A Mobile Intervention to Link Young Female Entertainment Workers in Cambodia to Health and Gender-Based Violence Services: Randomized Controlled Trial

Background Female entertainment workers (FEWs) in Cambodia experience a greater prevalence of human immunodeficiency virus (HIV), other sexually transmitted infections (STIs), psychological distress, substance abuse, and gender-based violence (GBV) than the general female population. Reaching FEWs with health education and linking them to services has been difficult because of their hidden and stigmatized status. Objective This study evaluated the efficacy of the Mobile Link intervention in improving FEWs’ health by engaging and connecting them to existing HIV, sexual and reproductive health, and GBV services. Methods A randomized controlled trial was conducted between March 2018 and June 2019 in the capital city and 3 other provinces in Cambodia. FEWs in the intervention arm received automated twice-weekly Short Message Service messages and voice messages with health information and direct links to outreach workers. The control group received the existing standard care, including free HIV and STI counseling and testing and a toll-free helpline staffed by trained counselors. We used a stratified random sampling method to select participants from 5 study sites in the 4 selected provinces. Initially, we randomly selected 600 participants from a list of 4000 FEWs by age group (18-24 and 25-30 years) and study site using a random number generator and enrolled them in person. The primary outcome measures included self-reported HIV and STI testing, condom use, and contraceptive use assessed through a face-to-face structured interview. We also measured secondary outcomes, including contact with outreach workers, escorted referral service use, forced drinking, and GBV experiences. Intervention effects were modeled using repeated measures, multilevel mixed-effects logistic regression. Results A total of 1118 participants were recruited and enrolled in the study. We included 218 FEWs in the intervention arm and 170 FEWs in the control arm in the per protocol analyses after removing 730 dropouts. Evidence of positive intervention effects was detected for the following secondary outcomes: contacting an outreach worker (at 30 weeks: adjusted odds ratio [AOR] 3.29, 95% CI 1.28-8.47), receiving an escorted referral (at 30 weeks: AOR 2.86, 95% CI 1.09-7.52; at 60 weeks: AOR 8.15, 95% CI 1.65-40.25), and never being forced to drink at work (at 60 weeks: AOR 3.95, 95% CI 1.62-9.60). Over time, no significant differences between intervention and control groups were observed for any primary outcomes in the fully adjusted models. Conclusions The Mobile Link intervention effectively connected FEWs with outreach workers and escorted referrals but did not show an effect on primary outcomes. Reduced forced drinking at work was also significantly more extensive in the intervention group than in the control group. Longer-term messaging may increase access to services and impact FEWs’ health outcomes in the future. Trial Registration Clinicaltrials.gov NCT03117842; https://clinicaltrials.gov/ct2/show/NCT03117842 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-018-2614-7

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet 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 offline 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.

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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 briefly explain why the item is not applicable/relevant for your study "A Mobile Intervention to link Female Entertainment Workers in Cambodia to Health and Gender-based Violence Services: Randomized Controlled Trial"

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").

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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 briefly explain why the item is not applicable/relevant for your study n/a 1a-iii) Primary condition or target group in the title 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 briefly explain why the item is not applicable/relevant for your study "Female Entertainment Workers in Cambodia"

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)

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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 briefly explain why the item is not applicable/relevant for your study "This study evaluates the Mobile Link intervention, aiming to improve FEWs' health by connecting them to health services using automated twice-weekly short message services and voice messages with health information and direct links to outreach workers." and "The control for this study received the existing standard care. Standard care included face-to-face counseling, free HIV and STI testing and condoms, and clinic phone numbers and hotline phone numbers with a toll-free help-line for clients staffed by trained counselors."

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)

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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-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 briefly explain why the item is not applicable/relevant for your study "automated twice-weekly short message services and voice messages" 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. offline), 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 offline 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)

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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 briefly explain why the item is not applicable/relevant for your study "The primary outcome measures included self-reported HIV and STI testing, condom use, and contraceptive use which we assessed through face-to-face structured interview." 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)

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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 briefly explain why the item is not applicable/relevant for your study "We included 218 FEWs in intervention and 170 FEWs in control arms in the perprotocol analyses after 212 removing dropouts." 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)

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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 briefly explain why the item is not applicable/relevant for your study " Longer-term messaging may increase access to services and impact FEWs' health outcomes in the future."

