learned from 20 years of diffusion of effective behavioral interventions (DEBI) and EBI projects will 
influence the next wave of dissemination and intervention initiatives. Implementation Science (IS) 
frameworks and methods provide the tools to incorporate these lessons into IS initiatives.23 
Furthermore, IS approaches allow us to measure systems-level HIV intervention implementation, a 
promising, but much rarer form of implementation.24 By systematically studying the factors that 
influence implementation at higher levels of implementation, as well as evaluating specific 
implementation outcomes, we can shift our focus from intervention efficacy to public health impact 
among those populations most affected by the epidemic, including racial/ethnic minority youth. 
 
IS approaches are necessary to understand and inform the roll out and scale up of effective 
strategies to increase ART adherence. IS studies have highlighted the need for multilevel 
interventions and diverse models of dissemination. Implementation science also provides relevant 
conceptual and measurement frameworks to guide a hybrid trial of clinical outcomes and 
implementation factors.25-28 
 
The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework is an 
evaluation and reporting scheme commonly used to examine the potential public health impact of an 
intervention.29 Reach represents the number and representativeness of patients who participate out 
of the eligible patient population. Effectiveness is the impact of the intervention on participant 
outcomes. 
Adoption is the number and representativeness of eligible staff/settings that agree to deliver the 
intervention out of all eligible staff/settings. Implementation is the fidelity to the intervention. 
Maintenance is the degree to which the intervention is sustained overtime. RE-AIM provides a 
useful measurement framework for capturing both clinical and implementation outcomes within the 
same study. 
 

 
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Implementation science also provides relevant conceptual and measurement frameworks to guide an 
assessment of factors which influence implementation outcomes. We will use the Consolidated 
Framework for Implementation Research (CFIR), which has been used to guide the implementation and 
evaluation of numerous evidence-based health programs, synthesizes the concepts of several available 
models into five inter-related domains: intervention characteristics, outer setting, inner setting, 
characteristics of individuals involved, and the process of implementation, with several constructs in 
each domain. 25 CFIR accounts for the non-linear process of implementation and incorporates 
consideration of the adaptation that is required for different context. 
 
 
Theoretical Framework of TXTXT Intervention 
 
TXTXT uses a two-way daily text reminder and response system designed by the mentor of the 
current PI, Dr. Garofalo, to improve ART adherence for 16-29 years old U.S. adolescents and young 
adults.18 Both HRSA and the CDC have designated TXTXT as an effective HIV treatment intervention 
for ART adherence (Appendix A-Text Messaging TXTXT (cdc.gov)). TXTXT is a theory-based 
intervention that is grounded in social cognitive theory. Social cognitive theory specifies a core set 
of factors and mechanisms that influence health behavior with a primary emphasis on self-
regulation (i.e., the accuracy and consistency of self-observation and self- monitoring) and self-
reflection, including self-efficacy.30 Social cognitive theory holds that cognition, behavior, and 
environmental influences interact and are reinforcing. Self-regulatory functions, for example, are 
enhanced by facilitative environmental conditions, such as reminder systems. A key developmental 
task for youth living with HIV is to take responsibility for management of their health care. Text 
messages are a supporting external influence, which is expected to enhance self-regulation, 
specifically the feeling of control over one’s ability to take medications as prescribed. Self-efficacy 
is the foundation of motivation and action. Receipt of text messages is expected to help overcome 
a key barrier to adherence, forgetting to take medication, which may increase self-efficacy and 
thus, motivation. Among youth living with HIV, motivation and self-efficacy are strongly related to 
adherence; a relationship which is likely to be mutually reinforcing. 

 
 
16 
 
 
 
STUDY OBJECTIVES 
There are two specific aims for this research: 
 
Aim 1 
 
Determine the real-world effectiveness of a regional scale up of an EBI- TXTXT- among poorly 
adherent racial/ethnic minority YYALH, aged 16-35 years on our primary  outcomes: adherence and 
viral load suppression at 3-month post initiation of the intervention; and secondary outcome: 
retention in HIV care, at 12-months post baseline. 
 
Aim 2 
 
Apply the Consolidated Framework for Implementation Research (CFIR) to describe the 
implementation process and identify barriers and facilitators needed to be addressed; and 
measure implementation outcomes of the TXTXT intervention using the RE-AIM framework 
(Reach, Efficacy, Adoption, Implementation, Maintenance).

17 
 
 
AIM 1: RESEARCH QUESTION AND OBJECTIVES 
 
Aim 1: Determine the real-world effectiveness of a regional scale up of an EBI- TXTXT- among poorly 
adherent racial/ethnic minority YYALH, aged 16-35 years on our primary  outcomes: adherence and viral 
load suppression at 3 months post initiation of the intervention; and secondary outcome: retention in 
HIV care at 12 months post baseline. 
 
RESEARCH DESIGN 
The proposed research uses a cluster randomized controlled trial design to evaluate the 
effectiveness of TXTXT intervention on adherence and viral load suppression at 3 months post 
intervention initiation. A total of 12 clinic sites in the Midwest will  be randomly assigned to either 
a 3- month observation period (i.e., comparison arm) or a 3-month intervention period (i.e., 
intervention arm). At the 3-month mark, sites randomized to the intervention arm will 
continue with the intervention for an additional 3 months, and sites initially assigned to the 
comparison arm will switch to the intervention for the 3 months. We will assess initial impact 
of the intervention by comparing the primary outcomes (i.e., ART adherence and viral load 
suppression) of the intervention arm to the comparison arm at 3-months post initiation of the 
intervention. This timepoint (3 months post baseline) was selected based on the findings of 
the randomized control trial used to establish efficacy of TXTXT.18 The study will also compare 
pre-post differences in adherence and viral load suppression for participants in the 
comparison arm at 6 months post baseline. Secondary outcomes of retention in HIV care and 
sustained impact of the intervention will be evaluated at 12 months post-baseline. At 3 
months, 6 months, and 12 months post baseline, electronic medical record (EMR) data from 
participating clinics will be used to determine viral load and retention in care measures.  
 
 
METHODS 
 
Audience and Stakeholder Participation 
 
The Midwest AIDS Training and Education Center (MATEC) is the ideal partner and stakeholder for us to carry out 
the proposed project. The partnership with MATEC will not only ensure the feasibility of this project but will also 
serve as a valuable partner in future work to increase dissemination of effective interventions throughout the 
Midwest and via strategic connections to the larger AIDS Training and Education Center (AETC) network. MATEC 
has a 32-year history as an AETC covering 7 jurisdictions across a 10-state region and oversees 8 different 
federally funded projects in the Midwest. Further, MATEC leads a practice transformation cohort consisting of 13 
Ryan White funded clinics with the goal of advancing plans to End the Epidemic by increasing testing, 
identification of PWH, linkage to and retention in HIV care, and increasing viral suppression. We sought 
collaboration with MATEC specifically for this project because they are a regional hub for capacity development 
among HIV/AIDS service providers in the Midwest.   
 
Study Population 

18 
 
 
Poorly adherent racial/ethnic minority youth living with HIV aged 16-35 years inclusive of all gender and sexual 
identities and orientations, including young gay, bisexual and other MSM, young cisgender women and young 
transgender women across multiple clinic sites in the Midwest US. 
 
Inclusion and Exclusion Criteria 
 
Clinic site inclusion criteria 
MATEC affiliated clinics in the Midwest region are eligible to participate in Aim 1 if meeting these 
criteria: (1) Clinic must have at minimum 40 current patients who are: racial/ethnic minority AND have 
a ‘detectable’ viral load AND are aged 16-35 years; (2) clinic must be willing to commit at least one staff 
person as lead for registering clients to receive the intervention, completing consent, and administering 
research surveys; (3) clinic must be willing to provide deidentified individual-level data for registered 
TXTXT participants, including viral load, retention in care (dates of clinic visits) at least twice per year; 
(4) clinic must not be using a competing medication reminder text messaging system; (5) clinic must be 
willing and able to rely on Lurie IRB. Once sites sign a memorandum of commitment, the study 
coordinator will schedule a conference call to  conduct a standard of care questionnaire (Appendix K). 
The standard of care questionnaire will document existing clinic approaches to support adherence as 
well as any ancillary services (e.g., transportation assistance). This information will form a descriptive 
profile for each clinic. 
 
Study Inclusion 
For inclusion in the TXTXT intervention individuals must meet the following criteria: 1) diagnosed with 
HIV-infection and on ART regimen for at least one month (not new to ART); 2) aged 16-35 years; 3) have 
a viral load ≥200c/mL and/or report poor adherence (<90% of pills taken in the last 30 days); 4) able to 
receive text messages; 5) provide informed consent for research component; and 6) are a patient of a 
participating clinic 
 
Study Exclusion 
Exclusion criteria includes: 1) those who are unable to give informed consent 2) those who are 
participating in other studies that impact primary and secondary outcomes.  
 
Procedures for Recruitment and Informed Consent 
Aim 1: Youth living with HIV (aged 16-35 years) who meet study inclusion criteria will be recruited by 
study staff from participating clinics. The EMR will identify potentially eligible patients who will be invited 
to complete further study screening and enrollment.  
 
We will ask each clinic to construct a list of eligible patients and carefully track outreach, screening, 
and enrollment on an enrollment log provided. Clinics may enroll up to 50 participants (to account 
for 20% attrition, final sample of 40 participants per clinic). 
 

19 
 
Participants will be contacted either by phone or in-person by staff members at participating clinics 
using the recruitment script/screener (Appendix C). If potential participants are interested in enrolling 
in the study (Aim 1), staff members at participating clinics which have received Institutional Review 
Board (IRB) certification will conduct eligibility assessment and consent conferences with participants. 
Potentially eligible participants will be contacted by clinic staff who will screen them for eligibility and 
further consent and enroll them if eligible (Appendix C). Those individuals who are ineligible will be 
thanked for their time. 
 
Lurie Children's IRB will ensure that the consent forms meet institutional and funding source 
standards. Lurie Children's requires that research participants review and sign an informed consent 
form. Participants aged 16-17 years will sign an assent form (a waiver of parental consent will be 
obtained prior to study start). Participants aged 16-17 years are eligible to provide assent in all 
participating clinics. The informed consent forms include information  about the overall purpose of the 
study, study procedures, potential risks, potential benefits to participating for individuals and society, 
alternatives to participating in the study, confidentiality of data, and contact information for the site’s 
Principal Investigator and the IRB (Appendix L). Once informed consent has been obtained, the clinic 
staff will have the form reviewed by a fellow team member, who will confirm that it is fully completed 
before it is filed in a secure location under double-lock when not in use and with restricted access 
during work hours and/or when unattended. 
 
Project staff will inform participants that they have the right to skip any questions that make them feel 
uncomfortable. Participants will be informed that participation is completely voluntary and that they 
are free to stop their involvement in the study at any time without any negative consequences. 
Participants can stop their text messages by replying “STOP” at any time or by calling the participating 
clinic to unenroll in the study. Participants will be informed of their rights to privacy and confidentiality 
and will be told that their answers to the survey (collected via computer-assisted self-interview [CASI]) 
will be kept confidential and not shared with others outside of the research staff. They will be informed 
that no information about them or provided by them during the research will be disclosed to others 
without their written permission, except if necessary to protect their rights or welfare (for example, if 
they are injured and need emergency care) or if required by law (i.e., child or elder abuse, harm to self 
or others). 
 
Dependent on site randomization, intervention sites will sign up eligible participants to receive 
automated SMS messages from the Dimagi CommCare platform. Participants will have the option to 
tailor the message content based on their own preferences and will be able to select to receive 
messages in English or in Spanish. The time the messages are delivered, and frequency will also be 
selected. Clinic staff will use the text message tailoring form to record tailored messages (Appendix D). 
Clinic staff will enter information from this form into the text messaging platform, and then test 
receipt of text messages by the participant before they complete this first intervention visit. If the 
participant choses a text message that discloses their HIV status, clinic staff will guide participants into 
selecting a discrete message and discuss options for alternate text. Participants at control sites will 
receive standard of care adherence counseling but will not  enroll in text messaging until their site is 
eligible to receive the intervention. Messages used previously include, “Have you taken your vitamins 

20 
 
yet?” and “Don’t forget!” The SMS platform is bi- directional and has an automated response system, 
so the participant is able to answer “1=yes” or “2=no” in response (press 1 or 2). When participants 
respond affirmatively, they will receive an encouraging message such as, “Great job!” However, when 
they respond with a “no” they will receive an acknowledging and encouraging message such as “You 
can do it!” (Appendix E).  
Participants will be asked to complete a self-administered online survey at baseline, 3 months and 6 
months post baseline. The survey will be hosted on REDCap and can be taken on a computer, tablet, or 
mobile phone. Participants will have the option of completing the survey remotely or coming to the 
clinic and taking the survey on-site (at a computer or tablet provided by the clinic). The online survey 
will be taken by both the intervention and comparison arm. The survey will measure demographics, 
self-reported ART adherence, HIV medication self-efficacy, barriers and facilitators of adherence, 
acceptability of TXTXT, and satisfaction (Appendix F). The survey CASI will be pilot tested with a small 
number of participants and adjusted as needed. Participants will also be asked to consent to release of 
specific EMR  data to include viral load and attendance at HIV care visits. 
 
At all study visits, staff will use the Fidelity Checklist to structure the visit and make sure that all 
procedures are followed (Appendix G). All study visits reflect the following general structure: 
1. 
Complete intervention assessment 
2. 
Complete standard-of care adherence counseling 
3. 
Complete TXTXT Personalization form 
4. 
Enter information into Dimagi platform (see Dimagi training, Appendix B ) 
5. 
Schedule date of next appointment 
6. 
Build general rapport 
7. 
Thank them for participation 
As part of the initial visit, basic ART adherence education should be provided, based on the 
practices and/or protocols at each site. For example, if a site does not have a standard 
practice for adherence counseling, at a minimum staff should review: 
1. 
The current list of medications prescribed to each participant and how each 
medication should be taken (make sure they know how to take their prescribed 
medication). 
2. 
In addition, basic facts on the importance of adherence should be reviewed 
with each participant, such as those described here: 
https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/54/hiv- 
medication-adherence 
 
Retention 
Retention will be facilitated through obtaining contact information for the participant during the 
initial stages of the enrollment process. To minimize participant and staff burden, the follow-up 
visits can be conducted virtually. Participants will be sent a personalized link to complete the follow-
up survey via  REDCap. Of note, there will not be financial reimbursement for participation in the 

21 
 
intervention as the goal of the project is to understand how TXTXT will work in the “real world” and 
inform wide scale routine implementation. Prior studies by Drs. Garofalo, Kuhns, and Johnson with 
vulnerable adolescent and other marginalized populations have maintained >80% retention. We will 
employ best practices in participant retention including: 1) collecting extensive locator information 
(multiple addresses/emails, phone numbers, social media profile names, etc.); 2) identification and 
discussion of difficult-to-reach participants and potential solutions during weekly team meetings; 
and 3) maintaining flexibility with mode of follow-up (e.g., in person options as well as internet 
based). The investigative team and participating clinic staff will review the study team’s retention 
plans and will be asked for guidance on how to best keep YYALH engaged in the study for at least 6 
months. No financial incentives will be provided to youth participating in the TXTXT intervention trial 
(Aim 1). At 3 months, 6 months, and 12 months post baseline, electronic medical record (EMR) data 
from participating clinics will be used to determine viral load; retention in care will be assessed for up 
to 12 months post baseline.

STUDY DESIGN AND DATA ANALYSIS 
22 
 
 
Study participation summary  
 
1. 
12 participating clinics randomized 1:1 into intervention or comparison arm 
2. 
50 participants at each clinic enrolled and complete baseline survey; baseline EMR data pulled 
3. 
Participants at intervention clinics begin TXTXT after baseline survey and continue for 6 months 
4. 
All participants complete a 3-month survey 
5. 
Participants at comparison clinics begin TXTXT after 3-month survey and continue for 3 months 
6. 
All participants complete a 6-month survey; 6-month EMR data pulled  
7. 
TXTXT intervention stops at 6 months post baseline for all participants 
8. 
12-month EMR data pulled  
Timepoint 
Who 
What 
Data collected 
 
zero 
12 participating clinics 
Randomized 1:1 intervention: 
comparison arm 
 
baseline 
50 participants at each clinic 
Participants at intervention 
clinics receive TXTXT 
 
Participants at comparison 
clinics do not receive TXTXT 
(i.e., standard of care) 
 
EMR data 
Baseline survey 
 
3 months 
50 participants at each clinic 
 
Participants at intervention 
clinics continue with TXTXT 
Participants at comparison 
clinics begin TXTXT 
3-month survey 
6 months 
50 participants at each clinic 
 
TXTXT stops for all 
participants 
EMR data 
6-month survey 
12 months 
50 participants at each clinic 
 
EMR data 
Sampling 
 
We will ask each clinic to construct a list of potentially eligible patients and carefully track outreach, 
screening, and enrollment on an enrollment log provided.  Participants (N=600, n=50  per each clinic site) 
will be enrolled.  
 
The list of potentially eligible patients will be constructed from available EMR data and will be queried based 
on: (1) diagnosed with HIV; (2) age range (16-35 years); (3) most recent viral load obtained in past 12 
months. If potential participants meet the first two criteria, they will be evaluated based on (#3) viral load 
data. The following scenarios are possible: 1) potential participant is virally suppressed; 2) potential 
participant is viremic (>200 copies/mL); 3) potential participant does not have viral load data available. 
Patients who are viremic and meet criteria 1-3 (HIV status, age) will be considered eligible for study inclusion  
and will be called by clinic staff to confirm eligibility and assess interest. Patients who meet criteria 1 and2 
and are virally suppressed or missing viral load data will be contacted to assess eligibility - specifically, those 
who are virally suppressed will be queried about medication adherence (if <90% of pills taken in the past 30 
days); for those who are missing viral load data they will be asked if they are willing to re-engage in HIV care 
and have labs drawn prior to enrollment (if so, they will follow steps outlined above for those with viral load 

STUDY DESIGN AND DATA ANALYSIS 
23 
 
 
(VL) data). The list and eligibility assessment will be documented and reviewed on a weekly basis with 
individual sites to ensure timely enrollment into the  study. 
 
 
 
 
 
 
 
 
 
 
 

24 
 
 
Data Analysis Plan and Variables  
The data manager and study coordinator will review the Dimagi platform data reports, which include 
logs of all texts sent, received, responded to, as well as a log of “STOP” requests. These reports will 
be pulled by week and by clinic. The data manager and study coordinator will provide summary data 
to clinic sites as well as action items (e.g., follow up with “STOP” participants  to inquire if they would 
like to discontinue from the study, or stop their messages for short time period). Summary statistics 
will be provided monthly as process data for the entire study team to review. 
 
Sites in the control arm will continue the standard of care, which will  include traditional 
adherence counseling. Data from the EMR will be gathered for both the control and 
intervention site participants to include viral load and visit attendance. 
 
At baseline, univariate analyses will be used to characterize the sample; and bivariate analysis will be 
employed to explore any differences between groups (e.g., differences between clinics; age categories; 
sex). Fisher’s Exact Test and χ2 tests (for categorical variables) and t-tests (for continuous variables) will 
be used to identify demographic and behavioral factors associated with adherence and retention in 
care. Generalized linear models (GLMs) will be used to assess the effect of the intervention on the 
outcomes between the intervention and the control arm at 3 months and pre-post differences in the 
control arm after received the intervention at 6 months. GLMs can accommodate dependent variables 
with normal, binary, Poisson, and negative binomial distributions and can be adapted to incorporate 
random and fixed effects (generalized linear mixed models; GLMMs) to account for within-subject 
correlation among repeated measures over time.31 The generalized estimating equation (GEE) can be 
used to compare ‘average’ population-level response to the intervention.32 Potential confounding and 
effect modification by sociodemographic characteristics and location (defined by urban vs. rural 
residence) will be examined in exploratory analysis and these variables will be selected for inclusion in 
multivariable models based on statistical significance and conceptual importance. All models will 
account for correlation among repeated measures on individuals and within sites over time as 
appropriate. Inclusion of random effects for intercept and trend over time will be explored to assess 
subject-specific variability. 
 
