Mobile Text Messaging to Improve Medication Adherence and Viral Load in a Vulnerable Canadian Population Living With Human Immunodeficiency Virus: A Repeated Measures Study

Background Combination antiretroviral therapy (cART) as treatment for human immunodeficiency virus (HIV) infection is effective and available, but poor medication adherence limits benefits, particularly in vulnerable populations. In a Kenyan randomized controlled trial, a weekly text-messaging intervention (WelTel) improved cART adherence and HIV viral load (VL). Despite growing evidence for short message service (SMS) text-message interventions in HIV care, there is a paucity of data utilizing these interventions in marginalized or female cohorts. Objective This study was undertaken to assess whether the standardized WelTel SMS text-message intervention applied to a vulnerable, predominantly female, population improved cART adherence and VL. Methods We conducted a repeated measures study of the WelTel intervention in high-risk HIV-positive persons by measuring change in VL, CD4 count, and self-reported adherence 12 months before and 12 months after the WelTel intervention was introduced. Inclusion criteria included VL ≥200 copies/mL, indication for treatment, and meeting vulnerability criteria. Participants were given a mobile phone with unlimited texting (where required), and weekly check-in text messages were sent for one year from the WelTel computer platform. Clinical data were collected for control and intervention years. Participants were followed by a multidisciplinary team in a clinical setting. Outcomes were assessed using Wilcoxon signed ranks tests for change in CD4 and VL from control year to study end and mixed-effects logistic regressions for change in cART adherence and appointment attendance. A secondary analysis was conducted to assess the effect of response rate on the outcome by modeling final log10 VL by number of responses while controlling for mean log10 VL in the control year. Results Eighty-five participants enrolled in the study, but 5 withdrew (final N=80). Participants were predominantly female (90%, 72/80) with a variety of vulnerabilities. Mean VL decreased from 1098 copies/mL in the control year to 439 copies/mL at study end (P=.004). Adherence to cART significantly improved (OR 1.14, IQR 1.10-1.18; P<.001), whereas appointment attendance decreased slightly with the intervention (OR 0.81, IQR 0.67-0.99; P=.03). A response was received for 46.57% (1753/3764) of messages sent and 9.62% (362/3764) of text messages sent were replied to with a problem. An outcome analysis examining relationship between reply rate and VL did not meet statistical significance (P=.07), but may be worthy of investigating further in a larger study. Conclusions WelTel may be an effective tool for improving cART adherence and reducing VLs among high-risk, vulnerable HIV-positive persons. Trial Registration Clinicaltrials.gov NCT02603536; https://clinicaltrials.gov/ct2/show/NCT02603536 (Archived by WebCite at http://www.webcitation.org/6qK57zCwv)


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if ofoine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The target group is clearly stated: "Vulnerable Canadian Population with HIV" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Human involvement is outlined as follows: 1.) text messages were received "from a clinic nurse" 2.) "Participants were followed by a multidisciplinary team in a clinical setting."

1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT
Mention how participants were recruited (online vs. ofoine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional ofoine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Participants were seen at interval appointments face-to-face by a team of doctors, nurses, pharmacists, social workers, etc as is expressed below: "Participants were followed by a multidisciplinary team in a clinical setting."

1b-iv) RESULTS section in abstract must contain use data
Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Participants enrolled/assessed: "Eighty-five participants enrolled in the study with five withdrawing resulting in 80 participants for final analysis." Use/uptake of intervention: "A response was received for 47% of messages sent and 9% of messages reported problems on a weekly basis." Primary/secondary outcomes: "Mean VL decreased from 1098 copies/mL in the control year to 439 copies/mL at study end (38/80 undetectable, P = .004). Adherence to cART significantly improved

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons.

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The problem being addressed is that cART is now effective and in many cases readily available however "non-adherence to medications, delayed initiation of therapy and poor follow-up are ongoing limitations of effective HIV management." This is particularly the case for females [ie "In British Columbia, there is emerging evidence that female cART is lagging behind that of males (59% versus 68% respectively)"] as well as persons with other vulnerabilities [ie "risk factors associated with poor adherence in both men and women include substance abuse, recent

2a-ii) Scienti/c background, rationale: What is known about the (type of) system
ScientiUc background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate),

2b) In INTRODUCTION: SpeciUc objectives or hypotheses
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The introduction specifies study objectives as follows: "Our goal in this study was to assess whether the standardized WelTel intervention applied to a vulnerable, predominantly female population, improved cART adherence and VL." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The study design is clearly outlined as follows: "Participants were enrolled in a repeated measures cohort study between April 2013 and May 2014 with the 12 months prior to initiation of the study used retrospectively as the control year." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Following study commencement, there were no additional changes made to the study design or eligibility criteria.

