Dataset Information

A Mobile Phone App to Support Adherence to Daily HIV Pre-exposure Prophylaxis Engagement Among Young Men Who Have Sex With Men and Transgender Women Aged 15 to 19 Years in Thailand: Pilot Randomized Controlled Trial.

ABSTRACT:

Background

Widespread smartphone use provides opportunities for mobile health HIV prevention strategies among at-risk populations.

Objective

This study aims to investigate engagement in a theory-based (information-motivation-behavioral skills model) mobile phone app developed to support HIV pre-exposure prophylaxis (PrEP) adherence among Thai young men who have sex with men (YMSM) and young transgender women (YTGW) in Bangkok, Thailand.

Methods

A randomized controlled trial was conducted among HIV-negative YMSM and YTGW aged 15-19 years initiating daily oral PrEP. Participants were randomized to receive either youth-friendly PrEP services (YFS) for 6 months, including monthly contact with site staff (clinic visits or telephone follow-up) and staff consultation access, or YFS plus use of a PrEP adherence support app (YFS+APP). The target population focus group discussion findings and the information-motivation-behavioral skills model informed app development. App features were based on the 3Rs-risk assessment of self-HIV acquisition risk, reminders to take PrEP, and rewards as redeemable points. Dried blood spots quantifying of tenofovir diphosphate were collected at months 3 and 6 to assess PrEP adherence. Tenofovir diphosphate ≥350-699 fmol/punch was classified as fair adherence and ≥700 fmol/punch as good adherence. Data analysis on app use paradata and exit interviews were conducted on the YFS+APP arm after 6 months of follow-up.

Results

Between March 2018 and June 2019, 200 participants with a median age of 18 (IQR 17-19) years were enrolled. Overall, 74% (148/200) were YMSM; 87% (87/100) of participants who received YFS+APP logged in to the app and performed weekly HIV acquisition risk assessments (log-in and risk assessment [LRA]). The median duration between the first and last log-in was 3.5 (IQR 1.6-5.6) months, with a median frequency of 6 LRAs (IQR 2-10). Moreover, 22% (22/100) of the participants in the YFS+APP arm were frequent users (LRA≥10) during the 6-month follow-up period. YMSM were 9.3 (95% CI 1.2-74.3) times more likely to be frequent app users than YTGW (P=.04). Frequent app users had higher proportions (12%-16%) of PrEP adherence at both months 3 and 6 compared with infrequent users (LRA<10) and the YFS arm, although this did not reach statistical significance. Of the 100 participants in the YFS+APP arm, 23 (23%) were interviewed. The risk assessment function is perceived as the most useful app feature. Further aesthetic adaptations and a more comprehensive rewards system were suggested by the interviewees.

Conclusions

Higher rates of PrEP adherence among frequent app users were observed; however, this was not statistically significant. A short app use duration of 3 months suggests that they may be useful in establishing habits in taking daily PrEP, but not long-term adherence. Further studies on the specific mechanisms of mobile phone apps that influence health behaviors are needed.

Trial registration

ClinicalTrials.gov NCT03778892; https://clinicaltrials.gov/ct2/show/NCT03778892.

