An Internet-Based, Peer-Delivered Messaging Intervention for HIV Testing and Condom Use Among Men Who Have Sex With Men in India (CHALO!): Pilot Randomized Comparative Trial

Background Leveraging internet-based communication tools (eg, messaging apps, SMS text messaging, and email) may be an effective avenue for delivery of HIV prevention messages to men who have sex with men (MSM) in India, but there are limited models for such internet-based interventions. Objective The CHALO! pilot was an online educational and behavioral intervention aimed to determine the feasibility, acceptability, and preliminary impact of a peer-delivered, internet-based messaging intervention for HIV testing and consistent condom use for MSM in India. The messages addressed barriers to HIV testing and condom use and were theoretically based on the information-motivation-behavioral skills model. Methods Between February and March 2015, we recruited, enrolled, and randomized 244 participants via online advertisements on mobile dating apps and Facebook. Eligible men (18 years or older, sexually active with other men, and self-reported HIV-negative or unknown status) were randomized to receive educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance (an undesirable outcome to be avoided) over 12 weeks via internet-based messaging platforms. Participants completed online surveys at baseline and immediately postintervention. Results Participants were similar across arms with respect to sociodemographic and behavioral characteristics. Over 82.0% (200/244) of participants were retained (ie, viewed final messages), and 52.3% (130/244) of them completed the follow-up survey. Of those completing the follow-up survey, 82.3% (107/130) liked or strongly liked participating in CHALO!. The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04). When including those who reported intentions to test, this percentage increased from 44.6% (58/130) at baseline to 65.4% (85/130) at follow-up (P<.01). When examining intentions to test among those without prior HIV testing, intentions increased from 32% (16/50) of the sample at baseline to 56% (28/50) of the sample at follow-up (P=.02). Condom use during anal sex did not significantly change from baseline to follow-up. HIV testing and condom use did not significantly differ between approach and avoidance conditions at follow-up. Conclusions As one of the first studies of an online HIV prevention intervention for Indian MSM, CHALO! was feasible to implement by a community-based organization, was acceptable to participants, and demonstrated potential to improve HIV testing rates.


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 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.

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   "Leveraging Internet based communication tools (e.g, messaging apps, SMS, email) may be an effective avenue for delivery of HIV prevention messages to men who have sex with men (MSM) in India, but there are limited models for such online

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.

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 Your answer 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 briefly explain why the item is not applicable/relevant for your study "Globally and in India, HIV disproportionately affects men who have sex with men (MSM), who are designated a key priority population by the Indian health ministry for targeted HIV prevention interventions " subitem not at all important