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)

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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 briefly explain why the item is not applicable/relevant for your study "The Mobile Link intervention is an mHealth project aiming to engage and connect

Clear selection
Does your paper address subitem 2a-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 briefly explain why the item is not applicable/relevant for your study "Health interventions using mobile phones -referred to as mobile health (mHealth) -presents a viable solution for connecting hard-to-reach, stigmatized, and criminalized populations such as FEWs to health services. In recent years, mHealth has received widespread attention due to its applicability in low-resource settings. mHealth has been used effectively in low-and middle-income countries to collect 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 briefly explain why the item is not applicable/relevant for your study "The Mobile Link intervention study is a two-arm multisite 60-week randomized controlled trial (RCT). The trial was conducted in two sites in Phnom Penh and one site each in Banteay Meanchey, Battambang, and Siem Reap." 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 briefly explain why the item is not applicable/relevant for your study "Protocol adaptations There are several protocol deviations to note. The original protocol called for a 12month (52 week) trial. However, due to high dropout rates at the midterm, we extended the trial to 60 weeks to recruit and enroll more participants who would have the chance to be exposed to the intervention for at least 30 weeks. We did not anticipate the level of loss to follow-up that occurred and, therefore, did not have a plan in place for replacement recruitment in our original protocol. We decided to recruit replacement participants at the midline by randomly selecting FEWs from our master list from the same venue and age group. In our analyses, we de ned exposure as having had at least 30 weeks of exposure to the intervention. Another deviation occurred in our group assignment plan. Initially, we planned to randomize at the entertainment venue level to conduct a cluster RCT. Before the implementation, we changed our trial design to randomize at the individual level due to the high level of movement of FEWs between venues. As a result, we modeled intervention effects using the individual rather than the venue as the analysis unit. We computed clustered standard errors based on the venue rather than including the venue as a level in the mixed-effects outcome models. Finally, we included the venue type (e.g., karaoke bar, beer garden, etc.) as a covariate in all our models.
In our protocol, we planned to send out weekly survey questions to intervention participants on various health topics. During intervention development, we heard from pilot participants that they felt reluctant to give that type of information through the phone. We were also concerned about message fatigue, privacy, and literacy and decided to omit that part of the intervention.
Finally, in our protocol, we stated that we would present an ITT analysis. Because the ITT and per-protocol ndings were the same, we decided to present h l l f f "

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff 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 briefly explain why the item is not applicable/relevant for your study n/a 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 briefly explain why the item is not applicable/relevant for your study "The intervention's participant inclusion criteria included: (1) working at an entertainment venue in the study sites; (2) being currently sexually active, de ned as having engaged in oral, vaginal, or anal sex in the past three months; (3) owning a mobile phone; (4) knowing how to retrieve VM or retrieve and read SMS; (5) selfidentifying as a FEW; (6) willing to receive two SMS/VM per week for one year; (7) providing written informed consent; and (8) agreeing to a follow-up visit after six months and 12 months."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study Education level is included in Table 1. Knowing how to retrieve VM or retrieve and read SMS is an eligibility criteria.
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. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased 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 confirmation, phone calls) were used to detect/prevent these. 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 briefly explain why the item is not applicable/relevant for your study "All participants were recruited in-person at the ve study sites by trained Mobile Link lay community health workers." 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.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "Community health workers provided verbal information to FEWs regarding the Mobile Link's details because of low literacy rates in this population. Eligible FEWs signed the informed consent form." 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 briefly explain why the item is not applicable/relevant for your study "The trial was conducted in two sites in Phnom Penh and one site each in Banteay Meanchey, Battambang, and Siem Reap. These provinces were selected because of substantial populations of FEWs and high HIV burdens."

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.

Clear selection
subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study "The primary and secondary outcomes were tracked and measured using selfreported data from the baseline, midline, and endline surveys." 4b-ii) Report how institutional affiliations are displayed Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations 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)

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "Development of the message-based intervention was conducted with the support of local partners, InSTEDD iLab and the Women's Media Center (WMC). InSTEDD developed the mobile platform for interactive message delivery and data management using an open-source software program. The WMC helped translate messages into Khmer and tailor the contents to be speci c, relevant, and engaging, given the cultural context. Example messages included can be found in a previously published paper [23]."

