Community Health Worker And MHealth to ImProve Viral Suppression
Phase: NA
Conditions: HIV/AIDS
Sponsor: Columbia University

 
 
 
 
 
 
 
 
 
Community Health Worker And MHealth to ImProve Viral Suppression 
(CHAMPS)  
 
 
NCT04562649 
05/23/2023 

 
Persons living with HIV (PLWH) now achieve a near-normal life expectancy due to antiretroviral therapy 
(ART) which has transformed HIV from a terminal diagnosis to a manageable chronic condition.1-4 Despite 
widespread availability of ART in the United States (US), many of the country’s approximate 1.1 million 
PLWH5—in diverse geographic locations—are not fully benefitting from ART due to poor adherence.6 
Suboptimal ART adherence is a challenge in the US South which accounts for 51% of new domestic cases 
annually.7 The Southern HIV epidemic is even more pronounced in the “Deep South”8 with striking numbers in 
Alabama (AL) where PLWH experience poor viral suppression (62%).9 Likewise, the heavy HIV burden in the 
US Northeast10 is in New York City (NYC) which accounts for 82% of all PLWH in NY state.11 Further, in the 
NYC region, only 67% of PLWH achieve sustained, or durable, viral suppression (the ultimate goal of ART). In 
response, the US government prioritized four NYC-area counties and AL (our study sites) as five of 55 areas 
with a substantial burden of HIV in the Ending the HIV Epidemic (EHE) plan.12 These suboptimal HIV health 
outcomes occur at a time when clinicians have limited time and the US healthcare system remains 
fragmented,13 further exacerbating the challenges inherent in the lives of underserved, marginalized groups, 
such as PLWH.14 Therefore, the development and evaluation of interventions using a cadre of community 
health workers (CHW) holds promise for addressing these challenges in the US.15, 16 Yet, research is urgently 
needed to bring CHW interventions to scale, particularly in EHE priority locations. 
Despite efforts to achieve UNAIDS 95-95-95 targets, marked deficits remain in HIV viral 
suppression and ART adherence among a growing number of PLWH.21-26 Progression of HIV disease and 
premature deaths among PLWH have been attributed foremost to insufficient engagement in medical care and 
adherence to HIV treatment regimens.27, 28 Quick access to ART and subsequent sustained ART adherence is 
central to therapeutic success and is a critical determinant of long-term health outcomes (e.g., viral 
suppression) in PLWH.29-31 For many chronic diseases, such as diabetes or hypertension, drug regimens 
remain effective even after treatment is resumed following a period of interruption. In the case of HIV, however, 
loss of virologic control as a consequence of ART non-adherence may lead to emergence of drug resistance 
and loss of future treatment options.32-34Therefore, developing effective interventions to enhance ART 
adherence is essential. 
Gaps in HIV treatment are particularly pronounced in the US South and Northeast, specifically, 
AL and NYC, the two high priority settings for our study. The Deep South, a colloquial term comprising 
nine US states, including AL, had the highest HIV diagnosis rates of any US region during the past decade.35 
In AL, HIV disproportionally affects racial minority groups with Blacks comprising 63.7% of PLWH and 73.8% of 
new diagnoses in 2019.36 Poorer HIV-related health outcomes are seen in AL as compared to other regions, 
with higher HIV-related mortality rates,37 higher rates of AIDS diagnoses38 (oftentimes an indicator of late 
diagnosis or poor disease management39-41), and lower rates of engagement in HIV care and viral 
suppression.42 While characteristically different from AL, NYC continues to have high HIV diagnosis rates as 
well.43 HIV disproportionally affects racial minority groups in NYC, too, with Blacks comprising 43.5% of PLWH 
and 45.9% of new diagnoses in 2018.44 Poorer HIV-health outcomes in the Bronx, as compared to other NYC 
boroughs, have been noted with higher HIV-related mortality rates,45 higher rates of AIDS diagnoses,43 and 
lower rates of viral suppression.46 
CHW and related models have demonstrated positive impact for medication support, seeking 
treatment, and clinic-patient relationships. Interventions with CHW have shown promise both globally47-49 
and in the US. One study in Seattle tested the effect of a 3-month CHW intervention and found an association 
with greater ART adherence at post-intervention.50 In another domestic study of an online CHW social support 
ART adherence intervention, substance using participants reported significantly higher overall ART 
adherence.51 A small study of 20 PLWH in Kansas City, Missouri showed the positive effect of “READY,” a 
peer-led CHW intervention for improving ART adherence in patients who had experienced repeated non- 
adherence.52 Collectively, these studies demonstrate the efficacy of CHW and other peer-led interventions for 
improving ART adherence. In addition, CHW can interface with the healthcare system at lower costs and 
require less training than clinicians.53-55 This is especially important now given the limited time of clinicians and 
the fragmented condition of the US healthcare and insurance system. 
However, CHW models do not provide strong evidence for improving key psychosocial or HIV health 
outcomes associated with ART adherence and viral suppression,56, 57 e.g., HIV-related stigma, quality of 
life, psychosocial distress/stress, adherence medication and skills, and adherence self-efficacy. Prior work in 
the Deep South suggests that it is the enhanced relationship between CHW and PLWH that is vitally important 
and is associated with improvements in linkage to care, retention in care, and viral suppression.58 In our BA2C 
RCT, CHW delivered an intervention adapted from ARTAS, a CDC evidence-based intervention (EBI) shown 
STUDY PURPOSE AND RATIONALE 

to significantly increase both linkage to and retention in care. While ARTAS was developed for new-to-care 
PLWH, BA2C was tailored and adapted for PLWH who had previously linked to but were not currently engaged 
in care. BA2C results showed that participants in both the intervention and comparison groups improved 
across multiple outcomes (linkage to care, retention in care, ART prescription, and viral suppression), but there 
was no significant difference between groups. Some of the limitations of the BA2C study included poor 
retention rates (70%) and difficulty attending CHW intervention sessions, suggesting that a hybrid intervention 
in which CHW sessions can be delivered through a mobile platform has the potential to improve the efficacy of 
the intervention. Given the limitations of the BA2C intervention59, 60 and in direct response to RFA-NR-20-002, 
Strengthening the Impact of Community Health Workers on the HIV Care Continuum in the US, we will 
leverage our mHealth work to overcome the limitations of the BA2C study. Namely, we will use mHealth 
technology to overcome logistic hurdles of connecting participants and their CHW and to improve engagement 
through the tools in our WiseApp. 
The ubiquitous nature of mHealth technologies in daily life creates opportunities for health 
behavior management tools that were not previously possible61 and has the potential to address many of 
the healthcare needs of PLWH. The use of mHealth can reduce geographic and economic disparities and 
personalize healthcare,62, 63 which is particularly relevant to PLWH since a majority represent underserved and 
minority groups.64-66 mHealth technology is especially important in the context of improving ART adherence in 
PLWH.67 There is preliminary evidence that mHealth technology is a feasible, attractive, accessible, and 
effective platform for improving ART adherence in PLWH.68-70 Eighty-one percent (81%) of Americans are 
smartphone owners,71 and our previous work suggests that this percentage is surprisingly higher with 83.7% of 
PLWH in Birmingham, AL owning a smartphone.72 In NYC, smartphone ownership among low-income 
racial/ethnic minority PLWH is even higher with only 1.7% of participants who screened for our clinical trials 
(NCT03205982, NCT03182738) being ineligible because they did not own a smartphone. There is evidence 
that underserved populations use smartphones as their primary method for accessing the Internet.73, 74 Finally, 
there is evidence that mHealth technology can promote the prevention and management of chronic illnesses 
such as HIV,75 thereby allaying weaknesses of the BA2C intervention. 
To that end, we developed the WiseApp using strong user-centered design research with underserved PLWH 
that draws on considerable formative work with PLWH, HIV clinicians, HIV case managers and the CDC 
(U01PS003715, PI: Schnall).19 We then built the app and integrated it with a smart pill box (CleverCap) to allow 
PLWH to self-manage their HIV and monitor their medication adherence in real-time (R01HS025071, PI: 
Schnall). The WiseApp is an innovative self-management tool aligned with the National Institute of Nursing 
Research (NINR) Strategic Plan76 currently being evaluated in a RCT (NCT03205982) with 200 PLWH in NYC 
with poor ART adherence. Further details are in the preliminary studies section below. Integrating the 
functionality of the WiseApp to deliver the CHW intervention remotely will overcome many of the limitations of 
the BA2C intervention, namely attendance at in-person sessions due to scheduling, distance, or finances. 
Implementation research is underutilized in HIV self-management, mHealth studies, and CHW 
interventions. Despite the development and well-documented success of behavior change interventions for 
PLWH, interventions often fail to sustain behavior change over time or demonstrate long-term efficacy.18 
mHealth technology has the potential to empower patients to self-manage a chronic condition, such as HIV.77 
However, implementation of mHealth technology is often fraught with barriers to adoption sometimes owing to 
a dearth of evidence related to implementation of these tools.78 CHW interventions, too, are rarely designed, 
implemented, or evaluated using theory-driven implementation frameworks.79 
Combining elements of clinical efficacy with implementation research can enhance public 
health impact. Implementation research is often overlooked and can be used to predict issues that may arise 
with the real-world implementation of an intervention. Guided by a rigorous implementation research 
framework, RE-AIM, we will assess the contextual factors that influence translation, adoption, replication, 
sustainability and implementation of CHAMPS across racial/ethnic groups and settings (Aim 3). A priori 
blending of clinical efficacy and implementation trials can more quickly translate research findings into routine 
practice80 which can potentially yield much richer data that is especially useful to advance science and 
significantly impact public health. In this study, we will conduct an efficacy trial and assess implementation 
factors to test a clinical intervention while gathering information on its delivery and/or its potential for 
implementation in a real-world situation. This method will allow us to evaluate the potential strategies for 
ensuring widespread implementation of CHAMPS in future work. 
In summary, this study addresses limitations in current research on CHW interventions to improve viral 
suppression and ART adherence. We propose to build on our strong preliminary data and directly respond to 
RFA-NR-20-002 by strengthening our CHW intervention (BA2C) using our existing mHealth approach 