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) 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 "Eligible men (18 years or older, sexually active with other men, and self-reported HIVnegative or unknown status) were randomized to receive educational and motivational messages framed as either: Approach (i.e., a desirable outcome to be achieved) or Avoidance (an undesirable outcome to be avoided) over 12 weeks via Internet-based messaging platforms" 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 "receive educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance (an undesirable outcome to be avoided) over 12 weeks via internet-based messaging platforms." 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) 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 "receive educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance (an undesirable outcome to be avoided) over 12 weeks via internet-based messaging platforms." subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study   "Over 82% of participants (n=200) were retained (ie, viewed final messages), and 53% (n=130) completed the follow-up survey. Of those completing the follow-up survey, 82% liked or strongly liked participating in CHALO!. The results showed a significant increase in self-reported HIV-testing in the past 6 months from baseline to follow-up (32% to 44%; P<.05). When including those who reported intentions to test, this percentage increased from 45% at baseline to 65% at follow-up (P<.01).
When examining intentions to test among those without prior HIV-testing, intentions increased from 32% of the sample at baseline, to 56% of the sample at follow-up (P<.05) Condom use during anal sex did not significantly change from baseline to follow-up. HIV-testing and condom use did not significantly differ between Approach subitem not at all important 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   "International organizations, including India's National AIDS Control Organization (NACO), recognize the public health potential of ICT, and have called for development and implementation of ICT-based HIV prevention strategies [17]. Besides evidence of their being acceptable to MSM, ICT also offer considerable scalability and efficiency of wide reach with high impact potential, even with relatively low intensity interventions [18,19]. Technology-based, peer-led approaches could be used to enhance efforts by community based and other organizations for dissemination of health messages and service availability [20]. Thus, rather than an alternative medium for implementation of existing interventions designed for face-to-face contact, social media may be a 'game changer' to engage MSM in India [21]. A meta-analysis found that social media interventions were effective in increasing HIV-testing, however none of the studies were conducted in a low-income country [22]. Two recent systematic reviews describing internet based interventions for HIV care continuum found diverse models targeting HIV-testing and prevention; however, most (over 85%) were in well-resource settings. [23,24] Few effective, scalable, and low-cost ICT-based interventions targeting HIV-testing and prevention exist for low income countries [25][26][27][28] and no published data are available on the effectiveness of ICT based approaches in India or other South Asian countries. In addition to the paucity of data about Internet based interventions in low-income settings for any population, there is little empirical data to guide health communication, i.e., messaging, for online dissemination to increase HIV-testing and condom use. Two messaging approaches, often called "frames" are widely used in health communication. The first, called "approach" or "gain framed, highlights the benefits of engaging in a specific health behavior. The second, called, "avoidance" or "loss-framed," focuses on negative consequences. Metanalytic reviews have indicated that gain-framed messaging is more effective in promoting prevention behavior, but loss-framed messaging may be more effective in promoting screening or illness detection behavior [29][30][31]. However, it is unclear which framing strategy is most effective when promoting a comprehensive approach to HIV prevention that includes promoting both HIV-testing and condom use. Prior research from a highincome country (United States) has found mixed-results with regards to condom use intentions [32,33] and HIV-testing behaviors, [34]. However, to our knowledge, no published data exist with regards to framing effects of health messages for HIV-2b) In INTRODUCTION: Specific objectives or hypotheses METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 briefly explain why the item is not applicable/relevant for your study   "To help close the gap in the use of ICT for public health purposes in India and address the high HIV-prevention needs of Indian MSM, the CHALO! ("Let's Go!") pilot study, developed and tested the feasibility, acceptability, and preliminary impact of an ICT-based HIV prevention intervention to increase HIV-testing and consistent condom use among MSM reached on internet-based social and dating platforms in Mumbai, India. " and " Our central hypothesis was that a peer-delivered ICT-based behavioral intervention can efficiently identify and reach sexually active Indian MSM, enroll them into an exclusively online study, motivate them to seek in-person health services (i.e., HIV-testing), and modify health promotion behaviors (increase 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 "CHALO! was a two-arm parallel randomized (1:1 randomization) comparative effectiveness trial comparing two message framing strategies (Avoidance-and Approach-framed messages) to promote HIV-testing and consistent condom use. " 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 4a) Eligibility criteria for participants 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 There were no important changes to the methods after the trial commencement.

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 changes, system failures/downtimes, etc. [2].
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 There are no bug fixes, downtimes, or content changes to report subitem not at all important 1 2 3 4 5 essential 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   "Eligible individuals were aged at least 18 years, identified as male, reported anal sex with another male partner in the past 2 years, lived in Mumbai, were fluent in either English or Hindi, self-reported being HIV-negative, or unaware of their status (ie, never tested or never received results), and provided a valid contact (email, mobile phone number, or Facebook ID -validated by a response to a confirmation message). Individuals were excluded if they reported being a staff member or any type of outreach worker for HST. Participants were screened into the study using an