In order to assess feasibility, acceptability and satisfaction of the intervention we will use descriptive 
statistics using a combination of objective (e.g., rates of participation, intervention completion) and 
subjective measures (e.g., reported satisfaction, acceptability). In order to characterize adherence and 
retention in care throughout the course of the study, Kaplan-Meier survival curves will be used to 
measure time to adherence and retention, and Cox proportional hazard ratios will be used to assess 
whether individual-level factors are associated with shorter mean time to outcome. To measure reach 
of the intended participants, we will compare the study sample to those available in the sampling frame 
(proportion of those enrolled to those eligible). To measure adoption of clinic partners, we will evaluate 
the number of clinic partners who propose to continue with text messaging as adherence support post 
study (proportion of clinics who propose to continue TXTXT post study to total clinics). Satisfaction and 
acceptability will be measured by standard quantitative scales, summary total scores will be evaluated 
to determine whether or not  ≥90% ratings were achieved. 

25 
 
 
Outcome definitions 
 
Medication adherence: greater than or equal to 90% on self-reported visual analog scaler 
(non- adherence categorized at less than 90%) 
 
Retention in care 33 : two visits 90 days apart in the past year will be considered retained in HIV 
care 
 
Viral suppression 34 : VL < 200 copies/mL will be considered virally suppressed 
 
 
Sample size, power calculation, and clinic scale up 
 
A total of 12 clinics and up to N=600 YYALH will be enrolled in this study for evaluation purposes. Each 
clinic will be able to enroll up to 50 participants for a maximum total of 600 participants. We assume a 
20% attrition rate, and therefore the sample size available for analysis will be N=480. Sites will be 
randomized to either a 3-month observation (i.e., comparison arm) or an immediate start intervention 
arm; at the end of the first 3-month period comparison arm sites will start the intervention for the 3 
months and intervention sites will continue the intervention for an additional 3 months (6 months 
total). Pre-post EMR data, SMS data, and participant satisfaction data will be collected to determine 
efficacy, durability, maintenance and satisfaction (see expected outcomes). Rapid interim data  analysis 
and interpretation will occur at 3 months. In Year 3, all clinics and participants (in both the initial control 
arm or intervention arm) will have their medical records abstracted In addition, de-briefing interviews 
will be conducted with clinic staff to assess implementation outcomes. Final analysis and sustainability 
plan will be conducted and elaborated. 
 
This cluster randomized control study is powered to detect 20% difference in ART adherence (>90%) 
among participants receiving the TXTXT intervention and the control groups. . The power is calculated 
based on 3 levels hierarchical model design (i.e., randomization at the site level, two measures for each 
participant). The correlations between the participants within the site is assumed to be 0.05 and 
correlation within a participant is assumed to be 0.2. The proportion of participants with ≥ 90% ART 
adherence for the control group is assumed to be 25%, 35%, 45% and 55%. The effect size is assumed to 
be 10%, 20% and 25%. Given Type I error rate is 0.05, using the mixed model approach, the corresponding 
power is listed below.35  The sample size with 6 sites in each arm and 50 participants from each site would 
have 80% power to detect 20% difference at 3 month post baseline.  
 
Table 2: Power (6 sites in each arm, 40 participants from each site) 
 
 
proportion of participants with ≥ 90% ART adherence 
(Control) 
Effect Size 
25% 
35% 
45% 
55% 
10% 
0.30 
0.29 
0.28 
0.29 
20% 
0.82 
0.80 
0.80 
0.83 
25% 
0.95 
0.94 
0.94 
0.96 

26 
 
 
Track Lessons Learned 
Throughout the course of the project, all staff are encouraged to provide feedback and any “lessons 
learned” to the project coordinator or the investigative team (Johnson & Wagner). These lessons will 
help to improve the implementation of the TXTXT intervention for long term implementation and 
sustainability. 
 
Track Costs 
 
Clinic sites will be involved in the assessment of overall program costs to estimate the costs of implementing the 
intervention (Appendix M). Program costs will include personnel time, labor hours, wages, fringe benefits, 
materials and supply costs, office overhead and equipment costs, and the opportunity cost of any donated labor 
and in-kind services. Non-labor costs will include such costs as materials, supplies, travel, equipment, technology 
costs, and indirect or overhead costs that are attributed to the project. These overhead costs may include office 
rent, repair and maintenance, network connection and maintenance, telephone service, and shared office 
equipment. 36 The site-level data collection documents will be developed in consultation with IS experts (Ms. 
Benbow) and CDC SME (Carla Galindo) submitted for local IRB review and approval before data collection, 
fielding, and data analysis.

27 
 
AIM 2: RESEARCH QUESTION AND OBJECTIVES 
 
Aim 2: Apply the Consolidated Framework for Implementation Research (CFIR) to describe the 
implementation process and identify barriers and facilitators needed to be addressed; and measure 
implementation outcomes of the TXTXT intervention using the RE-AIM framework (Reach, Efficacy, 
Adoption, Implementation, Maintenance). 
 
RESEARCH DESIGN 
 
To explore the second aim qualitative data will be collected in the form of interviews from participants and clinic 
staff members. The CFIR and RE-AIM frameworks will be used to evaluate the implementation of the TXTXT 
intervention. 
 
 
METHODS 
 
Audience and Stakeholder Participation 
 
The Midwest AIDS Training and Education Center (MATEC) is the ideal partner and stakeholder for us to carry out 
the proposed project. The partnership with MATEC will not only ensure the feasibility of this project but will also 
serve as a valuable partner in future work to increase dissemination of effective interventions throughout the 
Midwest and via strategic connections to the larger AETC network. MATEC has a 32-year history as an AETC 
covering 7 jurisdictions across a 10-state region and oversees 8 different federally funded projects in the 
Midwest. Further, MATEC leads a practice transformation cohort consisting of 13 Ryan White funded clinics with 
the goal of advancing plans to End the Epidemic by increasing testing, identification of PWH, linkage to and 
retention in HIV care, and increasing viral suppression. We sought collaboration with MATEC specifically for this 
project because they are a regional hub for capacity development among HIV/AIDS service providers in the 
Midwest.  
 
Study Population 
 
Poorly adherent racial/ethnic minority youth living with HIV aged 16-35 years inclusive of all gender and sexual 
identities and orientations, including young gay, bisexual and other MSM, young cisgender women and young 
transgender women across multiple clinic sites in the Midwest US. Staff at the clinic sites will be asked to give 
feedback on the implementation of the EBI. Staff must be 18 years or older, currently employed at the clinic site, 
have participated in the implementation of the EBI, and speak and understand English.  
 
Inclusion and Exclusion Criteria 
 
Study Inclusion 
CFIR Participant Feedback 
To provide feedback on the intervention, individuals must meet the following criteria: 1) 16-35 years old; 

28 
 
2) current HIV care patient of clinic site; 3) HIV positive as identified by the EMR; 4) speak and 
understand English; 5) have a viral load >200c/mL; and 6) participated in the TXTXT intervention. 
 
CFIR Staff Feedback 
Staff are eligible to provide feedback if they are: 1) 18 years of age or older; 2) currently employed at 
the clinic site; 3) have participated in the implementation of the TXTXT; 4) speak and understand 
English. 
 
Study Exclusion 
Exclusion criteria includes: 1) those who are unable to give informed consent; and 2) those who are 
participating in other studies that impact primary and secondary outcomes.  

29 
 
Procedures for Recruitment and Informed Consent 
 
Youth participants and clinic staff will be recruited to participate in implementation science surveys 
and interviews; youth participants will be referred to investigators from participating clinic staff; Ms. 
Wagner and Mr. Gosset will identify potential staff participants. 
 
When potential participants are interested in enrolling in the study (Aim 2),  members of the research 
team will conduct eligibility assessment and consent conferences with participants (Appendix K). 
Participants who are aged 16-17 years will complete informed assent; a waiver of parental consent will 
be obtained. Lurie Children's IRB will ensure that the assent/consent forms meet institutional and 
funding source standards. Lurie Children's requires that research participants review and sign an 
informed assent/consent form. The informed assent/consent forms include information about the 
overall purpose of the study, study procedures, potential risks, potential benefits to participating for 
individuals and society, alternatives to participating in the study, confidentiality of data, incentive for 
participation ($40), and contact information for the site’s Principal Investigator and the IRB (appendix 
K). Once informed consent has been obtained, the clinic staff will have the form reviewed by a fellow 
team member, who will confirm that it is fully completed before it is filed in a secure location under 
double-lock when not in use and with restricted access during work hours and/or when unattended. 
 
No identifying information is collected prior to informed assent/consent. Assent or consent is 
conducted in person, in a private room, by trained staff. Trained clinic staff will proceed through 
each component of the consent, written to Federal OHRP standards with 8th grade or below reading 
level. We will obtain a waiver of parental consent for participants aged 16-17 years. For potential 
participants aged 16-17 years, the staff reviews the assent to make a formal assessment of the 
youth’s decisional capacity to consent prior to signing, using a 2-step process. First, the staff person 
determines if the person understands the study goals by asking “Can you tell me what this study is 
about?” In step 2, potential subjects will be asked questions designed to assess their capacity to 
understand, appreciate, reason with, and express a  choice about participation in our specific 
protocol. We will use a modified version of the widely used Evaluation to Sign Assent/Consent Form: 
Subjects are asked to: (1) name things they will be expected to do during the study, (2) explain what 
they would do if they no longer wished to participate in the study, (3) explain what they would do if 
they experienced distress during the study and (4) identify potential risks for participating in the 
study. Respondents will be enrolled only if they are able to provide clear and correct answers to 
each of these items. If staff feel there is a question about the need for a more formal assessment of 
the decisional capacity of a potential participant, they will contact the principal investigator, who 
may refer the participant to medical or psychosocial services for evaluation. 
 
Project staff will inform participants that they have the right to skip any questions that make them feel 
uncomfortable. Participants will be informed that participation is completely voluntary and that they 
are free to stop their involvement in the study at any time without any negative consequences. 
Participants can stop their text messages by replying “STOP” at any time or by calling the participating 
clinic to unenroll in the study. Participants will be informed of their rights to privacy and confidentiality 
and will be told that their answers will be kept confidential and not shared with others outside of the 
research staff. They will be informed that no information about them or provided by them during the 

30 
 
research will be disclosed to others without their written permission, except if necessary to protect 
their rights or welfare (for example, if they are injured and need emergency care) or if required by law 
(i.e., child or elder abuse, harm to self or others). 
 
 
 
Retention 
Aim 2 participation is a single point in time, and therefore retention metrics will not be tracked.  

31 
 
 
Sampling 
 
Feedback will be collected from up to 60 participants. The study coordinator based at MATEC will work 
with participating clinics to randomly select 4-5 participants from their enrollment log. Potential 
participants will be invited to participate in this additional interview (Appendix H & I). Participating 
individuals will complete a short open-ended questionnaire that collects information regarding the CFIR 
constructs (Appendix J). 37 The interview will last up to 30 minutes. Feedback will also be collected from 
up to 24 clinic staff at participating sites (1-2 staff per clinic). Staff are eligible to provide feedback if 
they  are:1) 18 years of age or older; 2) currently employed at the clinic site; 3) speak and understand 
English. Clinic staff will be interviewed by the study coordinator or Dr. Johnson to determine what 
barriers and facilitators existed at each site that may have impacted the intervention. The interview will 
focus on the CFIR dimensions of inner setting, outer setting, intervention characteristics, individual 
characteristics, and process of implementation (Appendix J).The interview will last up to 60 minutes.  
 
Data Analysis Plan and Variables 
 
Analysis of qualitative interview data will be led by Dr. Johnson. Qualitative data will be audio recorded, 
transcribed verbatim then uploaded to Dedoose – a cloud-based flexible and adaptive qualitative 
analysis program. 38 After open coding 20% of the transcripts, Dr. Johnson will create a codebook 
providing clear definitions and examples for each code. Transcripts will be analyzed using a directed 
content analysis approach. 39 The coding team (Dr. Johnson, Ms. Cervantes) will establish and maintain 
high inter-rater reliability (80% agreement).40 Expert consensus (Drs. Garofalo, Kuhns, & Rivero) will be 
used to address coder disagreements. This structured analysis uses existing theory and prior research 
to guide the identification of key concepts or thematic categories. After coding, Dedoose  will be used to 
further categorize and visualize the data; organizing codes into frequency tables by participant and 
clinic descriptors to determine the occurrence and co-occurrence of codes in the sample. 
 
Univariate analyses will be used to characterize and describe the sample and results from the 
quantitative survey. 
 

32 
 
RISKS TO HUMAN PARTICIPANTS (Aim 1 and Aim 2) 
 
The largest risk to participants is a breach of confidential information.  
 
In Aim 1, participants will be advised to  delete the messages they receive from the Dimagi 
CommCare platform as a method of protecting the  participant’s HIV status. Participants will also be 
guided to select a personalized text message that does not disclose their HIV status (“remember to 
walk the dog”, “you’re your vitamins”, “read your  horoscope”, etc.). Additionally, participants will 
walk through safe guarding their cell phones including how to activate passcodes and biometrics, as 
well as what to do if they lose their cell phone, get a new number, or switch providers (contact 
clinic study staff to update dimagi platform). Participants will also be advised that assessment 
questions may make them uncomfortable, however they can skip any question they choose not to 
answer. 
 
In Aim 2, we will follow best practices to maintain confidentiality of participants, inclusive of staff 
and youth participants. Further, we will report findings in aggregate and will not use identifiers in 
qualitative quotes to ensure the identities of our participants remain confidential. In reporting 
qualitative findings, inclusive of quotes, we will use only study ID. Finally, we will not report back to 
clinics which staff or participants have enrolled in Aim 2.  
 
Potential Risks (Aim 1 and Aim 2) 
Also see “data and safety monitory” subsection for details on adverse event reporting. 
 
Potential risks to participants primarily consist of 1) feelings of discomfort or being upset as a result of 
the questions posed in the assessments and 2) breaches of confidentiality; however, the study does 
not involve any medical procedures, and the overall risk of harm to the participant is considered 
minimal. Participants are free to refuse to answer any question or not complete any intervention 
activity and may terminate participation in the study at any time. All information disclosed to the 
research team (including clinic site staff) will remain confidential. 
 
Adequacy of Protection against Risk 
 
As in any study, there is always risk of inadvertent breach of confidentiality. Teams at Lurie Children’s 
and MATEC have been involved with numerous local and national studies and have considerable 
experience implementing measures to protect confidentiality. Some of these steps include signed 
confidentiality agreements, in-service trainings on confidentiality, and the assignment of study ID 
numbers. Staff who conduct participant recruitment, screening, enrollment, and assessments are 
required to be trained in ethical human subject research and screening and interviewing techniques, to 
minimize participant risk as much as possible. 
 
If an individual reports coercion, staff should report this to the PI (Dr. Johnson) within 24 hours. The 
PI will review the incident, and follow the standard protocol for handling such occurrences, including 

33 
 
notification to the local IRB, as warranted. See “Data and Safety Monitoring” section for additional 
detail on adverse events. 
 
Because there is potential for psychological discomfort due to the research topic, we will make 
every effort to create a secure environment (ensuring privacy) prior to conducting baseline and 
follow-up assessments, participants will also be able to complete the brief follow-up assessment 
remotely. 
Participants will be told that they do not have to answer any question they do not wish to. Participants 
experiencing mild distress during the assessments will be offered a small break or rescheduled to 
complete the assessment at a later date. In the unlikely event that a participant experiences 
considerable distress we will make a referral (if needed) for clinical assessment and/or counseling. 
Participants will be given the names and office phone numbers of the study investigators and will be 
provided with referrals for mental health and support services. 
 
Additionally, Dr. Johnson will be on-call for any serious problems that arise during assessments. 
 
Incentive and risk of undue influence 
 
Aim 2 participants will receive a $40 incentive for their participation. Aim 1 study participants will  
not receive a monetary incentive as the purpose of the study is to implement the EBI as a program 
to determine if regional scale up is possible. Any study that pays an incentive may unduly influence 
participant behavior. Eliminating the all risk of undue influence by not awarding incentives would 
make it impossible to conduct many studies, and would shortchange subjects who provide time and 
energy, and may incur costs such as bus, train or car fares. The resolution to this problem is to 
ensure that incentives are not inappropriately large, to probe potential subjects to make sure they 
have not been influenced by the incentive, and to give persons who may have been coerced the 
opportunity not to enroll in the study in a manner that will protect them from retribution by the 
person coercing them. We believe we meet these conditions. The incentive we proposed is in use 
now in other studies at the lead site and has been reviewed by our own and other IRBs and deemed 
to not be unduly influential. 
 
PROPOSED BENFITS TO PARTICPANTS 
 
Individual participants may benefit from increased viral suppression, medication adherence and retention in 
care. Possible risks (i.e., discomfort answering questions, potential confidentiality breeches) are outweighed by 
the potential impact of sustained viral suppression among YYALH. 
 
PRIVACY AND CONFIDENTIALITY 
 
Certificate of Confidentiality 
Consistent with Section 301(d) of the Public Health Service Act, a Certificate of Confidentiality (CoC) 
applies to this research because this research is funded, conducted, or supported by CDC and the 
following is true: 

34 
 
1. 
The activity constitutes biomedical, behavioral, clinical, or 
other research; and 
2. 
The research involves information about an individual for 
which there is at least a very small risk, that some 
combination of the information, a request for the 
information, and other available data sources could be used 
to deduce the identity of an individual 
 
Therefore, CDC and any of its collaborators, contractors, grantees, investigators or 
collaborating institutions that receive “identifiable, sensitive information” as 
defined by subsection 301(d) of the Public Health Service Act shall not: 
1.  Disclose or provide, in any Federal, State, or local civil, criminal, 
administrative, legislative, or other proceeding “identifiable, sensitive 
information” that was created or compiled for purposes of the research, 
unless such disclosure or use is made with the consent of the individual to 
whom the information, document, or biospecimen pertains; or 
2.  Disclose “identifiable, sensitive information” or provide ISI to any other 
person not connected with the research. 
 
Disclosure is permitted only when: 
3. Required by Federal, State, or local laws (e.g., as required by the Food, 
Drug and Cosmetic Act or required by state laws requiring the reporting of 
communicable diseases to State and local health departments), excluding 
instances of disclosure in any Federal, State, or local civil, criminal, 
administrative, legislative, or other proceeding. 
4. Made with the consent of the individual to whom the 
information, document, or biospecimen pertains; or 
5. Made for the purposes of other scientific research that is in compliance 
with applicable Federal regulations governing the protection of human 
subjects in research. 
 
CDC and its collaborators and contractors conducting this research will establish and maintain 
effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the 
research is managed in compliance with subsection 301(d) of the Public Health Service Act. CDC will 
ensure: 1) that any investigator or  institution not funded by CDC who receives a copy of identifiable, 
sensitive information protected by this Certificate, understands that it is also subject to the 
requirements of the Certificate; and 2) that any subrecipient that receives CDC funds to carry out part 
of this research involving a copy of identifiable, sensitive information protected by a Certificate 
understands that it is subject to subsection 301(d) of the PHS Act. Therefore, all study staff will receive 
training on the importance of protecting the confidentiality of human research subjects and of 
personal information acquired, including the collection of biological specimens. 
 
All research subjects will be informed of the protections and the limits to the protections provided 
by this Certificate through the informed consent process. All study staff who obtain consent from 

35 
 
study subjects will be trained on how the Certificate protects the information collected and the 
limitations of the Certificate’s protections. 
 
We have developed systematic protocols for data handling and storage over multiple cohort and 
intervention studies. We maintain both paper files and computer files for each participant. Paper files 
primarily include locator information and informed consent but may also contain other paper data 
collection forms. The first two have identifying information and are linked to the data by the patient 
identification number (PID). To protect the integrity of the participant’s data, the study coordinator 
will assign each individual a unique PID at study enrollment. This code number will be used for all study 
data. We will maintain a list of participants with links between identifying information and PIDs for the 
purpose of avoiding any duplication in enrollment. Only research staff will have access to these lists, 
which will be kept behind double-locks or on a secure server with password-protected access. 
Consents will be stored in a locked cabinet away from workstations and will only be accessed in the 
event of a consent amendment or an audit. Locator files are kept in a locked cabinet in the research 
area, separate from data files, and are updated monthly and at each research visit. 
 
Computer files consist of the tracking database (locator information for study follow-up) and study 
data files. 
 