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).
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 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 briefly explain why the item is not applicable/relevant for your study "Development of the message-based intervention was conducted with the support of local partners, InSTEDD iLab and the Women's Media Center (WMC). InSTEDD developed the mobile platform for interactive message delivery and data management using an open-source software program. The WMC helped translate messages into Khmer and tailor the contents to be speci c, relevant, and engaging, given the cultural context. Example messages included can be found in a previously published paper [23]."

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.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "We conducted a series of formative research activities using participatory methods to create appropriate and relevant health-related messages for FEWs and inform the intervention's development. The formative research process occurred over six months. We collected data through focus group discussions (FGDs), indepth interviews (IDIs), and key informant interviews (KIIs) with the venue-and nonvenue-based FEWs in addition to outreach workers and eld staff that routinely work with this population [23]. Findings from the formative research revealed that FEWs were generally knowledgeable about HIV and STI prevention and transmission. However, they faced many structural barriers to optimal health, such as pressure to drink alcohol at work and complicated dynamics of negotiating condom use with clients in a criminalized environment [25,26]. Furthermore, we found that many FEWs faced barriers to accessing medical care and services due to stigma discrimination and mistreatment from healthcare workers "

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).
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 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 briefly explain why the item is not applicable/relevant for your study n/a

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

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "After development, the intervention underwent a four-week pilot in which 50 FEWs from each study site were randomly selected. The purpose of the pilot was to test whether the platform functioned well with the intervention design and whether the intervention was feasible and acceptable for the participants. " 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study The message bank is available upon request and has been given to the Ministry of

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.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study n/a

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 specific 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).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "A message was delivered twice a week for ten weeks, and the message from each topic area was repeated every ten weeks for 60 weeks. The health messages were framed using rights-based and health promotion frameworks. Participants could choose to receive the messages in an SMS or VM form that worked with simple and smartphone devices.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "The Mobile Link intervention was informed by both behavior change theories and extensive formative research. The intervention provided FEWs with information, resources, and reminders. By utilizing an SMS/VM platform, these services were provided in a convenient, accessible, inexpensive, and con dential manner. Therefore, we theorized that this delivery mechanism would improve FEWs' knowledge of existing resources, risks, risk behaviors, and positive attitudes related to these topics. Increasing knowledge and positive attitudes will contribute to skill acquisition and positive behavior change."

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.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "A message was delivered twice a week for ten weeks, and the message from each topic area was repeated every ten weeks for 60 weeks.

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 21 -generalizability).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "using automated short message service (SMS) and voice messages (VM)" and "Each health topic message was followed by a message providing FEWs with the option to be linked to an outreach worker for free."

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).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "Each health topic message was followed by a message providing FEWs with the option to be linked to an outreach worker for free. Participants who selected this option were called by the Mobile Link's staff, who would provide individualized information via telephone or face-to-face and, if needed, would escort the participant to services."

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 briefly explain why the item is not applicable/relevant for your study n/a 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 briefly explain why the item is not applicable/relevant for your study "The primary outcome measures of the Mobile Link intervention were: (1) HIV testing, (2) STI testing when experiencing symptoms, (3) contraceptive use, (4) always use condoms with non-paying partners, and (5) always use condoms with paying partners. The secondary outcome measures were: (1) contact with outreach workers, (2) utilization of escorted referrals, (3) forced drinking at work, and (4) responses to GBV and GBV acceptance. The primary and secondary outcomes were tracked and measured using self-reported data from the baseline, midline, and endline surveys. " 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].

Clear selection
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text n/a 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Participants lost to follow-up after baseline, resulting in missing outcome data at six months, were considered non-users." 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).

Clear selection
Does your paper address subitem 6a-iii?

Copy and paste relevant sections from manuscript text
This information is included in the description of the formative study.
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 briefly explain why the item is not applicable/relevant for your study This information is presented in the Protocol adaptations section.