(WiseApp). Guided by a rigorous theoretical model of supportive accountability, the literature and our 
preliminary work support the scientific premise that adding WiseApp to the CHW intervention will enable PLWH 
to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to 
viral suppression and ART adherence. The proposed study will provide further information regarding the 
successful wide-scale implementation of this combination intervention in two high priority settings. 
The proposed study will test the clinical efficacy and assess the implementation factors of the resultant 
CHW intervention, Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS), through 
the following specific aims with virally unsuppressed adult PLWH (n=150 in AL and 150 in NYC): 
1: Conduct an RCT to assess the efficacy and sustainability of CHAMPS on viral suppression 
(primary outcome) and ART adherence (secondary outcome) compared to the standard of care 
(standard of care, control group) over 6 and 12 months. 
PLWH randomized to CHAMPS will have significantly greater: 
H1: Viral suppression (primary outcome) than those in the standard of care group. 
H2: ART adherence (secondary outcome) than those in the standard of care group. 
2: Identify mediators and moderators of CHAMPS on study outcomes. 
H3: HIV medication taking self-efficacy, motivation expectancies, self-regulation skills, and HIV-related 
stigma mediate the effect of CHAMPS on viral suppression and ART adherence. 
H4: Depression, anxiety, and substance use moderate the strength of the effect of CHAMPS on viral 
suppression and ART adherence. 
3: Guided by the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, 
identify multi-level factors associated with successful implementation of CHAMPS to inform future 
implementation and scale-up. 
This study seeks to expand and strengthen a CHW model through an extant mHealth approach. Findings will 
inform the effect of CHAMPS on outcomes related to the HIV Care Continuum in two EHE priority settings. 
 
Theoretical Framework 
The intervention is guided by the conceptual model of supportive accountability illustrated in Figure 1.86 The 
model is based on the premise that human support increases medication adherence through accountability to 
a coach (in CHAMPS – a CHW) who is perceived as trustworthy, knowledgeable, and benevolent. 
Accountability should involve clear, process-oriented expectations guided by the patient (e.g., reporting 
adherence, problem-solving). The effect of accountability may be mediated by patient motivation, elicited 
through MI, so that patients with higher intrinsic motivation may actually require less support. The process of 
support is further supported by technology (WiseApp in this study) with different advantages and 
disadvantages for each mode. Multiple studies have demonstrated that human support is a strong predictor of 
viral suppression and adherence to ART.87-89 Although overall support predicted adherence in these studies, 
other components of social support, such as instrumental support (i.e., practical assistance) and informational 
support (advice or problem-solving) offered through CHAMPS, are also predictive.87 Both BA2C and 
WiseApp—and the proposed integrated intervention, CHAMPS—have been designed to validate the 
importance of viral suppression and ART 
adherence as well as to prompt problem-solving 
(through informational support). These interventions 
utilize human support to provide tailored 
conversations to improve both short- and long-term 
adherence. Social support theory also suggests 
that an ongoing alliance between the study 
participants and CHW could protect against 
depression, substance use, and anxiety.90-93 
 
Preliminary Data: We have conducted two studies 
to support the use of this intervention. 
1) Birmingham Access to Care (BA2C). BA2C 
(funded by AIDS United, Co-Is: Batey and 
Mugavero) was a single-site RCT conducted 
between July 2013 and February 2016 in 
partnership with Birmingham AIDS Outreach (BAO) 
Figure 1. Model of Supportive Accountability 

and the University of Alabama at Birmingham (UAB) 1917 HIV Clinic. The study focused on re-engagement to 
care among PLWH who had previously linked to care but who were not currently engaged at the time of the 
study (N=170). The BA2C intervention was based on a CDC-recognized EBI, ARTAS, which was the first RCT 
shown to significantly increase linkage to and retention in care among recently diagnosed PLWH.17, 82, 83 The 
ARTAS intervention consists of a brief, strengths-based case management/MI approach aimed at facilitating a 
close, supportive relationship between the CHW and participant and consists of up to five visits. BA2C, which 
was tailored and adapted to PLWH who dropped out of care, expanded on ARTAS to provide additional 
support over a longer period. Participants enrolled in the intervention arm received an initial face-to-face 
meeting with an assigned CHW prior to attending their first return HIV primary care visit and attended at least 
ten and up to 12 visits over six months in which the CHW worked collaboratively with participants to resolve 
any barriers to care. Depending on participant needs, the CHW may attend medical appointments with the 
participant and/or provide transportation. Participants in the control arm received standard of care. Study 
findings from BA2C showed that participants in both study arms improved across multiple outcomes (linkage to 
care 30 days after baseline; retention in care, ART prescription, and viral suppression at 12 months after 
baseline), but there was no statistically significant difference between groups. The lack of statistical 
significance was likely due to a small sample size and a 70% retention rate due to challenges participants had 
in attending study appointments. CHAMPS will build on the evidence-based premise of BA2C and the 
enhanced relationship between CHW and participants while adding an mHealth component to facilitate study 
retention, described below. 
2) WiseApp is derived from formative work funded by and in collaboration with the CDC (U01PS003715) to 
design a self-management app for PLWH84 with the goal of being more widely applicable across chronic illness 
populations who require medications and adding self-management strategies. A comprehensive process for 
the design of the self-management app was guided by the Information Systems Research (ISR) framework 
and incorporated end-user feedback throughout the design process.85 The resultant WiseApp is comprised of 
the following functional components: 1) testimonial videos of PLWH, 2) push-notification reminders, 3) 
medication trackers, (4) health surveys, and (5) a “To-Do” list outlining their tasks for the day, such as 
medications to take (See Figure 2). A key component of WiseApp is a medication tracker linked to an 
electronic pill bottle and a capability to link to a fitness tracker and 
monitor physical activity. WiseApp can then send tailored 
reminders based on the feedback from the linked devices, such 
as medication reminders if the pill bottle has not been opened. 
Additional images of the WiseApp are found in Table 2. The 
WiseApp is aligned with the NINR Strategic Plan76 and is 
currently being evaluated in an RCT (NCT03205982) in 200 
PLWH with poor ART adherence in NYC (R01HS025071, PI: 
Schnall). Preliminary data show evidence for the success of this 
intervention in comparison to the control group for improving ART 
adherence (primary outcome) (58% ART adherence, 47% ART 
adherence, respectively, p=0.03) in low-income racial and ethnic 
minority PLWH (mean age=49.1 years, SD±10.6). 
 
 
 
 
Aim 1: Assess the efficacy and sustainability of CHAMPS on viral suppression (primary outcome) 
and ART adherence (secondary outcome) compared to the standard of care (standard of care, control 
group) over 6 and 12 months. 
 
