Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus–Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial

Background Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive. Objective This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women. Methods This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat. Results Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial—358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33). Conclusions Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women. Trial Registration ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702. International Registered Report Identifier (IRRID) RR2-10.2196/10.2196/15863

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1l… 8/53 1a) TITLE: Identi cation as a randomized trial in the title 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 o ine 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.
Does your paper address subitem 1a-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 brie y explain why the item is not applicable/relevant for your study "One-way text messages"

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-ii?
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 brie y explain why the item is not applicable/relevant for your study "versus no text messages" 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * 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 brie y explain why the item is not applicable/relevant for your study "follow-up cervical cancer screening among HPV-positive Tanzanian Women"

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) subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * 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 brie y explain why the item is not applicable/relevant for your study "The intervention group received one-way text messages, and the control group received no text messages." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT 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) 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 brie y explain why the item is not applicable/relevant for your study No. It is described in the methods sections of the article but not directly in the abstract as it is implicit.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), 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 o ine 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) subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study "Participants were not blinded but outcome assessors were" 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) 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 brie y explain why the item is not applicable/relevant for your study "705 were included into this trial; 358 were allocated to the intervention group and 347 to the control group. " 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. (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) Does your paper address subitem 1b-v?
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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "The advantages of text messages are that they are easy to use, can be sent to the receivers simultaneously, and they require less staff. A recent systematic review and meta-analyse of one-way text message trials in Africa showed that one-way text messages have been tested within different clinical areas across Africa, though mainly in relation to medicine adherence and appointment attendance. The effect of one-way text messages varied across clinical areas, and overall the highest effect was found in relation to increasing attendance to a childhood immunization appointment [10]. In relation to cervical cancer screening attendance, a systematic review from 2017 concerning text message interventions on cancer screening rates [11], found one trial from Malaysia with no effect of one-way text messages improving attendance to a repeat cervical smear compared to postal letters [12]. However, recent trials from Tanzania and Kenya have shown that one-way text messages increased attendance to cervical cancer screening among screening-naïve women[13] and a repeat cervical smear [14] compared to no text messages. Yet, it is still unknown whether or not one-way text messages can increase the attendance rate of HPV-positive women who have been appointed a follow-up screening." 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 brie y explain why the item is not applicable/relevant for your study "The aim of this study (Connected2Care) was to assess the effect of one-way text messages on attendance to a provider-initiated follow-up screening appointment among women who had tested HPV-positive during a patientinitiated opportunistic screening 14 months earlier. In addition, we examined factors associated with attendance regardless of group allocation. " 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * 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 brie y explain why the item is not applicable/relevant for your study "Connected2Care is an unblinded, multi-centre, parallel-group randomized controlled trial (RCT)" 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 brie y explain why the item is not applicable/relevant for your study "Post-hoc we exploratively assessed factors that were associated with attendance, i.e. number of text messages received and socio-demographic characteristics, as well as assessed how attendance was increased postintervention period via phone calls and home visits. Pre-speci ed secondary outcomes included the cost-effectiveness of the intervention; the intervention's effect on knowledge of cervical cancer and screening (16 item true-false questionnaire); and barriers against implementing a text message intervention in Tanzania (mixed method study). The secondary outcomes, cost-effectiveness and knowledge, have not been assessed, and barriers against implementation have been assessed in a qualitative post-invention study together with factors that in uence screening attendance. The latter objective have been published elsewhere [17] whilst data on barriers related to the text message intervention is yet to be published. "

