Randomized Controlled Trial of a Remote Coaching mHealth Adherence Intervention in Youth Living with HIV.
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SUBMITTER: Amico KR
PROVIDER: S-EPMC9171094 | biostudies-literature | 2022 Dec
REPOSITORIES: biostudies-literature
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Randomized Controlled Trial of a Remote Coaching mHealth Adherence Intervention in Youth Living with HIV.
Amico K Rivet KR Lindsey Jane C JC Hudgens Michael M Dallas Ronald R Horvath Keith J KJ Dunlap Amanda A Goolsby Rachel R Johnson Megan Mueller MM Heckman Barbara B Crawford Jessica J Secord Elizabeth E Purswani Murli M Reirden Danial D Rathore Mobeen M Robinson Lisa-Gaye LG Gaur Aditya H AH
AIDS and behavior 20220607 12
Youth living with HIV (YLWH) in the US have low rates of viral suppression (VS). In a prospective randomized clinical trial (ATN152) that enrolled 89 YLWH on antiretroviral therapy (ART) with detectable viral load, we evaluated a 12 week triggered escalating real-time adherence (TERA) intervention with remote coaching, electronic dose monitoring (EDM), and outreach for missed/delayed doses compared to standard of care (SOC). Median [Q1, Q3] percent days with EDM opening was higher in TERA (72% ( ...[more]
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Project description:BackgroundPeople living with HIV often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) adherence. There is growing evidence that depression treatment may improve ART adherence and result in improved HIV outcomes. Given that mental health services are severely underequipped in low-resource settings, including in Uganda, new solutions to increase access to mental health care and close the treatment gap are urgently needed. This protocol paper presents the Suubi-Mhealth study, which proposed to develop a mobile health (mHealth) intervention for use among Ugandan youths (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs.ObjectiveThe proposed study is guided by the following objectives: (1) to develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of youths living with HIV; (2) to explore the feasibility and acceptability of Suubi-Mhealth on a small scale to inform subsequent refinement; (3) to test the preliminary impact of Suubi-Mhealth versus a waitlist control group on youths' outcomes, including depression and treatment adherence; and (4) to examine barriers and facilitators for integrating Suubi-Mhealth into health care settings.MethodsYouths will be eligible to participate in the study if they are (1) 14-17 years of age, (2) HIV-positive and aware of their status, (3) receiving care and ART from one of the participating clinics, and (4) living within a family. The study will be conducted in 2 phases. In phase 1, we will conduct focus group discussions with youths and health care providers, for feedback on the proposed intervention content and methods, and explore the feasibility and acceptability of the intervention. In phase II, we will pilot-test the preliminary impact of the intervention on reducing depression and improving ART adherence. Assessments will be conducted at baseline, 1-, 2-, and 6-months post intervention completion.ResultsParticipant recruitment for phase 1 is completed. Youths and health care providers participated in focus group discussions to share their feedback on the proposed Suubi-Mhealth intervention content, methods, design, and format. Transcription and translation of focus group discussions have been completed. The team is currently developing Suubi-Mhealth content based on participants' feedback.ConclusionsThis study will lay important groundwork for several initiatives at the intersection of digital therapeutics, HIV treatment, and mental health, especially among sub-Saharan African youths, as they transition through adolescence and into adult HIV care settings.Trial registrationClinicalTrials.gov NCT05965245; https://clinicaltrials.gov/study/NCT05965245.International registered report identifier (irrid)DERR1-10.2196/54635.
| S-EPMC10960218 | biostudies-literature
Project description:BackgroundThe World Health Organization recommends that all adults with HIV adhere to antiretroviral therapy (ART). Good adherence to ART is beneficial to patients and the public. Furthermore, mHealth has shown promise in improving HIV medication adherence globally.ObjectiveThe aim of this meta-analysis is to analyze the effectiveness of mHealth on adherence to antiretroviral therapy in patients living with HIV.MethodsRandomized controlled trials (RCTs) of the association between mHealth and adherence to ART published until December 2021 were searched in electronic databases. Odds ratios (ORs), weighted mean differences, and 95% CIs were calculated. This meta-analysis was performed using the Mantel-Haenszel method or the inverse variance test. We evaluated heterogeneity with the I2 statistic. If I2 was ≤50%, heterogeneity was absent, and a fixed effect model was used. If I2 was >50%, heterogeneity was present, and a random effects model was used.ResultsA total of 2163 participants in 8 studies were included in this meta-analysis. All included studies were RCTs. The random effects model was used for a meta-analysis of the effects of various intervention measures compared to routine nursing; the outcome was not statistically significant (OR 1.54, 95% CI 0.99-2.38; P=.05). In the subgroups, only short messaging service (SMS)-based interventions significantly increased adherence to ART (OR 1.76, 95% CI 1.07-2.89; P=.03). Further analysis showed that only interactive or bidirectional SMS could significantly increase ART adherence (OR 1.69, 95% CI 1.22-2.34; P=.001). After combining the difference in CD4 cell count before and after the interventions, we concluded that there was no statistical heterogeneity among the studies (I2=0%; tau2=0.37; P=.95).ConclusionsInteractive or bidirectional SMS can enhance intervention effects. However, whether mHealth can improve adherence to ART in patients with HIV needs further study. Owing to a lack of the required significant staff time, training, and ongoing supervision, there is still much more to do to apply mHealth to the clinical use of ART for patients living with HIV.Trial registrationPROSPERO CRD42022358774; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=358774.
| S-EPMC9903184 | biostudies-literature
Project description:BACKGROUND:Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. OBJECTIVE:This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). METHODS:YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will "step up" to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. RESULTS:Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. CONCLUSIONS:This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life. TRIAL REGISTRATION:ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/10791.