3b-i) Bug /xes, Downtimes, Content Changes
Bug Uxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inouenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The intervention had been previously used and therefore no downtimes or system bugs were encountered. The unexpected event of lost cellphones was encountered during our study for which we replaced a maximum of one cell phone for each individual. To clarify those phones that were replaced, we state as follows: "However, if an individual required a phone or phone plan at a later time, they were provided with one." 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The eligibility criteria (determined prior to study commencement) is outlined as below: "HIV+ patients were eligible for study participation if they met the following inclusion criteria: attendance at OTC for at least one year prior to study entry, an indication for cART (at time of study development, CD4 <500 cells/mm3), detectable VL (≥200 copies/mL) in the year prior to study entry (control year), age ≥14 years and high-risk for disengagement in treatment according to a list of predetermined criteria."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Our study design allows for some aspects of computer illiteracy by providing "instruction on how to use text messaging for communication" for any individual who required instruction. However, the exclusion criteria is also explicitly stated: "We excluded those who did not meet the above criteria or lived in an area with no cell phone service. Those who were unable to unable to communicate by text messaging due to language barriers, illiteracy or physical disabilities preventing use were also excluded." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_...
Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. ofoine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conUrmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Assessments are clearly described as "regular follow-up appointments" by an "interdisciplinary team".

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Recruitment is described as follows: "Prospective participants were introduced to the WelTel intervention during a routine clinical visit and provided written informed consent if interested." 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The data was collected at "the Oak Tree Clinic (OTC) in Vancouver, British Columbia (BC), Canada which is a provincial referral center for women and families living with HIV throughout British Columbia (BC)"

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Although self-assessment by questionnaires was a parameter under study, the focus of our study was objective measures of HIV care such as VL, CD4, appointment attendance, reported cART attendance. Self-assessment was not included in our results.

4b-ii) Report how institutional af/liations are displayed
Report how institutional afUliations are displayed to potential participants [on ehealth media], as afUliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study There were no institutional affiliations displayed in our intervention.

5)
The interventions for each group with sufUcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, af/liations of the developers, sponsors, and owners
Mention names, credential, afUliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conoict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The software is designed by Richard Lester and first published in his WelTel Kenya study. This is noted in our conflicts of interest.

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The first use of WelTel and its efficacy are outlined in the introduction.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study We have noted that we introduced changes into the original intervention design according to qualitative study results. These are then described in detail in the section "Methods: Intervention". "The SMS intervention was modeled after the WelTelKenya1 study with participant-driven modifications according to a qualitative assessment conducted with patient participants and health care providers at OTC prior to study start."

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Quality assurance was performed by first doing a qualitative assessment with a smaller patient population and integrating their suggestions into our final intervention platform.

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing ]owcharts of the algorithms used
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing oowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The intervention is explained in detail in the Methods. Furthermore, flowcharts of the intervention will be provided in the supplemental info.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This is not applicable since the intervention was not internet based.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciUc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Participants accessed the text messaging service free of charge with a cell phone provided if needed. "Participants were given a basic cell phone with unlimited text messaging capability if they did not have one. For those patients that did own a phone with a text messaging plan, no payment incentive was provided." subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
For the text messaging intervention, the mode of delivery (cell phone, confidential), features and functionality as well as theoretical features are outlined in #5 where the intervention is detailed and in 5-iii (for theoretical features).

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Responding to text messages was entirely optional in our study. If there was no response then participants would receive a text of further inquiry -""Haven't heard from you yet, how are you?"' and then a follow-up call.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Human involvement was 2-fold: 1.) bidirectional text messaging preformed by a study nurse with follow-up calls if needed. 2.) face-to-face follow-up appointments 1. "Not OK" received a follow-up call by a study nurse 2. "interdisciplinary team that included follow-up appointments every 1-4 months as clinically indicated"

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Prompts were as follows: 1.) a second text message was sent on Wednesday (day 2) stating, "Haven't heard from you yet, how are you?" 2.) If there was still no response, this was followed by a call on Thursday (day 3) by study nurses.