Tracking files are maintained in a highly secure scheduling and monitoring database. This database 
contains all contact information and is used to schedule and track study visits; it is password protected 
and is not accessible via Internet or wireless devices. The tracking database stores contact 
preferences; all communications strictly follow the participants’ contact guidelines(e.g., contact via 
text message only). The tracking database does not contain any clinical or research-based information; 
it only has information the participant agreed to provide for the purposes of tracking and 
communication. 
 
Computer-assisted self-interview (CASI) study data will be collected by REDCap, a high-quality online 
survey software tool which uses Transport Layer Security (TLS) encryption (also known as HTTPS) for all 
transmitted data. Data files are securely exported from REDCap and imported into Stata databases for 
storage and analysis. Computer data files never have any identifying information and are encrypted for 
transfer between study sites. Data files do not include information that could be used to identify the 
participant from the data file alone. 
 
Dimagi Commcare is HIPAA-compliant; no health information will be stored in the Dimagi platform. 
This is a secure system and will be further protected by login credentials for limited access, to protect 
confidentiality. Staff will only access Dimagi to register participants for text messages; Dr. Johnson, the 
data manager (Ms. Cervantes), and Co-Investigator Dr. Kuhns will have access to the SMS data (number 
of texts received; number responded) via encrypted, password protected files. 
 
DATA AND SAFETY MONITORING PLAN 
 
Lurie Children’s (Ms. Cervantes, supervised by Dr. Johnson) will be responsible for computerized 
survey programming, data capture, management and analysis. All study information will be identified 

36 
 
through the PID on all forms and computerized files. Computer data files will never contain any 
identifying information and are encrypted prior to transfer between study sites. All SMS-related data 
will be securely stored by Dimagi per their HIPAA-compliant privacy policy. 
 
Data entered into the Stata databases will not include any identifying information. Only authorized 
users with a password will be able to open up the computerized survey, and only those with 
administrative privileges (i.e., login name and password) will be able to access data. The study staff will 
use a password to gain access to the software in order to administer it to a participant, but they will 
have no ability to access the saved data. The Data Manager will set up the database, check data quality, 
and prepare the data for use. In addition, the database, data structure, and data quality will be 
routinely reviewed by Dr. Johnson. Data quality will be examined before statistical analyses are 
conducted, including examination of missing data, assessment of distributional assumptions, and 
identification of outliers. 
 
All proposed staff have participated in the NIH required trainings for conduct of studies that involve 
human subjects, and any future study staff will do so upon hiring. Training for all staff includes (but is 
not limited to) Human Subjects, Informed Consent, Good Clinical Practice, Quality Management, and 
Confidentiality and Reporting of Adverse Events. If any study staff discovers an untreated condition in a 
patient (e.g., onset of physical or mental health condition),they will refer participants to appropriate 
treatment immediately. 
 
 
Per guidance provided by the Office of Human Subjects Research at the NIH, an adverse event (AE) is any 
unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or 
disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears 
to worsen. A serious adverse event (SAE) is defined as untoward medical occurrences that: 
 
1. result in death 
2. are life threatening 
3. require (or prolong) hospitalization 
4. cause persistent or significant disability/incapacity 
5. result in congenital anomalies or birth defects or 
6. are other conditions, which in the judgment of the investigators represent significant hazards. 
 
Potential AEs that are unanticipated will be brought to the attention of the study PI and reported 
immediately to the IRB. All study staff will be trained to recognize and report AEs and SAEs. Possible 
adverse events will immediately (within 24 hours) be reported to the PIs by the study staff who identify 
the event. The study PIs will report the AEs and SAEs to the IRB in writing as soon as possible, but within 
7 calendar days for death or life-threatening events, and within 15 calendar days for all other AEs or 
SAEs. The IRB will determine whether it is appropriate to stop the study protocol temporarily or will 
provide suggestions/modifications to the study procedures as necessary. Possible modifications include 
adding these possible adverse events to the consent form and re-consenting all study participants. The 
PIs will be responsible for monitoring participant safety on a monthly basis at regularly scheduled 
research meetings. They will keep a written log of all events and ensure that the IRB is contacted 

37 
 
immediately. They will also keep a log of the outcome of IRB decisions regarding AEs and apprise the 
research team of any changes that need to occur as a result of IRB decisions. 
 
Protocol violations are any unapproved changes, deviations, or departures from the procedures of the 
research study that have not been reviewed and approved by the IRB. Major protocol violations are 
those that may affect participants’ rights or safety, or the completeness, accuracy, and reliability of the 
study data.  
Major violations will include any of the following: 
1. 
The violation has harmed, or posed a significant or substantive risk of harm, to the research 
participant 
2. 
The violation resulted in a change to the participant’s clinical or emotional condition or status 
3. 
The violation has damaged the scientific completeness or soundness of the data collected for the 
study 
4. 
The violation is evidence of willful or knowing misconduct on the part of the investigator(s) 
5. 
The violation involves serious or continuing noncompliance with federal, state or local regulations 
 
Minor protocol violations are those that do not impact or harm participants, including:  
1. 
The violation did not harm or pose a significant risk of substantive harm to the research participant 
2. 
The violation did not result in a change to the participant’s clinical or emotional condition or status 
3. 
The violation did not damage the completeness, accuracy and reliability of the data collected for 
the study 
4. 
The violation did not result from willful or knowing misconduct on the part of the investigator(s) 
 
Study staff will be trained to identify and report all protocol violations to the study PI. The Study PI will 
determine if the violation is major or minor, will report to the IRB, and will follow up with a plan of 
corrective action in consult with the IRB.  
 
Data Safety and Monitoring Board 
There will not be an appointed data safety and monitoring board. 
 
Data sharing 
 
All data from the project will be made available as de-identified datasets to internal and external 
investigators requesting access. Data will be made available once primary analysis has been 
completed, to ensure data cleaning, accuracy, and completeness. The de-identification will include 
ensuring no protected health information or other potentially identifying information is available in 
the data set. All those who request data sets will be required to sign a confidentiality and data use 
agreement that will outline agreed upon use and storage of the de-identified data. The CDC will be 
provided a copy of the de-identified datasets as required at the end of the funding period. Finally, 
Dr Johnson will be responsible for maintaining a log of requests for data sharing and for sending data 
via encrypted and secure methods. 

38 
 
 
 
IMPORTANCE OF KNOWLEDGE TO BE GAINED 
 
YYALH, particularly racial/ethnic minority youth, have the lowest rates of viral suppression among 
people living with HIV. Effective interventions exist to support adherence and should be scaled up 
to ensure equitable access. This proposal addresses these gaps and disparities by scaling up TXTXT, 
a CDC EBI, in the Midwest via a regional hub model with an established AIDS Education and 
Training Center (AETC), the Midwest AETC (MATEC). By using both a CDC EBI and HRSA AETC, we 
build on existing infrastructure, to test an implementation approach with potential for nation-wide 
scale up. We will simultaneously evaluate effectiveness at the regional level, as well as both the 
implementation process and outcomes and will engage YYALH, health care providers, and other 
key stakeholders in the implementation evaluation. This proposal is in line with the Ending the HIV 
Epidemic research agenda, specifically in efforts to reduce the incidence of HIV, advance cross 
cutting areas of research, and targeting high risk populations. This study combines behavioral and 
social science, implementation science, and information dissemination towards the ultimate goal 
of public health impact. Medication adherence is a key driver of viral suppression and this regional 
TXTXT initiative, with a longer-term objective of national dissemination and focused on patients at 
most risk of not achieving viral non- suppression will directly address local, regional, and national 
goals to End the Epidemic by 2030. 

39 
 
 
 
DISSEMINATION AND DATA ACCESS AND MANAGEMENT PLAN 
 
Ann & Robert H. Lurie Children’s Hospital of Chicago and the investigative team are committed to the 
open and timely dissemination of research outcomes. The investigative team has an extensive 
portfolio of publications, including peer-reviewed manuscripts and book chapters, and national and 
international conference presentations. 
 
If effective, the scale up of TXTXT has the potential to impact viral load and HIV transmission among  
racial/ethnic minority youth and young adults in the United States. A multi-faceted dissemination 
and  translation plan targeting various stakeholders is proposed. We will disseminate our findings to 
both clinical, community and academic audiences, via the following strategies: 
 
1. 
Members of the research team will present the results of the study in 
a number of different venues targeting different audiences, including 
conferences such as the annual meeting of the American Public Health 
Association, at regional meetings such as HIV planning bodies and 
Departments of Public Health, and at ID week/grand rounds at regional 
academic institutions/hospitals. 
2. 
We will present at CDC seminars, group site visits, and symposia to share 
interim findings 
3. 
We plan to publish our results in appropriate high-impact peer 
reviewed academic journals. 
4. 
We will create a lay summary to publish on our website, disseminate to 
community partners, and circulate through the AETC network. 
 
In addition, Lurie Children’s maintains a website to disseminate relevant information about 
research studies conducted by Lurie Children’s faculty. Summaries of the scientific presentations 
will be posted on this website on a regular basis, written primarily for a general audience. All final 
peer- reviewed manuscripts that arise from this proposal will be submitted to the digital archive 
PubMed Central. 
 
In addition to disseminating project outcomes the study team will also develop an implementation 
strategy to integrate TXTXT into HIV clinical care. Guided by the Consolidated Framework for 
Implementation Research (CFIR), 37,41 we will meet with key staff from participating sites to review the 
de-identified/aggregated study data and to identify factors that will facilitate or impede the integration 
of TXTXT and develop recommended procedures that will facilitate uptake and delivery (e.g., training, 
monitoring, supervision). In collaboration with MATEC, we will create and disseminate a recommended 
workflow that will facilitate ease of integration into clinics. Finally, we will create templates, tasks lists, 
and streamlined processes for patients and providers to guide integration of TXTXT into the clinic 
flow/care plan. 

40 
 
 
REFERENCES 
 
1 
Centers for Disease Control and Prevention. Diagnoses of HIV infection in the United States and 
dependent areas, 2019. (2019). 
2 
Denning, P. & DiNenno, E. in XVIII international AIDS conference. 
3 
Maulsby, C. et al. HIV among Black men who have sex with men (MSM) in the United States: a review of 
the literature. AIDS Behav 18, 10-25, doi:10.1007/s10461-013-0476-2 (2014). 
4 
Bangsberg, D. R. Less than 95% adherence to nonnucleoside reverse-transcriptase inhibitor therapy can 
lead to viral suppression. Clinical infectious diseases : an official publication of the Infectious Diseases 
Society of America 43, 939-941, doi:10.1086/507526 (2006). 
5 
Cohen, M. S. et al. Prevention of HIV-1 infection with early antiretroviral therapy. New England journal of 
medicine 365, 493-505 (2011). 
6 
Gardner, E. M., McLees, M. P., Steiner, J. F., del Rio, C. & Burman, W. J. The spectrum of engagement in 
HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clinical infectious 
diseases 52, 793-800 (2011). 
7 
Reisner, M. S. L. et al. A review of HIV antiretroviral adherence and intervention studies among HIV–
infected youth. Topics in HIV medicine: a publication of the International AIDS Society, USA 17, 14 (2009). 
8 
Agwu, A. L. et al. Disparities in antiretroviral treatment: a comparison of behaviorally HIV-infected youth 
and adults in the HIV Research Network. J Acquir Immune Defic Syndr 58, 100-107, 
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Giordano, T. P. et al. Patients referred to an urban HIV clinic frequently fail to establish care: factors 
predicting failure. AIDS Care 17, 773-783, doi:10.1080/09540120412331336652 (2005). 
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Lee, L. et al. The Impact of Youth-Friendly Structures of Care on Retention Among HIV-Infected Youth. 
AIDS Patient Care STDS 30, 170-177, doi:10.1089/apc.2015.0263 (2016). 
11 
Minniear, T. D. et al. Delayed entry into and failure to remain in HIV care among HIV-infected 
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12 
Ryscavage, P., Anderson, E. J., Sutton, S. H., Reddy, S. & Taiwo, B. Clinical outcomes of adolescents and 
young adults in adult HIV care. J Acquir Immune Defic Syndr 58, 193-197, 
doi:10.1097/QAI.0b013e31822d7564 (2011). 
13 
Torian, L. V. & Wiewel, E. W. Continuity of HIV-related medical care, New York City, 2005-2009: Do 
patients who initiate care stay in care? AIDS Patient Care STDS 25, 79-88, doi:10.1089/apc.2010.0151 
(2011). 
14 
Vijayan, T., Benin, A. L., Wagner, K., Romano, S. & Andiman, W. A. We never thought this would happen: 
transitioning care of adolescents with perinatally acquired HIV infection from pediatrics to internal 
medicine. AIDS Care 21, 1222-1229, doi:10.1080/09540120902730054 (2009). 
15 
Yehia, B. R., Fleishman, J. A., Metlay, J. P., Moore, R. D. & Gebo, K. A. Sustained viral suppression in HIV-
infected patients receiving antiretroviral therapy. Jama 308, 339-342, doi:10.1001/jama.2012.5927 
(2012). 
16 
Zanoni, B. C. & Mayer, K. H. The adolescent and young adult HIV cascade of care in the United States: 
exaggerated health disparities. AIDS patient care and STDs 28, 128-135 (2014). 
17 
MacDonell, K., Naar-King, S., Huszti, H. & Belzer, M. Barriers to medication adherence in behaviorally and 
perinatally infected youth living with HIV. AIDS Behav 17, 86-93, doi:10.1007/s10461-012-0364-1 (2013). 

41 
 
18 
Garofalo, R. et al. A randomized controlled trial of personalized text message reminders to promote 
medication adherence among HIV-positive adolescents and young adults. AIDS and Behavior 20, 1049-
1059 (2016). 
19 
Project, H. A. P. R. S.    (ed Centers for Disease Control and Prevention) 
https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html (2020). 
20 
Fauci, A. S., Redfield, R. R., Sigounas, G., Weahkee, M. D. & Giroir, B. P. Ending the HIV epidemic: a plan 
for the United States. Jama 321, 844-845 (2019). 
21 
Hosek, S. G., Harper, G. W. & Domanico, R. Predictors of medication adherence among HIV-infected 
youth. Psychology, Health & Medicine 10, 166-179 (2005). 
22 
Centers for Disease Control and Prevention.  Vol. 29  (ed Department of Health and Human Services) 
(Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, 
Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, 
Atlanta, GA, 2018). 
23 
Collins Jr, C. B. & Sapiano, T. N. Lessons learned from dissemination of evidence-based interventions for 
HIV prevention. American journal of preventive medicine 51, S140-S147 (2016). 
24 
Bauermeister, J. A., Tross, S. & Ehrhardt, A. A. A review of HIV/AIDS system-level interventions. AIDS and 
Behavior 13, 430-448 (2009). 
25 
Damschroder, L. J. et al. Fostering implementation of health services research findings into practice: a 
consolidated framework for advancing implementation science. Implementation science 4, 1-15 (2009). 
26 
Lambdin, B. H. et al. Implementing Implementation Science: An Approach for HIV Prevention, Care and 
Treatment Programs. Curr HIV Res 13, 244-249, doi:10.2174/1570162x1303150506185423 (2015). 
27 
Whiteley, L. B. et al. A Review of Interventions to Enhance HIV Medication Adherence. Curr HIV/AIDS Rep 
18, 443-457, doi:10.1007/s11904-021-00568-9 (2021). 
28 
Zullig, L. L., Deschodt, M., Liska, J., Bosworth, H. B. & De Geest, S. Moving from the Trial to the Real 
World: Improving Medication Adherence Using Insights of Implementation Science. Annu Rev Pharmacol 
Toxicol 59, 423-445, doi:10.1146/annurev-pharmtox-010818-021348 (2019). 
29 
Glasgow, R. E. & Emmons, K. M. How can we increase translation of research into practice? Types of 
evidence needed. Annu. Rev. Public Health 28, 413-433 (2007). 
30 
Bandura, A. Social cognitive theory: An agentic perspective. Annual review of psychology 52, 1-26, 
doi:10.1146/annurev.psych.52.1.1 (2001). 
31 
Hedeker, D. in Encyclopedia of Statistics in Behavioral Science   (eds B. Everitt & D. Howell)  (Wiley, 2005). 
32 
Diggle, P., Liang, K.-Y. & Zeger, S. L. Longitudinal data analysis. New York: Oxford University Press 5, 13 
(1994). 
33 
Lewis, M. A. et al. Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease 
HIV viral loads in patients seen in HIV primary care. Contemp Clin Trials 96, 106097, 
doi:10.1016/j.cct.2020.106097 (2020). 
34 
Mugavero, M. J. et al. Measuring retention in HIV care: the elusive gold standard. J Acquir Immune Defic 
Syndr 61, 574-580, doi:10.1097/QAI.0b013e318273762f (2012). 
35 
Health Resources & Services Administration. HIV/AIDS Bureau Performance Measures. (2019). 
36 
Ahn, C., Heo, M. & Zhang, S. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical 
Research. 1 edn,  223-225 (Chapman and Hall, 2015). 
37 
Keith RE, C. J., O’Malley AS, Cromp D, Taylor EF. Using the Consolidated Framework for Implementation 
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implementation. Implementation science 12 (2017). 

42 
 
38 
SocioCultural Research Consultants, L.     (Los Angeles, CA, 2018). 
39 
Hsieh, H.-F. & Shannon, S. E. Three Approaches to Qualitative Content Analysis. QUALITATIVE HEALTH 
RESEARCH 15, 1277-1288 (2005). 
40 
Tinsley, H. E. & Weiss, D. J. in Handbook of applied multivariate statistics and mathematical modeling     
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41 
Breimaier, H. E., Heckemann, B., Halfens, R. J. & Lohrmann, C. The Consolidated Framework for 
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implementation process in a hospital-based nursing practice. BMC nursing 14, 43 (2015). 
 
 
 
 

43 
 
APPENDICES 

44 
 
APPENDIX A: TXTXT Intervention Description  
 
 
 
 
 
 
 
 
 
 
 

45 
 
 
Appendix B Training Material 

46
TXTXT CommCare Platform Training 
Brothers Health Collective 
The Potocsnak Family Division of 
Adolescent and Young Adult Medicine 
November 12th, 2019 

47
 
Fundamentals 
 

48
1. 
Dimagi is a software technology company that designs clinical interfaces and health information systems 
2. CommCare is one of Dimagi’s products 
1. 
Open source mobile platform used to create apps for various purposes 
2. 
Designed for data collection, client management, decision support, etc. 
3. 
CommCare is the platform we are using to deploy TXTXT app (the text 
What is Dimagi and CommCare? 

49
1. 
Bidirectional text message intervention used to address ART adherence. Registering a client in the app means they: 
1. 
receive a reminder text message 
2. 
receive a question text message 15m later 
1. 
respond with “yes” or “no” 
3. 
receive an encouraging text message 
1. 
Client: 
1. 
customizes the reminder and question text 
2. 
can receive up to 3 daily texts 
3. 
can receive up to 1 weekly text 
What does the TXTXT App do? 

