Dataset Information

Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial.

ABSTRACT:

Background

Despite substantial investments in ending the HIV epidemic, disparities in HIV care persist, and there is an urgent need to evaluate novel and scalable approaches to improving HIV care engagement and viral suppression in real-world settings.

Objective

This paper aims to describe a study protocol for a pragmatic type II hybrid effectiveness-implementation randomized controlled trial comparing existing standard of care clinic HIV linkage, adherence, and retention (LAR) protocols to a mobile health (mHealth)-enhanced linkage, adherence, and retention (mLAR) intervention.

Methods

The study will enroll 450 participants from clinics in Baltimore City. Eligibility criteria include being ≥18 years of age, having a new HIV diagnosis or being HIV-positive and out of care, or being HIV-positive and deemed by clinic staff as someone who could benefit from linkage and retention services. Participants randomized to the intervention receive mHealth-supported patient navigation for 12 months. Participants in the control group receive the referring clinic's standard of care patient support. The primary outcome is HIV virologic suppression at 12 months. A subset of participants will be interviewed at 12 months to learn about their HIV care experiences and, for those in the intervention arm, their experiences with the mLAR intervention. This protocol was developed in collaboration with the Baltimore City Health Department (BCHD) and the Maryland Department of Health (MDH) and with input from a community advisory board.

Results

Enrollment began on February 25, 2020. As of August 11, 2022, 411 of the 450 target participants had been enrolled.

Conclusions

Pragmatic implementation science trials designed with input from key stakeholders, including health departments and community members, can help evaluate the evidence for mHealth interventions to reduce HIV health disparities.

Trial registration

ClinicalTrials.gov NCT03934437; https://clinicaltrials.gov/ct2/show/NCT03934437.

International registered report identifier (irrid)

DERR1-10.2196/42691.

SUBMITTER: Jones J

PROVIDER: S-EPMC9975915 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial.

Jones Joyce J McKenzie-White Jane J Saxton Ronald R Grieb Suzanne M SM Nonyane Bareng B Graham Cadeesha C Cano Anthony A Johnson Sheridan S Childs Lanisha L Greenbaum Adena A Flynn Colin C Pearlowitz Marcia M Celano Shivaun S Chang Larry W LW Page Kathleen R KR

JMIR research protocols 20230214

<h4>Background</h4>Despite substantial investments in ending the HIV epidemic, disparities in HIV care persist, and there is an urgent need to evaluate novel and scalable approaches to improving HIV care engagement and viral suppression in real-world settings.<h4>Objective</h4>This paper aims to describe a study protocol for a pragmatic type II hybrid effectiveness-implementation randomized controlled trial comparing existing standard of care clinic HIV linkage, adherence, and retention (LAR) pr ...[more]

PMID: 36787165

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Project description:BackgroundChildhood obesity is an ongoing problem in developed countries that needs targeted prevention in the youngest age groups. Children in socioeconomically disadvantaged families are most at risk. Mobile health (mHealth) interventions offer a potential route to target these families because of its relatively low cost and high reach. The Growing healthy program was developed to provide evidence-based information on infant feeding from birth to 9 months via app or website. Understanding user engagement with these media is vital to developing successful interventions. Engagement is a complex, multifactorial concept that needs to move beyond simple metrics.ObjectiveThe aim of our study was to describe the development of an engagement index (EI) to monitor participant interaction with the Growing healthy app. The index included a number of subindices and cut-points to categorize engagement.MethodsThe Growing program was a feasibility study in which 300 mother-infant dyads were provided with an app which included 3 push notifications that was sent each week. Growing healthy participants completed surveys at 3 time points: baseline (T1) (infant age ≤3 months), infant aged 6 months (T2), and infant aged 9 months (T3). In addition, app usage data were captured from the app. The EI was adapted from the Web Analytics Demystified visitor EI. Our EI included 5 subindices: (1) click depth, (2) loyalty, (3) interaction, (4) recency, and (5) feedback. The overall EI summarized the subindices from date of registration through to 39 weeks (9 months) from the infant's date of birth. Basic descriptive data analysis was performed on the metrics and components of the EI as well as the final EI score. Group comparisons used t tests, analysis of variance (ANOVA), Mann-Whitney, Kruskal-Wallis, and Spearman correlation tests as appropriate. Consideration of independent variables associated with the EI score were modeled using linear regression models.ResultsThe overall EI mean score was 30.0% (SD 11.5%) with a range of 1.8% - 57.6%. The cut-points used for high engagement were scores greater than 37.1% and for poor engagement were scores less than 21.1%. Significant explanatory variables of the EI score included: parity (P=.005), system type including "app only" users or "both" app and email users (P<.001), recruitment method (P=.02), and baby age at recruitment (P=.005).ConclusionsThe EI provided a comprehensive understanding of participant behavior with the app over the 9-month period of the Growing healthy program. The use of the EI in this study demonstrates that rich and useful data can be collected and used to inform assessments of the strengths and weaknesses of the app and in turn inform future interventions.