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study There were no co-interventions in this study.
6a) Completely deUned pre-speciUed primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Primary and secondary outcomes are described as below: "The primary outcome of the study was change in VL from control year (average VL over one year prior to study entry) to final VL at study end. Secondary outcomes included change in cART adherence, CD4 count, and appointment attendance following the WelTel intervention." Description of when they were assessed is as follows: "Parameters anticipated to respond after a lag time (VL and CD4) were compared using an average of all measurements in the control 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
No online questionnaires were utilized in this study.

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de/ned/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was deUned/measured /monitored (logins, logUle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-ii?

Copy and paste relevant sections from manuscript text
Use was recorded and measured by replies received in response to text messages: "All text messaging responses, follow-up calls and team member referrals were tracked and nature of the problem noted."

6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained
Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text The aspect of qualitative feedback was not an item for assessment in this study and therefore has not been included.
6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study There were no changes made to trial outcomes after commencement of the study.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Attrition was not accounted for when sample size was estimated, however, as the number of individuals pre-maturely stopping the study was low, we suspect that this made little difference in the analysis.

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This is not applicable to our study.
8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This was a repeated measures study so that each individual served as his/her own control. As such there was no randomization of allocation needed.
8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study All patients were subjected to the intervention, therefore negating the need for randomization. allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study

9) Mechanism used to implement the random
As above, questions pertaining to randomization of the intervention do not apply to this study design.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study As above, questions pertaining to randomization of the intervention do not apply to this study design.
11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_... participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

2 3 4 5 subitem not at all important essential
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Due to difficulties in blinding with the study and intervention design, participants, providers and outcome assessors were not blinded to the study as stated below: "Given the bidirectional nature of the text messaging intervention, participants and care providers were not blinded throughout. In addition, outcomes were assessed according to the pre/postintervention study design rather than blinded."

11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator"
Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The study design was repeat measures, therefore there was no comparator intervention.

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention)

Does your paper address CONSORT subitem 11b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This is not applicable to our study design.
12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Statistical analyses for the primary and secondary outcomes are described in the methods as follows: "To assess changes in VL and CD4, we computed the geometric mean (log10 transformed for VL) from raw data of all lab results from the control year for each participant. These means were then compared to the final VL or CD4 from the intervention year using non-parametric Wilcoxon signed ranks tests for paired data. For each participant, the number of possible appointments and doses was tallied within each year, and the proportion of those that were

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This was an issue that was addressed during the revision process.
As individuals with study attrition in many cases had complete omission of outcome year data, we opted to exclude them from our study analysis. This is described as follows: "Five participants dropped out of the study early on and were not included in the final analysis."

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The subgroup analysis is described as follows: "To facilitate a comparison between those patients regularly using mHealth technology versus those not actively using it, we analyzed variation in the number of responses to the text messages. All participants should have received 52 messages making the number of responses a useful proxy of engagement. We used bivariate negative binomial regression to analyze the number of responses by age, gender, ethnicity, income, long distance telephone, distance

X26-i) Comment on ethics committee approval
subitem not at all important essential

Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This was an approved study as described below: "The study protocol was approved by the University of British Columbia Research Ethics Board (H12-03002), and registered as a clinical trial (NCT02603536)"

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained ofoine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Privacy was important in our study especially given the delicate nature of HIV treatment. Our careful management of confidentiality is described as follows: "This open-ended check-in approach was specifically designed to preserve confidentiality and provide a personal connection to clinic staff to triage all problem types. For confidentiality reasons, health care providers did not text information relating to HIV status unless asked explicitly to do so by the participant."

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This is included in our consort diagram (Figure 1).

13b) For each group, losses and exclusions after randomisation, together with reasons
This is included in our consort diagram (Figure 1).

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Ugures or tables demonstrating usage/dose/engagement. 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Ugure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Two figures are relevant to attrition in our study. The first is our consort diagram which shows that 5 participants withdrew from the study and details the reasons behind withdrawal. The second is Figure 3 which shows the number of responses received and types of responses which show a 45% response rate and 9% reporting problems.

14a) Dates deUning the periods of recruitment and follow-up
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Definition of the dates of the study are included in the methods: "Participants were enrolled in a repeated measures cohort study between April 2013 and May 2014 with the 12 months prior to initiation of the study used retrospectively as the control year."

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study There were no "secular events" that occurred in the study period.
14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The trial was not ended early.

) and centers (volume) in each group
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Baseline demographics are included in Table 1 and Table 2. "Baseline demographics of remaining participants are outlined in Table 1. The population was predominantly female (90%) with a median age of 39 years. Six (7%) participants were ≤18 years old and received pediatric care at the clinic. The majority of the cohort had multiple vulnerabilities (76%) of which cART non-adherence, mental health illness, and active substance use were the three most common (54%, 48% and 28%; Table 1). Almost half of participants did not own a cell phone at the time of enrollment (47%)."