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 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 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 briefly explain why the item is not applicable/relevant for your study The sample size was 600 based on a signi cance level of .05, with 80% power and accounting for 30% attrition.
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 briefly explain why the item is not applicable/relevant for your study n/a -we had no speci ed stopping rules.
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 briefly explain why the item is not applicable/relevant for your study "At each site, 60 FEWs were randomly selected using a random number generator (30 in the age group of 18-24 and 30 in the age group of 25-30) for each arm (300 FEWs in the intervention and 300 FEWs in the control arm) for a total of 600 study participants." 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 briefly explain why the item is not applicable/relevant for your study " At each site, 60 FEWs were randomly selected using a random number generator in a 1:1 ratio. There were 30 in the age group of 18-24 and 30 in the age group of 25-30 for each arm at each site (300 FEWs in the intervention and 300 FEWs in the control arm) for a total of 600 study participants." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 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 briefly explain why the item is not applicable/relevant for your study n/a -no special concealment 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 briefly explain why the item is not applicable/relevant for your study "Field workers developed a list of more than 4000 FEWs from the ve study sites." and "All participants were recruited in-person at the ve study sites by trained Mobile Link lay community health workers. Community health workers provided verbal information to FEWs regarding the Mobile Link's details because of low literacy rates in this population." 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).

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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 briefly explain why the item is not applicable/relevant for your study "Reruited FEWs were assigned a unique identi cation number to protect their privacy and blind the researchers from their treatment arm assignment." subitem not at all important 1 2 3 4 5 essential 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) 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 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".

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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 briefly explain why the item is not applicable/relevant for your study See informed consent form.
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 briefly explain why the item is not applicable/relevant for your study n/a 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 briefly explain why the item is not applicable/relevant for your study "Statistical analyses STATA/SE 15.1 (College Station, TX, USA) was used for statistical analyses. We tabulated participants' baseline characteristics and distributions of primary and secondary outcome variables for intervention versus control arms for the analytic sample -participants with at least two observations -using frequencies and proportions for categorical variables and means and standard deviations (SDs) for continuous variables. These characteristics were compared by group using tests of association, including Pearson's Chi-squared tests of homogeneity for categorical variables and paired Student's t-tests for continuous variables to ensure the balance between the study arms. We conducted both crude and cluster-adjusted pooled tests of association to account for clustering within workplace venues.
Participant characteristics were then compared for the analytic sample (n=388) versus non-analytic sample (n=733) to assess signi cant differences within and between groups for those retained in the study per protocol for at least two survey assessments (i.e., analytic sample) versus those lost to follow up after the baseline assessment (i.e., non-analytic sample). Intervention effects were assessed using multilevel mixed-effects logistic regression to model all binary outcomes accounting for within-subject correlation from taking repeated measures on the same participants over time (two-level models with observations nested within individuals). Clustered standard errors were computed to account for the similarity of characteristics and behaviors among participants in the same venues. Separate models were conducted for each primary and secondary outcome. Model t was assessed for each outcome using the Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC).
Predictors in each simple unadjusted two-level mixed-effects logistic regression model included: group, time, and group by time interaction terms.
Intervention effects for each outcome were determined by group by time interaction terms at endline with a signi cant p-value <0·05. Odds ratios (ORs) and 95% con dence intervals (CIs) for intervention effects at endline are displayed in Tables 2 and 3 (group by time interactions at time 3). Signi cant interactions indicating intervention effects were graphed using the marginsplot command (Figures 1-3). Midline effects (signi cant group by time interactions at time 2) are displayed in the gures but not in the tables. For the fully adjusted primary and secondary outcome models, the following covariates were included to control for alternative explanations: entertainment job venue type, province, cohabitation, age, and education. For primary outcomes, contact with outreach workers in the last six months was also included as a covariate to assess the impact of linkage support on HIV and STI testing, contraceptive use, and condom use.
As a sensitivity analysis, we used intention-to-treat (ITT) principles for modeling primary and secondary outcomes with all participants (n=1121), according to the arm to which they were assigned and then compared to the results for each outcome from the per-protocol modeling with the analytic sample. Per-protocol analyses were undertaken to assess the intervention's impact among those who actively participated in the study. Participants lost to follow-up after baseline, resulting in missing outcome data at six months, were considered nonusers. ITT and per-protocol results were consistent for all outcomes regarding the direction, strength, and signi cance of associations. As such, only the per-protocol subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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]).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "Participants lost to follow-up after baseline, resulting in missing outcome data at six months, were considered non-users. ITT and per-protocol results were consistent for all outcomes regarding the direction, strength, and signi cance of associations. As such, only the per-protocol results are presented in the tables for ease of interpretation. " 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 briefly explain why the item is not applicable/relevant for your study "As a sensitivity analysis, we used intention-to-treat (ITT) principles for modeling primary and secondary outcomes with all participants (n=1121), according to the arm to which they were assigned and then compared to the results for each outcome from the per-protocol modeling with the analytic sample. Per-protocol analyses were undertaken to assess the intervention's impact among those who actively participated in the study." Does your paper address subitem X26-i?