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
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 "provided a valid contact (email, mobile phone number, or Facebook ID -validated by a response to a confirmation message). Individuals " subitem not at all important 1 2 3 4 5 essential 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 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 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 "from March to June, 2015, the four peer-outreach workers (two per arm) sent a standardized introductory message via the participant's chosen communication modality (ie, email, WhatsApp, or private Facebook group), followed by intervention messages two or three times per week for 12 weeks. Each set of 15 messages was sent out twice over the 12 weeks to help ensure that participants viewed them and reinforce the information contained within the messages. Thus, after the first set of 15 messages were sent out, another round of the same 15 messages was sent again. Messages for all participants were sent by the peer-outreach worker on the same days and times each week. Participants were also able to communicate with their assigned peer outreach worker for any reason via multiple modalities (text message, email, Facebook Messenger, or phone call), but only if the participant initiated contact. " subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "First, from February to March 2015, recruitment advertisements were disseminated on a popular MSM specific dating website, a geosocial networking mobile app, and on HST operated/subscribed Facebook pages. Potential participants clicked through the ads to complete an online consent and eligibility screener; if eligible, they automatically continued on to the baseline survey." subitem not at all important 1 2 3 4 5 essential 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 study took place online, between February and June 2015, targeting MSM living in Mumbai -India's largest city with a population of over 18 million, and a city with one of the highest HIV burdens in India. Mumbai accounted for over 19,000 new HIV diagnoses in 2016-2017 [17, 35], with the prevalence of HIV among MSM estimated to be 7%. At the time of the study, Mumbai had high Internet connectivity with an abundance of free or low-cost Wi-Fi spots, low-cost Internet cafes, and mobile service providers offering Internet/data plans for smartphones at a relatively low cost. For this pilot, recruited participants from two of India's most used MSM specific dating sites (which have now become the most commonly used avenues for MSM meet in urban India [36,37]) and from HST-operated Facebook pages. HST has three drop-in centers and a central office in the three major subdivisions of Mumbai, where HIV and STI testing, sexual health and psycho-social counseling, and linkage-to-care services are available. At the time of the study, HST was the only established community organization providing such services to MSM. "

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.
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 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 "Potential participants clicked through the ads to complete an online consent and eligibility screener; if eligible, they automatically continued on to the baseline survey. " and". "Participants then received a final intervention message and a personal link to the follow-up survey. "

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) 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

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).

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   "We used a participatory process with an interdisciplinary team at HST to develop all components of the intervention in an iterative process over a three-month period. The core team members at HST consisted of eight individuals: two communitybased researchers, two HIV-testing/counseling staff members, an HIV-positive peer patient navigator, and three peer outreach workers experienced in using MSM dating websites and apps for outreach to MSM in Mumbai. This intervention development team informed all aspects of the study including study design, participant eligibility, recruitment and retention, study measures, intervention implementation, and

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

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "The intervention target selection (i.e., which barriers to address) and messagedevelopment and refinement process was a community-led multi-phase and iterative process occurring over a two-day workshop with an interdisciplinary team: three facilitators (HST research staff members experienced in conducting HIV related trainings) and 10 participants (HST's community advisory board members, peer outreach workers, experienced in outreach and care-linkage for >5 years, and with online MSM dating apps), and HIV counseling and testing staff. The members had diverse sexual identities common in India] (gay, bisexual, kothi, panthi) [44, 45), genders (male, female, and hijra/transgender individuals), and demographic characteristics (with regards to education, age, and primary language used (English or Hindi)). Three members of the group were people living with HIV.
We used "open space technology" to facilitate communication and participation by all workshop members [46]. Open space technique is a process that has been used across disciplines to help ensure inclusion of diverse attitudes and experiences, and has been used to facilitate identification of challenges or barriers to a task or behavior (eg, HIV testing) and identification of potential solutions to overcome them. For this study, workshop members first identified challenges to HIV-testing and consistent condom use, and then mapped these to the IMB domains (i.e., the targets). The following targets were identified within the IMB Model: Information: Information about HIV transmission and prevention with condoms, logistical information (e.g., testing locations and hours); Motivation: Risk Perception, Stigma; and Behavioral Skills: how to access or make an appointment for free testing. Next, after receiving a brief orientation to "Approach" and "Avoidance" messaging frames, participants in small groups developed short social marketing messages that could be disseminated online addressing the above-identified targets or provided solutions for overcoming the barrier (e.g., a webpage vetted to be MSM friendly listing free HIV-testing centers, which addressed lack of knowledge about safe HIV-testing venues). Workshop participants developed between 3 to 5 messages for every identified target for both Approach and Avoidance frames. Thus, we developed approximately 25-30 messages for each message Frame (Approach and Avoidance). All messages were transcreated into English or Hindi based on the original language (eg, messages initially developed in Hindi were then transcreated into English and conversely from English into Hindi). We used transcreation (as opposed to translation) to retain the essence of the original message [47], while the text was then refined using a consensus approach to further ensure comprehension and equivalency in meaning, sentiment, and framing. Next, 30 peer-staff and MSM community members at the HST drop in-center (not involved in the workshop) voted for their favorite top three messages for each factor in each of the Approach and Avoidance frames. Finally, we selected the top one or two messages receiving the most votes for each target within each frame for use in the intervention, resulting in 15 messages for each arm; eight of the messages focused on HIV-testing and subitem not at all important