3b-i) Bug xes, Downtimes, Content Changes
Bug xes, 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 xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc.
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 brie y explain why the item is not applicable/relevant for your study "Six months into the study -after enrolment of 38 participants -we discovered that the SMS system did not dispatch the text messages as according to the study plan. We reassigned 38 participants into a new SMS system (www.connected2care.org), and they stayed in the groups they were originally allocated to [15]. We conducted a post-hoc sensitivity analysis excluding these women and another post-hoc analysis excluding 16 participants who were misclassi ed as HPV-positive and erroneously included into the study. " "We encountered several obstacles while conducting this trial. Firstly, we had to switch to a new SMS system six months into trial due to the rst system being unreliable. However, our sensitivity analysis found no difference in effect among the participants who had been enrolled using the rst system. Secondly, a number of women were misclassi ed as HPV-negative or -positive in the process of transferring the laboratory reports to the CONCEPT investigators. This led to a number of women being incorrectly excluded from or included into the trial. The sensitivity analysis of the incorrectly included women showed no difference in results. Even though these issues are study-speci c, they highlight a need for incorporating secure procedures when implementing a more complex screening method such as rapid HPV-testing in a setting like Tanzania 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 brie y explain why the item is not applicable/relevant for your study "Women 25-60 years of age, who attended a patient-initiated cervical cancer screening at the study sites, were assessed by a screening nurse for overall eligibility to participate in the CONCEPT study. Eligible women gave written informed consent. Exclusion criteria were pregnancy or menstruation on day of enrolment, previous hysterectomy, cervical cancer or diagnosis of cervical precancerous lesions within the past 12 months. The sub-group of CONCEPT participants, who tested high-risk HPV-positive at the enrolment screening, were assessed for eligibility to be further included into the Connected2Care study.
Women were ineligible for inclusion into Connected2Care if they did not own a private mobile phone, had provided an invalid phone number (i.e. digits missing) or were not informed of their positive HPV test result. Ineligible women were excluded prior to randomisation."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
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 brie y explain why the item is not applicable/relevant for your study No relevant for this study as it is a text message intervention.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), 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 con rmation, phone calls) were used to detect/prevent these.
subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study "Women 25-60 years of age, who attended a patient-initiated cervical cancer screening at the study sites, were assessed by a screening nurse for overall eligibility to participate in the CONCEPT study." 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.
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 brie y explain why the item is not applicable/relevant for your study "Eligible women were assigned an anonymous study id and interviewed by a trained nurse using a structured questionnaire. The nurse also registered their home address and phone numbers as well as provided general cervical cancer screening education and counselling as according to the national guidelines for cervical cancer screening in Tanzania." "Eligible women gave written informed consent." "Finally, the women were told that they may receive health educative and reminder text messages before their next screening appointment." "Data sharing statement All data collected for the Connected2Care study are available upon request.
Individual participant data will de-identi ed. Additional available data includes the CONCEPT protocol, the CONCEPT eligibility and informed consent form, the CONCEPT contact information form, the CONCEPT baseline questionnaire, the protocol for how to deliver HPV-positive results to participants, the protocol for how to trace non-attendants, statistical analyses, and the content of all the text messages for the trial -in Kiswahili and English. Data will be made available upon request by contacting the rst author of the study by email at dsondergaard@health.sdu.dk, who will then seek approval by the primary investigator in the CONCEPT project, Julius D. Mwaiselage." 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 brie y explain why the item is not applicable/relevant for your study "Connected2Care is an unblinded, multi-centre, parallel-group randomized controlled trial (RCT) conducted at three hospitals in Tanzania: Ocean Road Cancer Institute (ORCI) in Dar es Salaam, and Kilimanjaro Christian Medical Centre (KCMC) and Mawenzi Regional Hospital in Moshi. Originally, the study was designed as a double-site study (ORCI/KCMC); however, due to a slowerthan-expected recruitment rate, a third study site (Mawenzi Regional Hospital) was added six months into the recruitment phase." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
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 brie y explain why the item is not applicable/relevant for your study "Due to the overt nature of the text message intervention, the study participants were not concealed to their group allocation. Yet, the outcome assessors -in the form of screening nurses registering the attendance date -were blinded." 4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations 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) 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 brie y explain why the item is not applicable/relevant for your study Not relevant as the intervention is one-way text messages. 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 brie y explain why the item is not applicable/relevant for your study "An online text message portal (www.connected2care.org) -developed speci cally for this study -automatically dispatched the messages and sent them with the id "Elimu Ya Afya" (meaning "health education" in Kiswahili). " "We would also like to thank Andreas Hover Lundh for commenting upon the manuscript, Pia Veldt Larsen for statistical support, and Yusuph Kassim for developing SMS-system and providing technical support for the system throughout the trial."

