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A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV. OBJECTIVE:This study aims to describe a protocol investigating the feasibility of an mHealth intervention for treatment adherence among women living with HIV. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patient interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms. METHODS:Women (age ?18 years) who were followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed), will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinical standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust and resilience as a patient-level strength. The control arm will receive standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants' preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depression symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits-approximately 3 to 4 months from the baseline (time 1; T1) and 6 to 9 months from the baseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analyses will be conducted for each outcome variable-T1 and T2 values will be compared with values at T0 by the study group. RESULTS:As of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first 3 focus groups (1 in each of the 3 languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth texting system. CONCLUSIONS:The findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care and the mechanisms of an mHealth intervention that is customized for ethnic minority women living with HIV. TRIAL REGISTRATION:ClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17656.

SUBMITTER: Duthely LM

PROVIDER: S-EPMC7334759 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.

Duthely Lunthita M LM Sanchez-Covarrubias Alex P AP Mohamed Adhar B AB Potter JoNell E JE

JMIR research protocols 20200619 6

<h4>Background</h4>Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minori ...[more]

PMID: 32438338

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Project description:BackgroundWith high rates of HIV and multiple vulnerable subgroups across diverse settings, there is a need for culturally based, HIV stigma reduction interventions. Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives. Uptake of HIV services worldwide is hindered by stigma towards persons living with HIV/AIDS. While cultural context plays a key role in shaping HIV stigma, these insights have not yet been fully integrated into stigma reduction strategies. By utilizing the "What Matters Most" stigma framework, we propose that an intervention to counter culturally salient aspects of HIV stigma will improve treatment adherence and other relevant outcomes. A pragmatic clinical trial in Botswana will evaluate the "Mothers Moving towards Empowerment" (MME) intervention, which seeks to address HIV stigma in Botswana and to specifically engage pregnant mothers so as to promote antiretroviral therapy (ART) adherence in the postpartum period.MethodsThis study will test MME against treatment as usual (TAU) among pregnant mothers diagnosed with HIV and their infants. Outcomes will be assessed during pregnancy and 16 weeks postpartum. Women who meet eligibility criteria are assigned to MME or TAU. Women assigned to MME are grouped with others with similar estimated delivery dates, completing up to eight intervention group sessions scheduled before week 36 of their pregnancies. Primary outcomes among mothers include (i) reducing self-stigma, which is hypothesized to mediate improvements in (ii) psychological outcomes (quality of life, depression and social functioning), and (iii) adherence to antenatal care and ART. We will also examine a set of follow-up infant birth outcomes (APGAR score, preterm delivery, mortality (at < 16 weeks), birth weight, vaccination record, and HIV status).DiscussionOur trial will evaluate MME, a culturally based HIV stigma reduction intervention using the "What Matters Most" framework, to reduce stigma and improve treatment adherence among pregnant women and their infants. This study will help inform further refinement of MME and preparation for a future large-scale, multisite, randomized controlled trial (RCT) in Botswana.Trial registrationClinicalTrials.gov NCT03698981 . Registered on October 8, 2018.

Project description:BackgroundAdherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.ObjectiveThe primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.MethodsThis study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations.ResultsPhase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.ConclusionsThis study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.Trial registrationClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128.International registered report identifier (irrid)DERR1-10.2196/15356.

Project description:BackgroundCultural competence (CC) in health systems is the ability to provide care to patients with different values, beliefs and behaviors, and to match the care to their social, cultural and linguistic needs. In 2011, the Director-General of Israel's Ministry of Health issued a cultural competence directive to health care providers that sought to minimize health inequalities caused by cultural and linguistic gaps. This study assesses the status of organizational CC in Israeli general hospitals in the wake of the 2011 directive.MethodOrganizational CC was assessed using a 75-item structured questionnaire based on the 2011 directive and on international standards. Data were gathered via interviews conducted between December 2012 and February 2014. 35 of Israel's 36 general hospitals participated in the study, for a response rate of 97%. A composite CC score was calculated for each hospital as the average of the 75 items in the questionnaire.ResultsThe average composite score of all the hospitals was low to moderate (2.3 on a scale of 0-4), the median score was 2.4, and the range of composite scores was large, 0.7-3.2. The interquartile range was [1.94, 2.57]. Hospital CC is positively associated with non-private ownership status and location in the southern or central districts. Still, these differences are not statistically significant and immutable hospital characteristics such as ownership status and location account for only 21% of the inter-hospital variation in CC. This suggests that hospital leaders have significant discretion in the priority to be given to CC. Dimensions of CC with relatively low average scores include hospital connections with the community (1.28), staff training on CC (1.35), oral translation (i.e. interpreting) during treatment (1.62), and CC adaptation of human resources recruitment and evaluation (1.64). These areas appear to be particularly in need of improvement.ConclusionThe study findings suggest that hospitals and policy-makers can take significant steps to improve CC; these include setting more concrete and measurable implementation guidelines. We conclude with suggestions for policy and practices to improve cultural competence in the health system.