 
Two User Roles 
 

51
Mobile Worker: The TXTXT App 
1. App User 
2. Register a case (i.e., 
client/participant) to they can start 
receiving text messages 
3. Revise text message preferences 
for a previously registered case 
Web User: CommCareHQ 
4. Admin 
5. Monitor text message history for all 
cases 
6. Download aggregate text message 
data 
7. Manage Mobile Workers and Web 
Users 
8. Managing the system and users 
Two User Roles: App User and Admin 

52
Mobile Worker: The TXTXT App 
9. App User 
10. Register a case (i.e., 
client/participant) to they can start 
receiving text messages 
11. Revise text message preferences 
for a previously registered case 
12. 
Anyone who will register clients into the system to receive 
messages will need a Mobile Worker account 
Web User: CommCareHQ 
13. 
Admin 
14. 
Monitor text message history for 
all 
cases 
15. 
Download aggregate text 
message data 
16. 
Manage Mobile Workers and Web 
Users 
17. 
Managing the system and users 
18. Only the few people who will monitor study progress, run data 
queries, and manage users need a Web User account 
Two User Roles: App User and Admin 

53
Mobile Worker: The TXTXT App 
19. 
App User 
20. Register a case (i.e., 
client/participant) to they can start 
receiving text messages 
21. Revise text message preferences 
for a previously registered case 
22. 
Anyone who will register clients into the system to receive 
messages will need a Mobile Worker account 
Anything other than registering a client 
or updating a client’s preferences requires 
a Web User account 
Web User: CommCareHQ 
1. Admin 
2. Monitor text message history for all 
cases 
3. Download aggregate text 
message data 
4. Manage Mobile Workers and Web 
Users 
5. Managing the system and users 
6. Only the few people who will 
monitor study progress, run 
data queries, and manage 
users need a Web User 
account 
Two User Roles: App User and Admin 

54
You log in as a Mobile Worker and Web User using the same landing page, but with different credentials 
1. 
Mobile Worker 
1. Username: created for you by Web 
User 
2. Password: created for you by Web 
User 
Logs into TXTXT App 
1. Web User 
1. Username: Email 
2. 
Password: you set it up after 
you are invited via email to be 
a Web User 
 
Logs into CommCareHQ 
 
 
 
Two User Roles: App User and Admin 

Two User Roles: 
TXTXT App as a Mobile Worker 
55 
Username created 
for you 
Password created for 
you 

Two User Roles: 
TXTXT App as a Mobile Worker 
56 
 

Two User Roles: 
CommCare HQ as a Web User 
57 
Email 
Password you 
create 

Two User Roles: 
CommCare HQ as a Web User 
 

59
1. Mobile Worker 
1. Logs you into the TXTXT App 
2. Deploy the system and use the 
app 
3. Register case to receive text 
messages 
2. Web User 
1. Logs you into CommCareHQ 
2. Admin access to the system 
3. Manage all cases and access data 
Two User Roles 

60
 
 

61
 
Mobile Worker Task 1 of 2: Registering a case in the TXTXT App 
15 

62
1. Registration Form 
1. 
Collect essential participant information, including phone number 
1. PHONE NUMBER IS VERIFIED TO BE UNIQUE IN THE SYSTEM 
2. 
Set up daily and/or weekly SMS reminders 
1. Up to three times may be selected for daily reminders and one time for weekly 
3. 
Set-up the content of the initial message and of the follow-up question 
2. Follow-Up Form 
1. 
Edit any information originally collected in the Registration form 
1. EXCEPT Participant ID 
The TXTXT App 

Username created 
for you 
Password created for 
you 
17 
Two User Roles: 
TXTXT App as a Mobile Worker 

64
The TXTXT App 
Click this Icon to 
begin using the 
application 
Forms that a 
Mobile worker 
began, but did not 
Ensures that 
information/forms 
filled out on Web 
Where a mobile 
workers goes to 
clear user data, 

which is only 
important when 
you have deleted 
cases 
Apps is sent to 
CommCareHQ and 
that app updates 
are sent to Web 
Apps 
complete and 
submit 
The TXTXT App 
Click this Icon to 
begin using the 
application 
Forms that a 
Mobile worker 
began, but did not 
Ensures that 
information/forms 
filled out on Web 
Where a mobile 
workers goes to 
clear user data, 

which is only 
important when 
you have deleted 
cases 
Apps is sent to 
CommCareHQ and 
that app updates 
are sent to Web 
Apps 
complete and 
submit 
The TXTXT App 
Click this Icon to 
begin using the 
application 
Forms that a 
Mobile worker 
began, but did not 
Ensures that 
information/forms 
filled out on Web 
Where a mobile 
workers goes to 
clear user data, 
Start a habit of always 
1. syncing when you 
log in and 
2. syncing before you 
log out 

Ann & Robert H. Lurie 
Children's Hospital of Chicago· 
lJ!WEllAPl'S 
Sh.;.. Full l,l2nu 
APPLICATIONS 
 
 
 
 
 
 
 
SMS for ART Adherence 

Ann & Robert H. Lurie 
Children's Hospital of Chicago· 
HEAT TXTXT FOR ART ADHERENCE 
TXTXT Platform 
Formplayer Version: 2.43, App Versfon: 18 
 

Ann & Robert H. Lurie 
Children's Hospital of Chicago· 
yer Version: 2.43, App Versfon: 18 
 
 
HEAT TXTXT FOR ART ADHERENCE 
 
 
TXTXT Platform 
 
 
 
 

70
 

71
 

72 

73 

74 

75 

76 
 

77 
A client can receive 
1. Up to 3 daily texts 
2. A weekly text 
 

78 
 

79 
 

80 
 

81 
 

82 
 
The “yes” or “no” 
question 15 minutes later 

83 
 

84 
 
Using a 24 hour clock. 
When the first reminder 
text is sent. 

85 
 

86 
 
Can send up to 3 texts a 
day for 3 daily doses 

87 
 

88 
 
Don’t forget to 
click “Submit!” 

Phone Number Confirmation 
89 
3. The client should immediately receive a test text message 
reading “Testing” 
1. If they do not receive one, double check the phone number was entered 
correctly, check the number with the client, confirm the client can 
receive messages, or reach out to Lisa and Abby 
4. Their daily and weekly texts will begin immediately 

Time to try! 
90 
https://www.commcarehq.org/a/txtxt/dashboard/project/ 
1. Login to CommCare as a Mobile Worker 
2. Create a new case in the TXTXT App 

 
Mobile Worker Task 2 of 2: Updating a case in the TXTXT Application 
45 

92 
 

93 
 

94 
 

95 
 

96 
 

97 
 

98 

99 
 
If the client changes any setting, 
Confirm the rest of the information 
In this form is correct before submitting 

100
https://www.commcarehq.org/a/txtxt/dashboard/project/ 
1. Login to CommCare as a Mobile Worker 
2. Update an existing case in the TXTXT App 
Time to try! 

 
Web User Monitoring Texts 
59 

Email 
Password you 
create 
60 
Two User Roles: 
CommCare HQ as a Web User 

 
Links to learn more: 
1. 
https://www.commcarehq.org 
/home/ 
2. 
https://help.commcarehq.org/ 
display/commcarepublic/Begi
n ner+Tutorial+Part+1 
Basics of CommCareHQ: Sections of HQ 

 
Links to learn more: 
1. 
https://www.commcarehq.org 
/home/ 
2. 
https://help.commcarehq.org/ 
display/commcarepublic/Begi
n ner+Tutorial+Part+1 
Basics of CommCareHQ: Sections of HQ 

In the Reports section of HQ you can: 
1. 
View cases registered in the TXTXT app 
2. 
Access reports 
1. 
Message History 
2. 
Message Log 
3. 
SMS Opt Out Report 
4. 
Scheduled Messaging Events 
3. 
Access Monitor Worker reports (not all will be useful for this project) 
Basics of HQ: Reports 

Reports: Message Log 
106
Reports > Messaging > Message Log 
Manage all individual messages 
1. 
incoming or outgoing, 
2. 
in order sent or received 
3. 
displays message content, 
4. 
displays status, 
5. 
displays type of message. 

Reports: Message Log 
107
Establish a date range 
Drill down by message type (optional) 

108
Reports: Message Log 
Manage all individual messages 
1. 
incoming or outgoing, 
2. 
in order sent or received 
3. 
displays message content, 
4. 
displays status, 
5. 
display type of message 
6. 
one row of data per text 

Reports: Message History 
109
Reports > Messaging > Message History 
Manage all messages grouped by type 
1. 
Completed or incomplete or error 
2. 
Does not display message content 
3. 
Groups two-messaging for the question text 
4. 
Gives more details on errors 

Reports: Message History 
110
Establish a date range 
Add/delete communication type, select status, enter in a phone number (optional) 

Reports: Message History 
111
Manage all messages grouped by type 
1. 
Completed or incomplete or error 
2. 
Does not display message content 
3. 
Groups two-messaging for the question text 
4. 
Gives more details on errors 

Reports: Message History 
112
If there are messages failing to send, click, “View Details” and either 
1. 
troubleshoot with the client or 
2. 
submit a bug report to Dimagi 

Reports: Other 
113
SMS Opt Out Report 
3. 
Has a client opted out/back in of the messages 
Scheduled Messaging Events 
4. 
View all upcoming types of messages scheduled to be 
sent 

Reports: Saving 
114
You can save any reports for easy 
access 
Name the report, add a description, 
and establish a date range 
Reports will be saved under 
Reports > Tools > My Saved Reports 

Reports: Saved Reports 
115
Easy access 
Delete or edit 
Use “My Scheduled Reports” to create automatic emails 

Reports: My Scheduled Reports 
116
 

Reports: My Scheduled Reports 
117
 

Reports: My Scheduled Reports 
118
 

Reports: My Scheduled Reports 
119
 

Reports: My Scheduled Reports 
120
 

 
Web User 
Creating a Mobile Worker 
79 

Basics of HQ: Users 
In the Users section of HQ you can: 
1. 
Create Mobile Workers 
2. 
Set up case sharing 
3. 
Create Web Users 
4. 
Establish what Web Users have access to 

Basics of HQ: Users 
In the Users section of HQ you can: 
5. Create Mobile Workers 
6. Set up case sharing 
7. 
Create Web Users 
8. 
Establish what Web Users have access to 

 
Links to learn more: 
https://help.commcarehq.org/dis 
play/commcarepublic/CommCare 
+Fundamentals+- 
+Web+and+Mobile+Users 
https://help.commcarehq.org/dis 
play/commcarepublic/Create+an 
d+Manage+CommCare+Mobile+ 
Workers 
Basics of CommCareHQ: Users 

User Management: Mobile Users 
Links to learn more: 
https://help.commcarehq.org/dis 
play/commcarepublic/CommCare 
+Fundamentals+- 
+Web+and+Mobile+Users 
https://help.commcarehq.org/dis 
play/commcarepublic/Create+an 
d+Manage+CommCare+Mobile+ 
Workers 

Managing Mobile Workers: Creating 

Managing Mobile Workers: Creating 
 

Managing Users: Edit Mobile Workers 

Managing Users: Edit Mobile Workers 

Managing Users: Edit Mobile Workers 

Managing Users: Edit Mobile Workers 

Managing Users: Edit Mobile Workers 
 

Managing Users: Case Sharing 
5. The default in CommCare is that cases can only be accessed 
by the Mobile Worker who registered them 
6. In order for all Mobile Workers to access all cases in the 
system, permission must be granted 
7. This is accomplished by putting all mobile workers in an “All 
Mobile Worker” group and allow that group “case sharing” 
privileges 
91 

Managing Users: Case Sharing 

Managing Users: Case Sharing 

Managing Users: Case Sharing 

Managing Users: Case Sharing 
1. 
Once the group is set up and case sharing is turned on, you can add the 
mobile workers you have created. 

Managing Users: Case Sharing 
2. 
Once the group is set up and case sharing is turned on, you can add the 
mobile workers you have created. 
3. 
Whenever you add a new Mobile Worker, you can add them to the case 
sharing group here or by editing their information directly. 

Managing Users: Edit Mobile Workers 
Understand: 
1. 
After creating a new mobile worker, 
add them to the All Mobile Workers group 

140
1. 
Run reports of mobile worker 
1. 
Number of form submissions 
2. 
Type of form submissions 
3. 
Last form submitted 
4. 
Cases created case activity 
5. 
Worker activity times 
Managing Mobile Worker Performance 

141
https://www.commcarehq.org/a/txtxt/dashboard/project/ 
1. Login to CommCare as a Web User 
2. Create a Mobile Worker 
3. Add them to the “All Mobile Workers” case sharing group 
Time to try! 

 
Web User 
Creating a Web User 
100 

Basics of HQ: Users 
In the Users section of HQ you can: 
1. 
Create Mobile Workers 
2. 
Set up case sharing 
3. 
Create Web User 
4. 
Establish what Web Users have access to 

Basics of HQ: Users 
In the Users section of HQ you can: 
5. 
Create Mobile Workers 
6. 
Set up case sharing 
7. 
Create Web User 
8. Establish what Web Users have access to 

 
103 
Managing Users: Creating a Web User 

Managing Users: Creating Web User 
 
Web User will receive an email inviting them to join the project and create a password 

Managing Users: Web User Role 
 

Controlling Web Access (Cont’d) 
Click to define a role’s parameters 
Click to choose the levels of access on 
HQ and the reports that each type of 
role can access. 
To the right of the role, you can also edit 
the 
specific access on HQ for each existing 
role 
For example, you could create a unique role that 
would be constant across organizations 

Controlling Web Access (Cont’d) 
A Web User with Admin capabilities can remove the membership of other Web 
Users by clicking “Remove Membership” on the Web Users and Roles page. 

https://www.commcarehq.org/a/txtxt/dashboard/project/ 
1. Login to CommCare as a Web User 
2. Create a Web User 
3. Make sure their User Rights are accurate 
108 
Time to try! 

 
Web User: Other Functions Sending a Broadcast 
109 

In the Messaging section of HQ you can: 
1. 
Create case groups 
2. 
Send bulk messages to registered participants 
Basics of CommCareHQ: Messaging 

Finishing Client Registration 
1. 
Navigate to 
Messaging > Contacts > Case Groups 

2. 
Add every new case to the “All Participants” group using their case ID 
or phone number 
Finishing Client Registration 

Messaging: Broadcasts 
155 
1. 
Allows you to send a mass text to 
1. 
Mobile workers (if you added their number to their profile) 
2. Cases 

Messaging: Broadcasts 
156 
 

Messaging: Broadcasts 
157 
 

Messaging: Broadcasts 
158 
 

Messaging: Broadcasts 
159 
 

Messaging: Broadcasts 
160 
 

Messaging: Broadcasts 
161 
 

Messaging: Broadcasts 
162 
 

 
Technical Issues 
121 

Most Common Issues 
164 
Issues 
3. 
Conflation of Web User/Mobile Worker roles 
Solutions 
4. Only give those that need admin access a Web User 
account 
 
5. (Re)Train staff on different 
credentials and dashboards 

Most Common Issues 
165 
Issues 
6. Texts are not sending 
Solutions 
7. Confirm the phone number 
 
8. Confirm end date 
 
9. Confirm the ptp has not 
stopped texts 
 
10. Check Message 
History, Message Log, 
Scheduled Message 
Events 
 

Most Common Issues 
166 
11. Remember 
weekly texts 
begin same day, 
daily do not 

Technical Issues 
167 
 

Technical Issues 
168 
 

Technical Issues 
169 
 

Technical Issues: Reporting Issues 
170 
 

 
How does BHC request the TXTXT App? 
128 

172 
 
 
Your Clinic 
TXTXT App Set-Up 

TXTXT App Set-Up 
Your Clinic 
1. 
2. 
Negotiate licensing fee with Dimagi 
Set up license 
173 

TXTXT App Set-Up 
Your Clinic 
1. 
2. 
Negotiate licensing fee with Dimagi 
Set up license 
174 
 
 
Dimagi 

TXTXT App Set-Up 
Your Clinic 
1. 
2. 
Negotiate licensing fee with Dimagi 
Set up license 
175 
 
 
 
Dimagi 
1. 
Gives you access to a “project 
space” 
2. 
Make someone on your team a web 
user with “admin” access 

176 
TXTXT App Set-Up 
1. Negotiate licensing fee with Dimagi 
2. Set up license 
 
 
 
 
 
Your Clinic 
Dimagi 
1. 
Gives you access to a “project 
space” 
2. 
Make someone on your team a web 
user with “admin” access 
Your Clinic 

177 
TXTXT App Set-Up 
1. Negotiate licensing fee with Dimagi 
2. Set up license 
 
 
 
 
 
Your Clinic 
Dimagi 
1. 
Gives you access to a “project 
space” 
2. 
Make someone on your team a web 
user with “admin” access 
Your Clinic 
1. 
Make Abigail Muldoon at Lurie a web 
user with “admin” access. 
amuldoon@luriechildrens.org 
2. 
(optional) Any revisions to the 
encouraging messages 

178 
TXTXT App Set-Up 
1. Negotiate licensing fee with Dimagi 
2. Set up license 
 
 
 
 
 
Your Clinic 
Dimagi 
1. 
Gives you access to a “project 
space” 
2. 
Make someone on your team a web 
user with “admin” access 
Your Clinic 
1. 
Make Abigail Muldoon at Lurie a web 
user with “admin” access 
amuldoon@luriechildrens.org 
2. 
(optional) Any revisions to the 
encouraging messages 
Lurie 

179 
TXTXT App Set-Up 
1. Negotiate licensing fee with Dimagi 
2. Set up license 
 
 
 
 
 
Your Clinic 
Dimagi 
1. 
Gives you access to a “project 
space” 
2. 
Make someone on your team a web 
user with “admin” access 
Your Clinic 
1. 
Make Abigail Muldoon at Lurie a web 
user with “admin” access 
amuldoon@luriechildrens.org 
2. 
(optional) Any revisions to the 
encouraging messages 
Lurie 
1. Build/test your project space 
2. 
Change your clinic’s web user access 
to “admin_noapps” 

180 
TXTXT App Set-Up 
1. Negotiate licensing fee with Dimagi 
2. Set up license 
 
 
 
 
 
Your Clinic 
Dimagi 
1. 
Gives you access to a “project 
space” 
2. 
Make someone on your team a web 
user with “admin” access 
Your Clinic 
1. 
Make Abigail Muldoon at Lurie a web 
user with “admin” access 
amuldoon@luriechildrens.org 
2. 
(optional) Any revisions to the 
encouraging messages 
Lurie 
1. Build/test your project space 
2. 
Change your clinic’s web user access 
to “admin_noapps” 
Your Clinic 

8 
13 
TXTXT App Set-Up 
1. Negotiate licensing fee with Dimagi 
2. Set up license 
 
 
 
 
 
Your Clinic 
Dimagi 
1. 
Gives you access to a “project 
space” 
2. 
Make someone on your team a web 
user with “admin” access 
1. 
Add staff as mobile workers/web 
users 
2. Start registering users 
Your Clinic 
1. 
Make Abigail Muldoon at Lurie a web 
user with “admin” access 
amuldoon@luriechildrens.org 
2. 
(optional) Any revisions to the 
encouraging messages 
Lurie 
1. Build/test your project space 
2. 
Change your clinic’s web user access 
to “admin_noapps” 
Your Clinic 

139 
1. Negotiate licensing fee with Dimagi 
Your Clinic 
2. Set up license 
1. Gives you access to a “project 
space” 
Dimagi 
2. Make someone on your team a web 
user with “admin” access 
1. Make Abigail Muldoon at Lurie a web 
user with “admin” access 
Your Clinic 
2. (optional) Any revisions to the 
encouraging messages 
1. Build/test your project space 
Lurie 
2. Change your clinic’s web user access 
to “admin_noapps” 
1. Add staff as mobile workers/web 
Your Clinic 
users 
TXTXT App Set-Up 
You did it! 
Go you! 
2. 
Start registering users 

183 
APPENDIX C Eligibility Screener (Aim 1) 
 
 
 
 
  
ELIGIBILITY SCREENING INTERVIEW 
 
SCREENING DATE: 
| 
| 
|--| 
_| 
|--| 
| 
| 
| 
| 
Month 
Day 
Year 
 
STAFF INITIALS: | 
| 
| SCREENING PHASE: In Person | Phone 
(Circle one) 
 
Hi, My name is (name) and I’m one of the staff members working on the Midwest Treatment Text (TXTXT) 
project, which is being conducted in partnership with Midwest AIDS Education and Training Center (MATEC) 
and Lurie Children’s Hospital of Chicago. This  project will explore whether daily text message reminders can 
help adolescents and young adults living with  HIV do a better job of taking their medications and staying in 
HIV care. Are you interested in hearing more about it? 
Response: If yes, continue. If no, thank them for their time and discontinue screening. 
Thanks for your interest in our project. As I just said, the purpose of the study is to explore whether daily 
text message reminders can help adolescents and young adults living with HIV do a better job of taking their 
medications. 
If you are eligible and decide to enroll you will be asked to provide your cell phone number and to create a 
text message reminder for yourself. This personalized reminder will be sent to you daily, at a time that you 
decide. You will be asked to text back when you take your medications. You will also continue to meet with 
your medical provider. Additionally, we’ll ask you to complete a computer-based questionnaire at your first 
visit. We’ll also ask you to  fill out the questionnaire again at 3 months and 6 months. You will be able to 
complete the survey online if you prefer you can also come into the clinic site to fill out the computer survey.  
If you are eligible and decide to participate, we will keep all information we collect from you strictly 
confidential. We will need to ask you for contact information so that we can invite you back for various 
stages of the intervention. 
To find out if you’re eligible to participate in this project, I’ll need to take less than 5 minutes to ask you 
some questions. Your answers to these questions will be kept confidential. That is, at this point, I will not 
be asking you any identifying information: I won’t ask for your name, address, phone number or birthday. 
One of the reasons we stress confidentiality is that we do ask some very personal questions, and it is very 
important that you be as honest and as accurate as you can be with your answers. It is only if you are 
eligible and interested in participating that I will ask for your name and date of birth. 
 
