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

 
 
 
 
 
Community Health Worker And MHealth to ImProve Viral Suppression 
(CHAMPS Pilot)   
 
 
Rebecca Schnall, PhD, MPH, BSN, FAAN, FACMI 
NCT05938413 
Protocol Version 03/22/2024 

 
 
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, leading 
to poor health outcomes.6 In response, the US government prioritized 55 areas with a substantial burden of 
HIV in the Ending the HIV Epidemic (EHE) plan.7 These suboptimal HIV health outcomes occur at a time 
when clinicians have limited time and the US healthcare system remains fragmented,8 further exacerbating 
the challenges inherent in the lives of underserved, marginalized groups, such as PLWH.9 Therefore, the 
development and evaluation of interventions using a cadre of community health workers (CHW) holds 
promise for addressing these challenges in the US.10, 11 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.12-17 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.18, 19 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.20-22 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.23-25 Therefore, developing effective interventions to enhance ART adherence is essential. 
CHW and related models have demonstrated positive impact for medication support, seeking treatment, 
and clinic-patient relationships. Interventions with CHW have shown promise both globally26-28 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.29 In another domestic study of an online CHW social support ART 
adherence intervention, substance using participants reported significantly higher overall ART adherence.30 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.31 
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.32-34 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,35, 36 e.g., HIV-related stigma, quality of life, 
psychosocial distress/stress, adherence medication and skills, and adherence self-efficacy. Prior work 
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.37 In our BA2C RCT, 
CHW delivered an intervention adapted from ARTAS, a CDC evidence-based intervention (EBI) show 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 intervention38, 39 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 CleverCap App. 
The ubiquitous nature of mHealth technologies in daily life creates opportunities for health behavior 
management tools that were not previously possible40 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,41, 42 which is particularly relevant to PLWH since a majority represent underserved and minority 
groups.43-45 mHealth technology is especially important in the context of improving ART adherence in PLWH.46 
There is preliminary evidence that mHealth technology is a feasible, attractive, accessible, and effective 
platform for improving ART adherence in PLWH.47-49 Eighty-one percent (81%) of Americans are smartphone 
STUDY PURPOSE AND RATIONALE 

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Eligibility Criteria for Participants 
Inclusion criteria:1) Able to speak, read, and write in English or Spanish, 2) Aged ≥18 years; 3) Willing to 
provide a valid form of identification for verification; 4) Willing to participate in any assigned arm of the 
intervention; 5) Having been diagnosed with HIV ≥6 months ago; 6) Have an HIV-1 RNA level >50 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; 7) Own a smartphone; 8) Ability and willingness to 
provide informed consent for study participation and consent for access to medical records; and 9) Live in the 
United States.  
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 <3 months; 
and 3) Planning to move out of the country in the next 3 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, providing an ART-initiation intervention for these 
individuals that could compromise our study results. 
 
Recruitment Plan 
We will enroll a minimum of 25% women or transgender women and stop enrollment of men at 30 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.69-73 Participants will be recruited website postings, 
including Craigslist, Facebook, Instagram, Grindr, Jack’d, and Poz. 
Email: If interested volunteers send an email to the study email inbox inquiring about the study, the study 
staff will re-direct them by providing them the office number so they can call and speak with the study team to 
get more information about the study. 
Consistent with the multi-pronged recruitment approach designed to reduce recruitment bias74, 75 
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.76 Dr. Schnall has successfully recruited many African-American, Latino, and female 
PLWH.77-80 We plan to enroll a minimum of 50% African-American, Hispanic, Asian, and 25% 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). 
 