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.
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The sender id, content, timing, and number of text messages were pre-tested on screening clients as well as on screening nurses prior to the intervention starting. The rationale behind combining health education and reminders was that health education would enhance the perceived seriousness of the disease as well as the bene t of the screening and combined with reminders they would be cues to actions for screening attendance. The messages were not personalized out of privacy concerns, and they were developed in English and translated into Kiswahili using back-forth translation"

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 brie y explain why the item is not applicable/relevant for your study "An online text message portal (www.connected2care.org) -developed speci cally for this study -automatically dispatched the messages and sent them with the id "Elimu Ya Afya" (meaning "health education" in Kiswahili). The portal had a 'delivery note feature', which showed the discrepancy between the number of text messages sent and the number received." "Six months into the study -after enrolment of 38 participants -we discovered that the SMS system did not dispatch the text messages as according to the study plan. We reassigned 38 participants into a new SMS system (www.connected2care.org), and they stayed in the groups they were originally allocated to" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study No 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 owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c 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 brie y explain why the item is not applicable/relevant for your study Examples of content of text message intervention are given ( gure 1) and under the "Data sharing statement" it is stated that all content is available upon request. The actual source code of the sms dispatching system is not available as all researchers are also blind to this.

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 brie y explain why the item is not applicable/relevant for your study "An online text message portal (www.connected2care.org) -developed speci cally for this study -automatically dispatched the messages and sent them with the id "Elimu Ya Afya" (meaning "health education" in Kiswahili)."

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 speci c 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).
Does your paper address subitem 5-vii? * 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 brie y explain why the item is not applicable/relevant for your study "An online text message portal (www.connected2care.org) -developed speci cally for this study -automatically dispatched the messages and sent them with the id "Elimu Ya Afya" (meaning "health education" in Kiswahili)." subitem not at all important 1 2 3 4 5 essential 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework 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 brie y explain why the item is not applicable/relevant for your study "An online text message portal (www.connected2care.org) -developed speci cally for this study -automatically dispatched the messages and sent them with the id "Elimu Ya Afya" (meaning "health education" in Kiswahili)."" "The sender id, content, timing, and number of text messages were pre-tested on screening clients as well as on screening nurses prior to the intervention starting. The rationale behind combining health education and reminders was that health education would enhance the perceived seriousness of the disease as well as the bene t of the screening and combined with reminders they would be cues to actions for screening attendance. The messages were not personalized out of privacy concerns, and they were developed in English and translated into Kiswahili using back-forth translation." "Despite the fact that we pilot-tested the text messages prior to the trial starting, it is plausible that use of a health behaviour theoretical framework and further pilot testing of the intervention and the text messaging portal could have addressed some of the study challenges." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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.
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 brie y explain why the item is not applicable/relevant for your study "Over a period of 10 months, 10 health educative messages and ve reminders were sent to the women in the intervention group. "