Design Overview 
A randomized controlled trial will be conducted with 300 PLWH (n=150 in AL and 150 in NYC) over 12 
months. Participants will be randomly assigned to CHAMPS (intervention) or a standard-of-care control arm. 
Figure 2. Sample Image from the WiseApp 
List of currently prescribed medications 
 
STUDY DESIGN 

Intervention Arm. The CHAMPS intervention, 
outlined in Table 1, is a 6-month intervention 
guided by BA2C.17 The CHW will be 
demographically-matched to our study 
participants. 
 
Intervention Training and Support. The CHW 
will be trained on the intervention: content of 
each session, MI, strengths-based case 
management, ARTAS,17 HIV and substance 
use, and safety in the field. The CHW will also be trained on use of the WiseApp and CleverCap assuring all 
study participants and CHW are able to successfully use the mHealth technology. Training for the CHW will 
also be provided on: human subjects research protection, financial conflict of interest, HIPAA, and data privacy 
and security. The CHW will engage in supportive strengths-based case management and MI with the study 
participant. Intervention visits (~ten over a six-month 
period) will help participants access primary medical care 
by acknowledging and addressing barriers to care. 
Participants will have the option to participate in most 
CHW sessions in-person or via the App. This will help 
participants overcome many of the challenges to 
participating in-person, which was a frequent barrier in 
Birmingham and a current barrier due to COVID-19 in 
NYC. 
The WiseApp offers the following functionality listed 
in Table 2, and the CleverCap is linked to the WiseApp. 
The CleverCap fits on standard pill bottles, dispenses 
only the prescribed amount of medication, keeps track of 
medications dispensed, and communicates wirelessly 
with mobile devices. Participants are then able to self- 
monitor their medications, and the CHW will also be able 
to track study participants’ adherence to their ART 
medication in real time. Participants receive reminders 
through the WiseApp when they have not taken their 
medication on time and receive encouraging messages 
(e.g., Great job! You’ve met your goal for not forgetting 
your meds) when they have taken their medication. 
Communication, whether in-person or via the App, will 
enhance the relationship between the CHW and the 
study participant. 
The sessions and sample content are illustrated in 
Table 3. CHAMPS is a manualized intervention and 
study visits focus on topic areas such as linkage to care, 
medication adherence, health literacy, access to support 
services, and HIV disclosure. Ideally session #1 will be in 
person and #6 needs to be in-person during the care 
visit. 
The remaining visits can be in-person or through the 
WiseApp. The CHW maintains consistent communication 
with the participant to make sure the participant’s needs 
are addressed. Upon assignment to the intervention arm, 
a CHW is assigned to and meets with the participant as 
soon as possible, generally on the same day but no 
more than five business days. The WiseApp has a 
communication feature which will allow the CHW to 
deliver most of the sessions described in Table 3 
remotely. 
Table 1. Components of CHAMPS delivered over the 6 month 
intervention period 
10 sessions 
with the 
CHW 
Detailed in Table 3 below 
CleverCap 
Participants and CHW will be able to track ART adherence. 
WiseApp 
• CHW will be able to deliver sessions to the study 
participants through the WiseApp. 
• Participants will be able to self-manage their health 
through the content described in Table 2. 
• Participants and CHW can securely chat with one 
another. 
Table 2. WiseApp Features used for CHAMPS intervention 
WiseApp 
Feature 
CHW 
Integration 
WiseApp Screen-shot 
Medication Participant and 
 
Tracking 
CHW monitor 
medication 
adherence. 
Participants 
receive reminders 
when they have 
not taken their 
medication on 
time. 
CleverCap 
CleverCap syncs 
with the WiseApp 
to record 
medication 
adherence. 
 
Chat 
1:1 chat for 
participant and 
CHW for individual 
conversations, 
allowing CHW to 
provide 
intervention 
sessions. 
 
Testimonials Stories of CHW’s 
 
of Lived 
experiences living 
Experiences with and/or 
supporting PLWH. 

Table 3. Outline of CHW Sessions with study participants guided by BA2C and ARTAS content 
Title 
Sample Content for Each Session 
1 
Building the Relationship 
Introduce the goals of CHAMPS 
2 
Introduction to the WiseApp 
Discuss how the App can be used to facilitate communication between the CHW and the 
provider. Review the medication tracking function and how this can be used by the CHW and 
the participant. 
3 
Emphasizing Personal Strengths 
To help the patient self-identify personal strengths, abilities, and skills. 
4 
Learning to Make Contact 
Assist patient in preparing a list of questions to ask care provider 
5 
Reminder Call 
Call at the agreed upon time; Remind participant of any needed documents 
6 
Primary Care Provider Appointment #1 
Support patient’s efforts during care provider visit 
7 
Debriefing Provider Visit with Client #1 
Solicit patient’s input on what went well for the patient. Elicit from the patient what he or she 
learned from the care visit and what strengths he or she demonstrated during the care visit. 
8 
Reviewing Progress 
Plan for and review the transition process between the CHW and study participant 
9 
Debriefing Provider Visit with Client #2 
Solicit patient’s input on what went well for the patient. Elicit from the patient what he or she 
learned from the care visit and what strengths he or she demonstrated during the care visit. 
10 
Completing the work 
Review the transition process/ Transition to long term/Ryan White case manager or other 
providers 
 
Standard of Care (Control Arm) 
The control condition includes standard health services offered at each site (e.g., mental health services, case 
management, referral to clinical care) and a brief adherence educational session. The standard educational 
session consists of a review of medications and recommended dosing (i.e., to understand regimen), adherence 
expectations, toxicity expectations, and medication misperceptions. During the educational session, 
participants can ask questions and receive answers to reinforce their current ART regimen. All participants 
receive referrals to mental health, drug/alcohol treatment, and/or other HIV services as necessary. In 
summary, standard of care at each of the sites is comprehensive (far more extensive than standard of care for 
the general non-HIV infected population) and follows the Department of Health and Human Services HIV 
guidelines.113 All sites also provide mental health and psychosocial support services. 
 
Eligibility Criteria for Participants 
Inclusion criteria:1) Able to speak, read, and write in English or Spanish (at the New York City site only); 2) 
Aged ≥18 years; 3) Willing to participate in any assigned arm of the intervention; 4) Having been diagnosed 
with HIV ≥6 months ago; 5) Have an HIV-1 RNA level >200 copies/mL, or at least one “no-show” visit in the 
past 12 months, or report either not virally suppressed in the past 12 months or virally unsuppressed in the 
past 12 months; 6) Own a smartphone; and 7) Ability and willingness to provide informed consent for study 
participation and consent for access to medical records. Participants are not eligible if they meet any exclusion 
criteria: 1) Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment; 
2) Terminal illness with life expectancy <6 months; and 3) Planning to move out of the area in the next 12 
months. 
Inclusion consideration: We carefully considered including newly diagnosed patients (diagnosed <6 months) 
and have chosen to not include this subset of PLWH because: 1) Our piloted interventions did not include 
newly-diagnosed persons; 2) Newly-diagnosed individuals are treatment naïve and their adherence behaviors 
are unknown and may change frequently as they begin their ART regimen; and 3) The advent of rapid-start 
ART for newly-diagnosed individuals is currently under trial in both locations, providing an ART-initiation 
intervention for these individuals that could compromise our study results. 
 
Recruitment Plan 
We will enroll a minimum of 50% women or transgender women combined across sites and stop enrollment of 
men at 150 to meet this goal. We will track the reasons and demographic characteristics of those refusing to 
participate and examine those data as part of our ongoing monitoring and implementation evaluation activities 
(see Human Subjects). 
We will use the following strategies for recruiting PLWH for all aims of the study; these approaches 
have been successfully used by our team in past studies.94-98 Planned offline and online recruitment venues 
include the following: 
• 
Clinic and Community Outreach: Clinic social workers and peer outreach staff will distribute information 
about the study using flyers and electronic advertisement boards in clinic waiting rooms. 
• 
Community Presentations: Across sites, study staff will attend and/or make study presentations at selected 
activities and social events sponsored by community partners, e.g., community advisory boards, health 

fairs, and clinic/organization staff meetings. When making presentations, the presenting recruiter will 
provide a brief study background and invite all interested potential participants to speak to one of the study 
recruiters. 
• 
Social Networking Websites and Apps: We will recruit participants online through various websites and 
apps. We will use psychographic targeting (i.e., in-depth, publicly available consumer data such as 
interests, city) to advertise to potentially eligible individuals in the two cities. 
 