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 briefly explain why the item is not applicable/relevant for your study Your answer

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
subitem not at all important 1 2 3 4 5 essential 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 Your answer 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.
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

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 briefly explain why the item is not applicable/relevant for your study Your answer

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 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 intervention target selection (i.e., which barriers to address) and messagedevelopment and refinement process was a community-led multi-phase and iterative process occurring over a two-day workshop with an interdisciplinary team: three facilitators (HST research staff members experienced in conducting HIV related trainings) and 10 participants (HST's community advisory board members, peer outreach workers, experienced in outreach and care-linkage for >5 years, and with online MSM dating apps), and HIV counseling and testing staff. The members had diverse sexual identities common in India] (gay, bisexual, kothi, panthi) [44, 45), genders (male, female, and hijra/transgender individuals), and demographic characteristics (with regards to education, age, and primary language used (English or Hindi)). Three members of the group were people living with HIV.
We used "open space technology" to facilitate communication and participation by all workshop members [46]. Open space technique is a process that has been used across disciplines to help ensure inclusion of diverse attitudes and experiences, and has been used to facilitate identification of challenges or barriers to a task or behavior (eg, HIV testing) and identification of potential solutions to overcome them. For this study, workshop members first identified challenges to HIV-testing and consistent condom use, and then mapped these to the IMB domains (i.e., the targets). The following targets were identified within the IMB Model: Information: Information about HIV transmission and prevention with condoms, logistical information (e.g., testing locations and hours); Motivation: Risk Perception, Stigma; and Behavioral Skills: how to access or make an appointment for free testing. Next, after receiving a brief orientation to "Approach" and "Avoidance" messaging frames, participants in small groups developed short social marketing messages that could be disseminated online addressing the above-identified targets or provided solutions for overcoming the barrier (e.g., a webpage vetted to be MSM friendly listing free HIV-testing centers, which addressed lack of knowledge about safe HIV-testing venues). Workshop participants developed between 3 to 5 messages for every identified target for both Approach and Avoidance frames.

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 briefly explain why the item is not applicable/relevant for your study "The four peer-outreach workers (two per arm) sent a standardized introductory message via the participant's chosen communication modality (ie, email, WhatsApp, or private Facebook group), followed by intervention messages two or three times per week for 12 weeks. Each set of 15 messages was sent out twice over the 12 weeks to help ensure that participants viewed them and reinforce the information contained within the messages. Thus, after the first set of 15 messages were sent out, another round of the same 15 messages was sent again. Messages for all participants were sent by the peer-outreach worker on the same days and times each week. "

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).
subitem not at all important 1 2 3 4 5 essential 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   As quoted from the paper in earlier subitems, peer leaders deliver messages to participant's via their chosen communication mode. Participants could communicate with their peer leader if they choose to either via email, Facebook

