Health Care Provider Utilization and Cost of an mHealth Intervention in Vulnerable People Living With HIV in Vancouver, Canada: Prospective Study.

Improving adherence to combined antiretroviral therapy (cART) can be challenging, especially among vulnerable populations living with HIV. Even where cART is available free of charge, social determinants of health act as barriers to optimal adherence rates. Patient-centered approaches exploiting mobile phone communications (mHealth) have been shown to improve adherence to cART and promote achievement of suppressed HIV plasma viral loads. However, data are scarce on the health care provider (HCP) time commitments and health care costs associated with such interventions. This knowledge is needed to inform policy and programmatic implementation. The purpose of this study was to approximate the resources required and to provide an estimate of the costs associated with running an mHealth intervention program to improve medication adherence in people living with HIV (PLWH). This prospective study of HCP utilization and costs was embedded within a repeated measures effectiveness study of the WelTel short-message service (SMS) mHealth program. The study included 85 vulnerable, nonadherent PLWH in Vancouver, Canada, and resulted in improved medication adherence and HIV plasma viral load among participants. Study participants were provided mobile phones with unlimited texting (where required) and received weekly bidirectional text messages to inquire on their status for one year. A clinic nurse triaged and managed participants' responses, immediately logging all patient interactions by topic, HCP involvement, and time dedicated to addressing issues raised by participants. Interaction costs were determined in Canadian dollars based on HCP type, median salary within our health authority, and their time utilized as part of the intervention. Participant-identified problems within text responses included health-related, social, and logistical issues. Taken together, management of problems required a median of 43 minutes (interquartile range, IQR 17-99) of HCP time per participant per year, for a median yearly cost of Can $36.72 (IQR 15.50-81.60) per participant who responded with at least one problem. The clinic nurse who monitored the texts solved or managed 65% of these issues, and the remaining were referred to a variety of other HCPs. The total intervention costs, including mobile phones, plans, and staffing were a median Can $347.74/highly vulnerable participant per year for all participants or Can $383.18/highly vulnerable participant per year for those who responded with at least one problem. Bidirectional mHealth programs improve HIV care and treatment outcomes for PLWH. Knowledge about the HCP cost associated, here less than Can $50/year, provides stakeholders and decision makers with information relevant to determining the feasibility and sustainability of mHealth programs in a real-world setting. ClinicalTrials.gov NCT02603536; https://clinicaltrials.gov/ct2/show/NCT02603536 (Archived by WebCite at http://www.webcitation.org/70IYqKUjV).

Campbell AR ，Kinvig K ，Côté HC ，Lester RT ，Qiu AQ ，Maan EJ ，Alimenti A ，Pick N ，Murray MC ... -  《JMIR mHealth and uHealth》

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

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

King E ，Kinvig K ，Steif J ，Qiu AQ ，Maan EJ ，Albert AY ，Pick N ，Alimenti A ，Kestler MH ，Money DM ，Lester RT ，Murray MCM ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Development and Feasibility Testing of an mHealth (Text Message and WeChat) Intervention to Improve the Medication Adherence and Quality of Life of People Living with HIV in China: Pilot Randomized Controlled Trial.

Most people living with HIV (PLWH) reside in middle- and low-income countries with limited access to health services. Thus, cost-effective interventions that can reach a large number of PLWH are urgently needed. The objective of our study was to assess the feasibility and acceptability of an mHealth intervention among PLWH in China. Based on previous formative research, we designed an mHealth intervention program that included sending weekly reminders to participants via text messages (short message service, SMS) and articles on HIV self-management three times a week via a popular social media app WeChat. A total of 62 PLWH recruited from an HIV outpatient clinic were randomly assigned to intervention or control group. The intervention lasted for 3 months, and all participants were assessed for their medication adherence, presence of depression, quality of life (QoL), and CD4 (cluster of differentiation 4) counts. Upon completing the intervention, we interviewed 31 participants to further assess the feasibility and acceptability of the study. At baseline, the intervention and control groups did not differ in terms of demographic characteristics or any of the major outcome measures. About 85% (53/62) of the participants completed the intervention, and they provided valuable feedback on the design and content of the intervention. Participants preferred WeChat as the platform for receiving information and interactive communication for ease of access. Furthermore, they made specific recommendations about building trust, interactive features, and personalized feedback. In the follow-up assessment, the intervention and control groups did not differ in terms of major outcome measures. This pilot study represents one of the first efforts to develop a text messaging (SMS)- and WeChat-based intervention that focused on improving the medication adherence and QoL of PLWH in China. Our data indicates that an mHealth intervention is feasible and acceptable to this population. The data collected through this pilot study will inform the future designs and implementations of mHealth interventions in this vulnerable population. We recommend more innovative mHealth interventions with rigorous designs for the PLWH in middle- and low-income countries. Chinese Clinical Trial Registry ChiCTR1800017987; http://www.chictr.org.cn/showprojen.aspx?proj=30448 (Archived by WebCite at http://www.webcitation.org/71zC7Pdzs). RR1-10.2196/.

Guo Y ，Xu Z ，Qiao J ，Hong YA ，Zhang H ，Zeng C ，Cai W ，Li L ，Liu C ... -  《-》

The Implementation of a Text Messaging Intervention to Improve HIV Continuum of Care Outcomes Among Persons Recently Released From Correctional Facilities: Randomized Controlled Trial.