Are you willing to answer some questions to determine if you are eligible for the study? 
 
Response: If yes, continue with Screening Questions. If no, ask for reasons why: 
 
No interest . . . . . . . . . . . . . . . . . . . . 01 
Worried about anonymity . . . . . . . . 02 
Study takes too long . . . . . . . . . . . . 03 
If other, specify   
 
Afraid of research/guinea-pig . . ... 
04 
Rather not say . . . . . . . . . . . . . . . . . 05 
Other . . . . . . . . . . . . . . . . . . . . . . . . 06 
Thank the participant for their time. 

184 
 
 
 
Page 1 of 5 
Screening Interview 
Text Message Study 
INSTRUCTIONS: This screening interview may be conducted in person or by phone. If eligibility is 
determined by phone, participants must make an appointment to reconfirm their answers to the screening 
questions in person before signing consent. Participant ID numbers will only be assigned (a) after the screening 
questions determine the volunteer to be eligible for this study and (b) after the participant signs the 
assent/consent form. Regardless of whether or not the participant is eligible, record the participant‘s responses 
to all questions. 

185 
 
RECRUITER INITIALS: | 
| 
| 
SCREENING DATE: | 
| 
|--| 
| 
_|--| 
| 
| 
| 
| 
Month 
Day 
Year 
 
1. 
First, how old are you? 
| 
| 
| years (If participant is not 16-35 yrs., check ineligible and continue) 
Ineligible 
2. 
What was sex assigned at birth? 
Male 
Femal
e 
Interse
x 
3. 
How do you self-identify in terms of 
gender? Male 
Female 
Transgender woman  
Transgender man 
Other, Specify ________________ 
 
4. 
Are you of Hispanic (Spanish) or Latino 
origin? Yes 
No 
5. 
How do you describe your race or ethnic 
background? Asian/Pacific Islander 
Black/African American 
Native American/Alaskan 
Native White 
Latino/Hispanic 
Multi-racial 5a) If “Multi-racial,” specify   
 
 
Other 5b) If “Other,” specify   
 
 
6. 
What is your preferred language? 
English 
Spanis
h 
Other language, if “other”, specify   
 (Check ineligible and continue) 
 

186 
 
7. 
Do you have a cell phone that can send and receive text messages? 
Yes 
No (Check ineligible and continue) 
Ineligible 

Page 187 
Eligibility Screening Interview 
Text Message Study 
 
RECRUITER INITIALS: | 
| 
| 
SCREENING DATE: | 
| 
|--| 
| 
_|--| 
| 
| 
| 
| 
Month 
Day 
Year 
 
 
 
8. 
How often would you say you use your cell phone for sending or receiving text messages? 
Never (Check ineligible and continue)
 
Ineligibl
e 1-2 times per week 
3-5 times per 
week Almost 
every day Every 
day 
Several times a day 
 
9. 
Have you ever been told by a doctor or other health care provider that you have HIV 
infection or have AIDS? 
Yes 
No (Check ineligible and go to ineligible script) 
Ineligible 
 
 
10. Have you ever taken antiretroviral medications or HIV 
medications? Yes 
No (Check ineligible and go to ineligible script)) 
Ineligible 
 
 
11. Can you tell me when you started taking antiretroviral medications or HIV medications? 
 
≤ 1 month ago (Check ineligible and 
continue) 
1. 
1 but ≤ 6 months ago 
2. 6 but ≤ 24 months ago 
3. 24 months ago 
Ineligibl
e 
 
 
12. 
Are you currently participating in any other research studies or programs about HIV treatment 
or medication adherence (support for taking your HIV medications)?  
Yes (Check ineligible and go to ineligible script)) 
No 
Ineligible 
 
13. 
I need to know how you are doing with taking your HIV medications. Remember that this is a 
study for people who are having trouble taking their meds. Please answer as honestly as you 
can. 
 
1. 
How many medication doses would you say you missed in the past 7 days? 
doses 
 
 

Page 188 
Eligibility Screening Interview 
Text Message Study 
 
2. 
How many medication doses would you say you missed last month? 
 
If a) is 1 or less AND b) is less than 3, check ineligible 
 
 
Ineligible 
 
 
Questions 14-18 are for the interviewer only. 
DO NOT ASK THESE QUESTIONS OF THE 
PARTICIPANT. 

Page 189 
Eligibility Screening Interview 
Text Message Study 
 
RECRUITER INITIALS: | 
| 
| 
SCREENING DATE: | 
| 
|--| 
| 
_|--| 
| 
| 
| 
| 
Month 
Day 
Year 
 
3. 
Does the volunteer appear to speak and understand English or Spanish? 
Yes 
No (Check ineligible and continue) 
Ineligible 
 
4. 
Does the volunteer appear cognitively functioning and able to understand the 
assent/consent process? 
Yes 
No (Check ineligible and continue) 
Ineligible 
 
5. 
Does the volunteer appear visibly distraught or emotionally unstable (i.e. suicidal, manic, 
exhibiting violent behavior)? 
Yes (Check ineligible and continue)
 
Ineligibl
e No 
 
6. 
Does the volunteer appear intoxicated or under the influence of psychoactive agents? 
Yes (Check ineligible)
 
Ineligible 
No 
 
7. 
Aside from eligibility criteria, does the volunteer appear to be a good fit for the 
project? Yes 
No (Check ineligible and briefly explain below) 
Ineligible 
 
 
 
 
 
SCRIPT FOR INELIGIBLE VOLUNTEERS: 
Participants for this project are selected based on the questions you were just asked. 
Based on your answers, it turns out you’re not eligible to participate. Thank you for taking 
the time to talk with me about our project. 
 
SCRIPT FOR ELIGIBLE VOLUNTEERS: 
Thank you very much for the information you provided. Based on your answers to these 
questions, you are eligible to participate in this project. That means that if you want to 
participate in the text message project, you may. Do you think you might be interested in 
taking part in this project? 
 
Response: If “NO”, thank them for their time. If “YES”: 
 
Before we go any further, I need to get your name and birthdate, then schedule an 
appointment with you. 
INSTRUCTIONS: If any of the above ineligible boxes are checked, read the INELIGIBLE script. If none of 
the ineligible boxes are checked, read the ELIGIBLE script below. 

Page 190 
Eligibility Screening Interview 
Text Message Study 
 
 
 
Participant Name*: 
Date of Birth*: | 
| 
|--| 
| 
|--| 
| 
| 
| 
| 
Month 
Day 
Year 
CONFIRM AGE GIVEN WITH DOB 
*With the completion of this box, this document now contains confidential identifying information and should be securely filed with other 
confidential identifying records for this participant (e.g., Contact Information Sheet, Consent/Assent Form). 

Page 191 
Eligibility Screening Interview 
Text Message Study 
 
RECRUITER INITIALS: | 
| 
| 
SCREENING DATE: | 
| 
|--| 
| 
_|--| 
| 
| 
| 
| 
Month 
Day 
Year 
 
 
 
What’s a good time for you to come in? | | 
|--| 
| 
|at 
: 
AM /PM 
 
And if we miss you at that time, what’s a good way to contact you to 
follow up? Phone: 
 
What’s your cell phone provider?   
 
 
 
Ok to leave a voicemail 
message? 
 
Just as a reminder, we need you to bring your cell phone with you to the visit because if you 
are randomly chosen to receive texts, we will test the text message system with your phone. 
 
Email: 
Ok to email? 
 
 
Entered into screening database 
Screening ID:   
 
Investigator/Designe
Signature 
Print Name 
Date 

192 
 
APPENDIX D Text message tailoring form (Aim 1) 
 
Personalization Tool 
TXTXT Intervention 
[INSERT DIMAGI web address here] 
1. What is the name of your cell phone provider? 
 
 
1. 
AT&T 
2. 
Boost Mobile 
3. 
Cricket 
4. MetroPCS 
5. 
Sprint 
6. 
Tello 
7. 
T-mobile 
8. 
TracFone 
9 - US 
Cellular 10 – 
US Mobile 11 
– Verizon 
12- Virgin 
97 – Other 
 
 
1a.If Other, specify:   
 
 
 
 
 
2. What is your cell phone number?  ------------------  
 
 
 
[NOTE: Counsel Participant to text “STOP” if they want to stop receiving texts, 
“START” to receive them again] 
 
 

193 
 
3. What language do you want to receive text 
messages in? 1- English 
2- Spanish 

194 
 
 
For first medication dose: 
 
 
4. What time would you like to receive the text message reminder to take your medication? 
  
: 
AM/PM 
 
 
4a. What do you want the text message reminder to say? (Limit 160 characters) 
 
 
 
 
 
Note to interviewer: Does chosen text message disclose status? If so, discuss with 
participant and suggest alternate options. 
 
 
4b. Fifteen minutes after you receive the first text, we will send you another text that will 
ask you to respond (via text) once you have taken your medication. What do you want 
this text message to say? 
 
 
 
 
 
+_respond “1:Yes” if you took your medication, “2: No” if you did not 
 
 
 
If a second medication dose: 
Note to interviewer: If only one medication dose, skip to END 
 
 
5. Time : 
AM/PM 
 
 
If a third medication dose: 
Note to interviewer: If only two medication doses, skip to END 
 
 
6. Time : 
AM/PM 

APPENDIX E Encouraging messages (Aim 1) 
 
Encouraging Messages 
The following is a list of encouraging messages to be programmed for automated reply. 
Replies for “Yes” Taken Meds 
1. 
Great job! 
2. 
Way to go! 
3. 
Keep it up! 
4. 
Good work! 
5. 
You rock! 
6. 
Nice! 
7. 
That’s great! 
8. 
Sweet! 
9. 
Woo who! 
10. 
YEAH!! 
11. 
Good work! 
12. 
I’m so glad to hear that! 
13. 
Yay! 
14. 
That’s wonderful! 
15. 
That’s amazing! 
16. 
You’re awesome! 
17. 
That is excellent 
18. 
You should be proud! 
19. 
Fabulouso! 
20. 
That’s fantastic! 
21. 
Super duper 
22. 
You’re a rock star 
23. 
high five! 
24. 
thumbs up! 
25. 
Hurray! 
26. 
Woot! Woot! 
27. 
Spectacular! 
28. 
Splendid 
29. 
You are so magical 
30. 
Tremendous! 
31. 
Marvelous 
32. 
You’re extraordinary 
33. 
YAS! 
34. 
Awesome! 
35. 
Killing it! 
36. 
You got this! 

Replies for “No” Taken Meds 
1. 
You can do it! 
2. 
Go for it, you still have time! 
3. 
Ooops! Now! 
4. 
Uh oh, but you still have time. 
5. 
Come on! You got this! 
6. 
Oh no! You got this, don’t quit! 
7. 
Shoot! Better a little late than never. 
8. 
Shucks, you still have time. 
9. 
You’ve got it, you still have time! 
10. 
Try, try again 
11. 
Just do it! 
12. 
Dang! Now! 
13. 
Drat, you still got this! 
14. 
Bummer! Don’t quit! 
15. 
Fooey, do it now! 
16. 
Blast. Do it now! 
17. 
Aw crud. Better late, than never. 
18. 
Darn! You still have time! 
19. 
Dangit! 
20. 
It is what it is. You got this! 
 
 
Appointment Reminder messages 
 
1. 
You have a visit coming up on [DATE/time] 
2. 
Don’t forget your visit on [DATE/time] 
3. 
See you on [DATE/time] for your visit 
4. 
See ya soon! [DATE/time] 
5. Your scheduled visit is 
[DATE/time] Medication Refill 
reminder 
1. 
Pick up your vitamins [DATE] 
2. 
Thumbs up for pick-up [DATE] 
3. 
Just a reminder to get your things [DATE] 
4. 
You have a pick up [DATE] 
5. 
Package for you [DATE] 

APPENDIX F Measures via CASI (Aim 1) 
 
 
People may miss taking their HIV medications for various reasons. Here is a list of possible reasons why 
you may have missed taking any HIV medication in the past month. 
 
In the past month, how often have you missed taking your medications because you: 
 
 
Please circle only one response for each question 
1 
Never 
Were away from home? 
0 
Rarely 
1 
Sometimes 
2 
Often 
3 
2 
Were busy with other things? 
0 
1 
2 
3 
3 
Simply forgot? 
0 
1 
2 
3 
4 
Had too many pills to take? 
0 
1 
2 
3 
5 
Wanted to avoid the side effects? 
0 
1 
2 
3 
6 
Did not want others to notice you taking medication? 0 
1 
2 
3 
7 
Had a change in daily routine? 
0 
1 
2 
3 
8 
Felt like the drug was toxic/harmful? 
0 
1 
2 
3 
9 
Fell asleep/slept through dose time? 
0 
1 
2 
3 
10 
Felt sick or ill? 
0 
1 
2 
3 
11 
Felt depressed/ overwhelmed? 
0 
1 
2 
3 
12 
Had problem taking pills at specified times 
0 
1 
2 
3 
(with meals, on empty stomach, etc.)? 
13 
Ran out of pills? 
0 
1 
2 
3 
14 
Felt good? 
0 
1 
2 
3 
 
15 
Do you use a pillbox to help you remember to take your medications? □ 1 Yes 
□ 0 No 
 
1. Are there circumstances in your life that make taking your medications on a regular basis more difficult? 
 
1. 1 Yes 
□ 0 No (SKIP to Q18) 
BARRIERS AND FACILITATORS OF ADHERENCE 

1. 
What are the circumstances in your life that make taking your medications 
 
 
2. 
difficult?(Describe in brief) 
 
2. 
Are there circumstances in your life that make taking your medications on a regular 
basis easier? 
1. 1 Yes 
□ 0 No (SKIP to next measure) 
1. 
What are the circumstances in your life that make taking your medications easier? 
  
_ 

199 
 
DEMOGRAPHIC QUESTIONNAIRE 
 
DEM1. What is your date of birth? 
/ 
/ 
[mm/dd/yyyy] 
 
 
DEM2. Which of the following best represents how you think of yourself? 
 
1-Gay (lesbian or gay) 
2 -Straight, this is not gay (or lesbian or 
gay) 3 –Bisexual 
97 -Something else 
       DEM2a. If =97, specify 
 
 
DEM3. What is your sex assigned at birth/biological sex? 
 
1. 
– Male 
2. 
– Female 
97 – Something else 
. DEM3a. If =97, specify: 
 
 
DEM4. How do you describe your gender identity? 
1. 
Male 
2. 
Female 
3. Transgender woman 
4.  4- Transgender man 
1. 
Non binary 
2. 
Gender queer/Gender expansive 
 
97-Something else 
 
DEM4a. If =97, specify: 
 
 
DEM5. Are you Hispanic or Latino/a? 
 
1-   Yes 
0- 
No 
 
DEM5a. (If =1), Are you: Mexican, Mexican American, or Chicano/a; Puerto Rican; Cuban; or another 
category of Spanish/Hispanic/Latino/a that we have not mentioned? 

200 
 
1. 
- Yes, Mexican, Mexican American, Chicano/a 
2. 
-Yes, Puerto Rican, Puerto Rican 
American 3 - Yes, Cuban, Cuban American 
97 – Yes, Other Spanish/Hispanic/Latina 
 
DEM5b. If =97, specify: 
 
 
 
DEM6. What do you consider to be your primary race or ethnic background (check all that apply)? 
 
1. 
– White 
2. 
– Black/African 
American 3 – Asian 
1. 
– American Indian/Alaskan Native 
2. 
– Native Hawaiian or Other Pacific Islander 
DEM7. What is your highest level of education? 
 
1 - Less than 8th grade  
2 -  Completed 8th grade, no high 
school  
1. 
- Some high school (completed some grades 9th-12th, but no diploma or GED) 
2. - High school diploma or GED  
3.  - Trade School Certificate 
1. 
- Some college 
2. - 
Undergraduate 
degree  
3.  - Some graduate school  
4. -Graduate degree 
 
DEM8. Are you currently a student? 
1-Yes 
0-No 
 
DEM9. What was your household income over the past 12 months from all sources before taxes? 
Household income refers to the total amount of money from all people living in the household. 
 
1 - Less than 
$10,000 2 -$10,000 
- $19,999 
3 - $20,000 – $29,999 
4 - $30,000 - $39,999 
5 - $40,000 - $49,999 
6 - $50,000 - $59,999 
7 - $60,000 - $69,999 
8 - $70,000 - $79,999 

201 
 
9 - $80,000 or more 
77- Don’t know  
 
DEM10. 
Including yourself, how many people depend on this income?  
 
DEM11. 
Do your sources of income or support include any of the following? Your sources of 
income may include public assistance and non-traditional jobs. Check all that apply: 
 
1- Traditional job (retail, office, restaurant; paid in regular 
intervals) 2- Day labor (paid by the day, no promise of 
additional work) 
3- Selling or dealing drugs 
1. 
Sex work, survival sex or prostitution 
2. Street income (panhandling, boosting or 
stealing) 5- Unemployment benefits 
6- SSI or 
disability 7- Food 
stamps 
1. 
Income provided by a partner 
2. Income provided by other family 
members 10- Income provided by a 
“sugar daddy” 
1. 
No income 
2. Student 
stipend 13 None of 
the Above 
14 Under-the-table (“off the books,” not reported to the government by the 
employer) 97- Something else 
 
DEM11a. 
If =97, specify:  
 
DEM12. In your lifetime, have you ever been homeless at all? That is, you slept in a shelter for homeless 
people,  on the streets, at a friend or relative’s house for a few nights or weeks, or another place not intended 
for sleeping. 
 
1 – Yes 
0 – No (skip to DEM26) 
 
 
DEM12a. Approximately how many total nights have you not had a regular place to stay during your lifetime? 
  
years and 
nights 
 
 
 
DEM12b. In the past 3 months, were you homeless at any time? 

202 
 
1 – Yes 
0 – No 
 
DEM13. What is your zip code where you currently live? 
 
 
DEM14. Which of the following best describes your current living situation? By current living situation we 
mean where you have been staying during the past seven days. 
 
1. 
Your own place, a room, apartment, or house that is your home 
2. 
Temporarily doubled up with others, in someone else’s house, apartment, or room 
3. 
A temporary or transitional housing program 
4. 
An SRO, that is a “single room occupancy” hotel or motel 
5. 
In a shelter for homeless people 
6. 
In jail, prison, or a halfway house 
7. 
In drug treatment, a detox unit, or drug program housing 
8. 
In a hospital, nursing home, or hospice 
9. 
In an abandoned building, a public place like a bus station, a store or another place not intended for 
sleeping 
10. On the street or anywhere outside such as a park, under a bridge, or in a 
campground 97- Something else 
 
DEM14a. 
If =97, specify: 
 
 
 
DEM15. How long have you lived at your current place (in # of years and # of months)?    
 
 
DEM16. Are you currently involved in a committed relationship with someone who you consider your 
boyfriend/girlfriend, spouse, or domestic partner? 
 
1. 
- Yes 
0- No (skip to END of DEM) 
 
DEM16a. How long have you been in this relationship? (If you are currently involved in more than one 
relationship, select the most significant one). 
 