SUBMITTER: Kawichai S

PROVIDER: S-EPMC9073624 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:Strategies are needed to curb the increasing HIV incidence in young men who have sex with men (YMSM) and transgender women (YTGW) worldwide. We assessed the impact of youth-friendly services (YFS) and a mobile phone application (app) on adherence to pre-exposure prophylaxis (PrEP) in YMSM and YTGW in Thailand. METHODS:A randomized control trial was conducted in YMSM and YTGW aged 15 to 19 years. Participants were provided daily oral tenofovir disoproxil fumerate/emtricitabine (TDF/FTC), condoms and randomized to receive either YFS or YFS plus a PrEP app (YFS + APP), whose features included self-assessment of HIV acquisition risk, point rewards and reminders for PrEP and clinic appointments. Clinic visits occurred at zero, one, three and six months and telephone contact at two, four and five months. HIV testing was performed at every clinic visit. PrEP adherence was evaluated with intracellular tenofovir diphosphate (TFV-DP) concentrations in dried blood spot (DBS) samples at months 3 and 6. The primary endpoint assessed was "PrEP adherence" defined as TFV-DP DBS concentrations ?700 fmol/punch (equivalent to ?4 doses of TDF/week). RESULTS:Between March 2018 and June 2019, 489 adolescents were screened at three centres in Bangkok. Twenty-seven (6%) adolescents tested positive for HIV and 200 (41%) adolescents participated in the study. Of these, 147 were YMSM (74%) and 53 YTGW (26%). At baseline, median age was 18 years (IQR 17 to 19), 66% reported inconsistent condom use in the past month. Sexually transmitted infection prevalence was 23%. Retention at six months was 73%. In the YFS + APP arm, median app use duration was three months (IQR 1 to 5). PrEP adherence at month 3 was 51% in YFS and 54% in YFS + APP (p-value 0.64) and at month 6 was 44% in YFS and 49% in YFS + APP (p-value 0.54). No HIV seroconversions occurred during 75 person years of follow-up. CONCLUSIONS:Youth-friendly PrEP services enabled good adherence among half of adolescent PrEP users. However, the mobile phone application tested did not provide additional PrEP adherence benefit in this randomized trial. Adolescent risk behaviours are dynamic and require adaptive programmes that focus on "prevention-effective adherence."

Project description:BackgroundIn 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.ObjectiveThe 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.MethodsThis 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.ResultsBaseline 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.ConclusionsIf 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.Trial registrationClinicalTrials.gov NCT02782130; https://clinicaltrials.gov/ct2/show/NCT02782130 (Archived by Webcite at http://www.webcitation.org/6yGODyerk).

Project description:BackgroundDaily and on-demand pre-exposure prophylaxis (PrEP) has been well demonstrated to effectively prevent HIV acquisition for men who have sex with men (MSM). More than half of the MSM PrEP users in Taiwan prefer on-demand PrEP; however, on-demand PrEP involves a complicated dosing regimen because it requires precoital and postcoital dosing and sex events are hard to anticipate. Although there are a growing number of mobile apps designed to improve access to HIV prevention services and HIV medication adherence, few mobile apps focus on adherence to PrEP or are designed to accommodate a complicated, on-demand PrEP dosing schedule.ObjectiveThe aim of this project is to evaluate the usability of a newly developed mobile app (UPrEPU) to assist MSM PrEP users to self-monitor their adherence to either daily or on-demand PrEP using a user-centered scheme.MethodsThis research will be conducted in 2 phases: app development and usability study. In the app development phase, we will first conduct formative research with end users and stakeholders through in-depth interviews; the results will provide PrEP users' and PrEP navigators' personas as material used in the app conceptualization stage. PrEP navigators are individuals in the health care system that help HIV-negative individuals who need assistance in accessing PrEP care. A low-fidelity prototype of the app feature will be formatted by applying a participatory design approach to engage PrEP users, designers, and app developers in the design process of the app. Then, a high-fidelity prototype of the app will be developed for the usability study and refined iteratively by the multidisciplinary team and new internal testers. Internal testers include the research team consisting of experts in public health, infectious disease, and industrial design and a close network of the research team that is taking PrEP. In the usability study phase, we will enroll 70 MSM PrEP users and follow them up for 4 months. Usability, feasibility, and effectiveness of adherence monitoring will be evaluated.ResultsRefinement of the UPrEPU app is currently ongoing. The usability study commenced in May 2020.ConclusionsThe UPrEPU app is one of the first apps designed to help MSM PrEP users to self-manage their PrEP schedule better regardless of dosing modes. With a design-thinking approach and adapting to the cultural context in Taiwan's MSM population, this novel app will have substantial potential to be acceptable and feasible and contribute to the reduction of new HIV infections.Trial registrationClinicalTrials.gov NCT04248790; https://clinicaltrials.gov/ct2/show/NCT04248790.International registered report identifier (irrid)PRR1-10.2196/20360.