Consistent with the multi-pronged recruitment approach designed to reduce recruitment bias99, 100 and to 
minimize potential recruitment problems, our team will carefully monitor each approach. This will involve 
weekly review of recruitment data with staff to assess efforts. In this way, recruitment will be a dynamic 
process and will reach the proposed diverse group of PLWH. 
Sex and Race/Ethnicity Considerations: The HIV literature is limited in interventions among women and 
racial/ethnic minorities.102 Drs. Schnall and Batey have successfully recruited many African-American, Latino, 
and female PLWH.103-106 We plan to enroll a minimum of 50% African-American, Hispanic, Asian, and 50% 
female participants, resulting in representative findings. Sex as a biological variable will be analyzed as a 
potential effect-modifier in our outcomes. Data will be sex-stratified to explore sex-specific responses as an 
exploratory analysis (e.g., not powered to detect sex-specific differences in outcomes). 
 
 
 
Sample Size and Power Calculation 
We have estimated the statistical power for the primary outcome of viral suppression (viral load ≤ 200). We will 
recruit and enroll 300 participants (n=150 in each site) and use a 1:1 random assignment to the intervention 
arm and the control arm (i.e., 75 in each arm per site). We estimate the statistical power to examine efficacy of 
the intervention at six months for the total subjects. All power estimations are based on α=0.05 and 2-sided 
tests and following assumptions: (1) an 80% retention rate, at each follow-up assessment for each study arm 
(based on our 86.1% retention rate in New York City WiseApp trial); (2) a correlation of 0.6 of outcome 
measure for participants at different time points of assessment; (3) an intra-cluster correlation (ICC) of 0.2 of 
participants of same study sites; and (4) 75% baseline viral suppression rate (based on preliminary data of the 
BA2C study). 
For the total sample (n=300), the proposed study will have at least 80% power to detect a difference of 12% or 
greater in viral suppression. The 12% difference in viral suppression is equivalent to a small effect size 
(Cohen’s D of 0.31). Therefore, the proposed study will have sufficient power (≥80%) to detect a small effect 
size or greater. Based on findings from our BA2C and WiseApp interventions, we expect a combined 
improvement of 12% on viral suppression as compared to the control arm. 
We have also estimated the statistical power to assess sustainability of the intervention at 12 months. For this 
analysis, we will conduct a non-inferiority test of viral suppression at Month 12 as compared to Month 6. This 
study will have at least 80% power to conduct a non-inferiority test with a margin of 10%. 
Sampling approach to successfully enroll PLWH who are not optimally engaged in HIV Care: Using active and 
passive recruitment methods, the project coordinator at each site will oversee and participate in recruitment 
efforts. The study staff hired through this project and the peer-to-peer networking efforts at each site will be 
used to recruit study participants. Our study team at both sites has extensive experience in recruitment efforts 
for projects similar to the one proposed here and will be able to successfully recruit the study sample. 
 
Eligibility Screening 
Potential participants will either call, text, or email the study team via the advertised phone number or email 
address or, if contact information is gathered at the recruitment venue, be called, texted, or emailed by project 
staff. Screening will be conducted over the phone, in person for walk-ins, or electronically via REDCap. Each 
potential participant will be screened for eligibility based on the inclusion/exclusion criteria. Participants who do 
not have a recent (≤8 weeks) available viral load test result will need to complete a study blood draw. 
Participants may also sign a Release of Information (ROI) form, in-person or remotely, to allow study staff to 
access their electronic medical record (EMR) and determine eligibility based on past “no-show” visits. Forms 
completed electronically will be conducted via video conferencing such as Skype, Zoom, FaceTime using 
REDCap to collect the e-ROI and answer participant questions. Through the REDCap platform, participants will 
STATISTICALPROCEDURES 

be able to securely download a copy of the e-ROI for their records. As part of the REDCap e-consent platform 
e-ROIs will be automatically archived and securely stored in REDCap. If deemed eligible, staff will work with 
the potential participant to schedule an enrollment visit at a convenient time for the participant. 
Randomization 
Using the randomization approach described below, there will be random or minimally biased assignment of 
subjects to study arms. Randomization will be achieved through a blocked design utilizing permuted blocks of 
random sizes. The design ensures equal representation of treatment assignment across groups and protects 
the study team and investigators from easily anticipating treatment allocation.107-110 Randomization to CHAMPS 
or standard of care is 1:1. Participants will be randomized using computer-generated random numbers at 
baseline. The randomization database will be stored on a password protected computer at Columbia University 
and will only be accessible to MPI Schnall to avoid the possibility of the study sites subverting randomization 
as has been noted in previous studies.111 Following completion of the informed consent and baseline 
assessment, participants will be randomly assigned to one of two trial arms using sequentially numbered, 
opaque, sealed envelopes containing the intervention assignment, which the staff member opens at the 
moment of randomization.112 
 
Procedures 
Upon arrival at the screening visit, we will collect written informed consent prior to enrolling into the study trial 
(See Protection of Human Subjects). The informed consent form provides details of the study procedures, 
risks, benefits, site contact information, and the nature of confidentiality and voluntary participation. The 
consent process also covers information on the trial and compensation for time. 
Participants in both the intervention and control arms will visit the study sites (BAO/1917 Clinic-AL and 
Columbia University School of Nursing–NYC) at the screening, baseline, 6, and 12-month visits. Following the 
completion of the baseline study instruments, study participants in the CHAMPS intervention arm will be given 
a CleverCapTM Lite dispenser and trained on how to use it; they will also be trained by study team members on 
how to use the different features of the Wise App and receive medication reminders. Upon assignment to the 
intervention arm, a CHW is assigned to and meets with the participant as soon as possible, generally on the 
same day but no more than five business days. The CHW will deliver the interventions outline in Table 3 either 
in-person or remotely throughout the course of the study. 
Participants will be texted appointment reminders for study visits. Hard to reach participants will also be 
sent scheduling reminders. These reminders will be sent via Qualtrics, REDCap and/or encrypted e-mails from 
the study’s secure CUMC e-mail address. 
Participants in both arms will receive $40 at baseline, $50 at 6-months, and $60 at 12-months as a 
token of appreciation for their time participating in the study visits and for their blood draws. Participants 
who complete Qualitative Interviews will be compensated $40 for completing that interview.  
 
Overview of Data Collection Time Points 
Follow-up visits will be scheduled 30 days before to 30 days after the target window based on participant 
availability and site capacity. Timing of follow-up visits is scheduled to allow site flexibility while still scheduling 
follow-up visits within a reasonable time span. 
Sound Retention Efforts 
Using the retention efforts described above and in the Recruitment and Retention attachment, we are confident 
that we will retain at least 80% of our study sample at the follow-up assessments as we have done 
previously.114 
 
Data Management 
Data will be electronically collected, managed, and secured using REDCap™ by study staff trained on 
REDCap data entry, management, and security.125 Quality assurance measures, including built-in skip 
patterns, validation ranges, and logic checks, minimize data collection and data capturing errors. Quality 
control measures, including internal monitoring systems and daily and weekly reporting, are run to ensure 
expedient error correction and to optimize data integrity. 

Study Outcomes 
The study outcomes are described 
in Table 4. The primary outcome 
of the study is viral suppression 
which will be operationalized as 
viral load ≤200 at 6 months. Viral 
load is the biologic correlate of the 
ART adherence behavior; yet, to 
achieve biologic change, there 
must be change in the adherence 
behavior. As suggested through 
the “Undetectable equals 
Untransmittable,” or “U=U,” public 
health campaign,126, 127 PLWH who 
take ART as prescribed and 
achieve and maintain viral 
suppression have effectively no 
risk of sexually transmitting the 
virus to an serodiscordant 
partner.126 Our secondary and 
related outcomes include ART 
adherence measured in two ways: 
1) a single-item self-report 
measure, an empirically validated 
instrument,101 and 2) electronic pill 
bottle data, collected via the 
CleverCap bottle. The electronic 
pill bottle data provide a less subjective measure as compared to self-report. We will also measure missed 
healthcare visits using electronic medical record (EMR) data. 
Limitations and Considerations of the Study Outcome. We recognize that all the approaches for measuring 
viral suppression and ART adherence are limited. First, viral suppression does not directly measure a 
behavioral outcome but, rather, the biologic effects of the behavior. Second, the self-report measure is biased 
and has ceiling effects. Finally, the electronic pill box is limited to data collected from the intervention group. 
While this is a limitation, providing the electronic pillbox to the standard of care (control group) is likely to bias 
our intervention effects since this pillbox will, in fact, have intervention effects as we have found from our 
preliminary findings from our WiseApp trial. We closely considered each of these limitations and have, 
therefore, decided that this three-pronged (i.e., viral load, self-report, and electronic pillbox) approach which 
will provide the most rigorous approach to measuring our primary and secondary outcomes of viral 
suppression and ART adherence. 
 