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 brie y explain why the item is not applicable/relevant for your study "The rst author (DSL) assigned participants to the trial by uploading the phone numbers of the eligible participants into the text messaging system " "The random sequence generation was developed by the external IT-consultant, who developed the text messaging system, and it was concealed to all investigators." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed 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).
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 brie y explain why the item is not applicable/relevant for your study "Over a period of 10 months, 10 health educative messages and ve reminders were sent to the women in the intervention group. The health educative messages were sent once a month and contained information about screening, risk factors, and symptoms for cervical cancer (Figure 1). The reminders were sent 14, seven, and one day prior to the 14-months follow-up screening appointment as well as one and seven days post the appointment date" 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. 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 brie y explain why the item is not applicable/relevant for your study Not applicable. 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 brie y explain why the item is not applicable/relevant for your study "The primary outcome was attendance to a health provider-initiated follow-up screening at 14-months. It was measured as whether or not the participants attended the follow-up screening within 30 days of their screening appointment.
Pre-speci ed secondary outcomes included the cost-effectiveness of the intervention; the intervention's effect on knowledge of cervical cancer and screening (16 item true-false questionnaire); and barriers against implementing a text message intervention in Tanzania (mixed method 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 de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "An online text message portal (www.connected2care.org) -developed speci cally for this study -automatically dispatched the messages and sent them with the id "Elimu Ya Afya" (meaning "health education" in Kiswahili). The portal had a 'delivery note feature', which showed the discrepancy between the number of text messages sent and the number received. " "The SMS dispatching system showed that all participants in the intervention group received at least one of the 15 text messages sent to them; 8% (n=26) received between 1-4 text messages, and 32% (n=111) received all 15 text messages ( 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 brie y explain why the item is not applicable/relevant for your study "Post-hoc we exploratively assessed factors that were associated with attendance, i.e. number of text messages received and socio-demographic characteristics, as well as assessed how attendance was increased postintervention period via phone calls and home visits. " "Thirdly, the attendance rate was much lower than what we had anticipated, which led us to part from some of our originally pre-planned secondary outcomes and examine what affects attendance in more detail. However, we clearly speci ed which analyses and results were conducted post-hoc in order not to hypothesize after the results were known (i.e. avoid HARKing) [21]. " 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.
7b) When applicable, explanation of any interim analyses and stopping guidelines 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 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 brie y explain why the item is not applicable/relevant for your study "The sample size was calculated based on the methods described by Altman [18]. We estimated that the intervention would increase the attendance rate with 15 points, and that 73% in the intervention group and 58% in the control group would attend their follow-up appointment. With an allocation ratio of 1:1, a two-sided of 5% and 80% power, we required approximately 350 participants in each arm. At the time of design, no other text message interventions on cervical cancer had been conducted in Africa, and the estimation was based on the effect of mHealth interventions found within other clinical areas in Eastern Africa [19,20]. " 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 brie y explain why the item is not applicable/relevant for your study No interim analyses were conducted. Not stated in manuscript.
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 brie y explain why the item is not applicable/relevant for your study "The random sequence generation was developed by the external IT-consultant, who developed the text messaging system, and it was concealed to all investigators. Screening nurses enrolled participants and were concealed to the latter group allocation." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 brie y explain why the item is not applicable/relevant for your study "Participants were randomly assigned to the intervention or control group with a 1:1 ratio." "parallel-group randomized controlled trial" 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 brie y explain why the item is not applicable/relevant for your study "The random sequence generation was developed by the external IT-consultant, who developed the text messaging system, and it was concealed to all investigators. Screening nurses enrolled participants and were concealed to the latter group allocation." 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 subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Participants were randomly assigned to the intervention or control group with a 1:1 ratio. The randomisation occurred through an incorporated algorithm in the text message system, which automatically assigned participants to the intervention or control group. The random sequence generation was developed by the external IT-consultant, who developed the text messaging system, and it was concealed to all investigators." "The rst author (DSL) assigned participants to the trial by uploading the phone numbers of the eligible participants into the text messaging system and was not concealed to the group allocation." 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 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).
subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study "Screening nurses enrolled participants and were concealed to the latter group allocation." "The rst author (DSL) assigned participants to the trial by uploading the phone numbers of the eligible participants into the text messaging system and was not concealed to the group allocation. Due to the overt nature of the text message intervention, the study participants were not concealed to their group allocation. Yet, the outcome assessors -in the form of screening nurses registering the attendance date -were blinded." "The random sequence generation was developed by the external IT-consultant, who developed the text messaging system, and it was concealed to all investigators." 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 brie y explain why the item is not applicable/relevant for your study "Due to the overt nature of the text message intervention, the study participants were not concealed to their group allocation." "Due to lack of blinding of participants, there is a risk of performance bias and risk of contamination, which could have affected the internal validity of the 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 brie y explain why the item is not applicable/relevant for your study Not applicable.
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 brie y explain why the item is not applicable/relevant for your study "We calculated a risk ratio to determine if the proportion of participants who attended their follow-up screening differed between groups and used a relative risk regression by use of a generalised linear model with log-link function and binomial distribution as statistical family." 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] 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 brie y explain why the item is not applicable/relevant for your study "After randomisation, four participants in each group developed cervical cancer and four from each group died from the disease (n=16). These participants were excluded from the analysis, leaving 689 women for analysis." 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 brie y explain why the item is not applicable/relevant for your study "In subgroup analyses, we assessed if the intervention had differential effect across subgroups by including an interaction term between the intervention allocation and a subgroup de ning variable." "In subgroup analyses, we assessed if the intervention had differential effect across subgroups by including an interaction term between the intervention allocation and a subgroup de ning variable." Does your paper address subitem X26-ii?