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 briefly explain why the item is not applicable/relevant for your study "the four peer-outreach workers (two per arm) sent a standardized introductory message via the participant's chosen communication modality (ie, email, WhatsApp, or private Facebook group), followed by intervention messages two or three times per week for 12 weeks. " subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

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   "HST research staff selected four MSM peer-outreach workers for the intervention who were fluent in Hindi and English and reported comfort and experience with using online dating apps, Facebook, and email, and not involved with development of the messages. Chosen peers had previously received training in HIV-related communication, community engagement, and were experienced in HIV-related outreach in Mumbai. For this pilot, the peer-outreach worker received additional specific training on online research ethics, maintaining confidentiality and privacy, and communicating via online tools.Two peer-outreach workers were randomly assigned to each arm. Peers were then randomly assigned to serve as the online peer outreach worker for half the participants within their assigned arm. Each peer was responsible for sending intervention messages to their assigned participants and to communicate with participants, if and when a participant chose to initiate any communication. There was no cross-arm communication from the peer-"HIV-testing. To assess the HIV-testing outcomes, we asked at baseline and follow-up "When was your last HIV test?" with response categories of "Less than 1 month ago", "2 to 6 months ago", "7 to 12 months ago", "more than 12 months ago", and "Never." We then dichotomized responses for analysis to 6 months vs. all others, based on recommended tesging guidelines for MSM [48]. To ascertain testing intentions during and immediately after the intervention ended, we asked "Do you intend to test in the next three months?" (at baseline) and "Do you intend to test in the next month?" (at follow-up) with the answer options of Yes or No.
Consistent Condom Use. Condom use outcomes was assessed at both baseline and follow-up using the question "In the last three months, how often have you used condoms during anal sex?", with the response options of "Always", "Most of the time", "Sometimes", "Rarely" and "Never;" for analyses, we dichotomized responses as Always vs. Inconsistent (including all the other response options). " To determine feasibility, we assessed 3 process measures: (1) enrollment data (number of individuals completing the screening survey, proportion eligible, and the proportion enrolling into the study); (2) retention (measured by a composite indicator consisting of WhatsApp and Facebook message viewed indicators, participant responses to reminder emails about completing the follow-up assessment, or completion of the follow-up assessment), and (3) completion rate (proportion of participants completing the follow-up assessment). We also assessed the relationship between completion of the follow-up assessment and baseline participant characteristics using chi-square, Fisher's exact or t-tests as appropriate.
To determine acceptability, we tabulated the Likert-scale responses to questions about how much the group liked participating in CHALO! and used chi-square to examine differences between conditions. We thematically analyzed and coded the field notes and the brief open-ended responses on the follow-up survey based on three general categories: what was most liked, disliked, and suggestions for improving the intervention. Two team members independently coded the responses and discrepencies were resolved through discussion.
To determine early efficacy, we undertook several steps. We first described the sample using frequencies and means, and examined potential differences in baseline characteristics and behaviors using chi-square and t-tests, as appropriate. To assess the intervention's early impact, we examined potential changes in four outcomes ((1) composite of HIV-testing plus Intention to test (2) HIV-testing alone, (3) intention to test for HIV, and (4) consistent condom use), we first compared the two arms among those completing the post-intervention assessment using chi-square tests. Next, we conducted a pooled pre-post analysis ( Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
The online questionnaires were pilot and refine with the target audience.