Mediators 
Several mediators are hypothesized to explain the mechanisms through which the intervention is anticipated to 
improve viral suppression. Hypothesized mediators include: self-efficacy, motivation expectancies, self- 
regulation skills, and HIV-related stigma. The HIV Medication Taking Self-Efficacy Scale is also used to 
measure ART adherence self-efficacy, or the confidence to take medications in various situations.128 Motivation 
and outcome expectancies of ART adherence are assessed as three separate dimensions: attitudes, norms, 
and behavioral intentions to adhere to ART medication.118 Self-regulation skills, which include self-monitoring, 
goal-setting, and enlistment of self-incentives/plans, are also assessed.119 In prior studies of ART adherence, 
HIV-related stigma and discrimination have been strongly associated with non-adherence;14, 129 thus, we also 
measure HIV-related stigma. 
 
Moderators 
Several moderators are hypothesized to affect the strength of the intervention to yield improvements in viral 
suppression and will be explored. Hypothesized moderators include: depression, anxiety and substance use. 
Table 4. Measures and Schedule of Events 
Screening Baseline 6 mos 
12 mos 
Sociodemographic:(e.g., age, race/ethnicity, 
education, housing) 
X 
Primary Outcome Measures 
Viral Load through a blood draw 
X 
X 
X 
Secondary Outcome Measures 
ART adherence (SRSI)101 and the CleverCap 
(intervention group only) 
X 
X 
X 
Additional Outcome Measures 
X 
X 
X 
Quality of Life (PROMIS-29)115 
X 
X 
X 
HIV Symptom Index 116 
X 
X 
X 
Engagement in HIV Care 117 
X 
X 
X 
Mediators 
The HIV Medication Taking Self-Efficacy Scale 
X 
X 
X 
Motivation and outcome expectancies of ART 
adherence are assessed as three separate 
dimensions: attitudes, norms, and behavioral 
intentions to adhere to ART medication118 
X 
X 
X 
Self-regulation skills, which include self- 
monitoring, goal-setting, and enlistment of self- 
incentives/plans119 
X 
X 
X 
HIV-regulated Stigma120 
X 
X 
X 
Moderators 
Alcohol, Smoking & Substance Involvement 
Screening Test (ASSIST)109 
X 
X 
X 
Depression and Anxiety (Beck Symptom 
Inventory) 121-124 
X 
X 
X 

Depression and anxiety will be measured through the Brief Symptom Inventory, a multi-item scale of mental 
health in the last seven days that gives a global index and nine primary symptom domains, including 
depression and anxiety (α>0.80). Problem alcohol and drug use are also assessed with the Alcohol, Smoking 
& Substance Involvement Screening Test (ASSIST).130 The ASSIST consists of nine items, covering ten 
substances (used in the past four months), including: tobacco, alcohol, cannabis, cocaine, stimulants, 
inhalants, sedatives, hallucinogens, opioids, and other drugs. The ASSIST assesses frequency of use and 
associated problems for each substance with good to excellent reliability and validity. 
 
Other Important Outcomes 
Quality of life will be measured through the PROMIS-29, an NINR Common Data Element, and an instrument 
which was validated by Dr. Schnall for use with PLWH.115 HIV symptoms and management will be measured 
with the HIV Symptom Index116 and Engagement in HIV Care117 will also recorded at all assessment points. 
The blood draw at baseline will also be tested for genotyping, GSA chip and qPCR, hormone blood levels 
(Estrogen and FSH), and cytokine blood levels (IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-13, TNFα, and CRP). The 
genotyping with GSA chip and qPCR, cytokine blood level and CRP, and hormone blood tests will only be 
collected once during the course of the study, at Baseline or at the 12-month follow-up if not completed at 
Baseline. The genotyping, GSA chip and qPCR will be performed by the Feinstein Institute for Medical 
Research at Northwell Health. 
 
Data Analysis 
The distribution of all variables will be assessed, as will the correlations between all variables and the 
primary/secondary outcomes. We will assess for patterns of missing data, which are expected to be low as the 
study utilizes computer-assisted self-interview (CASI) for sensitive data, which reduces participant 
nonresponse. The primary anticipated reason for missing data is attrition due to loss to follow-up. Based on our 
preliminary studies, we are accounting for 20% attrition from randomization to the 12-month assessment. 
All multivariate analyses will be preceded by standard descriptive bivariate analyses to describe key variables 
and relationships among them. These analyses will include means, frequency tables, histograms, and 
examination of distributions. All statistical tests will be two-sided tests with the level of significance at 0.05. The 
primary hypothesis 1 will be a comparison of viral suppression (primary outcome) between CHAMPS and 
standard of care. We will also compare the drop in viral load (measured in logarithmic scale with base 10) 
between the two groups. Our secondary and related outcome is ART adherence measured in two ways: 1) a 
single-item self-report measure, an empirically validated instrument (SRSI)101 and 2) electronic pill bottle data 
which we will be collecting in the intervention group since all participants will receive a CleverCap bottle for 
their medications. All the analyses will be based on initial assignment to groups, using the intention-to-treat 
principle.131, 132 
The primary hypothesis 1 (H1) will be tested using a generalized linear mixed model (GLMM) with logit-link 
function for binary outcomes (i.e., viral suppression) or a linear mixed model (LMM) for continuous outcomes 
(i.e., viral load measured in logarithmic scale) to account for the non-independence of repeated measurements 
within individuals.133 The models will include a random intercept and fixed effects for intervention group, time, 
and interaction term of group and time which is for testing efficacy of the intervention. The model may include 
stratification variables, such as study site, age, and sex as covariates. A site by group interaction will be also 
examined and included in each model (above) if significant at the .05 level. All analyses will be tested for 
goodness-of-fit using the Wald-type test, which shows satisfactory performance for models with fewer (<5) 
covariates.134 A similar GLMM will be used to test sustainability of the intervention at month 12. For this 
analysis, we will conduct a non-inferiority test135 to compare viral suppression rate between month 12 and 
month 6. For primary hypothesis 2 (H2), testing for intervention effect on ART adherence measured by SRSI 
(secondary outcome), we will use a similar LMM as mentioned above. For electronic pill bottle data in the 
intervention group, we will also examine the trend of electronic pill bottom data over time with a GLMM which 
will include a first-order autoregressive (AR1) covariance structure, as described by Hedeker and Gibbons.133 
We will also aggregate the electronic pill bottle data at different time points (0, 6, and 12 months) and examine 
the association between the election pill bottle data and ART adherence data measured by SRSI using 
Spearman nonparametric correlation.101 Similar GLMMs or LMMs will be used for secondary outcomes, with 
GLMMs for binary outcomes and LMMs for continuous outcomes. 

Aim 2: Identify mediators and moderators of CHAMPS on study outcomes. 
 
Data Analysis 
Mediators. If the intervention arm shows improved viral suppression in greater magnitude than the standard of 
care, we will explore the extent to which this relationship works through several possible mediators, including: 
self-efficacy, motivation expectancies, self-regulation skills, and HIV-related stigma. For mediation analyses, 
we will employ MEDIATE procedures.130 MEDIATE estimates the total, direct, and indirect effects of causal 
variable(s) (xlist) on the outcome variable (yvar) through a proposed mediator variable or set of mediator 
variables (mlist), controlling for (optional) one of more variables in (covlist). MEDIATE is similar to INDIRECT136 
but allows multiple variables and also offers features for handling and coding a single multi-categorical 
variable. Inferences for indirect effects can be based on either percentile bootstrap confidence intervals or 
Monte Carlo confidence intervals. For effect modification analyses, we will add interaction terms one-by-one for 
the intervention condition and the potential moderators (e.g., depression). Significant or large interaction terms 
suggest that the effects of the intervention differ for different subgroups, as defined by the moderators. 
 