| S-EPMC6414817 | biostudies-literature
Project description:BackgroundEvidence-based HIV treatment adherence interventions have typically shown medium-sized effects on adherence. Prior evidence-based HIV treatment adherence interventions have not been culturally adapted specifically for Black/African Americans, the population most affected by HIV disparities in the USA, who exhibit lower adherence than do members of other racial/ethnic groups.PurposeWe conducted a randomized controlled trial of Rise, a 6-month culturally congruent adherence counseling intervention for HIV-positive Black men and women.MethodsRise was delivered by a trained peer counselor who used a problem-solving approach to address culturally congruent adherence barriers (e.g., medical mistrust, HIV stigma) and assisted with linkage to supportive services. A total of 215 participants were randomized to the intervention group (n = 107) or a wait-list control group (n = 108). Adherence was assessed daily via electronic monitoring.ResultsIn a repeated measures multivariate logistic regression model of dichotomous adherence (using a clinically significant cutoff of 85% of doses taken), adjusted for sociodemographic and medical covariates, adherence in the intervention group improved over time relative to the control group, (OR = 1.30 per month (95% CI = 1.12-1.51), p < 0.001), representing a large cumulative effect after 6 months (OR = 4.76, Cohen's d = 0.86).ConclusionsRise showed a larger effect on adherence than prior HIV adherence intervention studies. For greater effectiveness, interventions to improve adherence among Black people living with HIV may need to be customized to address culturally relevant barriers to adherence. ( ClinicalTrials.gov #NCT01350544).
| S-EPMC5650942 | biostudies-literature
Project description:BACKGROUND:Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. OBJECTIVE:The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures-HIV viral suppression (VLS), defined as both <200 copies/ml and <50 copies/ml at 12 weeks, and (2) secondary outcome measures-VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. METHODS:The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM has not been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. RESULTS:Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. CONCLUSIONS:Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care. TRIAL REGISTRATION:ClinicalTrials.gov NCT03292432; https://clinicaltrials.gov/ct2/show/NCT03292432 (Archived by WebCite at http://www.webcitation.org/768J8ijjp). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11416.
| S-EPMC6441855 | biostudies-literature
Project description:BackgroundTaking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l'immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally.ObjectiveWe aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT).MethodsThis RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups.ResultsThe sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4).ConclusionsThis study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities.Trial registrationClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340.
| S-EPMC7199130 | biostudies-literature
Project description:BACKGROUND:The overall goal of the Supporting Adolescent Adherence in Vietnam (SAAV) study is to improve understanding of an adherence feedback mHealth intervention designed to help adolescents living with HIV (ALHIV) maintain high adherence to antiretroviral therapy (ART), critical to effective treatment. Specifically, we aim to: (1) conduct formative research with Vietnamese ALHIV and their caregivers to better understand adherence challenges and refine the personalized mHealth intervention package; and (2) assess the feasibility, acceptability, and efficacy of the intervention to improve ART adherence by implementing a randomized controlled trial (RCT). METHODS:The study will utilize mixed methods. The formative phase will include 40 in-depth interviews (IDIs) with 20 adolescent (12-17?years)/caregiver dyads and eight focus group discussions with adolescents, caregivers, and clinicians at the National Hospital for Pediatrics (NHP) in Hanoi, Vietnam. We will also conduct 20 IDIs with older adolescents (18-21?years) who have transitioned to adult care at outpatient clinics in Hanoi. We will then implement a seven-month RCT at NHP. We will recruit 80 adolescents on ART, monitor their adherence for one month to establish baseline adherence using a wireless pill container (WPC), and then randomize participants to intervention versus control within optimal (??95% on-time doses) versus suboptimal (<?95% on-time doses) baseline adherence strata. Intervention participants will receive a reminder of their choice (cellphone text message/call or bottle-based flash/alarm), triggered when they miss a dose, and engage in monthly counseling informed by their adherence data. Comparison participants will receive usual care and offer of counseling at routine monthly clinic visits. After six months, we will compare ART adherence, CD4 count, and HIV viral suppression between arms, in addition to acceptability and feasibility of the intervention. DISCUSSION:Findings will contribute valuable information on perceived barriers and facilitators affecting adolescents' ART adherence, mHealth approaches as adherence support tools for ALHIV, and factors affecting adolescents' ART adherence. This information will be useful to researchers, medical personnel, and policy-makers as they develop and implement adherence programs for ALHIV, with potential relevance to other chronic diseases during transition from adolescent to adult care. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03031197 . Registered on 21 January 2017.
| S-EPMC6394014 | biostudies-literature
Project description:BackgroundMost 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.ObjectiveThe objective of our study was to assess the feasibility and acceptability of an mHealth intervention among PLWH in China.MethodsBased 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.ResultsAt 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.ConclusionsThis 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.Trial registrationChinese Clinical Trial Registry ChiCTR1800017987; http://www.chictr.org.cn/showprojen.aspx?proj=30448 (Archived by WebCite at http://www.webcitation.org/71zC7Pdzs).Registered report ientifierRR1-10.2196/.
| S-EPMC6231726 | biostudies-literature
Project description:BackgroundMany children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice.Methods and designThis paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured.DiscussionTwenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.
| S-EPMC3352109 | biostudies-literature
Project description:BACKGROUND:HIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, "adaptive" ART adherence intervention protocol for HIV-infected adolescents and young adults. METHODS:This is a randomized controlled trial (RCT) to establish the efficacy of "Positive STEPS," a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report. DISCUSSION:Behavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings. TRIAL REGISTRATION:ClinicalTrials.gov number NCT03092531 , registered March 28, 2017.
| S-EPMC6043988 | biostudies-literature