Project description:BackgroundCulturally and linguistically diverse patients access healthcare services less than the host populations and are confronted with different barriers such as language barriers, legal restrictions or differences in health beliefs. In order to reduce these disparities, the promotion of cultural competence in healthcare organizations has been a political goal. This scoping review aims to collect components and strategies from evaluated interventions that provide culturally competent healthcare for culturally and linguistically diverse patients within healthcare organizations and to examine their effects on selected outcome measures. Thereafter, we aim to organize identified components into a model of culturally competent healthcare provisions.Methods and findingsA systematic literature search was carried out using three databases (Pubmed, PsycINFO and Web of Science) to identify studies which have implemented and evaluated cultural competence interventions in healthcare facilities. PICO criteria were adapted to formulate the research question and to systematically choose relevant search terms. Sixty-seven studies implementing culturally competent healthcare interventions were included in the final synthesis. Identified strategies and components of culturally competent healthcare extracted from these studies were clustered into twenty categories, which were organized in four groups: Components of culturally competent healthcare-Individual level; Components of culturally competent healthcare-Organizational level; Strategies to implement culturally competent healthcare and Strategies to provide access to culturally competent healthcare. A model integrating the results is proposed. The overall effects on patient outcomes and utilization rates of identified components or strategies were positive but often small or not significant. Qualitative data suggest that components and strategies of culturally competent healthcare were appreciated by patients and providers.ConclusionThis scoping review used a bottom-up approach to identify components and strategies of culturally competent healthcare interventions and synthesized the results in a model of culturally competent healthcare provision. Reported effects of single components or strategies are limited because most studies implemented a combination of different components and strategies simultaneously.

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.

Project description:BACKGROUND:The shortage of organs for kidney transplantation for patients with end-stage renal disease (ESRD) is magnified in Hispanics/Latin Americans in the United States. Living donor kidney transplantation (LDKT) is the treatment of choice for ESRD. However, compared to their representation on the transplant waitlist, fewer Hispanics receive a LDKT than non-Hispanic whites. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and language barriers. Few interventions have been designed to reduce LDKT disparities. This study aims to reduce Hispanic disparities in LDKT through a culturally targeted intervention. METHODS/DESIGN:Using a prospective effectiveness-implementation hybrid design involving pre-post intervention evaluation with matched controls, we will implement a complex culturally targeted intervention at two transplant centers in Dallas, TX and Phoenix, AZ. The goal of the study is to evaluate the effect of Northwestern Medicine's® Hispanic Kidney Transplant Program's (HKTP) key culturally targeted components (outreach, communication, education) on Hispanic LDKT rates over five years. The main hypothesis is that exposure to the HKTP will reduce disparities by increasing the ratio of Hispanic to non-Hispanic white LDKTs and the number of Hispanic LDKTs. We will also examine other process and outcome measures including: dialysis patient outreach, education session attendance, marketing efforts, Hispanic patients added to the waitlist, Hispanic potential donors per potential recipient, and satisfaction with culturally competent care. We will use mixed methods based on the Promoting Action on Research Implementation in Health Services (revised PARIHS) and the Consolidated Framework for Implementation Research (CFIR) frameworks to formatively evaluate the fidelity and innovative adaptations to HKTP's components at both study sites, to identify moderating factors that most affect implementation fidelity, and to identify adaptations that positively and negatively affect outcomes for patients. DISCUSSION:Our study will provide new knowledge about implementing culturally targeted interventions and their impact on reducing health disparities. Moreover, the study of a complex organizational-level intervention's implementation over five years is rare in implementation science; as such, this study is poised to contribute new knowledge to the factors influencing how organizational-level interventions are sustained over time. TRIAL REGISTRATION:(ClinicalTrials.gov registration # NCT03276390 , date of registration: 9-7-17, retrospectively registered).

Project description:BackgroundVulnerable adolescents and emerging adults (aged 18-29 years), particularly young transgender women, are among the fastest-growing HIV positive populations worldwide. Thailand has the highest adult HIV seroprevalence in Asia, with a rate of infection among this population of 18%. Widespread technology offers opportunities for innovative mobile health (mHealth) interventions. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for at-risk individuals. PrEP is highly effective when taken as prescribed, but uptake and adherence have been low, with high discontinuation rates among youth.ObjectiveWe propose to develop and pilot a multi-component, technology-based intervention to promote PrEP usage. We will adapt an existing 2-session, technology-delivered, motivational interviewing-based intervention to focus on PrEP use in transgender women in Thailand. We call this the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also refine and enhance YaCool, a mobile app with integrated text messaging developed and used clinically by our Thai team. The new version of the app is called Enhanced YaCool, and it enables self-management of gender and sexual health (including PrEP). Our primary aim is to develop and assess the preliminary efficacy of this mHealth intervention.MethodsWe will utilize a multiphase optimization strategy (MOST) to identify the most effective intervention component or combination of components to improve PrEP usage in Thai transgender women. The study includes two phases: phase I (R21) includes qualitative interviews with key stakeholders to explore barriers and facilitators of PrEP usage through thematic analysis to inform intervention adaptation. Following this, we will adapt and beta-test MES-PrEP and Enhanced YaCool for functionality and feasibility using a community advisory board of HIV-negative Thai transgender women. In phase II (R33), we will conduct a MOST design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool. Eighty HIV-negative participants who are currently taking PrEP and 80 participants who are not will be randomized to four conditions: (1) standard PrEP counseling (the control condition); (2) MES-PrEP and standard PrEP counseling; (3) Enhanced YaCool and standard PrEP counseling; and (4) MES-PrEP, Enhanced YaCool, and standard PrEP counseling. Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of participants who initiate PrEP and their level of adherence to PrEP. Assessments will be at baseline and 1, 3, 6, 9, and 12 months postintervention. Biomarkers of adherence to PrEP, HIV, and other sexually transmitted infections will be collected.ResultsUpon project completion, we will have an optimized mHealth intervention to support the use of PrEP by transgender women that will be ready for testing in a larger efficacy trial.ConclusionsEven though transgender women in Thailand face increasing risks of HIV, few interventions have targeted them. Effective developmentally and culturally tailored interventions are needed to prevent HIV transmission in this high-risk population.Trial registrationClinicalTrials.gov NCT05262426; https://clinicaltrials.gov/ct2/show/NCT05262426.International registered report identifier (irrid)PRR1-10.2196/37659.

Dataset Information

A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.

Publications

A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.

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