X26-i) Comment on ethics committee
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 brie y explain why the item is not applicable/relevant for your study "Eligible women gave written informed consent."

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)

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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 brie y explain why the item is not applicable/relevant for your study "The messages were not personalized out of privacy concerns" "Women were ineligible for inclusion into Connected2Care if they did not own a private mobile phone" "To preserve privacy, we did not personalize the text messages, and we excluded women who did not own a private mobile phone." 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 brie y explain why the item is not applicable/relevant for your study "Altogether 4080 women were enrolled into the CONCEPT study. Of these, 705 were included into Connected2Care (Figure 2). After randomisation, four participants in each group developed cervical cancer and four from each group died from the disease (n=16). These participants were excluded from the analysis, leaving 689 women for analysis. " "The intervention and control group were comparable (Table 1), and the primary analysis showed that the intervention had no effect on attendance to a follow-up screening appointment; 24% attended in both the intervention (n=84/350) and in the control group (n=80/339); (RR: 1.02; 95% CI: 0.79-1.33)." subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * 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 brie y explain why the item is not applicable/relevant for your study "After randomisation, four participants in each group developed cervical cancer and four from each group died from the disease (n=16). These participants were excluded from the analysis, leaving 689 women for analysis." See gure 2: Flow chart of trial 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 gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study "The SMS dispatching system showed that all participants in the intervention group received at least one of the 15 text messages sent to them; 8% (n=26) received between 1-4 text messages, and 32% (n=111) received all 15 text messages (Table 2). When examining factors potentially associated with attendance to screening, we found that the number of text messages received did not appear to affect the attendance rate. " See 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 brie y explain why the item is not applicable/relevant for your study "Study participants were enrolled into the study between 17 August 2015 and 6 July 2017, and the follow-up ended by 6 October 2018." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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 brie y explain why the item is not applicable/relevant for your study Not applicable.
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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study See " Table 1: Baseline characteristics" 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.
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 brie y explain why the item is not applicable/relevant for your study See " 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: 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 speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) 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 brie y explain why the item is not applicable/relevant for your study "The intervention and control group were comparable (Table 1), and the primary analysis showed that the intervention had no effect on attendance to a follow-up screening appointment; 24% attended in both the intervention (n=84/350) and in the control group (n=80/339); (RR: 1.02; 95% CI: 0.79-1.33)."

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 brie y explain why the item is not applicable/relevant for your study "The analysis was intention-to-treat (ITT)" 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 brie y explain why the item is not applicable/relevant for your study "The intervention and control group were comparable (Table 1), and the primary analysis showed that the intervention had no effect on attendance to a follow-up screening appointment; 24% attended in both the intervention ( 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 de nitions 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 de ned (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 brie y explain why the item is not applicable/relevant for your study

No
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 brie y explain why the item is not applicable/relevant for your study "The intervention and control group were comparable (Table 1), and the primary analysis showed that the intervention had no effect on attendance to a follow-up screening appointment; 24% attended in both the intervention (n=84/350) and in the control group (n=80/339); 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 brie y explain why the item is not applicable/relevant for your study See " Figure 3. Forrest plot of subgroup analysis" See " Table 2: Factors associated with attendance"