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 Your answer subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "Qualitative Feedback. To evaluate acceptability, identify implementation challenges, and elicit suggestions to refine CHALO!, we collected field notes from 1) our weekly project meetings with the research team, 2) peer-outreach staff during and at the end of study, and 3) two focus groups of CHALO! participants (N=6 to 8 per group) after intervention completion. Peer intervention staff also elicited feedback via email, WhatsApp, or Facebook Messenger from those not completing the follow-up assessment to evaluate reasons for survey non-completion. " 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 There were no changes to trial outcomes after the trial commenced 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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 There are no applicable interim analyses or 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) 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 Please see 8b for randomization details.
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 Peer Leaders ".Two peer-outreach workers were randomly assigned to each arm. Peers were then randomly assigned to serve as the online peer outreach worker for half the participants within their assigned arm. Each peer was responsible for sending intervention messages to their assigned participants and to communicate with participants, if and when a participant chose to initiate any communication. There was no cross-arm communication from the peer-outreach workers to participants in the arm to which they were not assigned." Participants: " . After confirming contact information provided, participants were randomized 1:1 to either the Approach or Avoidance framed conditions." 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 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 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 Not applicable.
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 Random allocation sequence was computer generated by the lead author. Participants were enrolled by a Research Assistant and the RA also assigned participants to the intervention.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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).

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 The participants were blinded since they were randomly assigned to either of the conditions, with no knowledge of another arm. The statistician was also blinded.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

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 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 Participants were not aware of another arm 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 This is not relevant.
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 "To determine feasibility, we assessed 3 process measures: (1) enrollment data (number of individuals completing the screening survey, proportion eligible, and the proportion enrolling into the study); (2) retention (measured by a composite indicator consisting of WhatsApp and Facebook message viewed indicators, participant responses to reminder emails about completing the follow-up assessment, or completion of the follow-up assessment), and (3) completion rate (proportion of participants completing the follow-up assessment). We also assessed the relationship between completion of the follow-up assessment and baseline participant characteristics using chi-square, Fisher's exact or t-tests as appropriate.
To determine acceptability, we tabulated the Likert-scale responses to questions about how much the group liked participating in CHALO! and used chi-square to examine differences between conditions. We thematically analyzed and coded the field notes and the brief open-ended responses on the follow-up survey based on three general categories: what was most liked, disliked, and suggestions for improving the intervention. Two team members independently coded the responses and discrepencies were resolved through discussion.
To determine early efficacy, we undertook several steps. We first described the sample using frequencies and means, and examined potential differences in baseline characteristics and behaviors using chi-square and t-tests, as appropriate. To assess the intervention's early impact, we examined potential changes in four outcomes ((1) composite of HIV-testing plus Intention to test (2) HIV-testing alone, (3) intention to test for HIV, and (4) consistent condom use), we first compared the two arms among those completing the post-intervention assessment using chi-square tests. Next, we conducted a pooled pre-post analysis (i.e., within-subjects, across time) for HIVtesting, intention to test for HIV, and consistent condom use using Mcnemer's test. " subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 briefly explain why the item is not applicable/relevant for your study " There were no significant differences between conditions in the proportion of participants retained, accessing the follow-up assessment, and completing the followup assessment. There were also no significant differences in baseline demographic and behavioral characteristics among those retained or completing the follow-up assessment, except in regards to sexual orientation (Supplementry Table)." 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 This is not applicable. Analysis have been previously described in earlier subitems.

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
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 Your answer

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 "Potential participants clicked through the ads to complete an online consent and eligibility screener; if eligible, they automatically continued on to the baseline survey. "

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) 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 "For this pilot, the peer-outreach worker received additional specific training on online research ethics, maintaining confidentiality and privacy, and communicating via online tools" 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 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 Figure 1 and Table 1 present this information. A total of 244 participant were randomized and analyses in the analysis.
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 "Overall, 200 of the 244 enrolled participants (82%) were retained through the end of the intervention (Figure 1). The post-intervention assessment link was clicked on by 153 (63%) participants and was completed by 130 (53%) participants. There were no significant differences between conditions in the proportion of participants retained, accessing the follow-up assessment, and completing the follow-up assessment. There were also no significant differences in baseline demographic and behavioral characteristics among those retained or completing the follow-up assessment, except in regards to sexual orientation (Supplementry Table). " subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up

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.