Moderators. In addition, we will study the moderators of treatment effect. This is a potentially impactful goal, 
given the gradual but assured paradigm shift in behavioral interventions from a “one-size-fits-all” approach to 
modern personalized medicine. Potential moderators in the current context are depression, anxiety and 
substance use. Regression analysis including potential moderators in the model as interaction terms will be 
conducted. If any interactions are significant, then patient characteristics can be used to better inform 
dissemination of this intervention. Moderation analysis will be performed using the R software package 
qLearn.137 
 
Missing data. Missing data may occur in the proposed study in several ways. First, it may occur due to item 
non-response. When missing data is limited to only a few items on a measure, we will prorate total scores for a 
measure by taking an average score on the measure and multiplying it by the total number of items in the 
scale. Missing data can also occur from attrition due to missed assessments or dropout from the study. Prior to 
performing any outcome analyses, we will evaluate the amount, reasons, and patterns of missing data. If the 
reason for missing data is not related to the outcome of interest, then they are considered to be missing 
completely at random, and complete case analysis will still generate unbiased estimates.138 We will conduct 
sensitivity analyses to compare estimates of treatment effects with and without multiple imputation to assess 
the effect of missing data on statistical inference. 
 
Aim 3: Guided by the Reach Effectiveness Adoption Implementation Maintenance 
(RE-AIM) framework, identify multi-level factors associated with successful 
implementation of CHAMPS to inform future implementation and scale-up. 
 
Overview 
We will use a mixed-methods, multi-stakeholder (i.e., patients, clinic and CBO staff and clinicians) process 
evaluation using a theory-based model for implementation evaluation (RE-AIM) to understand the barriers and 
facilitators to CHAMPS implementation. We will work with study participants, clinic, and CBO staff and 
clinicians to better understand how we can disseminate this CHW intervention more broadly and how this can 
be implemented as part of the HIV care delivery in the clinic setting, attending to nuances at our geographically 
diverse study sites. To that end, we have focused our RE-AIM analysis on factors which are unique to 
widespread implementation with a focus on predisposing, enabling, and reinforcing factors to program 
implementation139 as well as paradata to better understand study participants use of the app. MPI Schnall has 
conducted extensive implementation analysis of her eHealth and mHealth interventions by examining these 
factors.140-143 MPI Batey has conducted implementation work around the acceptability and feasibility of a 
workshop intervention to reduce HIV-related stigma among healthcare workers in AL and Tennessee,144 and 
he currently collaborates with Co-I Mugavero on implementation evaluation of a clinic-wide risk stratification 
with enhanced personal contacts for retention in HIV care at seven clinics in AL.145 Additionally, we have 
consulted extensively with Dr. Smith (consultant), an implementation expert,146-150 on the development of the 

Table 5. Summary of RE-AIM Dimensions and Measures 
Study Questions 
Methods, Variables, & Measures 
Reach: The absolute number, proportion, and representativeness of individuals who participate in the CHAMPS Trial. 
What percentage of the study participants use the 
intervention? 
% and characteristics of PLWH randomized to CHAMPS who use the 
intervention; Comparisons on sociodemographic variables of users and non- 
users among those randomized to intervention arm 
What percentage of the CHW visits did study 
participants attend in person or through the App? 
% and characteristics of PLWH randomized to CHAMPS who attended their 
CHW visit 
Were participants representative of target 
population? 
% and characteristics of eligible participants who joined the study and those 
who didn’t; Sociodemographic comparisons between CHAMPS participants 
and eligible study participants who did not join the study 
Efficacy: The impact of an intervention on outcomes including potential negative effects, quality of life. 
Did the intervention achieve primary and 
secondary outcomes? 
Between-group comparisons on primary and secondary outcomes (Aim 1) 
Did it produce unintended adverse 
consequences? 
Review notes from participant study withdrawal, Notifications to the IRB about 
participant complaints 
What effect did the mediators and moderators 
have on the primary and secondary outcomes? 
Data analyzed in Aim 2 
Adoption: The absolute number, proportion, and acceptability of CHAMPS; proportion of eligible patients that enroll. 
Did the intervention help the organization address 
its mission, values, and priorities? 
Key informant interviews with clinic staff, research staff, CHW, and 
administration - descriptive, interpretative analysis for key themes 
Implementation: At the setting level, includes consistency of delivery and predisposing, enabling, and reinforcing factors. At the 
individual level, implementation refers to individual’s use of strategies.152 
Were intervention components delivered as 
intended? 
Paradata Analysis –App use by component 
What barriers to implementation were identified 
and how were they addressed? 
Key informant interviews with study staff; In-depth interviews with study 
participants.  - descriptive, interpretative analysis for key themes 
What enabling (facilitating) factors were required 
to support the intervention? 
Project meeting minutes 
Interviews with stakeholders 
Maintenance: Individual – Understanding Use of the App over time. 
Did the intervention produce lasting effects at 
individual level? 
Long-term efficacy of CHAMPS intervention over 12 months 
Is there the potential for sustaining CHAMPS over 
time? 
Key informant interviews with clinic staff, research staff, CHW and clinicians, 
CBO staff and study participants. 
How did the intervention evolve? 
Project meeting minutes; Paradata 
implementation evaluation for this proposal; Dr. Smith will provide oversight, along with MPIs Schnall and 
Batey, for all implementation activities. 
 
Process Evaluation Outcomes 
The RE-AIM evaluation dimensions and associated measures in our study are summarized in Table 5. In 
addition to testing the Efficacy of CHAMPS, we will concurrently measure the four remaining RE-AIM 
dimensions151 as follows: 
 
Reach –1) percent and demographic and clinical characteristics of those who joined the study based on the 
current national statistics of PLWH, and 2) percent and demographic and clinical characteristics of those 
randomized to the intervention who attended visits with the CHW and who used the App compared to those 
who did not. 
Adoption – We will recruit a random sample of study participants post-intervention to assess acceptability and 
perceived usefulness of CHAMPS (see Sample Interview Guide – Table 6) and recruitment logs to calculate 
the percent and representativeness of patients that agree to participate in the study. Interviews will be collected 
until saturation is reached, but we estimate a total of 60 participants (40% of study sample). 
 
Table 6. Follow-up Sample Interview Guide 
• Describe your general perceptions of CHAMPS and its usefulness for 
helping with ART adherence. 
• How helpful was CHAMPS for improving your ART adherence? 
• How helpful was CHAMPS for improving your viral suppression? 
• What would you change or improve about CHAMPS? 
• How did CHAMPS help you gain information about your ART adherence? 
• How did CHAMPS help you gain information about viral suppression? 
• How comfortable were you in using the App in social settings? Probe: 
where and when did you use it mostly? 

 
Implementation and Maintenance will be 
evaluated through interview data with the 
study participants (N=60) and clinic staff and 
research staff (N=15), CHW (N = 2 
Birmingham, 2 NYC), and clinic 
administration (N = 2 Birmingham, 2 NYC) (Table 6). We will use post-intervention testing interviews with study 
participants and clinic administration and staff to assess acceptability and perceived usefulness of the 
CHAMPS intervention at the 6-month and 12-month follow-up timepoints. 30 participants will be randomized for 
interviews at each time point; each site will conduct 15 interviews per time point. Interviews will be collected 
until saturation is reached. All in-depth interviews will be audio-recorded with two digital recorders to safeguard 
against mechanical failure. The study team will also take field notes. Participants will be compensated $40 for 
completing these interviews.  
At the individual level, we will understand participants’ use of the App over time through 
the collection of paradata153 (Table 7). Paradata is considered “free” in that it does not 
require any additional effort from the user.154 To explore barriers and facilitators to 
widespread implementation of CHAMPS, we will collect data during the intervention, 
implementation, and after the trial has ended. 
Data Analysis 
Quantitative Data Analysis of RE-AIM Dimensions 
We will use descriptive statistics to characterize process evaluation outcomes around RE-AIM (e.g., Reach: 
penetration; Adoption: representativeness of persons living with the disease). We will examine Reach and 
Implementation as a function of individual (e.g., perceptions of barriers to care) and organizational level factors 
(e.g., provider type). Variance components analysis155 on Reach and Implementation outcomes will be used to 
determine the relative percentages of the overall implementation variability being introduced at each level. 
Multi-level regression models156 will be employed to assess the unique contribution of individual-level factors 
on outcomes. 
 