1. 
- Less than a month 
2. 
- One month to six months 
3. 
- More than six months to a year 

203 
 
4. - More than a year to three 
years 5 - More than three years 

204 
 
HIV Medication Taking Self-efficacy Scale 
Indicate on the following scale how confident you are in the following: 
 
 
1. 
That you can keep a clinic appointment 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
2. 
That you can follow your overall treatment regimen 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
3. 
That you can follow a plan for taking HIV medication 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
4. 
That you can take HIV medication with correct intervals 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
5. 
That you can take the correct dose 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
6. 
That you can take HIV medication at work 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

205 
 
7. 
That you can take HIV medication on a weekday 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
8. 
That you can take HIV medication on a weekend 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
9. 
That you can take HIV medication at social outing 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
10. 
That you can take HIV medication at a party 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
11. 
That you can take HIV medication at a planned event 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
12. 
That you can take HIV medication at an unplanned event 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

13.That you can take HIV medication at travel 
Not 
Confident 
Totally 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
206 
 
 
 
1. 
That you can take HIV medication when you feel well 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
2. 
That you can take HIV medication when you feel ill 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
3. 
That you can take HIV medication when you are having medication side effects 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
4. 
That you can take HIV medication when you are having in a crisis 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Outcome expectancy (OE) 
5. 
That taking HIV medication will improve your health 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

19.That taking HIV medication will improve quality of life 
Not 
Confident 
Totally 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
207 
 
 
 
 
1. 
That taking HIV medication will improve function ability 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
2. 
That taking HIV medication will allow for a long life 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
3. 
That taking HIV medication will allow you to lead a near normal life 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
4. 
That taking HIV medication will decrease HIV related symptoms 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
5. 
That taking HIV medication will decrease viral load 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

208 
 
6. 
That taking HIV medication will increase T-cell count 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
7. 
That taking HIV medication will prevent hospitalization 
 
 
Not 
Totally 
Confident 
Confident 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

209 
 
 
HIV Medication Adherence 
 This questionnaire asks you how often you take your HIV medication. Some people get busy and forget 
to take their HIV medications or forget to carry their medications with them. Other times people find it hard 
to take their medications like their doctor told them to, such as “with food” or “on an empty stomach.” 
Other people decide to skip medications to avoid side effects (like feeling sick to your stomach) or to just 
not take their medications that day. It’s important for us to understand what people with HIV are really 
doing with their medications. For these questions, please report what you are actually doing. Don’t worry 
about it if you don’t take all of your medicine. We want to know what is really happening, not what you 
think we “want to hear.” 
 
 
1. 
Do any of your HIV medications have special instructions, such as “take with food” or “on an empty 
stomach” 
or “with plenty of fluids?” 
 
□ 1 Yes 
□ 2 No 
(If NO, skip to question #2) 
 
1. 
IF YES, how often did you follow those special instructions over the last four days? 
 
Never 
Some of 
the time 
About half 
of the time 
Most of 
the time 
All of 
the time 
□ 0 
□ 1 
□ 2 
□ 3 
□ 4 
 
 
 
2. 
Some people find that they forget to take their pills on the weekend days. Did you miss any of your HIV
 
medications last weekend—last Friday, Saturday or Sunday? 
 
□ 1 Yes 
□ 2 No 
 
3. 
During the past 4 days, on how many days have you missed taking all doses of your HIV 
medications? 
 
1. 
none 
2. 
one day 
3. 
two days 
4. 
three days 
5. 
four days 

210 
 
Now I’m going to ask you about the last 30 days. For all of your current HIV medications, what 
percent time (%) from 0 to 100 did you take your medication as prescribed in the last 30 days? 
 
0% time would mean, “NONE of the time,” 50% time would mean HALF of the time and 100% would 
mean ALL of the time. Numbers in-between would mean amounts between NONE and ALL of the 
time. 
 
6. 
Please put an “X” on the line below at the point showing your best guess about how much you have taken 
these drugs in the last 30 days. [display VAS SCALE GRAPHIC]. 
 
 
NONE 
ALL 
 
 

 
Treatment acceptability measure 
Adapted from: https://link.springer.com/content/pdf/10.1007/bf00960091.pdf 
 
 
 
How effective do you think this program (TXTXT) is 
might be? 
1= very ineffective 
2 
3 
4 
5 
6 
7= very effective 
How acceptable do you find the program (TXTXT) to 
be? 
1= very unacceptable 
2 
3 
4 
5 
6 
7= very acceptable 
How likely do you think it is that this program 
(TXTXT) will have negative impact? 
1= very unlikely 
2 
3 
4 
5 
6 
7= very likely 

212 
 
TXTXT Acceptability Survey 
 
1. 
Did you receive text message reminders on the days and times you requested 
them? 
 
1- Yes 
2- No 
 
 
2. 
How often did you read the text messages? 
 
4- Always 
3- Often 
2- Sometimes 
1- Never 
 
 
3. 
How often did you find the text messages intrusive or bothersome? 
 
4- Always 
3- Often 
2- Sometimes 
1- Never 
 
 
4. 
Did anyone find out you were HIV+ because you received the text messages? 
 
1- Yes 
2- No 
 
 
5. 
How often did you respond “yes” to the text indicating you took your 
medication, when you really didn’t take them? 
 
4- Always 
3- Often 
2- Sometimes 
1- Never 
 
The goal of the TXTXT intervention is to support daily medication adherence and ultimately 
improve viral suppression. 
 
6. 
Thinking about your experience with the TXTXT intervention, what worked best? 
What would you like to see changed? 
 
 
7. 
Do you have any other suggestions for improving the TXTXT intervention? 
 
 

213 
 
 
Client Satisfaction Questionnaire (CSQ-8) 
 
Please help us improve the text messaging intervention by answering some questions 
about your experiences. We are interested in your honest opinion, whether they are 
positive or negative. Please answer all of the questions. 
 
1. 
How would you rate the quality of your experience with the text message reminders? 
 
4 
3 
2 
1 
Excellen
t 
Goo
d 
Fair 
Poo
r 
 
2. Did you get the kind of text message reminder experience that you wanted? 
 
4 
3 
2 
1 
No, definitely 
not 
No, not 
really 
Yes, 
generally 
Yes, 
definitely 
 
3. To what extent have the text messaging reminders met your needs? 
 
4 
3 
2 
1 
Almost all of my 
needs have been 
met 
Most of my needs 
have been met 
Only a few of my 
needs have been 
met 
None of my needs 
have been met 
 
4. If a friend were in need of similar help taking their medication, would you 
recommend the text reminder intervention to him or her? 
 
4 
3 
2 
1 
No, definitely 
not 
No, not 
really 
Yes, 
generally 
Yes, 
definitely 
 
5. How satisfied are you with the amount of help you have received with the reminders? 
 
4 
3 
2 
1 
Quite 
dissatisfied 
Indifferent or 
mildly 
dissatisfied 
Mostly 
satisfied 
Very 
satisfied 
 
6. Have the text messaging reminders helped you to take your medication? 
 
4 
3 
2 
1 

214 
 
Yes, they helped a 
great deal 
Yes, they 
helped 
somewhat 
No, they really didn’t 
help 
No, they seemed to 
make things 
worse 

215 
 
7. In an overall, general sense, how satisfied are you with the text message 
reminder intervention? 
 
4 
3 
2 
1 
Very 
satisfied 
Mostly 
satisfied 
Indifferent or 
mildly 
dissatisfied 
Quite 
dissatisfied 
 
8. If you were to seek help again, would you want to receive the text 
message reminders? 
 
4 
3 
2 
1 
No, definitely 
not 
No, not 
really 
Yes, 
generally 
Yes, 
definitely 

1. 
likert scale: Not at all, slightly, somewhat, mostly, very 
Intervention Utility Questionnaire; modified from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2954428/#!po=76.6667 
1. To what extent did you find the TXTXT intervention easy to use? 
2. To what extent did you find the TXTXT intervention convenient to use? 
3. To what extent did you find the TXTXT intervention understandable? 
4. To what extent did you find the TXTXT intervention useful? 
5. To what extent did you find the TXTXT intervention enjoyable? 
6. To what extent did you find the TXTXT intervention consistent with other adherence strategies? 
7. To what extent did you find the TXTXT intervention suitable for helping you remember 
to take your medication? 
8. To what extent did you find the TXTXT intervention generally effective? 
9. To what extent did you find the TXTXT intervention effective as a long term 
support for adherence? 

217 
APPENDIX G Fidelity Checklist (Aim 1) 
 
  
FIDELITY CHECKLIST 
 
PARTICIPANT NAME: 
INTERVIEWER INITIALS: | 
| 
| 
 
VISIT DATE: | 
| 
|--| 
| 
|--| 
| 
| 
| 
| 
VISIT TYPE (CIRCLE): Initial | 3M | 6M 
 
Month 
Day 
Year 
1. Completed study assessment? 
□ Yes 
□ No 
1. Completed adherence counseling (initial visit only)? 
□ Yes 
□ No 
□ N/A 
1. Completed personalization form (or updated at FU)? 
□ Yes 
□ No 
1. Next appointment scheduled (initial, 3M only)? 
□ Yes 
□ No 
□ N/A 
o Date 
/ 
/ 
Time 
: 
am/pm 
1. Updated contact information? 
□ Yes 
□ No 
□ N/A 
 
 
Comments: 
 
 
 
 

218 
 
   APPENDIX H Recruitment script: Aim 2 TXTXT participants ages 16-35 years (Aim 2)  
 
 
Hi, My name is (name) and I’m one of the staff members working on the Midwest Treatment Text (TXTXT) project, 
which is being conducted in partnership with MATEC and Lurie Children’s Hospital of Chicago. Thank you so much for 
your participation in this important project. I’m reaching out today to see if you are interested in taking part in a short interview to tell 
me more about your experiences with the TXTXT program. The interview will take about 30 minutes and you will receive a 
$40 incentive for your participation.  Are you interested in hearing more about it? 
Response: If yes, continue. If no, thank them for their time and discontinue. 
Thanks for your interest in our project. As I just said, the purpose of this interview is to hear more about your 
experience with daily text message reminders. I will ask you a series of questions, and I’ll want to hear about both the good 
things about the program and things that you might suggest we do differently. Your feedback will help us improve the program 
for the future. Do you have any questions? 

219 
 
 
 
 
APPENDIX I Recruitment script: Aim 2 TXTXT clinic staff ages 18+ (Aim 2)  
 
Hi, My name is (name) and I’m one of the staff members working on the Midwest Treatment Text (TXTXT) project, 
which is being conducted in partnership with MATEC and Lurie Children’s Hospital of Chicago. Thank you so much for 
your participation in this important project. I’m reaching out today to see if you are interested in taking part in a short interview to tell 
me more about your experiences with the TXTXT program. The interview will take about 60 minutes.  Are you interested 
in hearing more about it? 
Response: If yes, continue. If no, thank them for their time and discontinue. 
Thanks for your interest in our project. As I just said, the purpose of this interview is to hear more about your 
experience with the TXTXT intervention. I will ask you a series of questions, and I’ll want to hear about both the good things 
about the program and things that you might suggest we do differently. Your feedback will help us improve the program for the 
future. Do you have any questions? 
 

220 
 
 
APPENDIX J Semi-structured Interview Guide (Aim 2) 
 
 
MIDWEST TXTXT 
Semi-structured Interview Guide for Clinic staff 
Interview Date:  / 
/ 
   
Start Time: : AM/PM 
Site: 
 
  
 
   
Interviewer Initials:   
   
INTRODUCTION AND PURPOSE OF THE INTERVIEW 
Thank you for your participation in this interview. This interview is being audio recorded only 
(not video recorded). The interview is confidential so I’m not going to ask your name and I ask 
that you not identify anyone else by name, if you can avoid it. If you do identify individuals, do 
not worry, when this interview is transcribed, we will remove all references to individuals. 
I’m going to go through a set of questions that asks you about the Midwest TXTXT program, 
including your experiences with the way the program was set-up and how it worked, as well 
of the internal and external factors that may have influenced implementation at your clinic 
location. Any questions so far? 
OK, let’s begin… 
Section A: General Questions 
Before we begin our conversation, I have a few quick questions about you. 

 
 
 
 
 
 
 
 
 
 
Executive 
 
 
 
 
 
 
 
 
 
 
 
 
 
□ 
Asian 
 
 
 
Other: 
year
s 
year
s 
year
s 
year
s 

 
 
 
 
Section B: Questions about the TXTXT Program: 
 
 
Intervention Characteristics 
B1. [Evidence and Strength] What was your impression of how effective TXTXT would be before it was 
implemented? 
Probe: What were your feelings or impressions about the promise of the 
intervention to promote adherence? 
Probe. What do influential stakeholders think of the intervention? 
influential stakeholders may include well-respected/senior clinicians, administrative leaders, etc. 
B2. [Relative Advantage] How does TXTXT compare to other ART adherence 
interventions in your setting? 
B3. [Relative Advantage] Is there another intervention that you would rather implement? If so, what 
intervention? Talk me through why you would rather implement this intervention opposed to TXTXT. 
B4. [Adaptability] Did you make any adaptations in how you implemented the TXTXT in 
comparison to how you were trained to implement it? 
Probe: If you made adaptations, how successful were they? 
Probe: Were there adaptations that you wanted to make but couldn’t? 
B5. How complicated is the intervention to implement? 
Probe: Duration (length), scope, radicalness/differentness, centrality to mission, intricacy 
and number of steps required to implement, special knowledge? 
B6. What is your impression of the training materials and supporting materials? 
Probe: Did you consult the training materials when you had a question? Why or 
why not? Probe: Did you need other resources that you didn’t have? 
B7. What were the costs associated with implementing the intervention? 
Probe: What are your impressions of the costs? Reasonable, not reasonable? 

 
Outer Setting 
B8. [Patient Needs, Resources]: How well do you think the intervention meets the needs of the program 
participants? 
Probe: How important is medication adherence support in comparison to other needs 
they have? 
B9. [Patient Needs, Resources]: What barriers did the participants have to receipt of the 
intervention, if any? 
B10. [Patient Needs, Resources]: Have you heard stories from individuals about their 
experiences with the intervention? If so, what did they say? 
B11. [Cosmopolitanism]: What kind of information exchange do you have with others outside of 
your clinic related to the intervention? 
Probe: What type of information is exchanged? 
Probe: Does the organization encourage you to network with others? 
 
 
B12. [Peer Pressure]: Can you tell me what you know about other organizations that have 
implemented similar programs? 
Probe: Does implementing this intervention provide an advantage to your organization 
over others? 
 
 
B13. [External Policies & Incentives]: What kind of local, state or national guidelines or expectations 
influenced your decision to implement this intervention? 
 
 
Inner Setting 
B14. [Structural Characteristics]: How did the infrastructure of your organization impact the 
implementation (social architecture, size, # years serving the community, physical layout]? 
Probe: Are changes needed to better accommodate the intervention? 
 
 
B15. [Networks & Communications]: Were meetings about the intervention 
implementation held regularly? If so, with what frequency. If not, why not? 
B16. [Networks & Communications]: When new information like staff departures occur, how do 
you find out? 
 

 
 
B17. [Networks & Communications]: When you need to solve a problem, who are the go-to people? 

225 
 
 
B18. [Culture]: How would you describe the culture of your organization? 
Probe: Do you think the organization’s culture impacted the implementation of 
the intervention? 
 
 
B19. [Culture]: To what extent are new ideas embraced to make improvements at your organization? 
B20. [Implementation Climate]: What was the general receptivity in your organization to 
implementing the intervention? 
Probe: Was there a strong need for the intervention? How essential is 
it? Probe: How well does it fit? 
Probe: Was it well integrated? 
Probe: Did it complement current programs? 
B21. [Implementation Climate]: Was the intervention implementation a priority for the organization? 
Probe: How did you juggle competing priorities in your work on this project? 
B22. [Implementation Climate]: Were there any incentives to implement this intervention (will 
your role be recognized)? 
 
 
B23. [Implementation Climate]: Were there goals set for implementation of this initiative? 
Probe: Were the goals monitored for progress? 
 
 
B24. [Implementation Climate]: If you saw a problem with implementation what did you do? 
Probe: What was the reaction to this problem? 
 
 
B25. How supportive was leadership of this initiative? 
Probe: What support did you receive to make it 
successful? B26. Were there sufficient resources to implement 
the intervention? 
Probe: Technical assistance? 
 

226 
 
 
B27. Was the level of training adequate? 
Probe: When you had questions about implementation, who did you ask? 

MIDWEST TXTXT Semi-Structured Interview Guide, Version 
227 
 
Probe: What was the relationship with MATEC like? Describe the level of training, support, 
communication you received from MATEC. 
Characteristics of Individuals 
 
 
B28. [Knowledge and Beliefs] Do you think the intervention was effective? 
B29. [Confidence] How confident are you that you successfully implemented the intervention? 
 
 
B30. [Stage of Change]: How well prepared were you to implement the intervention? 
B31. [Individual Identification with the Organization]: How much do you identify with the mission of the 
organization? 
Probe: Does that impact your commitment to the organization and/or this initiative? 
 
 
B32. [Other Personal Attributes]: Are there any personal traits that you have that helped 
with implementation of this initiative? For you or others? 
Probe: Are there skills that were needed on the team but you didn’t have? 
 
 
 
 
Process 
B33. [Planning]: Was there a clear plan articulated to you to implement this initiative? 
 
 
B34.[Engaging]: Was there a formal project manager or coordinator appointed to run the intervention? 
 
 
B35. [Engaging]: Were there people outside the agency that were supposed to help to 
implement it? Did that work as planned? 
 
 
B36. [Engaging] How did you communicate to individuals that might be eligible for the 
intervention? Did that work as planned? 
 
 
B37. [Executing]: Was the intervention implemented as planned? Why or Why not? 

MIDWEST TXTXT Semi-Structured Interview Guide, Version 
228 
 
Section E: Closing 
 
Is there anything else you think is important for me to know to understand how the Midwest 
TXTXT program is working for young people living with HIV? 
 
 
Thank you for your time. 
 
Turn off recorder. 
 
END TIME: : AM/PM 

MIDWEST TXTXT Semi-Structured Interview Guide, Version 
229 
 
 
 
Interview Date:     / / 
  
Start Time:    : 
AM/PM 
Site: 
 
 
  
Interviewer Initials:   
 
 
 
MIDWEST TXTXT 
Semi-structured Interview Guide-TXTXT PARTICIPANT 
Semi-structured Interview Guide (Aim 2) 
 
INTRODUCTION AND PURPOSE OF THE INTERVIEW 
Thank you for your participation in this interview. This interview is being audio recorded only (not video 
recorded). The interview is confidential so I’m not going to ask your name and I ask that you not identify 
anyone else by name, if you can avoid it. If you do identify individuals, do not worry, when this interview is 
transcribed, we will remove all references to individuals. 
I’m going to go through a set of questions that asks you about the Midwest TXTXT program, including your 
experiences with the way the program was set-up and how it worked. Any questions so far? 
OK, let’s begin… 
Questions about the TXTXT Program: 
Intervention Characteristics 
1. [Evidence and Strength] What was your impression of how effective TXTXT would be when you first heard 
about it? Probe: What were your feelings or impressions about the promise of the intervention to 
promote adherence? 
2. 
[Relative Advantage] In your opinion, should [clinic name] continue to make offering TXTXT a priority? 
3. [complexity] What did you find most complex in participating in the TXTXT 
intervention? Outer Setting 
4. 
[Patient Needs, Resources]: Tell me about your experiences with TXTXT. 
5. [Patient Needs, Resources]: What barriers did you face in participating in TXTXT, 
if any? Inner Setting 
1. 
[Structural Characteristics]: What types of changes should we make to how 
we conduct TXTXT? Characteristics of Individuals 
2. 
[Knowledge and Beliefs] Do you think the intervention was effective? 
3. 
[Stage of Change]: Have you recommended TXTXT to others? Why or why not? 
4. 
[Knowledge and Beliefs] What value or benefit did you receive from 
participating in the TXTXT? Process 
5. 
[adaptability] In what settings might TXTXT work best? How should we offer TXTXT to patients? Who should offer 
it? 
 
Closing 
 
Is there anything else you think is important for me to know to understand how the Midwest TXTXT program is 
working for young people living with HIV? 
 
 
Thank you for your time. 
 
Turn off recorder. 
 

MIDWEST TXTXT Semi-Structured Interview Guide, Version 
230 
 
END TIME:    : 
AM/PM 

    APPENDIX K (Aim 2): Standard of care questionnaire  
Standard of care questionnaire 
Clinic name: 
Date: 
 
This set of questions is designed to document the current standard of HIV care and adherence supports for youth and young adults 
living with HIV at your site. We are interested in learning more about your clinic’s HIV care services, the staff involved, programmatic 
supports, challenges and facilitators for retention in care.  
 