Project description:BackgroundThere is a critical need to expand the pool of available kidneys for African Americans who are on the transplant wait-list due to the disproportionally lower availability of deceased donor kidneys compared with other races/ethnic groups. Encouraging living donation is one method to fill this need. Incorporating mHealth strategies may be a way to deliver educational and supportive services to African American transplant-eligible patients and improve reach to those living in remote areas or unable to attend traditional group-session-based programs. Before program development, it is essential to perform formative research with target populations to determine acceptability and cultivate a patient-centered and culturally relevant approach to be used for program development.ObjectiveThe objectives of this study were to investigate African American kidney transplant recipients' and kidney donors'/potential donors' attitudes and perceptions toward mobile technology and its viability in an mHealth program aimed at educating patients about the process of living kidney donation.MethodsUsing frameworks from the technology acceptance model and self-determination theory, 9 focus groups (n=57) were administered to African Americans at a southeastern medical center, which included deceased/living donor kidney recipients and living donors/potential donors. After a demonstration of a tablet-based video education session and explanation of a group-based videoconferencing session, focus groups examined members' perceptions about how educational messages should be presented on topics pertaining to the process of living kidney donation and the transplantation. Questionnaires were administered on technology use and perceptions of the potential program communication platform. Transcripts were coded and themes were examined using NVivo 10 software.ResultsQualitative findings found 5 major themes common among all participants. These included the following: (1) strong support for mobile technology use; (2) different media formats were preferred; (3) willingness to engage in video chats, but face-to-face interaction sometimes preferred; (4) media needs to be user friendly; (5) high prevalence of technology access. Our results show that recipients were willing to spend more time on education than the donors group, they wanted to build conversation skills to approach others, and preferred getting information from many sources, whereas the donor group wanted to hear from other living donors. The questionnaires revealed 85% or more of the sample scored 4+ on a 5-point Likert scale, which indicates high degree of interest to use the proposed program, belief that other mHealth technologies would help with adherence to medical regimens, and doctors would make regimen adjustments quicker. In addition, high utilization of mobile technology was reported; 71.9% of the participants had a mobile phone and 43.9% had a tablet.ConclusionsOur study supports the use of an mHealth education platform for African Americans to learn about living donation. However, potential recipients and potential donors have differing needs, and therefore, programs should be tailored to each target audience.