Paradata Data Analysis 
The primary paradata that will be collected is shown in Table 7. From this data, we will derive the following use 
of data for each session: duration on each page, page progression through the application, time from login to 
result, and total time from login to logout. We will analyze the data on multiple scales and perspectives: 
individual-level (i.e., user-level), application-level, page-level, session-level, and how these differ by 
demographic characteristics, technology use, and outcomes measures. Additionally, we will measure the 
amount in bytes of user data transmitted. Importantly, longitudinal analysis will determine if user-experience 
changes with repeated use. The paradata collected from each page will be analyzed to generate a “heatmap” 
of user-interaction (i.e., the distribution of activity for each link/button). Use of the heatmap will inform user 
duration on each page of the application and user interaction with the app content, the contact pages, and the 
help page. We will explore usability issues with consideration for how many times users accessed help and 
what page of the app referred them to the help, implying the need for clarification. We will analyze differences 
in the aggregated data by demographic group (e.g., age) to allow us to better understand engagement with the 
intervention and potential facilitators and barriers to App use. 
Qualitative Data Analysis of Interview Data 
The study team will meet and review transcripts and notes from the interviews. Drs. Schnall, Batey, and Kay143, 
157-163 have extensive experience in qualitative analysis and will work with two research assistants to code the 
transcripts. Field notes and transcripts will be analyzed by the researchers using NVivo™ (QSR International, 
Victoria, Australia) software. Participants’ statements will be captured using memoing and then sorted into the 
categories of interest. Open coding will be used to develop initial data categories. Some codes will be derived 
from the questions included in the interview and other codes will emerge from themes and patterns identified in 
the narratives. An initial set of codes will be independently generated by two coders. Codes will then be 
compared and synthesized to result in shared coding categories and sub-categories, all with definitions, 
inclusion and exclusion criteria, and examples. Coders will discuss discrepancies until they reach consensus. 
Findings will guide modifications of CHAMPS, if warranted. 
Scientific Rigor: The team will adhere to qualitative research processes to ensure the credibility, confirmability, 
dependability, and transferability of the qualitative data from these analyses. To support the credibility of the 
data, we will conduct peer debriefing. We will also use “member checks,” i.e., sharing of initial data 
 How often did you use the App in a typical week? Would you recommend 
it to a friend? 
 Did you stop using the App altogether at some point? (If yes) Why? 
 Describe the usefulness of the reminders to take your medication and 
attend the meeting with your CHW. 
 Is there the potential for sustaining CHAMPS over time (clinic 
administration) 
Table 7. Paradata 
Collected for Each 
App Use 
1. Unique Code 
2. Page accessed 
3. Time stamp 
4. Device Type 

interpretations with participants to ensure accurate interpretations. Triangulation of findings, along with 
reflexivity, will enhance the confirmability of the interpretations. The investigators will carefully record an audit 
trail and keep extensive field notes to facilitate transferability of study findings into other contexts. 
 
Risks to Human Subjects 
Research Environment and Commitment to Protection of Human Subjects: 
Columbia University Irving Medical Center (CUIMC), Birmingham AIDS Outreach (BAO), and University of 
Alabama at Birmingham (UAB) are committed to safeguarding the rights and welfare of human subjects in all 
research activities, and all have a current Assurance of Compliance with the Office for Human Research 
Protections (OHRP). The investigators will follow all required policies related to the protection of human 
subjects. All investigators have fulfilled human subjects protection and Health Insurance Portability and 
Accountability Act (HIPAA) training requirements (including CITI basic and refresher courses, Good Clinical 
Practices, and conflicts of interest) and are up-to-date with these certifications. The study described in this 
application will be reviewed and approved by Western Institutional Review Board (IRB), and we will seek 
reliant review at UAB and BAO (to fulfill the single IRB policy) prior to any participant recruitment or data 
collection activities. All prospective participants will be fully informed of the intent of the study and expectations 
of participants prior to enrollment using an IRB-approved informed consent form. 
 
Human Subjects Involvement, Characteristics, and Design 
Characteristics of the Population: 
The trial will involve the recruitment and retention of men and women (n=300) with HIV infection who are virally 
unsupressed in New York City (NYC) and Birmingham, Alabama. Study volunteers must meet general criteria 
to be eligible for further screening for participation in the study. In most cases, this information will be acquired 
during a telephone interview prior to a screening/consent visit. The inclusion and exclusion criteria have been 
carefully selected to enroll the most appropriate study population while also ensuring the generalizability of the 
findings. All participants will engage in a 6-month randomized adaptive intervention and will be followed for an 
additional six months following the intervention period. The total study duration will be 12 months. 
 
Potential participants will be recruited primarily from partnering HIV specialty clinics in NYC and Birmingham. 
Persons living with HIV (PLWH) will be included if they meet the following eligibility criteria: 
 
There are limited inclusion criteria to support the generalizability of our findings. 
Participants. Inclusion criteria: 
1) Able to speak, read, and write in English or Spanish; 
2) Aged ≥18 years; 
3) Willing to participate in any assigned arm of the intervention; 
4) Having been diagnosed with HIV ≥6 months ago; 
5) Have an HIV-1 RNA level >200 copies/mL, or at least one “no-show” visit in the past 12 months, or report 
either not being virally suppressed in the past 12 months or being virally unsuppressed in the past 12 
months; 
6) Own a smartphone; and 
7) Ability and willingness to provide informed consent for study participation and consent for access to medical 
records. 
Participants are not eligible if they meet any exclusion criteria: 
1) Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment; 
2) Terminal illness with life expectancy <6 months; 
3) Planning to move out of the area in the next 12 months. 
 
Our study participants will be recruited from two geographic locations: Birmingham, Alabama and NYC. 
Electronic medical record (EMR) data from the UAB 1917 Clinic, a Ryan-White funded, patient-centered HIV 
primary and specialty medical clinic. suggests that at least 1,150 PLWH receiving care at this site during 2018 
would meet study inclusion criteria based on viral load results. In NYC, the Comprehensive Health Program of 
New York-Presbyterian/Columbia (NYP-CHP) is a Ryan White funded, bilingual, patient-centered clinic that 
emphasizes sexual health, hepatitis management, and HIV care. It primarily serves Upper Manhattan and the 
South Bronx where residents are disproportionately affected by HIV. NYP-CHP’s large multidisciplinary team 
RISKS, BENEFITS & MONITORING 

provides HIV care to a population of more than 2,300 children, adolescents, and adults through more than 
16,000 visits per year. NYP-CHP clients are 58% male, 40% female, and 2% male to female transgender. We 
estimate that at least 1,200 PLWH receiving care at the NYC site would meet our inclusion criteria and would 
be eligible for enrollment. 
If we have trouble recruiting, we have access to additional community sites in both NYC and Birmingham as 
well as entities associated with our academic medical centers with similar demographics. In addition, all 
members of the investigative team are involved in their institutions’ respective and local Centers for AIDS 
Research (CFARs), which can be utilized to assist with study recruitment via patient registries. Each member 
of the investigative team is well known in their respective communities. 
 
Study Procedures, Materials, and Potential Risks 
Study Procedures and Materials: 
All materials for the proposed study obtained from the participants will be in the form of specimens, EMR 
information, and data. Each Multiple Principal Investigator (MPI), Dr. Rebecca Schnall at CUIMC and Dr. Scott 
Batey at UAB, will be responsible for ensuring all information is collected according to the study protocol. 
Information used to identify potentially eligible participants will be obtained using the UAB 1917 Clinic and the 
NYP-CHP EMR systems. We will also use patient-reported data obtained after consent. Trained and certified 
professional staff will obtain all data according to detailed study protocols. Data will be collected directly from 
study participants and their respective EMR and used specifically for research purposes. 
 
The following human subjects-related data elements will be collected for this study with the source(s) of 
information noted: 
• 
Participant demographic and clinical characteristics including age, sex, gender, race/ethnicity, 
employment status, and ART adherence (self-report) 
• 
Clinical diagnoses, clinical HIV lab values (CD4 and viral load), medication history, comorbid health 
conditions, and primary care visit data (electronic medical records) 
• 
Laboratory measured values of CD4 and viral load (study-specific blood draw) 
• 
Notes from the Community Health Worker encounters with the study participants 
• 
Usage data captured through the WiseApp and the electronic pill bottles (CleverCap) 
 
Our study team is extremely prudent in keeping subject data secure and confidential. All laboratory specimens, 
evaluation forms, reports, and other records will be identified by a unique coded number to maintain participant 
confidentiality. The material, records, and data obtained through participation in the study will be specific for 
research purposes. Existing health records may be used with the permission of the participants. Materials will 
be obtained by trained staff at each study site. Data will be stored using REDCap (Research Electronic Data 
Capture) at each respective performance site, and, then, the completely deidentified data will be merged at 
CUIMC. All laboratory specimens will be identified only by the identification number. The code linking the 
participant identification number to subject identifying information (name, address, etc.) is maintained at the 
study sites through REDCap, and only authorized site personnel have access to the code. Limited individually 
identifiable private information is collected that is essential for processing participant payments and for analysis 
purposes. 
 