1. Describe the clinic’s standard of care for HIV care (probe: define, staff involved, barriers/facilitators, changes 
implemented, how this compares with other clinics in the area) 
 
 
 
2. Describe linkage to HIV care for youth and young adults. (probe: define, staff involved, barriers/facilitators, 
changes implemented, how this compares with other clinics in the area) 
 
 
 
3. Describe retention in HIV care for youth and young adults. (probe: define, staff involved, barriers/facilitators, 
changes implemented, how this compares with other clinics in the area) 
 
 
 
4. Describe current adherence supports for youth and young adults living with HIV. (probe: define, staff involved, 
barriers/facilitators, changes implemented, how this compares with other clinics in the area) 
 
 
 
5. Describe the demographics of the youth and young adults who receive HIV care services at your agency. Are there 
any trends in retention in care or adherence among subgroups of youth and young adults? (if yes, probe more 
details) 
6. Does the clinic offer any of the following as a part of HIV care (or to support retention in care): 
1. 
Transportation assistance   
2. 
Childcare 
3. 
Food assistance 
4. 
Housing assistance 
5. 
Legal assistance 
6. 
Benefits navigation 
7. 
Stipend or monetary incentive 
8. 
Any other supports not mentioned? List other: 

232 
APPENDIX L Informed Consent Forms 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
233 
 
 
 
 
Adult Consent to Take Part in a Research Study 
Aim 1: Participants aged 18-35 years 
 
Study Name: Midwest TXTXT 
Sponsored by: U.S Centers for Disease Control and Prevention U01PS005214 
Name of Study Doctor/Researcher: Amy K Johnson, PhD 
 
This consent form describes a research study for which you might qualify being conducted by a researcher at Ann 
& Robert H. Lurie Children's Hospital of Chicago (“Lurie Children’s”), the Midwest AIDS Training and Education 
Center (MATEC), and [local clinic name].  
 
In this study we are interested in learning about how receiving daily text message reminders to take HIV 
medication might impact viral suppression and retention in HIV care.  
 
Research studies help us learn more about conditions and develop new treatments. Taking part in a research study 
is voluntary. It is your choice to take part in this research study. Please read this consent form and ask questions 
about anything you do not understand. You may talk to others such as your  family or healthcare providers before 
you decide to take part in this study. The study staff will also explain the study  to you and answer any questions 
that you may have. Your decision will not affect your regular care. 
 
What are the purpose and goals of this study? 
The main purpose of this research study is to determine how well text messaging (Short Message Service 
- SMS) works to improve of the rate of HIV in the blood (viral load) of young persons receiving HIV 
treatment at [Insert site name]. The study will also evaluate whether the text messaging works to 
improve how well young persons  take their HIV medications (called adherence) and remain under the 
care of their medical providers (called retention in care), and whether young persons accept and are 
satisfied with the program being tested. 
 
We are asking you to be in this research study because we want to learn more about ways to support young 
people adhering to  HIV medications and remaining in HIV care. 
 
If I agree to take part in this study, what would I need to do? 
 
There will be a total of up to 600 participants in this study at different sites throughout the United States. Up to 
50 participants will be included at [Insert Site Name]. You will be in this study for 12 months and complete 3 
computer assisted surveys during this time. 
 
At each time point (baseline, 3 months, 6 months), we will collect information from you in a computer 
questionnaire  format on your HIV treatment knowledge, adherence to medication, and satisfaction the text 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
234 
 
messaging program. This questionnaire will take about 15 minutes to complete. You will be able to complete the 
surveys at 3 months and 6 months online from home or you could come in to the [local clinic name] to complete 
the survey on a computer. 
 
During the study, we will also look at your medical records to collect information about the dates when you pick-
up your HIV medication from the pharmacy, the dates of your clinic visits, and the results of viral load and other 
monitoring tests that the clinic has performed on you. This will help us to see how the study worked over time. 
We will keep your name and other identifying information confidential. 
 
In addition to these things, your site will be randomly assigned to begin the study intervention. The timing for 
when this happens is chosen at random, like the flip of a coin. When this happens, you may receive the 
intervention right away for at least 6 months or will start about 3 months from now and receive the intervention 
for at least 3 months. Once you begin the intervention, you will receive daily- automated text messages at the 
usual time you take your medication to remind you to use them. You will be involved in the development of the 
messages that you will receive to remind you to take your medication, and these messages will be personal to you 
and based on the choices you make. The content of the reminders will be such that people around will not 
understand the message you have received. Only you will understand. This is to protect your privacy. You will be 
expected to acknowledge receiving the message and indicate whether you have taken your medication with a YES 
or NO. In response to this acknowledgment, you will receive an encouraging follow- up message. 
 
What are the risks, side effects, or discomforts related to the study? 
You may find some of the survey questions difficult to answer or you may not want to answer them. You may skip 
any question that you do not want to answer. During this study, you will be informed about anything that may 
affect your continued participation or your health. 
 
What are the benefits from this study? 
The information learned may help researchers learn more about designing programs and support for young people 
living with HIV to support medication adherence. You may or may not benefit from receiving the text messages to 
support HIV medication adherence. This information learned from this study may help others in the future. 
 
What other options do I have? 
You do not have to be in this study if you don’t want to. Your doctors at [Insert Site Name] will not be upset with 
you. If you join the study and then change your mind, it is okay for you to leave this study at any time. 
 
What if the researcher or I do not think I should stay in the study? 
You can stop taking part in this study at any time. Your decision will not affect your regular care. 
 
Returning Study Results: 
The study team will not return study results to you. You can ask the study team any questions you have about study 
results. 
 
Important New Information: 
We will tell you if we learn new information that may make you change your mind about being in this study. 
 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
235 
 
Will my information be used in future research studies? 
The study team may share your information for future research. They will remove identifiers such as your name 
and other information that can be linked to you before this is done. The study team and other researchers may 
use this for other studies without getting consent from you. 
 
Costs Related to this Study:  
 
The study requires use of an existing cell phone with text messaging capabilities, you will not incur any costs beyond 
your existing cell phone plan. The study sponsor will not pay for your cell phone or cell phone plan. 
 
Payment for Taking Part in this Study: 
 
You will not be paid for taking part in this study. 
 
Your Rights When Taking Part in this Study: 
 
If you agree to take part in this study, you are not giving up any of your legal rights. You can stop participating in 
this study at any time. Your choice will not affect your regular care. 
 
Additional Information: 
Who can answer my questions about this study? 
You can ask Amy K Johnson (akjohnson@luriechildrens.org; 312 227 7733) or the clinic staff at [Insert Site Name] 
anything about the study or if you feel you have been harmed. If you are not happy with this study and want to talk 
with someone else or want to talk about your rights as a participant, not the study doctor or the people working 
with the study doctor, you may contact the IRB Office by telephone at (312) 503-7110 or by email at 
IRB@luriechildrens.org. 
 
You will be given a copy of this consent form. 
 
Certificate of Confidentiality  
 
This research project has a Certificate of Confidentiality from the Centers for Disease Control and Prevention (CDC). 
Unless you say it is okay, researchers cannot release information that may identify you for a legal action, a lawsuit, 
or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, 
legislative, or other proceedings. As an example, the Certificate would protect your information from a court 
subpoena. There are some important things that you need to know. The Certificate DOES NOT protect your 
information if a federal, state, or local law says it must be reported. For example, some laws require reporting of 
abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT BE USED to stop 
a federal or state government agency from checking records or evaluating programs. 
The Certificate DOES NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The 
Certificate also DOES NOT stop your information from being used for other research if allowed by federal 
regulations. 
 
Researchers may release your information when you say it is okay. For example, you may give them permission to 
release information to insurers, your doctors, or any other person not connected with the research. The Certificate 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
236 
 
of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting 
copies of your own information. 
 
Planned Sharing of Your Information: 
 
For this study, the [local clinic name] will share information from your medical records, including your most recent 
viral load, CD-4 count, and date of HIV services with the study team at Lurie Children’s Hospital. Federal and state 
laws do not allow sharing of sensitive health records without your permission. 
 
If you agree to take part in this study, you also give permission for the use and sharing of your de-identified 
information from which we removed any information that may identify you like your name and birthdate 
(“deidentified”) with persons outside of this study. This permission lasts until the study is completed.  
 
The study staff, employees, and Medical Staff of Lurie Children’s, the Midwest AIDS Training and Education 
Center (MATEC), and [local clinic name] may use your information for this study and share it, as required for 
auditing purposes, with: 
 
1. 
The Institutional Review Board (the committee that is in charge of protecting the rights of all adults and 
children who take part in research studies). 
2. 
The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other 
government offices. 
 
These are the only people to which we will give your information. We cannot guarantee that those listed above will 
not share it with others without your permission. 
Your name will not be included in any written or verbal reports of study results. 
 
What if I decide not to give permission to use and give out my information? 
If you decide not to allow the release your information, you will not be able to take part in this study. If you give 
permission to the use of your information, you can withdraw it at any time. Your request should be submitted 
directly to the researcher using either the email or phone number (akjohnson@luriechildrens.org; 312 227 
7733). The study team can still use any information collected before you tell them to stop. 
 
Can I review or copy my information? 
You cannot see your study records while the study is ongoing. You still have a right to request a copy of 
your medical record and tests related to regular medical care that is given during the same time as the 
study. 
 
Signatures: 
Participant/LAR Signature: 
By signing this form, I affirm: 
1. I have read this form. 
2. The research has been explained to me. 
3. All of my questions have been answered. I consent to take part in this research study. 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
237 
 
Signature of Participant or Legally Authorized Representative (LAR): 
Date: 
Printed Full Name: 
 
Signature of Authorized Person Obtaining Consent/Witness*: 
I certify that I have explained the above to the participant/LAR and the signature was 
obtained voluntarily. 
Signature: 
Date: 
Printed Full Name: 
*If the study includes the use of records related to mental health or developmental disabilities, the person 
obtaining consent also serves as the witness to consent for use of relevant records. 
 
Signature of Interpreter/Witness*: 
Not applicable, no interpreter used. 
I attest that the study information has been presented to the participant/LAR in their native 
language. 
Signature of Interpreter/Witness: 
Printed Full Name or Unique Phone ID/Company Name: 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
238 
 
Note to Investigators: When obtaining consent from a non-English speaking participant/ LAR 
When a study-specific translated consent document is not available, a translated “short form” (available in several 
languages on the IRB website) may be used, in combination with a verbal presentation of study information (as 
outlined in this English consent) with the aid of an interpreter. 
1. 
The consent process must be witnessed by an individual who is fluent in both English and the language 
understandable to the subject. The interpreter may serve as the witness and should sign both the English 
consent document and short form. 
2. 
The participant/LAR should sign the short form (in the language they understand). 
3. 
The investigator and/or study staff authorized by the IRB to obtain consent must sign the approved English version 
of the consent form. 
4. 
A copy of both the IRB-approved English consent form (i.e., the summary) and the translated version of the short 
form must be given to the participant/LAR. 
 
 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
239 
 
 
Adolescent Agreement to Take Part in a Research Study 
Aim 1: Adolescent assent for aged 16-17 years 
 
Study Name: Midwest TXTXT 
Sponsored by: U.S Centers for Disease Control and Prevention U01PS005214 
Name of Study Doctor/Researcher: Amy K Johnson, PhD 
 
We want to tell you about a research study at Lurie Children’s, the Midwest AIDS Training and 
Education Center (MATEC), and [local clinic name].  
 
In this study we are interested in learning about how receiving daily text message reminders to take HIV 
medication might impact viral suppression and retention in HIV care.  
 
Research studies help us find better ways to take care of and treat children and young adults. 
Taking part in a research study is voluntary. It is your choice to take part in this research study. 
 
Why is this study being done? 
The main purpose of this study is to determine how well text messaging (Short Message Service - 
SMS) works to improve of the rate of HIV in the blood (viral load) of young persons receiving HIV 
treatment  at [Insert site name]. The study will also evaluate whether the text messaging works to 
improve how well young persons take their HIV medications (called adherence) and remain under 
the care of their medical providers (called retention in care), and whether young persons accept 
and are satisfied with the program being tested. 
 
We are asking you to be in this research study because we want to learn more about ways to 
support young people adhering to HIV medications and remaining in HIV care. 
 
What will happen in this study? 
There will be a total of up to 600 participants in this study at different sites throughout the United 
States. Up to 50 participants will be included at [Insert Site Name]. You will be in this study for 12 
months and complete 3 computer assisted surveys during this time. 
 
At each time point (baseline, 3 months, 6 months), we will collect information from you in a 
questionnaire format on your HIV treatment knowledge, adherence to medication, and satisfaction 
the text messaging program. This questionnaire will take about 15 minutes to complete. 
 
During the study, we will also look at your medical records to collect information about the dates 
when you pick-up your HIV medication from the pharmacy, the dates of your clinic visits, and the 
results of viral load and other monitoring tests that the clinic has performed on you. This will help us 
to see how the study worked over time. We will keep your name and other identifying information 
confidential. 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
240 
 
 
In addition to these things, your site will be randomly assigned to begin the study intervention. The 
timing for when this happens is chosen at random, like the flip of a coin. When this happens, you will 
receive the intervention for at least 3 months and up to 6 months. Once you begin the intervention, 
you will receive daily automated text messages at the usual time you take your medication to remind 
you to use them. You will be involved in the development of the messages that you will receive to 
remind you to take your medication, and these messages will be personal to you and based on the 
choices you make. The content of the reminders will be such that people around will not understand 
the message you have received. Only you will understand. This is to protect your privacy. You will 
be expected to acknowledge receiving the message and indicate whether you have taken your 
medication with a YES or NO. In response to this acknowledgment, you will receive an encouraging 
follow-up message. If your clinic site is randomized to the observation, that is randomly assigned to 
start the intervention at the 3-month timepoint, you will not receive text messages but will receive 
the standard of care at the clinic you are enrolled at. At the 3-month time point, you will be enrolled 
into the text messaging reminder intervention.  
 
What are the bad or harmful things that could happen in this study? 
You may find some of the questions difficult to answer or you may not want to answer them. You 
may skip any question that you do not want to answer. During this study, you will be informed about 
anything that may affect your continued participation or your health. 
 
What are the good things that could happen in this study? 
You may or may not have any benefit from being in the study. It is possible that you will get 
better, stay the same, or get worse. If the study helps you, we do not know how long this will 
last. We hope to learn something that could help other children in the future. During your 
participation in this study, you may enjoy receiving text message reminders for medication and 
clinic appointment adherence. 
 
What other options are there? 
You do not have to be in this study if you don’t want to. Your doctors at [Insert Site Name] will 
not be upset with you. If you join the study and then change your mind, it is okay for you to 
leave this study at any time. 
 
Who will see your information? 
We will do everything we can to make sure that your medical records are kept confidential.  
 
For this study, the [local clinic name] will share information from your medical records, including your 
most recent viral load, CD-4 count, and date of HIV services with the study team at Lurie Children’s 
Hospital. 
 
Federal and state laws do not allow sharing of sensitive health records without your permission. 
 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
241 
 
If you agree to take part in this study, you also give permission for the use and sharing of your de-
identified  information from which we removed any information that might identify you like your name 
and birthdate (“deidentified”) with persons outside of this study. This permission lasts until the study is 
completed.  
The study staff, employees, and Medical Staff of Lurie Children’s and [Insert Site Name] may use 
your information for this study and share it with: 
1. 
The Institutional Review Board (the committee that is in charge of protecting the rights of all adults 
and children who take part in research studies). 
2. 
The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other 
government offices. 
3. 
Other Researchers who request access to the de-identified data for research purposes.  
These are the only people to which we will give your information. We cannot guarantee that 
those listed above will not share it with others without your permission. 
 
Your name will not be included in any written or verbal reports of study results. 
 
To protect the information that you will give us, we will assign you a unique participant identification 
number (PID) at study enrolment. Your PID will be used by you throughout the period of your 
participation in this study. We will ensure the privacy of your information by keeping it in a secured 
place and by protecting them with the password. 
 
In order to send you text messages, your phone number (but not your name or other information) 
will be entered into a website owned by Dimagi, Inc. This company has policies in place to protect 
your privacy and will not to give your phone number out to anyone else. 
 
Certificate of Confidentiality 
 
This research project has a Certificate of Confidentiality from the Centers for Disease Control and 
Prevention (CDC). Unless you say it is okay, researchers cannot release information that may 
identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an 
example, the Certificate would protect your information from a court subpoena. There are some 
important things that you need to know. The Certificate DOES NOT protect your information if a 
federal, state, or local law says it must be reported. For example, some laws require reporting of 
abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT 
BE USED to stop a federal or state government agency from checking records or evaluating 
programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug 
Administration (FDA). The Certificate also DOES NOT stop your information from being used for 
other research if allowed by federal regulations. 
 
Researchers may release your information when you say it is okay. For example, you may give 
them permission to release information to insurers, your doctors, or any other person not 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
242 
 
connected with the research. The Certificate of Confidentiality does not stop you from releasing 
your own information. It also does not stop you from getting copies of your own information. 
 
Will there be payment or gifts for being in this study? 
You will not be paid for taking part in this study. 
 
What if I decide not to give permission to use and give out my information? 
If you decide not to allow the release your information, you will not be able to take part in this study. 
If you give permission to the use of your information, you can withdraw it at any time. Your request 
should be submitted directly to the researcher using either the email or phone number 
(akjohnson@luriechildrens.org; 312 227 7733). The study team can still use any information 
collected before you tell them to stop. 
 
Who can answer questions about this study? 
 
You can ask Amy K Johnson (akjohnson@luriechildrens.org; 312 227 7733) or the clinic staff at 
[Insert Site Name] anything about the study or tell her if you think you have been harmed. If you 
are not happy with this study and want to talk with someone else, not the study doctor or the 
people working with the study doctor, you may contact the IRB Office by telephone at (312) 
503-7110 or by email at IRB@luriechildrens.org. 
 
We will tell you if we learn new information that may make you change your mind about being 
in this study. 
 
If you do not want to be in this study, that is okay. 
 
Signatures Participant 
Signature: 
By signing this form, I affirm: 
1. I have read this form. 
2. The research has been explained to me. 
3. All of my questions have been answered. 
4. I give my assent to take part in this research study. 
Signature of Adolescent: 
Date: 
Printed Name: 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
243 
 
 
Signature of Authorized Person Obtaining Assent/Witness: 
I certify that I have explained the above to the participant/LAR and the signature was obtained 
voluntarily. 
Signature: 
Date: 
Printed Name: 
*If the study includes the use of records related to mental health or developmental disabilities, 
the person obtaining consent also serves as the witness to consent for use of relevant records. 
 
When it is not possible to obtain written assent: 
To be completed by the Person Obtaining Assent. 
This adolescent is unable to given written assent, but has given verbal assent 
to participate in the study. 
Initials 
 
This adolescent is unable to give written or verbal assent. The study PI (or delegate) has 
obtained a waiver of assent from the IRB Chair. Note: To request a waiver, e-mail 
IRB@LurieChildrens.org. 
Initials 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
244 
 
 
 
 
 
Adolescent Agreement to Take Part in a Research Study 
Aim 2: For participants aged 16-17 years 
 
Study Name: Midwest TXTXT 
Sponsored by: U.S Centers for Disease Control and Prevention U01PS005214 
Name of Study Doctor/Researcher: Amy K Johnson, PhD 
 
We want to tell you about a research study at Lurie Children’s, the Midwest AIDS Training and 
Education Center (MATEC), and [local clinic name].  
 
We are asking you to be in this research study because you have participated in the text 
messaging study and we are interested in learning more about your experiences and your 
thoughts on receiving the text messages.  
 
Research studies help us find better ways to take care of and treat children and young adults. 
Taking part in a research study is voluntary. It is your choice to take part in this research study. 
 
Why is this study being done? 
The main purpose of this study is to determine how well text messaging (Short Message Service - 
SMS) works to improve the amount of HIV in the blood (viral load) of young persons receiving HIV 
treatment  at [Insert site name]. The study will also evaluate whether the text messaging works to 
improve how well young persons take their HIV medications (called adherence) and remain under 
the care of their medical providers (called retention in care), and whether young persons accept 
and are satisfied with the program being tested. 
 
We are asking you to be in this research study because you have participated in the text 
messaging study and we are interested in learning more about your experiences. 
 
What will happen in this study? 
There will be a total of up to 60 participants in this study at different sites throughout the midwestern 
United States. About 4-5 participants will be included at [Insert Site Name]. This study visit is only one 
time and you will be asked to complete an interview which will take about 30 minutes to complete, 
the interview will be conducted either in person, by phone, or by secure video call 
 
What are the bad or harmful things that could happen in this study? 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
245 
 
You may find some of the questions difficult to answer or you may not want to answer them. You 
may skip any question that you do not want to answer. During this study, you will be informed about 
anything that may affect your continued participation or your health. 
 
