Dataset Information

Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men.

ABSTRACT: BACKGROUND:The suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented. OBJECTIVE:The aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City. METHODS:A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence. RESULTS:Participant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019. CONCLUSIONS:The efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features. TRIAL REGISTRATION:ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10182.

SUBMITTER: Horvath KJ

PROVIDER: S-EPMC6002671 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men.

Horvath Keith J KJ Amico K Rivet KR Erickson Darin D Ecklund Alexandra M AM Martinka Aldona A DeWitt James J McLaughlin Jeffery J Parsons Jeffrey T JT

JMIR research protocols 20180531 5

<h4>Background</h4>The suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are imp ...[more]

PMID: 29853437

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Project description:BackgroundAntiretroviral therapy (ART) adherence is still suboptimal among some key populations, highlighting the need for innovative tailored strategies. This randomized controlled trial (RCT) aimed to evaluate the effect of a differentiated digital intervention on ART adherence among men who have sex with men (MSM) living with HIV in China.MethodsThe two-armed parallel RCT was conducted at one HIV clinic in Jinan of China from October 19, 2020, to June 31, 2021. Men were referred by health providers to join the study and then choose one of three digital strategies-text message, only instant message, or instant message plus social media. They were assigned in a 1:1 ratio to the intervention arm or control arm using block randomization, and inside each arm, there were three groups depending on the type of delivering the message. The groups were divided according to participants' preferred digital strategies. The intervention arm received ART medication messages, medication reminders, peer education, and involved in online discussion. The control arm received messages on health behavior and nutrition. The primary outcome was self-reported optimal ART adherence, defined as not missing any doses and not having any delayed doses within a one-month period. Secondary outcomes included CD4 T cell counts, viral suppression, HIV treatment adherence self-efficacy, and quality of life. Intention-to-treat analysis with generalized linear mixed models was used to evaluate the intervention's effect.ResultsA total of 576 participants were enrolled, including 288 participants assigned in the intervention arm and 288 assigned in the control arm. Most were ≤ 40 years old (79.9%) and initiated ART ≤ 3 years (60.4%). After intervention, the proportion of participants achieving optimal ART adherence in the intervention arm was higher than in the control arm (82.9% vs 71.1%). The differentiated digital intervention significantly improved ART adherence (RR = 1.74, 95%CI 1.21-2.50). Subgroup analysis showed one-to-one instant message-based intervention significantly improved ART adherence (RR = 2.40, 95% CI 1.39-4.17).ConclusionsThe differentiated digital intervention improved ART adherence among MSM living with HIV in China, which could be integrated into people living with HIV (PLWH) management and further promoted in areas where PLWH can access text messaging and instant messaging services.Trial registrationChiCTR2000041282. Retrospectively registered on 23 December 2020.

Project description:Introduction: Depression is the most frequently observed psychiatric disorder among HIV patients. The effect of depression on adherence among men who have sex with men (MSM) HIV patients has not been well studied in the Philippines. Depression is commonly undiagnosed and consequently untreated, which leads to a negative influence on antiretroviral therapy (ART) adherence. Other risk factors such as HIV-related stigma, self-body image satisfaction, and nutritional status are recognized as potential barriers to access HIV prevention and treatment services issues and poor adherence. Methods: Hospital anxiety and depression scale (HADS) was used to screen depressive symptoms during scheduled clinic visits. ART adherence was self-reported using a visual analog scale questionnaire covering the last 30 days. Structured questionnaires were used for measuring risk factors and socio-demographic data. Anthropometry was conducted and body composition was assessed using bioelectrical impedance analysis. Results: One-hundred and ninety-three participants were recruited from the SHIP clinic between 7th March and 30th September 2018, of whom, 42 (21.8%) screened positive for depression (HADS score ≥ 8) and 24 (12.4%) were non-adherent to ART (<95% of medication taken as prescribed). The most common reported reason for non-adherence was simply forgotten (18 out of 42, 42.9%). Increasing depressive symptoms were associated with non-adherence [crude odds ratio (OR) = 1.13; 95% CI: 1.02-1.26]. Social family support (SFS) and body image (BI) scores were also associated with non-adherence, but were not statistically significant in multivariable models. Factors significantly associated with depressive symptoms (but not non-adherence) included the following: using intravenous drugs, being in a relationship, anxiety, self-esteem, and stigma scores. Conclusions: Increased depression symptoms, low social family support, and body image dissatisfaction may be interconnected risk factors for ART non-adherence among Filipino MSM HIV patients. Comprehensive mental health services beyond regular post-HIV testing counseling may increase adherence to ART and improve HIV treatment outcomes. Further prospective studies are needed to address the causal/reverse causal pathway between depression and non-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).

Dataset Information

Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men.

Publications

Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men.

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