Potential Risks: 
There is no more than a minimal risk associated with any of the proposed study activities. The study 
activities meet the general definition found in Subpart A (46.102) that the probability and magnitude of 
harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological assessments or 
tests. 
 
The risks of participating in this study are few. Potential risks are those related to venipuncture, discomfort 
with study interview questions, and potential breaches of confidentiality. It is possible that certain questions 
on the survey may make participants feel uncomfortable, but participants are free to decline to answer any 
questions. Additionally, clinical study sites have co-located mental health and/or counseling services that 
may be consulted should a participant enter crisis. Participation in research can involve loss of privacy. All 
study data will be maintained on CUIMC, UAB, and BAO servers that are secure and HIPAA compliant. All 
signed consent forms, study data, and payment receipts used in this study will be kept in locked files at both 
sites which only the investigators can access. We will also receive a Federal Certificate of Confidentiality 
which will protect against attempts by law enforcement or other government agencies to access our data. 

Venipuncture: 
There is a small risk of local hematoma or infection associated with blood sampling. On rare occasions, 
drawing blood can cause dizziness, presyncope, and even syncope. 
 
Confidentiality and Privacy: 
The use of questionnaires, interviews, and collection of personal medical information poses a risk to 
confidentiality and privacy and may cause embarrassment. 
 
Adequacy of Protection Against Risks 
Informed Consent and Assent: 
Recruitment for participation in the study will occur following IRB approval. Recruitment strategies will be 
developed in collaboration with local clinics and community-based organizations (see Recruitment and 
Retention Plan). Study staff at both sites will complete an in-person training to standardize the recruitment 
and consenting procedures. The consenting process is part of the initial study visit, which will take place in a 
quiet meeting room. Volunteers may request a copy of the consent form in advance, and they will be given 
one at the start of the orientation; time is allowed for review of the consent form. Volunteers then meet with 
a member of the research team to a) have the study explained in detail; b) discuss their reasons and 
motivation for wanting to participate to determine whether they are realistic; c) discuss any practical 
problems (e.g., scheduling conflicts, vacations) that could interfere with participation; d) have their questions 
answered; and e) demonstrate their ability to provide informed consent by describing their understanding of 
the major study goals and what is expected of them if they choose to participate. 
 
Participants are given a signed copy of the consent form and a signed copy is maintained in the study chart for 
each participant. HIPAA authorization is included in the consent form. Each MPI (Dr. Schnall and Dr. Batey) 
will have the responsibility of ensuring that research personnel are prepared to convey information to 
participants specific to the study protocol. The individual is informed of the purpose of the study, potential 
medical and social risks of participation, their right to withdraw at any time, and compensation. If willing to 
participate, the volunteer and a study team member will sign the document. 
 
Protections Against Risk: 
The inclusion/exclusion criteria are designed to assure that participants at highest risk for adverse events 
(AEs) are excluded while preserving study generalizability. In addition, the specific measures to decrease risks 
on the study procedures are detailed below. 
 
Venipuncture: 
The risks of hematoma and infection are minimized by having trained clinical personnel perform the 
procedures using sterile techniques. 
 
Confidentiality and Privacy: 
Risks will be minimized by not including personal identifying information on the forms, when possible, and by 
conducting interviews and collection of personal information in a private setting. Reminder text messages will 
make no mention of HIV. All data will be collected using unique patient identification codes. All laboratory 
specimens, evaluation forms, reports, and other records will be identified by a coded number to maintain 
participant confidentiality. All records will be stored in a locked file cabinet. Study data from all sites will be 
collected and managed using REDCap. REDCap is a secure web application designed to support data capture 
for research studies, providing user-friendly web-based case report forms, real-time data entry validation (e.g., 
for data types and range checks), audit trails, and a de-identified data export mechanism to common statistical 
packages (SPSS, SAS, Stata, R/S-Plus). REDCap data collection projects rely on a thorough study-specific 
data dictionary defined in an iterative self-documenting process by all members of the research team. This 
iterative development and testing process results in a well-planned data collection strategy for individual 
studies. REDCap also includes a powerful tool for building and managing online surveys. The research team 
can create and design surveys in a web browser and engage potential respondents using a variety of 
notification methods. REDCap is flexible enough to be used for a variety of types of research and provides an 
intuitive user interface for database and survey design and data entry. Lastly, clinical information will not be 
released without written permission of the participant, except as necessary for monitoring by the IRB or the 
National Institutes of Health (NIH). 
 
Unexpected and Serious Adverse Event Reporting: 

A detailed monitoring plan will be included as part of the study protocol, submitted to the IRB, and reviewed 
and approved by the funding Institute and Center before the study begins. Prior to initiation of the study, 
agreement about the data safety monitoring plan will be confirmed to ensure the safety of subjects and the 
validity and integrity of the data. The research coordinator at each site will report serious adverse events 
(SAEs) that are unexpected and study-related immediately to a study physician who will convey this 
information to the study team, IRB, and NIH. All AEs and SAEs will be captured, reports will be completed, and 
information will be entered into the study database. A safety report will detail all serious and unexpected AEs 
or other unanticipated problems that involve risk to study participants or others and whether these appeared to 
be related to the study-based interventions or research assessment protocols. If the study team, CUIMC or 
UAB IRB, or NIH has concerns regarding SAEs, the Western IRB will be notified and a copy of the safety 
summary will be filed with both IRBs. Actions taken by the Western, CUIMC, or UAB IRB offices in response to 
AE concerns will be reported to the NIH. All AEs will be reviewed every six months, or sooner, with the 
designated safety officer. 
 
Vulnerable Subjects: 
Economically and/or educationally disadvantaged persons will be enrolled. While this group is considered a 
vulnerable population, the study team has considerable experience enrolling these participants. As these 
groups carry the burden of the majority of HIV incidence in both study sites and demonstrate considerable 
challenges with achieving optimal HIV health outcomes, it is important that they are not excluded from 
participation in this study. Additionally, our study will analyze the potential impact of the intervention(s) on racial 
and ethnic groups, perhaps providing new information on the disproportionate impact of HIV felt by these 
populations. 
 
The study will be conducted according to Good Clinical Practice (GCP) guidelines, the U.S. Code of Federal 
Regulations (CFR) Title 21 CFR (Part 50 – Protection of Human Subjects and Part 56 – Institutional Review 
Boards) and the Declaration of Helsinki. This protocol will be submitted to the IRB at the Western IRB for 
approval and will be reliantly reviewed at UAB. The informed consent of each subject will be obtained in 
accordance with 21 CFR Part 50 and the Declaration of Helsinki before protocol-specified procedures are 
carried out. 
 
A study research assistant will obtain the participant’s written informed consent prior to any study-related 
procedures. Consent will be documented by the dated signature of the subject. The signature confirms that the 
consent is based on information that has been understood. Each subject's signed informed consent form will 
be kept in secure files by the investigators for possible inspection by regulatory authorities. 
 
Potential Benefits of Proposed Research to the Participant and Others 
 
The potential benefits to an individual participant in the study are not known. The potential benefits of the study 
to others could be considerable. If our hypotheses are true, this study will make a significant contribution 
towards helping PLWH who are virally unsuppressed improve adherence to their antiretroviral therapy (ART) 
regimen and ultimately achieve viral suppression. If the intervention is effective, the direct benefit to 
participants is the increased ART adherence, retention in HIV primary care, and viral suppression. Increasing 
ART adherence for PLWH will yield significant benefits in current efforts to achieve HIV elimination. Possible 
risks (i.e., discomfort answering questions, potential confidentiality breaches) are outweighed by the new 
knowledge gained regarding increasing ART adherence among PLWH. 
 
Importance of Knowledge to be Gained 
 
The knowledge gained from this research will enable the scientific community, clinicians, and PLWH to 
improve the HIV care continuum in the US. Consistent with the priorities of RFA-NR-20-002, findings from 
this study will focus on the efficacy of an adaptive Community Health Worker intervention to improve HIV 
care among PLWH. 
 
Data and Safety Monitoring Plan 
Data and Safety Monitoring Plan is attached separately. 
 
ClinicalTrials.gov Requirements 
This trial will be registered with ClinicalTrials.gov. 

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