Project description:BACKGROUND: The use of mobile phones, and specifically smartphones, in the last decade has become more and more prevalent. The latest mobile phones are equipped with comprehensive features that can be used in health care, such as providing rapid access to up-to-date evidence-based information, provision of instant communications, and improvements in organization. The estimated number of health care apps for mobile phones is increasing tremendously, but previous research has highlighted the lack of critical appraisal of new apps. This lack of appraisal of apps has largely been due to the lack of clinicians with technical knowledge of how to create an evidence-based app. OBJECTIVE: We discuss two freely available methodologies for developing Web-based mobile phone apps: a website builder and an app builder. With these, users can program not just a Web-based app, but also integrate multimedia features within their app, without needing to know any programming language. METHODS: We present techniques for creating a mobile Web-based app using two well-established online mobile app websites. We illustrate how to integrate text-based content within the app, as well as integration of interactive videos and rich site summary (RSS) feed information. We will also briefly discuss how to integrate a simple questionnaire survey into the mobile-based app. A questionnaire survey was administered to students to collate their perceptions towards the app. RESULTS: These two methodologies for developing apps have been used to convert an online electronic psychiatry textbook into two Web-based mobile phone apps for medical students rotating through psychiatry in Singapore. Since the inception of our mobile Web-based app, a total of 21,991 unique users have used the mobile app and online portal provided by WordPress, and another 717 users have accessed the app via a Web-based link. The user perspective survey results (n=185) showed that a high proportion of students valued the textbook and objective structured clinical examination videos featured in the app. A high proportion of students concurred that a self-designed mobile phone app would be helpful for psychiatry education. CONCLUSIONS: These methodologies can enable busy clinicians to develop simple mobile Web-based apps for academic, educational, and research purposes, without any prior knowledge of programming. This will be beneficial for both clinicians and users at large, as there will then be more evidence-based mobile phone apps, or at least apps that have been appraised by a clinician.

Project description:BACKGROUND:Growing evidence shows that fixed, nonpersonalized daily step goals can discourage individuals, resulting in unchanged or even reduced physical activity. OBJECTIVE:The aim of this randomized controlled trial (RCT) was to evaluate the efficacy of an automated mobile phone-based personalized and adaptive goal-setting intervention using machine learning as compared with an active control with steady daily step goals of 10,000. METHODS:In this 10-week RCT, 64 participants were recruited via email announcements and were required to attend an initial in-person session. The participants were randomized into either the intervention or active control group with a one-to-one ratio after a run-in period for data collection. A study-developed mobile phone app (which delivers daily step goals using push notifications and allows real-time physical activity monitoring) was installed on each participant's mobile phone, and participants were asked to keep their phone in a pocket throughout the entire day. Through the app, the intervention group received fully automated adaptively personalized daily step goals, and the control group received constant step goals of 10,000 steps per day. Daily step count was objectively measured by the study-developed mobile phone app. RESULTS:The mean (SD) age of participants was 41.1 (11.3) years, and 83% (53/64) of participants were female. The baseline demographics between the 2 groups were similar (P>.05). Participants in the intervention group (n=34) had a decrease in mean (SD) daily step count of 390 (490) steps between run-in and 10 weeks, compared with a decrease of 1350 (420) steps among control participants (n=30; P=.03). The net difference in daily steps between the groups was 960 steps (95% CI 90-1830 steps). Both groups had a decrease in daily step count between run-in and 10 weeks because interventions were also provided during run-in and no natural baseline was collected. CONCLUSIONS:The results showed the short-term efficacy of this intervention, which should be formally evaluated in a full-scale RCT with a longer follow-up period. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02886871; https://clinicaltrials.gov/ct2/show/NCT02886871 (Archived by WebCite at http://www.webcitation.org/6wM1Be1Ng).