Project description:BACKGROUND:Mobile health (mHealth) interventions are promising avenues to promote cardiovascular (CV) health among African-Americans (AAs) and culturally tailored technology-based interventions are emerging for this population. OBJECTIVE:The objectives of this study were to use a community-based participatory research (CBPR) approach to recruit AAs into a pilot intervention study of an innovative mHealth CV health promotion program and to characterize technology use patterns and eHealth literacy (EHL). METHODS:Community partners from five predominately AA churches in southeast Minnesota collaborated with our academic institution to recruit AA congregants into the pilot study. Field notes as well as communications between the study team and community partners were used to design the recruitment strategy and its implementation with a goal of enrolling 50 participants. At its core, the recruitment strategy included community kickoff events to detail the state-of-the-art nature of the mHealth intervention components, the utility of CV health assessments (physical examination, laboratory studies and surveys) and the participants' role in advancing our understanding of the efficacy of mHealth interventions among racial/ethnic minority groups. Detailed recruitment data were documented throughout the study. A self-administered, electronic survey measured sociodemographics, technology use and EHL (eHEALS scale). RESULTS:A total of 50 participants (70% women) from five AA churches were recruited over a one-month period. The majority (>90%) of participants reported using some form of mobile technology with all utilizing these technologies within their homes. Greater than half (60% [30/50]) reported being "very comfortable" with mobile technologies. Overall, participants had high EHL (84.8% [39/46] with eHEALS score ≥26) with no differences by sex. CONCLUSIONS:This study illustrates the feasibility and success of a CBPR approach in recruiting AAs into mHealth intervention research and contributes to the growing body of evidence that AAs have high EHL, are high-users of mobile technologies, and thus are likely to be receptive to mHealth interventions.

Project description:BackgroundSchizophrenia is a severe and disabling condition that presents a dire health equity challenge. Our initial 6-month trial (previously reported) using mobile texting and lay health supporters, called LEAN, significantly improved medication adherence from 0.48 to 0.61 (adjusted mean 0.11, 95% CI 0.03 to 0.20, P=.007) for adults with schizophrenia living in a resource-poor village in rural China.ObjectiveWe explored the effectiveness of our texting program in improving participants' medication adherence, functioning, and symptoms in an extended implementation of the intervention after its initial phase.MethodsIn an approximated stepped-wedge wait-list design randomized controlled trial, 277 community-dwelling villagers with schizophrenia were assigned 1:1 in phase 1 into intervention and wait-list control groups. The intervention group received (1) lay health supporters (medication or care supervisors), (2) e-platform (mobile-texting reminders and education message) access, (3) a token gift for positive behavioral changes, and (4) integration with the existing government community-mental health program (the 686 Program) while the wait-listed control group initially only received the 686 Program. Subsequently (in the extended period), both groups received the LEAN intervention plus the 686 Program. The primary outcome was antipsychotic medication adherence (percentage of dosages taken over the past month assessed by unannounced home-based pill counts). The secondary outcomes were symptoms measured during visits to 686 Program psychiatrists using the Clinical Global Impression scale for schizophrenia and functioning measured by trained student assessors using the World Health Organization Disability Assessment Schedule 2.0. Other outcomes included data routinely collected in the 686 Program system (refill records, rehospitalization due to schizophrenia, death for any reason, suicide, wandering, and violent behaviors). We used intention-to-treat analysis and missing data were imputed. A generalized estimating equation model was used to assess program effects on antipsychotics medication adherence, symptoms, and functioning.ResultsAntipsychotics medication adherence improved from 0.48 in the control period to 0.58 in the extended intervention period (adjusted mean difference 0.11, 95% CI 0.04 to 0.19; P=.004). We also noted an improvement in symptoms (adjusted mean difference -0.26, 95% CI -0.50 to -0.02; P=.04; Cohen d effect size 0.20) and a reduction in rehospitalization (0.37, 95% CI 0.18 to 0.76; P=.007; number-needed-to-treat 8.05, 95% CI 4.61 to 21.41). There was no improvement in functioning (adjusted mean difference 0.02, 95% CI -0.01 to 0.06; P=.18; Cohen d effect size 0.04).ConclusionsIn an extended implementation, our intervention featuring mobile texting messages and lay health workers in a resource-poor community setting was more effective than the 686 Program alone in improving medication adherence, improving symptoms, and reducing rehospitalization.Trial registrationChinese Clinical Trial Registry; ChiCTR-ICR-15006053 https://tinyurl.com/y5hk8vng.

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Dataset Information

Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial.

Similar Datasets

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