Long-term Effects of a Social Media–Based Intervention (Run4Love) on Depressive Symptoms of People Living With HIV: 3-Year Follow-up of a Randomized Controlled Trial

Background Emerging studies have shown the effectiveness of mobile health (mHealth) interventions in reducing depressive symptoms among people living with HIV. Most of these studies included only short-term follow-up, with limited data on long-term effects. Objective The purpose of this study is to assess the long-term effects of a randomized controlled trial called Run4Love on depressive symptoms among people living with HIV at 1-year and 3-year follow-ups. Methods A total of 300 people living with HIV with depressive symptoms were recruited and randomized to an intervention or a control group in Guangzhou, China, from September 2017 to January 2018. The intervention group received a 3-month Run4Love program, including adapted evidence-based cognitive behavioral stress management courses and exercise promotion via WeChat (Tencent), a popular social media app. The control group received usual care and a brochure on nutrition. The primary outcome was reduction in depressive symptoms, measured using the Center for Epidemiological Studies–Depression (CES-D) scale. Data used in this study were collected at baseline and at the 1-year and 3-year follow-ups. Generalized estimating equations were used to examine the group differences at 1-year and 3-year follow-ups. Results Approximately half of the participants completed the assessment at 1-year (149/300, 49.7%) and 3-year (177/300, 59%) follow-ups. At 1-year follow-up, participants in the intervention group reported significant reduction in depressive symptoms compared with the control group (CES-D: from 23.9 to 18.1 in the intervention group vs from 24.3 to 23.3 in the control group; mean −4.79, SD 13.56; 95% CI −7.78 to −1.81; P=.002). At 3-year follow-up, between-group difference in CES-D remained statistically significant (from 23.9 to 20.5 in the intervention group vs from 24.3 to 24.4 in the control group; mean −3.63, SD 13.35; 95% CI −6.71 to −0.54; P=.02). No adverse events were reported during the 3-year follow-up period. Conclusions The mHealth intervention, Run4Love, significantly reduced depressive symptoms among people living with HIV, and the intervention effects were sustained at 1-year and 3-year follow-ups. Further research is needed to explore the mechanisms of the long-term effects of mHealth interventions such as Run4Love and to implement these effective interventions among people living with HIV. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-IPR-17012606 International Registered Report Identifier (IRRID) RR2-10.2196/10274

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. 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 其他: 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.  T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u  s  . subitem not at all important 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

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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). 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 Yes, we stated that participants were recruited (face-to-face) in an outpatient clinic. The assessments (baseline and follow-up surveys) was administered using a tablet. 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 Yes. We stated that we recruited a total of 300 participants and they were randomly assigned to intervention or control with a ratio of 1:1. 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 Yes, our participation eligibility include smart phone ownership and using WeChat. 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.
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 Yes. In the Methods, we stated that participants were recruited from an outpatient clinic (face-to-face); they completed the baseline survey on a tablet at the time of recruitment. The intervention assignment was not blind, participants needed to give research staff their WeChat ID and phone number.
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, we stated that "Patients in the waiting area were invited by the research staff to participate in the study. They rst completed a brief screening questionnaire in a private space. Those who met the eligibility criteria (see below) were provided with a pamphlet with description of the Run4Love study and invited to join the study. Patients interested to participate were given further information about the study." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, we stated that the assessments were conducted on a tablet.  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. The program was developed by our research team.

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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.
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 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). 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 Provide information on quality assurance methods to ensure accuracy and quality of information 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 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. 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 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.
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 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). 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 Yes, we stated that participants will receive information on their own WeChat account on their own smartphones. The study does not require downloading a new app or logging in.

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- 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 Yes, we described the Run4Love intervention components, functions, and theoretical framework, and comparator on manuscript (p6-7). The intervention protocol was also detailed in a published paper, reference #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 Yes, we described the Run4Love intervention components, functions, and theoretical framework, and comparator on manuscript (p7-8). The intervention protocol was also detailed in a published paper, reference #19.