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 brie y explain why the item is not applicable/relevant for your study Not applicable.
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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "Six months into the study -after enrolment of 38 participants -we discovered that the SMS system did not dispatch the text messages as according to the study plan. We reassigned 38 participants into a new SMS system (www.connected2care.org), and they stayed in the groups they were originally allocated to [15]. We conducted a post-hoc sensitivity analysis excluding these women and another post-hoc analysis excluding 16 participants who were misclassi ed as HPV-positive and erroneously included into the study. 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 brie y explain why the item is not applicable/relevant for your study "Pre-speci ed secondary outcomes included ... barriers against implementing a text message intervention in Tanzania (mixed method study)." "...data on barriers related to the text message intervention is yet to be published." 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).
subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study "Principal results This trial shows that one-way text messages did not improve the attendance rate to a health provider-initiated follow-up cervical cancer screening among HPVpositive women. Overall, one-fourth of the participants attended their follow-up screening regardless of whether or not they had received text messages. Hence, the barrier of getting women to return to the clinic was not one which one-way text messages appeared to overcome. 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 brie y explain why the item is not applicable/relevant for your study "The outcome of our trial is highly relevant, both in a larger mHealth context and in relation of how to address the cervical cancer burden in East Africa. Rapid HPV-testing is an area that has potential to improve prevention of the disease, however, this trial shows that implementation of rapid HPV-testing leads to the challenge of providing proper follow-up of the women who test HPV-positive.
This is an issue which policy makers and global health clinicians should be aware of in relation to implementing rapid HPV-testing as a primary screening method in future cervical cancer screening programs in Africa. Our post-trial follow-up strategy indicates that phone calls where nurses engage with the women and emphasise the importance of re-attendance, may be more effective than a one-way text message intervention. " "How best to implement rapid HPV-tests, the overall care pathway for HPVpositive women, and the potential of phone call reminders for cervical cancer follow-up are areas worth exploring in future studies in Africa."

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.
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 brie y explain why the item is not applicable/relevant for your study "Limitations We encountered several obstacles while conducting this trial. Firstly, we had to switch to a new SMS system six months into trial due to the rst system being unreliable. However, our sensitivity analysis found no difference in effect among the participants who had been enrolled using the rst system. Secondly, a number of women were misclassi ed as HPV-negative or -positive in the process of transferring the laboratory reports to the CONCEPT investigators.
This led to a number of women being incorrectly excluded from or included into the trial. The sensitivity analysis of the incorrectly included women showed no difference in results. Even though these issues are study-speci c, they highlight a need for incorporating secure procedures when implementing a more complex screening method such as rapid HPV-testing in a setting like Tanzania. Thirdly, the attendance rate was much lower than what we had anticipated, which led us to part from some of our originally pre-planned secondary outcomes and examine what affects attendance in more detail. However, we clearly speci ed which analyses and results were conducted post-hoc in order not to hypothesize after the results were known (i.e. avoid HARKing) [21]. Despite the fact that we pilot-tested the text messages prior to the trial starting, it is plausible that use of a health behaviour theoretical framework and further pilot testing of the intervention and the text messaging portal could have addressed some of the study challenges.
Due to lack of blinding of participants, there is a risk of performance bias and risk of contamination, which could have affected the internal validity of the trial [22]. To preserve privacy, we did not personalize the text messages, and we excluded women who did not own a private mobile phone. However, this exclusion criterion affects the external validity of the trial as the participants may not represent the target population. Despite our effort to ensure privacy for the study participants, we cannot guarantee that the participants found the messages con dential enough. If this was an issue, it could have affected the acceptability and effectiveness of the messages. Our explorative subgroup analysis indicated that HIV-status may be a potential effect modi er. However, our trial was not dimensioned to assess differential effects across subgroups, and it is likely an artefact of the data and a false discovery rather than HIV-status modifying the relationship between text messages and follow-up." 21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 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 brie y explain why the item is not applicable/relevant for your study "To preserve privacy, we did not personalize the text messages, and we excluded women who did not own a private mobile phone. However, this exclusion criterion affects the external validity of the trial as the participants may not represent the target population. " 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 brie y explain why the item is not applicable/relevant for your study Not described. 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 brie y explain why the item is not applicable/relevant for your study "Trial registration: ClinicalTrials.gov; NCT02509702." 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 brie y explain why the item is not applicable/relevant for your study "The study protocol has been published elsewhere [15]," 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 brie y explain why the item is not applicable/relevant for your study "Role of the funding source The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. DSL, JDM, and VR had access to all the data in the study, and DSL had the nal responsibility for the decision to submit for publication." "Acknowledgements The study is funded by the Danish International Development Agency (Danida; 14-P02-Tan/A26775) and the University of Southern Denmark (internal funds)." X27) Con icts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-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 brie y explain why the item is not applicable/relevant for your study

"Declaration of Interests
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