 
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 Pilot 
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 remotely 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 

 
 
Sample Size and Power Calculation 
Since this is a pilot study, we will be collecting a sample size to estimate the effect size for future efficacy trials 
and to establish the feasibility of this intervention.  
Sampling approach to successfully enroll PLWH who are not optimally engaged in HIV Care: Using active and 
passive recruitment methods, the project coordinator will oversee and participate in recruitment efforts. The 
study staff hired through this project and the peer-to-peer networking efforts will be used to recruit study 
participants. Our study team 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. Screening will be conducted over the phone 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 DBS (dried blood spot) collection as 
part of a screening visit. Participants may also sign a Release of Information (ROI) form to allow study staff to 
access their electronic medical record (EMR) and determine eligibility based on past viral load data and “no-
show” visits. Forms completed electronically will be conducted via video conferencing such as Skype, Zoom, 
or FaceTime using REDCap to collect the e-ROI and answer participant questions. Through the REDCap 
platform, participants will 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.81-84 Randomization to CHAMPS 
Pilot 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 PI Schnall. Following completion of the informed consent and baseline 
assessment, participants will be randomly assigned to one of two trial arms in REDCap.  
 
Procedures 
All study visits will occur remotely via Zoom. Staff members will collect digital 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 study and compensation for time. 
Participants in both the intervention and control arms will complete remote visits at the baseline and 3-
month follow-up. Following the completion of the baseline study instruments, study participants in the 
CHAMPS Pilot intervention arm will be mailed 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 remotely throughout the course of the study. Participants will also 
be provided the opportunity to complete a follow-up interview at their follow-up visit. Follow-up interviews will 
be recorded via Zoom and will be semi-structured. Study staff members will take field notes and interview 
recordings will be transcribed prior to analysis.  
Dried Blood Spot (DBS) kits will be used to measure participant viral load. DBS kits will be shipped to 
participants, allowing them to collect their sample in their home or other secure environment. Instructions will 
be included with the kit, including information about how to collect the dried blood spot and how to mail the 
sample back to the research team. Participants will be instructed to call research staff to confirm they have 
STATISTICAL PROCEDURES 

received the kit, have collected the sample, and have mailed the sample back, as well as if they have any 
questions. 
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 and $50 at 3-months as a token of 
appreciation for their time participating in the study visits and for their dried blood spot samples. 
Participants electing to complete follow-up qualitative interviews will receive an additional $35. 
 
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.85 
 
Data Management 
Data will be electronically collected, managed, and secured using REDCap™ by study staff trained on 
REDCap data entry, management, and security.86 Quality assurance measures, including built-in skip 
patterns, validation ranges, and logic 
checks, minimize data collection and data 
capturing errors. Quality control measure, 
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 ≤50 at 3 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,87, 88 PLWH 
who take ART as prescribed and achieve 
and maintain viral suppression have 
effectively no risk of sexually transmitting the 
virus to a serodiscordant partner.87 Our 
secondary and related outcomes include 
ART adherence measured in two ways: 
1) a single-item self-report 
measure, an empirically validated 
instrument,89 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 
Table 4. Measures and Schedule of Events 
Screening Baseline 3 mos 
2
o
s
Sociodemographic:(e.g., age, race/ethnicity, 
education, housing) 
X 
Primary Outcome Measures 
Viral Load through dried blood spot kit 
X 
X 
Secondary Outcome Measures 
ART adherence (SRSI)89 and the CleverCap 
(intervention group only) 
X 
X 
Additional Outcome Measures 
X 
X 
Quality of Life (PROMIS-29)90 
X 
X 
HIV Symptom Index91 
X 
X 
Engagement in HIV Care92 
X 
X 
Mediators 
The HIV Medication Taking Self-Efficacy Scale 
X 
X 
Motivation and outcome expectancies of ART 
adherence are assessed as three separate 
dimensions: attitudes, norms, and behavioral 
intentions to adhere to ART medication93 
X 
X 
Self-regulation skills, which include self- 
monitoring, goal-setting, and enlistment of self- 
incentives/plans94 
X 
X 
HIV-regulated Stigma95 
X 
X 
Moderators 
Alcohol, Smoking & Substance Involvement 
Screening Test (ASSIST)83 
X 
X 
X
Depression and Anxiety (Beck Symptom 
Inventory)96-99 
X 
X 
X

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.100 Motivation 
and outcome expectancies of ART adherence are assessed as three separate dimensions: attitudes, norms, 
and behavioral intentions to adhere to ART medication.93 Self-regulation skills, which include self-monitoring, 
goal-setting, and enlistment of self-incentives/plans, are also assessed.94 In prior studies of ART adherence, 
HIV-related stigma and discrimination have been strongly associated with non-adherence;62,101 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. 
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).102 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, and an instrument which was validated by Dr. 
Schnall for use with PLWH.90 HIV symptoms and management will be measured with the HIV Symptom 
Index91 and Engagement in HIV Care92 will also recorded at all assessment points.  
 