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 Please refer to figure 1 in the manuscript 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

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" 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 This is 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 briefly explain why the item is not applicable/relevant for your study The trial did not end or stop early subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 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 presents baseline demographic characteristics for each group.

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 briefly explain why the item is not applicable/relevant for your study Demographics associated with digital divide issues are presented in table. subitem not at all important

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.

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 All denominators are included (please refer to table 1 and table 2).

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 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

Your answer
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 For primary and secondary outcomes N (%) and p value are presented. Please refer to table 2.

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).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 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 This is not applicable 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 This is not applicable.
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 Analysis of potential contamination is presented in the results section.

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

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 briefly explain why the item is not applicable/relevant for your study

Your answer
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 There were no unintended effects.
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 "Content analysis of free-text responses about what participants liked most about CHALO! revealed the following themes: the intervention was useful and provided supportive information; messages were engaging or motivating; created a sense of community and acceptance; and made them feel good about helping their community by participating in the study. In regards to what participants least liked about CHALO!, individuals reported the survey was too long or redundant, felt that messages were not frequent enough, or had comments pertaining to the graphical appearance of the messages. Suggestions for improvement included having a larger social media presence, continuing the messaging for a longer duration, expanding topics, and using audio-visual or interactive graphics (e.g., video-clips). Field notes and feedback from peer-outreach staff indicated that the most common reason for not completing the follow-up assessment was not finding the Amazon.co.in incentive useful." 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 briefly explain why the item is not applicable/relevant for your study "Using a community based participatory research process, we developed and implemented an Internet-based HIV prevention intervention for MSM in India. Findings from this pilot study showed that the CHALO! intervention delivery model was feasible to implement by a community based organization, and acceptable to participants, particularly those identifying as gay/homosexual. The intervention also demonstrated preliminary evidence for improving HIV-testing and intention to test for HIV across both trial arms by self-report, with a greater increase in the Avoidance-framed arm. However, the intervention had no impact on condom use." 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   "Fully powered Internet-based intervention studies are warranted to examine the impact of these online models with more objective measures of HIV-testing, as well as assessment of downstream outcomes of linkage to care (for both treatment and prevention). Additionally, HIV prevention studies of longer duration of fully online interventions in India and other low-income settings are needed to understand long term retention and program effectiveness. Unlike online interventions which rely on specific software platforms or require high technical expertise and resources, the CHALO! intervention model -including the rigorous community based development process for message creation -may also serve as a model for future ICT-based interventions that are able to accommodate the constantly shifting sociotechnical

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.

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial findings 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 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 "This study should be interpreted in light of its limitations. First, our measures were self-report, which may have introduced social desirability bias. However, given that we only observed changes in HIV-testing and not for condom use, as well as the relatively anonymous nature of participant enrollment, social desirability may have played a limited role. Future studies with more objective measures are nevertheless needed. Second, this study recruited MSM online who reported living in Mumbai, and thus may not be generalizable to online MSM elsewhere in India, particularly in settings which may not have MSM-sensitive physical services or a wide range of HIV-testing sites available. Third, men who identified as bisexual and straight had low retention, indicating this pilot intervention likely had minimal impact on these groups, who may be at higher risk for HIV. [65,66] Future Internet based interventions for HIV prevention may benefit from taking into account sexual identity and tailoring contents specific to bisexual and straight identified MSM. Finally, there could have been potential contamination between study arms, given that a quarter of participants reported sharing the digital messages and a quarter knew of others participating in the study. "

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 subitem not at all important 1 2 3 4 5 essential

OTHER INFORMATION
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 "Our pilot study extends the literature by demonstrating the potential utility of a peerdelivered messaging intervention in a low-income country setting. Our findings also support the feasibility of implimenting online interventions for MSM in India, with other recent data showing the ability to rapidly engage diverse Indian MSM online, including in rural areas"

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 briefly explain why the item is not applicable/relevant for your study Your answer 23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders 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 This is not applicable 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