What are the good things that could happen in this study? 
There are no direct benefits to you for participating in this survey. The information learned may 
help researchers learn more about designing programs and support for young people living with 
HIV to support medication adherence. 
 
What other options are there? 
You do not have to be in this study if you don’t want to. Your doctors at [Insert Site Name] will 
not be upset with you. If you join the study and then change your mind, it is okay for you to 
leave this study at any time. 
 
Who will see your information? 
 
 
There will be no sensitive health information about you collected or shared. 
 
If you agree to take part in this study, you also give permission for the use and sharing of your de-
identified information from which we removed any information that might identify you like your name 
and birthdate (“deidentified”) with persons outside of this study. This permission lasts until the study is 
completed.  
 
The study staff, employees, and Medical Staff of Lurie Children’s, , the Midwest AIDS Training and 
Education Center (MATEC), and [local clinic name] may use your information for this study and 
share it with: 
1. The Institutional Review Board (the committee that is in charge of protecting the rights of all adults 
and children who take part in research studies). 
2. The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other 
government offices. 
3. Other Researchers who request access to the de-identified data for research purposes.  
 
These are the only people to which we will give your information. We cannot guarantee that those listed 
above will not share it with others without your permission. 
 
Your name will not be included in any written or verbal reports of study results. 
 
Certificate of Confidentiality 
 
This research project has a Certificate of Confidentiality from the Centers for Disease Control and 
Prevention (CDC). Unless you say it is okay, researchers cannot release information that may 
identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
246 
 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an 
example, the Certificate would protect your information from a court subpoena. There are some 
important things that you need to know. The Certificate DOES NOT protect your information if a 
federal, state, or local law says it must be reported. For example, some laws require reporting of 
abuse, communicable diseases, and threats of harm to yourself or others. The Certificate 
CANNOT BE USED to stop a federal or state government agency from checking records or 
evaluating programs. The Certificate DOES NOT stop reporting required by the U.S. Food and 
Drug Administration (FDA). The Certificate also DOES NOT stop your information from being used 
for other research if allowed by federal regulations. 
 
Researchers may release your information when you say it is okay. For example, you may give them 
permission to release information to insurers, your doctors, or any other person not connected with the 
research. The Certificate of Confidentiality does not stop you from releasing your own information. It also 
does not stop you from getting copies of your own information. 
 
Will there be payment or gifts for being in this study? 
 
You will receive $40 (cash or gift card) as a token of appreciation after completing the survey. 
 
 
Who can answer questions about this study? 
 
You can ask Amy K Johnson (akjohnson@luriechildrens.org; 312 227 7733) or the clinic staff at 
[Insert Site Name] anything about the study or tell her if you think you have been harmed. If you 
are not happy with this study and want to talk with someone else, not the study doctor or the 
people working with the study doctor, you may contact the IRB Office by telephone at (312) 
503-7110 or by email at IRB@luriechildrens.org. 
 
We will tell you if we learn new information that may make you change your mind about being 
in this study. 
 
If you do not want to be in this study, that is okay. 
 
Signatures 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
247 
 
Participant Signature: 
By signing this form, I affirm: 
1. I have read this form. 
2. The research has been explained to me. 
3. All of my questions have been answered. 
4. I give my assent to take part in this research study. 
Signature of Adolescent: 
Date: 
Printed Name: 
 
 
Signature of Authorized Person Obtaining Assent/Witness: 
I certify that I have explained the above to the participant/LAR and the signature was obtained 
voluntarily. 
Signature: 
Date: 
Printed Name: 
*If the study includes the use of records related to mental health or developmental disabilities, 
the person obtaining consent also serves as the witness to consent for use of relevant records. 
 
When it is not possible to obtain written assent: 
To be completed by the Person Obtaining Assent. 
This adolescent is unable to given written assent, but has given verbal assent 
to participate in the study. 
Initials 
 
This adolescent is unable to give written or verbal assent. The study PI (or delegate) has 
obtained a waiver of assent from the IRB Chair. Note: To request a waiver, e-mail 
IRB@LurieChildrens.org. 
Initials 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
248 
 
 
 
 
Adult Consent to Take Part in a Research Study 
Aim 2: Consent for participants ages 18-35 years 
 
Study Name: Midwest TXTXT 
Sponsored by: U.S Centers for Disease Control and Prevention U01PS005214 
Name of Study Doctor/Researcher: Amy K Johnson, PhD 
 
This consent form describes a research study for which you might qualify being conducted by a researcher 
at Ann & Robert H. Lurie Children's Hospital of Chicago (“Lurie Children’s”) the Midwest AIDS Training and 
Education Center (MATEC), and [local clinic name].  
 
We are asking you to be in this research study because you have participated in the text messaging 
study and we are interested in learning more about your experiences and your thoughts on 
receiving the text messages.  
 
Research studies help us learn more about conditions and develop new treatments. Taking part in a 
research study is voluntary. It is your choice to take part in this research study. Please read this consent 
form and ask questions about anything you do not understand. You may talk to others such as your family 
or healthcare providers before you decide to take part in this study. The study staff will also explain the 
study to you and answer any questions that you may have. Your decision will not affect your regular care. 
 
What are the purpose and goals of this study? 
The main purpose of this study is to determine how well text messaging (Short Message Service - SMS) 
works to improve suppression of HIV in the blood of young persons receiving HIV treatment at [Insert 
site name]. The study will also evaluate how well the intervention fits into the current clinic 
environment. 
We are asking you to be in this research study because you work at [Insert site name] and we believe you will 
have valuable insight into how the intervention fits at your agency. 
 
If I agree to take part in this study, what would I need to do? 
 
There will be a total of about 24 participants in this study at different sites throughout the midwestern United 
States. Up to 2 participants will be included at [Insert Site Name]. The study consists of a one time 
individual interview that will last up to one hour. Interviews will be conducted either in person, via phone, 
or secure video call.  
 
What are the risks, side effects, or discomforts related to the study? 
You may find some of the questions difficult to answer or you may not want to answer them. You may 
skip any question that you do not want to answer. 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
249 
 
 
What are the benefits from this study? 
The information learned may help researchers learn more about designing programs and support for 
young people living with HIV to support medication adherence. You will not benefit from taking part in 
this study. This information learned from this study may help others in the future. 
 
What other options do I have? 
You do not have to be in this study if you don’t want to. Your doctors at [Insert Site Name] will not be 
upset with you. If you join the study and then change your mind, it is okay for you to leave this study at any 
time. 
 
What if the researcher or I do not think I should stay in the study? 
You can stop taking part in this study at any time. Your decision will not affect your regular care. 
 
Returning Study Results: 
The study team will not return study results to you. You can ask the study team any questions you have 
about study results. 
 
Important New Information: 
We will tell you if we learn new information that may make you change your mind about being in this study. 
 
Will my information be used in future research studies? 
The study team may share your information for future research. They will remove identifiers such as your 
name and other information that can be linked to you before this is done. The study team and other 
researchers may use this for other studies without getting consent from you. 
 
 
Costs Related to this Study:  
 
There are no costs associated with taking part in this study. 
 
Payment for Taking Part in this Study:  
 
You will not be paid for taking part in this study. 
 
Your Rights When Taking Part in this Study: 
 
If you agree to take part in this study, you are not giving up any of your legal rights. You can stop 
participating in this study at any time. Your choice will not affect your regular care. 
 
Additional Information: 
Who can answer my questions about this study? 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
250 
 
You can ask Amy K Johnson (akjohnson@luriechildrens.org; 312 227 7733) or the clinic staff at[Insert Site 
Name] anything about the study or report to her if you think you have been harmed. If you are not happy 
with this study and want to talk with someone else, not the study doctor or the people working with the 
study doctor, you may contact the IRB Office by telephone at (312) 503-7110 or by email at 
IRB@luriechildrens.org. 
 
You will be given a copy of this consent form. 
 
Certificate of Confidentiality  
 
This research project has a Certificate of Confidentiality from the Centers for Disease Control and Prevention 
(CDC). Unless you say it is okay, researchers cannot release information that may identify you for a legal 
action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. As an example, the Certificate would protect your 
information from a court subpoena. There are some important things that you need to know. The Certificate 
DOES NOT protect your information if a federal, state, or local law says it must be reported. For example, 
some laws require reporting of abuse, communicable diseases, and threats of harm to yourself or others. 
The Certificate CANNOT BE USED to stop a federal or state government agency from checking records or 
evaluating programs. The Certificate DOES 
NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also DOES 
NOT stop your information from being used for other research if allowed by federal regulations. 
 
Researchers may release your information when you say it is okay. For example, you may give them 
permission to release information to insurers, your doctors, or any other person not connected with the 
research. The Certificate of Confidentiality does not stop you from releasing your own information. It also 
does not stop you from getting copies of your own information. 
 
Planned Sharing of Your Information:  
 
The information that may be collected and shared will include your: 
5. Personal information 
6. Records from study visits and phone calls 
 
There will be no sensitive health information about you collected or shared  
 
. If you agree to take part in this study, you also give permission for the use and sharing of your information 
from which we removed any information that may identify you like your name and birthdate (“deidentified”) 
with persons outside of this study This  permission lasts until the study is completed.  
 
The study staff, employees, and Medical Staff of Lurie Children’s, the Midwest AIDS Training and 
Education Center (MATEC), and [local clinic name] may use your deidentified information for this study 
and share it with: 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
251 
 
7. 
The Institutional Review Board (the committee that is in charge of protecting the rights of all adults and 
children who take part in research studies). 
8. 
The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other 
government offices. 
9. Other Researchers who request access to the de-identified data for research purposes.  
10. 
 
 
These are the only people to which we will give your information. We cannot guarantee that those listed 
above will  not share it with others without your permission. 
 
Your name will not be included in any written or verbal reports of study results. 
 
What if I decide not to give permission to use and give out my information? 
If you decide not to allow the release your information, you will not be able to take part in this study. If 
you give permission to the use of your information, you can withdraw it at any time. Your request should 
be in writing and sent to the researcher. The study team can still use any information collected before you 
tell them to stop. 
 
Can I review or copy my information? 
You cannot see your study records while the study is ongoing. You still have a right to request a copy of 
your medical record and tests related to regular medical care that is given during the same time as the 
study. 
 
Signatures: 
Participant/LAR 
Signature: 

252 
 
 
 
 
Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
By signing this form, I affirm: 
1. I have read this form. 
2. The research has been explained to me. 
3. All of my questions have been answered. I consent to take part in this research study. 
Signature of Participant or Legally Authorized Representative (LAR): 
Date: 
Printed Full Name: 
 
Signature of Authorized Person Obtaining Consent/Witness*: 
I certify that I have explained the above to the participant/LAR and the signature was obtained 
voluntarily. 
Signature: 
Date: 
Printed Full Name: 
*If the study includes the use of records related to mental health or developmental disabilities, the person obtaining 
consent also serves as the witness to consent for use of relevant records. 
 
Signature of Interpreter/Witness*: 
Not applicable, no interpreter used. 
I attest that the study information has been presented to the participant/LAR in their 
native language. 
Signature of Interpreter/Witness: 
Printed Full Name or Unique Phone ID/Company Name: 
 
Note to Investigators: When obtaining consent from a non-English speaking participant/ LAR 
When a study-specific translated consent document is not available, a translated “short form” (available in several 
languages on the IRB website) may be used, in combination with a verbal presentation of study information (as 
outlined in this English consent) with the aid of an interpreter. 
4. 
The consent process must be witnessed by an individual who is  fluent in both English and the language 
understandable the subject. The interpreter may serve as the witness and should sign both the English consent 
document and short form. 

253 
 
5. 
The participant/LAR should sign the short form (in the language they understand). 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
254 
 
 
 
 
6. 
The investigator and/or study staff authorized by the IRB to obtain consent must sign the approved English version 
of the consent form. 
7. 
A copy of both the IRB-approved English consent form (i.e., the summary) and the translated version of the 
short form must be given to the participant/LAR. 
 
 
 
Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
255 
 
Adult Consent to Take Part in a Research Study 
Aim 2: Consent for staff ages 18+  
 
Study Name: Midwest TXTXT 
Sponsored by: U.S Centers for Disease Control and Prevention U01PS005214 
Name of Study Doctor/Researcher: Amy K Johnson, PhD 
 
This consent form describes a research study for which you might qualify being conducted by a researcher at Ann 
& Robert H. Lurie Children's Hospital of Chicago (“Lurie Children’s”) the Midwest AIDS Training and Education 
Center (MATEC), and [local clinic name].  
 
We are asking you to be in this research study because you were employed at[local clinic name] during the 
implementation of the text  messaging study. We are interested in learning more about your experiences 
and your thoughts on implementing the study in your local clinic.  
 
Research studies help us learn more about conditions and develop new treatments. Taking part in a research study 
is voluntary. It is your choice to take part in this research study. Please read this consent form and ask questions 
about anything you do not understand. You may talk to others such as your family or healthcare providers before 
you decide to take part in this study. The study staff will also explain the study to you and answer any questions 
that you may have. Your decision will not affect your regular care. 
 
What are the purpose and goals of this study? 
The main purpose of this study is to determine how well text messaging (Short Message Service - SMS) works 
to improve suppression of HIV in the blood of young persons receiving HIV treatment at [Insert site name]. The 
study will also evaluate how well the intervention fits into the current clinic environment. 
We are asking you to be in this research study because you work at [Insert site name] and we believe you will have 
valuable insight into how the intervention does or does not fit at your agency. 
 
If I agree to take part in this study, what would I need to do? 
 
There will be a total of about 24 participants in this study at different sites throughout the midwestern United States. 
Up to 2 participants will be included at [Insert Site Name]. The study consists of a one time individual interview 
that will last up to one hour. Interviews will be conducted either in person, via phone, or secure video call.  
 
What are the risks, side effects, or discomforts related to the study? 
You may find some of the questions difficult to answer or you may not want to answer them. You may skip 
any question that you do not want to answer. 
 
What are the benefits from this study? 
The information learned may help researchers learn more about designing programs and support for young 
people living with HIV to support medication adherence. You will not benefit from taking part in this study. This 
information learned from this study may help others in the future. 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
256 
 
 
What other options do I have? 
You do not have to be in this study if you don’t want to. Your doctors at [Insert Site Name] will not be upset with 
you. If you join the study and then change your mind, it is okay for you to leave this study at any time. 
 
What if the researcher or I do not think I should stay in the study? 
You can stop taking part in this study at any time. Your decision will not affect your regular care. 
 
Returning Study Results: 
The study team will not return study results to you. You can ask the study team any questions you have about 
study results. 
 
Important New Information: 
We will tell you if we learn new information that may make you change your mind about being in this study. 
 
Will my information be used in future research studies? 
The study team may share your information for future research. They will remove identifiers such as your name and 
other information that can be linked to you before this is done. The study team and other researchers may use this 
for other studies without getting consent from you. 
 
 
Costs Related to this Study:  
 
There are no costs associated with taking part in this study. 
 
Payment for Taking Part in this Study:  
 
You will not be paid for taking part in this study. 
 
Your Rights When Taking Part in this Study: 
 
If you agree to take part in this study, you are not giving up any of your legal rights. You can stop participating in 
this study at any time. Your choice will not affect your regular care. 
 
Additional Information: 
Who can answer my questions about this study? 
You can ask Amy K Johnson (akjohnson@luriechildrens.org; 312 227 7733) or the clinic staff at[Insert Site Name] 
anything about the study or if you think you have been harmed. If you are not happy with this study and want to 
talk with someone else, not the study doctor or the people working with the study doctor, you may contact the 
IRB Office by telephone at (312) 503-7110 or by email at IRB@luriechildrens.org. 
 
You will be given a copy of this consent form. 
 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
257 
 
Certificate of Confidentiality  
 
This research project has a Certificate of Confidentiality from the Centers for Disease Control and Prevention 
(CDC). Unless you say it is okay, researchers cannot release information that may identify you for a legal action, a 
lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings. As an example, the Certificate would protect your information 
from a court subpoena. There are some important things that you need to know. The Certificate DOES NOT 
protect your information if a federal, state, or local law says it must be reported. For example, some laws require 
reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT BE 
USED to stop a federal or state government agency from checking records or evaluating programs. The Certificate 
DOES 
NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also DOES NOT 
stop your information from being used for other research if allowed by federal regulations. 
 
Researchers may release your information when you say it is okay. For example, you may give them permission to 
release information to insurers, your doctors, or any other person not connected with the research. The Certificate 
of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting 
copies of your own information. 
 
Planned Sharing of Your Information:  
 
 
There will be no sensitive health information about you collected or shared. 
 
If you agree to take part in this study, you also give permission for the use and sharing of your information from 
which we removed any information that may identify you like your name and birthdate (“deidentified”) with persons 
outside of this study. This  permission lasts until the study is completed.  
The study staff, employees, and Medical Staff of Lurie Children’s, , the Midwest AIDS Training and Education 
Center (MATEC), and [local clinic name] may use your information for this study and share it with: 
8. 
The Institutional Review Board (the committee that is in charge of protecting the rights of all adults and 
children who take part in research studies). 
9. 
The Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), or other 
government offices. 
10. 
Other Researchers who request access to the de-identified data for research purposes.  
 
 
These are the only people to which we will give your deidentified information. We cannot guarantee that those 
listed above will not share it with others without your permission. 
 
Your name will not be included in any written or verbal reports of study results. 
 
What if I decide not to give permission to use and give out my information? 

Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
 
258 
 
If you decide not to allow the release your information, you will not be able to take part in this study. If you give 
permission to the use of your information, you can withdraw it at any time. Your request should be via phone or 
email  sent to the researcher (akjohnson@luriechildrens.org; 312 227 7733). The study team can still use any 
information collected before you tell them to stop. 
 
Can I review or copy my information? 
You cannot see your study records while the study is ongoing. You still have a right to request a copy of your 
medical record and tests related to regular medical care that is given during the same time as the study. 
 
Signatures: Participant/LAR 
Signature: 

259 
 
 
 
 
Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 
By signing this form, I affirm: 
11. I have read this form. 
12. The research has been explained to me. 
13. All of my questions have been answered. I consent to take part in this research study. 
Signature of Participant or Legally Authorized Representative (LAR): 
Date: 
Printed Full Name: 
 
Signature of Authorized Person Obtaining Consent/Witness*: 
I certify that I have explained the above to the participant/LAR and the signature was obtained 
voluntarily. 
Signature: 
Date: 
Printed Full Name: 
*If the study includes the use of records related to mental health or developmental disabilities, the person obtaining 
consent also serves as the witness to consent for use of relevant records. 
 
Signature of Interpreter/Witness*: 
Not applicable, no interpreter used. 
I attest that the study information has been presented to the participant/LAR in their 
native language. 
Signature of Interpreter/Witness: 
Printed Full Name or Unique Phone ID/Company Name: 
 
Note to Investigators: When obtaining consent from a non-English speaking participant/ LAR 
When a study-specific translated consent document is not available, a translated “short form” (available in several 
languages on the IRB website) may be used, in combination with a verbal presentation of study information (as 
outlined in this English consent) with the aid of an interpreter. 
14. The consent process must be witnessed by an individual who is  fluent in both English and the language 
understandable the subject. The interpreter may serve as the witness and should sign both the English consent 
document and short form. 

260 
 
15. The participant/LAR should sign the short form (in the language they understand). 
 
 
 
16. The investigator and/or study staff authorized by the IRB to obtain consent must sign the approved English version 
of the consent form. 
17. A copy of both the IRB-approved English consent form (i.e., the summary) and the translated version of the 
short form must be given to the participant/LAR. 
 
 
 
Affix Patient Label Here 
Note: Label required for cover page, but is optional for 
other pages if the following information is provided: 
Patient Name: 
MRN: 

261 
 
 
 
 
 
APPENDIX M: Cost Analysis Variables (Aim 1) 
 
Staffing 
Number of staff  
Per each staff: 
Role of staff person 
Monthly salary 
Total hours worked per month  
Total hours worked per month on TXTXT project 
 
Activities 
Report on hours per month, by activity, per staff: 
Training/review SOPs 
Preparing materials 
Screening participants 
Enrolling participants 
Conducting follow-up with participants  
Attending team meetings  
Data management  
Administrative tasks 
Other <specify> 
 
Non Labor  
Computer/phone usage 
Software  
Rent for space  
Other <specify>