X26-i) Comment on ethics committee approval
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 briefly explain why the item is not applicable/relevant for your study "The Mobile Link intervention engaged community and public health stakeholders to ensure that the study incorporates best practices and strong ethical standards.
Due to the sensitive nature of HIV, SRH, and GBV topics presented in the surveys and questionnaires, additional steps were taken to ensure participants' safety and well-being. First, all data collectors received training related to asking sensitive questions. Second, upon obtaining informed consent, community health workers disclosed information, making clear the sensitive topics discussed in the data collection process. Third, participants were offered escorted referrals to counseling services and provided with services upon request. Participants could be connected to services in the event of an adverse outcome through the SMS/VM platform. Also, participants could leave the study at any time. Furthermore, participants' identities were kept con dential and stored securely in password-protected les. Coded identi ers were given to participants after obtaining informed consent. No participants' personal identi ers were used in analyses or report writing.
Participants received $5 in compensation and transportation reimbursement for their participation. This study was approved by the National Ethics Committee for Health Research (NECHR, No. 142NECHR) within the Ministry of Health in Cambodia and the Touro College Institutional Review Board (No PH-0117) "

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline 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 briefly explain why the item is not applicable/relevant for your study "Community health workers provided verbal information to FEWs regarding the Mobile Link's details because of low literacy rates in this population. Eligible FEWs signed the informed consent form."

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 briefly explain why the item is not applicable/relevant for your study " First, all data collectors received training related to asking sensitive questions. Second, upon obtaining informed consent, community health workers disclosed information, making clear the sensitive topics discussed in the data collection process. Third, participants were offered escorted referrals to counseling services and provided with services upon request. Participants could be connected to services in the event of an adverse outcome through the SMS/VM platform. Also, participants could leave the study at any time. Furthermore, participants' identities were kept con dential and stored securely in password-protected les. Coded identi ers were given to participants after obtaining informed consent. No participants' personal identi ers were used in analyses or report writing. Participants received $5 in compensation and transportation reimbursement for their participation. " 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 briefly explain why the item is not applicable/relevant for your study "Before the intervention started, 3295 FEWs were assessed for eligibility, of whom 828 FEWs did not meet the eligibility criteria, 134 declined to participate, and 325 FEWs were excluded because of other reasons. Of the included FEWs, 435 FEWs were allocated to the intervention group and 683 FEWs to the control group. By the end of 30 weeks, 217 FEWs in the intervention and 513 FEWs in the control group discontinued the study and were replaced. We included 435 FEWs in the intervention and 683 FEWs in the control group in intention-to-treat analyses and 218 FEWs in the intervention and 170 FEWs in the control group in the per-protocol analyses." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow 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 briefly explain why the item is not applicable/relevant for your study 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

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 figures or tables demonstrating usage/dose/engagement.

Clear selection
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study n/a 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 briefly explain why the item is not applicable/relevant for your study "The randomized controlled trial was conducted between March 2018 and June 2019." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources"

Clear selection
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 briefly explain why the item is not applicable/relevant for your study n/a

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study n/a 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 briefly explain why the item is not applicable/relevant for your study Table 1 and "Participant characteristics were then compared for the analytic sample (n=388) versus non-analytic sample (n=733) to assess signi cant differences within and between groups for those retained in the study per protocol for at least two survey assessments (i.e., analytic sample) versus those lost to follow up after the baseline assessment (i.e., non-analytic sample)." and "We compared the characteristics of the analytic (retained) vs. non-analytic (lost to follow-up) samples and identi ed signi cant baseline differences in believing that something can be done if someone experiences abuse and forced drinking at work.
Participants in the analytic sample were more likely to believe that something can be done if a person experiences abuse and to report ever being forced to drink at work. No other baseline differences were identi ed between analytic and nonanalytic samples. "