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Demographics reported that relate to a digital divide were age, socioeconomic status, and gender. Basic mobile phone literacy was not reported because for those that did not have this knowledge, instruction on cell phone use was provided. Education was also not included and would likely have been low for many of the participants given the vulnerable nature of the cohort.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide de/nitions Report multiple "denominators" and provide deUnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This information is provided in the consort diagram ( Figure 1).

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Our study was not performed as an intent-to-treat since those participants that quit early on in the analysis were not included. This is because these participants had a large amount of missing data. This is an issue that is currently under discussion between our reviewers and the authors.
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study For primary outcome (HIV VL) 95% confidence interval is included. For the secondary outcomes (cART adherence, appointment attendance) odds ratios are reported.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational deUnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is deUned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The design of the intervention was such that exposure time was very minimal unless a problem was identified. Metrics of use are described in Figure 3, response rates. However, further assessment of exposure time, etc is included in a follow-up study on cost-effectiveness.
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Our study outcomes did not lend themselves to presentation of absolute or relative effect sizes.

18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Our subgroup analysis is described as follows: "Based on these findings, an exploratory subgroup analysis was undertaken to compare demographic characteristics and VL by the number of replies to the text messages."

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study We opted to do an outcome analysis based on response rate, however we included all participants in this analysis so that there is no selection bias.

19) All important harms or unintended effects in each group
(for speciUc guidance see CONSORT for harms)

Does your paper address CONSORT subitem 19? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study There was potential for unintended effects just through cell phone ownership which we address in our discussion: "Another limitation was that a large proportion of our cohort (47%) received a cell phone from us during the study, and we cannot control for all effects of cell phone ownership alone. Owning a mobile phone may impact several social determinants of health by impacting relationships, mobility, mental health and self-perception."

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study There were no privacy breeches encountered in our study.

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)
Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This is addressed as follows: "This study showed that a cohort of difficult-to-engage, vulnerable individuals living with HIV showed evidence of improved measures of HIV care (VL, cART adherence) when exposed to a weekly bidirectional text messaging intervention. The study is unique in that participants were provided with mobile phones, allowing for increased engagement of marginalized populations that would otherwise be difficult to access. This intervention could potentially bring substantial health benefits to vulnerable populations in an era

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Future studies are suggested as follows: "As WelTel moves toward broadening its application, future studies investigating the optimal duration of text-messaging interventions and the durability of its effect would help to guide implementation of this tool." Other areas for study are outlined as follows: "Moving forward, further identification of subgroups poised to benefit most from WelTel will be important, particularly if the intervention includes the provision of a cell phone and phone plan. Finally, a cost analysis would shed light on the feasibility of introducing WelTel in a larger scale to targeted 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Limitations addressed in our study: "This study is a repeated measures study rather than a randomized control trial and we are therefore only able to infer association not causation." "Another limitation was that a large proportion of our cohort (47%) received a cell phone from us during the study, and we cannot control for all effects of cell phone ownership alone. Owning a mobile phone may impact several social determinants of health by impacting relationships, mobility, mental health and self-perception." 21) Generalisability (external validity, applicability) of the trial Undings NPT: External validity of the trial Undings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The question of generalizability is discussed in our limitations: "Our study is limited by its sample size, its predominantly female composition, and its high risk population studied and is therefore not generalizable to all populations."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study The study was very much carried out as it would be in the real world setting so there was little to elaborate on here. In fact, participants who were interested carried on with this intervention with essentially no changes after the study end.

23) Registration number and name of trial registry
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Registry number as provided in abstract: "Registration: Clinicaltrials.cov/ct2/show/NCT02603536." 24) Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study We have included sufficient details in our methods section to replicate this protocol if desired and therefore have not referred readers to a full trial protocol.

25)
Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study As in our acknowledgements, the funding was provided by Gilead Sciences and mobile support by Telus. "Acknowledgments: We would like to thank Gilead Sciences for funding this study, and Telus Mobility for providing in-kind technical support and cell phone minutes for the duration of the study."

4-5 hrs
As a result of using this checklist, do you think your manuscript has improved? * yes no Other:

Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document yes no Other:

Any other comments or questions on CONSORT EHEALTH
STOP -Save this form as PDF before you click submit To generate a record that you Ulled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary Ule.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you! CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_...