Project description:BackgroundAdolescents face socio-structural, personal and programmatic barriers to HIV prevention services, highlighting the importance of understanding knowledge and acceptability as essential aspects to promote their broader access to pre-exposure prophylaxis (PrEP). We analyzed the acceptability of PrEP among adolescent men who have sex with men (MSM), travestis and transgender women (TGW).MethodsA qualitative investigation was conducted as part of the formative research of the PrEP15-19 study, an ongoing demonstration study that analyzes the effectiveness of daily PrEP among adolescent MSM, travestis and TGW aged 15-19 in three Brazilian cities. A total of 37 semi-structured interviews and 6 focus groups were conducted. Building from thematic analysis focusing on participants' sexual encounters, perceptions about PrEP efficacy, and vulnerability contexts, we analyzed prospective acceptability of PrEP.FindingsKnowledge about PrEP was incipient and characterized by adolescents' frequent doubts about its prescription and efficacy. The 'ideal' use of PrEP appeared together with consistent condom use, especially in casual sex. PrEP use was also mentioned as depending on increased learning about prevention management over time. Main barriers to PrEP use included the incorporation of a daily medication into participants' routine and its impact on their social lives, especially related to stigma. Concerns over short- and long-term side effects were also reported as barriers to PrEP use. TGW and travestis contrasted using PrEP with the precarity of their life conditions, and some expressed a critical vision about PrEP by associating it with pharmaceuticalization and trans necropolitics.ConclusionsParticipants' low knowledge and acceptability of PrEP are circumscribed by a rigid perception of condom as the ideal prevention method and the context of their sexual relations. Prospective acceptability highlights that the successful uptake of PrEP depends on overcoming barriers of access to health services and confronting transphobia and homophobia as part of care.

Project description:BACKGROUND:In the United States, young minority men who have sex with men (MSM) are most likely to become infected with HIV. The use of antiretroviral medications to reduce the risk of acquiring HIV infection (pre-exposure prophylaxis, PrEP) is an efficacious and promising prevention strategy. There have been significant advances regarding PrEP, including the definitive demonstration that PrEP reduces HIV acquisition and the development of clinical prescribing guidelines. Despite these promising events, the practical implementation of PrEP can be challenging. Data show that PrEP's safety and effectiveness could be greatly compromised by suboptimal adherence to treatment, and there is concern about the potential for an increase in HIV risk behavior among PrEP users. Due to these challenges, the prescribing of PrEP should be accompanied by behavioral interventions to promote adherence. OBJECTIVE:This study aimed to develop an immersive, action-oriented iPhone gaming intervention to improve motivation for adherence to PrEP. METHODS:Game development was guided by social learning theory, taking into consideration the perspectives of young adult MSM who are taking PrEP. A total of 20 young men who have sex with men (YMSM; aged 18-35 years) were recruited from a sexually transmitted infection (STI), HIV testing, and PrEP care clinic in Jackson, Mississippi, between October 2016 and June 2017. They participated in qualitative interviews guided by the information-motivation-behavioral skills (IMB) model of behavior change. The mean age of participants was 26 years, and all the participants identified as male. Acceptability of the game was assessed with the Client Service Questionnaire and session evaluation form. RESULTS:A number of themes emerged that informed game development. YMSM taking PrEP desired informational game content that included new and comprehensive details about the effectiveness of PrEP, details about PrEP as it relates to doctors' visits, and general information about STIs other than HIV. Motivational themes that emerged were the desire for enhancement of future orientation; reinforcement of positive influences from partners, parents, and friends; collaboration with health care providers; decreasing stigma; and a focus on personal relevance of PrEP-related medical care. Behavioral skills themes centered around self-efficacy and strategies for adherence to PrEP and self-care. CONCLUSIONS:We utilized youth feedback, IMB, and agile software development to create a multilevel, immersive, action-oriented iPhone gaming intervention to improve motivation for adherence to PrEP. There is a dearth of gaming interventions for persons on PrEP. This study is a significant step in working toward the development and testing of an iPhone gaming intervention to decrease HIV risk and promote adherence to PrEP for YMSM.