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. 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 briefly explain why the item is not applicable/relevant for your study Table 1 and associated narrative: " Table 1 displays characteristics of the sample strati ed by intervention vs. control group with crude and cluster-adjusted pooled association tests. When accounting for clustering by the venue, there were no differences in sample characteristics by the group at baseline except a signi cantly lower proportion of currently married participants in the intervention than in the control group (19% vs. 28%, p=0.047). There were crude differences identi ed by province and entertainment job venue type when not accounting for clustering within venues. The intervention group had a higher proportion of participants from Battambang than the control group (16% vs. 9%, p=0.04). There were marginal but not signi cant crude differences in the proportions of intervention vs. control participants in each of the other three provinces. The intervention group had a higher proportion of participants working in karaoke bars (67% vs. 55%, p=0.01). In contrast, the control group had a higher proportion of participants working in beer gardens (12% vs. 22%, p=0.009). All other characteristics were successfully matched between arms with no statistically signi cant differences between intervention and control groups "

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: 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 specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

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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 briefly explain why the item is not applicable/relevant for your study Tables 1-3

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).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 briefly explain why the item is not applicable/relevant for your study "ITT and per-protocol results were consistent for all outcomes regarding the direction, strength, and signi cance of associations. As such, only the per-protocol results are presented in the tables for ease of interpretation." 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 briefly explain why the item is not applicable/relevant for your study Tables 1-3 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 definitions 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 defined (e.g., timeout after idle time) [1] (report under item 6a).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study n/a 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study n/a

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).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study n/a 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 briefly explain why the item is not applicable/relevant for your study n/a -non detected

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].

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subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study none encountered 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.

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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 briefly explain why the item is not applicable/relevant for your study Not included in this manuscript. We have conducted a qualitative follow up study and are still processing the data.
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).

Clear selection
subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "Our ndings suggest that the Mobile Link intervention effectively connected FEWs with outreach workers for health information and escorted referrals. However, the ndings do not indicate an impact on HIV and STI testing, condom use, and contraceptive use. Reductions in forced drinking at work were signi cantly larger in the intervention group than in the control group."

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

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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 briefly explain why the item is not applicable/relevant for your study "Our study did not detect changes in health outcomes, perhaps because these changes take longer to occur. It is also possible that several trial implementation challenges may have limited ability to detect health outcomes changes, including the high loss to follow-up, which was identi ed as an issue for other mHealth studies in Cambodia."

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 briefly explain why the item is not applicable/relevant for your study "Limitations These ndings should be interpreted with regard to study limitations. First, differential loss to follow-up was observed between intervention and control groups, and attrition was particularly high among control and replacement participants. Second, recruiting new participants to replace those lost to follow-up was conducted according to the initially intended distribution of participants per province rather than where participants were lost, resulting in an overrepresentation of control participants in smaller provinces. Third, high levels of movement between venues among FEWs led to a protocol change resulting in individual-level rather than venue-level sampling and non-random assignment to intervention and control groups. Finally, the participant were not blinded to the intervention. As such, the ndings should be interpreted with caution. However, a balance between study arms at baseline was achieved on all primary and secondary outcomes, in both the analytic sample and full sample, suggesting that intervention and control participants were appropriately matched based on participant characteristics and health behaviors "

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

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "Given the positive ndings on service linkages for this intervention, we will consider using the Mobile Link model with other key populations in Cambodia and the region. " 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.

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "The traditional in-person visitation model by community health workers on two- week or monthly rotations, the standard of care during this trial, may be enhanced by interventions such as the Mobile Link. " 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 briefly explain why the item is not applicable/relevant for your study NCT03117842 -Clinicaltrials.gov 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 briefly explain why the item is not applicable/relevant for your study https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5907699/pdf/13063_2018_Article _2614.pdf

X27) Conflicts 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 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 briefly explain why the item is not applicable/relevant for your study And we would like to acknowledge our funders: the 5% Initiative and Expertise France (Grant No. 16SANIN210).
X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial 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.

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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 briefly explain why the item is not applicable/relevant for your study The authors declare that they have no competing interests.
As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
More details about recruitment and enrollment; more details about reporting methods in general.
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This content is neither created nor endorsed by Google. Report Abuse -Terms of Service -Privacy Policy As a result of using this checklist, do you think your manuscript has improved? * 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

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Any other comments or questions on CONSORT EHEALTH It would be nice to have the ability to save and come back later since this is a very long process.