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 3-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 Pilot 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)89 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.103, 104 
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.105 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, 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.106 A 
similar GLMM will be used to test sustainability of the intervention at month 3. For this analysis, we will 
conduct a non-inferiority test107 to compare viral suppression rate between month 3 and baseline. 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.105 We will also aggregate 
the electronic pill bottle data at different time points (0 and 3 months) and examine the association between 
the election pill bottle data and ART adherence data measured by SRSI using Spearman nonparametric 
correlation.89 Similar GLMMs or LMMs will be used for secondary outcomes, with GLMMs for binary outcomes 
and LMMs for continuous outcomes. 
 
Aim 2. Conduct follow-up interviews to assess the barriers and facilitators to the recruitment, enrollment 
and retention procedures and to understand the acceptability of the intervention. 
 
Data Analysis 
Qualitative Data Analysis of Interview Data 
The study team will meet and review transcripts and notes from the interviews. Dr. Schnall has 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 Pilot, 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 
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) is committed to safeguarding the rights and welfare of 
human subjects in all research activities, and has 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 the Columbia University Institutional Review 
Board. 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=40) with HIV infection who are virally 
unsuppressed in the United States. 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 remote visit. The inclusion and exclusion criteria have been carefully 
RISKS, BENEFITS & MONITORING 

selected to enroll the most appropriate study population while also ensuring the generalizability of the findings. 
All participants will engage in a 3-month randomized adaptive intervention. The total study duration will be 3 
months. A maximum of 25 follow-up interviews will be conducted, with an oversampling of participants in the 
intervention group. 
 
Potential participants will be recruited online using social media platforms. Persons living with HIV (PLWH) 
will be included if they meet the following eligibility criteria: 
 
There are limited inclusion criteria in order 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 provide a valid form of identification for verification; 
4) Willing to participate in any assigned arm of the intervention; 
5) Having been diagnosed with HIV ≥6 months ago; 
6) Have an HIV-1 RNA level >50 copies/mL, or report either not being virally suppressed in the past 12 
months or being virally unsuppressed in the past 12 months; 
7) Own a smartphone;  
8) Ability and willingness to provide informed consent for study participation and consent for access to medical 
records; and 
9) Live in the United States 
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 <3 months; 
3) Planning to move out of the country in the next 3 months. 
 
Our study participants will be recruited nationally.  
 
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. Principal Investigator (PI), Dr. Rebecca Schnall, 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 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 (viral load), medication history, comorbid health 
conditions, and primary care visit data (electronic medical records) 
• 
Laboratory measured values of viral load (dried blood spot collection) 
• 
Notes from the CHW 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. Data will be stored using REDCap (Research Electronic Data Capture). 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 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 dried blood spot collection, 
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, mental health and/or counseling services are available should a 
participant enter crisis. Participation in research can involve loss of privacy. All study data will be maintained 
on CUIMC servers that are secure and HIPAA compliant. All signed consent forms, study data, and payment 
receipts used in this study will be kept in a secured server 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. 
 
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. Study staff will complete a 
training to standardize the recruitment and consenting procedures. The consenting process is part of the 
initial study visit, which will take place remotely over Zoom. Volunteers will meet remotely 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 provided with a digital 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. The PI, Dr. Schnall, 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. 
 
Confidentiality and Privacy: 
Risks will be minimized by not including personal identifying information on the forms, when possible, and by 
conducting remote 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 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: 
The study team will regularly review the data to ensure the integrity and safety of the participants. The 
research coordinator 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, IRB, or NIH has concerns regarding SAEs, a copy 
of the safety summary will be filed with the IRB. Actions taken by CUIMC 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 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 for approval. 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 member will obtain the participant’s digital 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 
The study team will regularly review the data to ensure the integrity and safety of the participants.

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