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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). 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 Yes. We stated that "Allocation to treatment group was carried out by a computer-generated randomization list with a block size of 4 using SAS software version 9.4 (SAS Institute, Inc., Cary, NC, USA). By the nature of the trial design, neither research staff nor participants were blinded to the intervention." 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 Yes. We reported details of statistical analyses. We stated that "For primary and secondary outcome analysis, the repeated measures generalized estimating equation (GEE) linear regression models were conducted to assess the intervention effects.
[37] As a model well suited for longitudinal data analysis, GEE improves statistical power because it allows for simultaneous analysis of intervention effects at multiple time points in a single model with an exchangeable working correlation matrix accounting for potential correlation due to within-subject dependencies across time. In this study, the main effects of group and time, and the interaction effects between group and time were examined in the GEE using repeated measurements of the two groups at baseline and the five follow-up points (i.e., at 3-, 6-, 9-, 12-, and 36-month follow-ups), adjusting for baseline demographic and HIV-related characteristics (i.e., age, gender, BMI, education, sexual orientation, family monthly income, marital status, duration of HIV infection, and employment) and psychological outcomes (e.g., scores of CES-D). The R package geepack (R Foundation, version 4.0.5) was used to conduct the GEE analysis. " 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] 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 Yes. We stated that "For missing values, multivariate imputation by chained equations was performed using the R package mice (R Foundation, version 4.0.5), and 80 imputed datasets were obtained. The final dataset was the average of the 80 imputed datasets. All the statistical analyses were conducted using the complete dataset after imputation. In addition, a sensitivity analysis was conducted using data with missing values to assess the robustness of the results. " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We stated that "Cohen's d was calculated to measure the effect size of the intervention.
[38] The between-group effect size was calculated by the difference between the mean score change of the intervention group from baseline and mean score change of the control group from baseline, which was then divided by the standard deviation of pooled score changes. 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 Yes, we reported that a total of 300 participants were enrolled in the study. The follow-up rates were 91.3% (92.7% in intervention and 90.0% in control), 88.3% (88.0% in intervention and 88.7% in control), 86.7% (88.7% in intervention and 84.7% in control) , 49.7% (49.3% in intervention and 50.0% in control), and 59.0% (56.7% in intervention and 61.3% in control) at 3, 6, 9, 12 and 36 months respectively.  D  o  e  s  y  o  u  r  p  a  p  e  r  a  d  d  r  e  s  s  C  O  N  S  O  R  T  s  u  b  i  t  e  m  1  3  b  ?  (  N  O  T  E  :  P  r  e  f  e  r  a  b  l  y  ,  t  h  i  s  i  s  s  h  o  w  n  i  n  a  C  O  N  S  O  R  T  f  l  o  w  d  i  a  g  r  a  m  ) * 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 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. 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 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 Yes, we specied the recruitment and follow-up with a diagram (Figure 1). 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  s  e  l  i  n  e  d  e  m  o  g  r  a  p  h  i  c  a  n  d  c  l  i  n  i  c  a  l  c  h  a  r  a  c  t  e  r  i  s  t  i  c  s  f  o  r  e  a  c  h  g  r  o  u  p   N  P  T  :  W  h  e  n  a  p  p  l  i  c  a  b  l  e  ,  a  d  e  s  c  r  i  p  t  i  o  n  o  f  c  a  r  e  p  r  o  v  i  d  e  r  s  (  c  a  s  e  v  o  l  u  m  e  ,  q  u  a  l  i  f  i  c  a  t  i  o  n  ,  e  x  p  e  r  t  i  s  e  ,  e  t  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 Yes. 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. 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 Yes, we reported that the primary analysis used intent-to-treat analysis. 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) 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 Yes, we acknowledge the limited generalizability of the study. For example, "Second, all the participants were recruited from a large hospital in a capital city in south China, and the majority of them were men, especially young men, so the results from the current study may not be generalizable to PLWH living in rural areas or females who live with HIV." 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 Yes, we listed the funding sources at the end of the manuscript.  T  o  g  e  n  e  r  a  t  e  a  r  e  c  o  r  d  t  h  a  t  y  o  u  f  i  l  l  e  d  i  n  t  h  i  s  f  o  r  m  ,  w  e  r  e  c  o  m  m  e  n  d  t  o  g  e  n  e  r  a  t  e  a  P  D  F  o  f  t  h  i  s  p  a  g  e  (  o  n  a  M  a  c  ,  s  i  m  p  l  y  s  e  l  e  c  t  "  p  r  i  n  t  "  a  n  d  t  h  e  n  s  e  l  e  c  t  "  p  r  i  n  t  a  s  P  D  F  "  )  b  e  f  o  r  e  y  o  u  s  u  b  m  i  t  i  t  .   W  h  e  n  y  o  u  s  u  b  m  i  t  y  o  u  r  (  r  e  v  i  s  e  d  )  p  a  p  e  r  t  o  J  M  I  R  ,  p  l  e  a  s  e  u  p  l  o  a  d  t  h  e  P  D  F  a  s  s  u  p  p  l  e  m  e  n  t  a  r  y  f  i  l  e  .   D  o  n  '  t  w  o  r  r  y  i  f  s  o  m  e  t  e  x  t  i  n  t  h  e  t  e  x  t  b  o  x  e  s  i  s  c  u  t  o  f  f  ,  a  s  w  e  s  t  i  l  l  h  a  v  e  t  h  e  c  o  m  p  l  e  t  e  i  n  f  o  r  m  a  t  i  o  n  i  n  o  u  r  d  a