Previously incarcerated individuals have suboptimal linkage and engagement in community HIV care. Mobile health (mHealth) interventions have been shown to be effective in addressing these gaps. In Washington, District of Columbia (DC), we conducted a randomized trial of an SMS text messaging-based mHealth intervention (CARE+ Corrections) to increase linkage to community HIV care and antiretroviral treatment adherence among HIV-infected persons involved in the criminal justice system. This study aimed to describe the SMS text messaging-based intervention, participant use of the intervention, and barriers and facilitators of implementation. From August 2013 to April 2015, HIV-positive incarcerated individuals were recruited within the DC Department of Corrections, and persons released in the past 6 months were recruited within the community via street-based recruitment, community partnerships, and referrals. Participants were followed for 6 months and received weekly or daily SMS text messages. Formative research resulted in the development of the content of the messages in 4 categories: HIV Appointment Reminders, Medication Adherence, Prevention Reminders, and Barriers to Care following release from jail. Participants could customize the timing, frequency, and message content throughout the study period. Of the 112 participants enrolled, 57 (50.9%) were randomized to the intervention group and 55 (49.1%) to the control group; 2 control participants did not complete the baseline visit, and were dropped from the study, leaving a total of 110 participants who contributed to the analyses. Study retention was similar across both study arms. Median age was 42 years (IQR 30-50), 86% (49/57) were black or African American, 58% (33/57) were male, 25% (14/57) were female, and 18% (10/57) were transgender. Median length of last incarceration was 4 months (IQR 1.7-9.0), and median lifetime number of times incarcerated was 6.5 (IQR 3.5-14.0). Most participants (32/54, 59%) had a baseline viral load of <200 copies/mL. Nearly all participants (52/57, 91%) chose to use a cell phone provided by the study. The most preferred Appointment Reminder message was Hey how you feeling? Don't forget to give a call and make your appointment (19/57, 33%). The most preferred Medication Adherence message was Don't forget your skittles! (31/57, 54%), and 63% (36/57) of participants chose to receive daily (vs weekly) messages from this category at baseline. The most preferred Prevention Reminder message was Stay strong. Stay clean (18/57, 32%). The most preferred Barriers to Care message was Holla at your case manager, they're here to help (12/57, 22%). Minor message preference differences were observed among participants enrolled in the jail versus those from the community. Participants' ability to customize their SMS text message plan proved helpful. Further large-scale research on mHealth platforms is needed to assess its efficacy among HIV-infected persons with a history of incarceration. ClinicalTrials.gov NCT01721226; https://clinicaltrials.gov/ct2/show/NCT01721226.

Uhrig Castonguay BJ ，Cressman AE ，Kuo I ，Patrick R ，Trezza C ，Cates A ，Olsen H ，Peterson J ，Kurth A ，Bazerman LB ，Beckwith CG ... -  《JMIR mHealth and uHealth》

Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

In the United States, young men who have sex with men (YMSM) and transgender women who have sex with men (YTWSM) bear a disproportionate burden of prevalent and incident HIV infections. Once diagnosed, many YMSM and YTWSM struggle to engage in HIV care, adhere to antiretroviral therapy (ART), and achieve viral suppression. Computer-based interventions, including those focused on behavior change, are recognized as effective tools for engaging youth. The purpose of the study described in this protocol is to evaluate the efficacy of Epic Allies, a theory-based mobile phone app that utilizes game mechanics and social networking features to improve engagement in HIV care, ART uptake, ART adherence, and viral suppression among HIV-positive YMSM and YTWSM. The study also qualitatively assesses intervention acceptability, perceived impact, and sustainability. This is a two-group, active-control randomized controlled trial of the Epic Allies app. YMSM and YTWSM aged 16 to 24 inclusive, with detectable HIV viral load are randomized 1:1 within strata of new to care (newly entered HIV medical care ≤12 months of baseline visit) or ART-nonadherent (first entered HIV medical care >12 months before baseline visit) to intervention or control conditions. The intervention condition addresses ART adherence barriers through medication reminders and adherence monitoring, tracking of select adherence-related behaviors (eg, alcohol and marijuana use), an interactive dashboard that displays the participant's adherence-related behaviors and provides tailored feedback, encouragement messages from other users, daily HIV/ART educational articles, and gamification features (eg, mini-games, points, badges) to increase motivation for behavior change and app engagement. The control condition features weekly phone-based notifications to encourage participants to view educational information in the control app. Follow-up assessments are administered at 13, 26, and 39 weeks for each arm. The primary outcome measure is viral suppression. Secondary outcome measures include engagement in care, ART uptake, ART adherence, and psychosocial barriers to engagement in care and ART adherence, including psychological distress, stigma, and social support. Baseline enrollment began in September 2015 and was completed in September 2016 (n=146), and assessment of intervention outcomes continued through August 2017. Results for primary and secondary outcome measures are expected to be reported in ClinicalTrials.gov by April 30, 2018. If successful, Epic Allies will represent a novel adherence intervention for a group disproportionately impacted by HIV in the United States. Adherent patients would require less frequent clinic visits and experience fewer HIV-related secondary infections, thereby reducing health care costs and HIV transmission. Epic Allies could easily be expanded and adopted for use among larger populations of YMSM and YTWSM, other HIV-positive populations, and for those diagnosed with other chronic diseases such as diabetes and hypertension. ClinicalTrials.gov NCT02782130; https://clinicaltrials.gov/ct2/show/NCT02782130 (Archived by Webcite at http://www.webcitation.org/6yGODyerk).

LeGrand S ，Muessig KE ，Platt A ，Soni K ，Egger JR ，Nwoko N ，McNulty T ，Hightow-Weidman LB ... -  《JMIR Research Protocols》