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The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam.

ABSTRACT: 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 (

SUBMITTER: DeSilva M

PROVIDER: S-EPMC6394014 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam.

DeSilva Mary M Vu Cong Nguyen CN Bonawitz Rachael R Hai Le Thanh LT Van Lam Nguyen N Yen Le Thi LT Gifford Allen L AL Haberer Jessica J Linh Dang Thuy DT Sabin Lora L

Trials 20190228 1

<h4>Background</h4>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 interve ...[more]

PMID: 30819228

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Project description:BACKGROUND:Mobile health (mHealth) apps have the potential to support patients' medication use and are therefore increasingly used. Apps with broad functionality are suggested to be more effective; however, not much is known about the actual use of different functionalities and the effective engagement. OBJECTIVE:The aim of this study was to explore the use and the effective engagement of adolescents (aged 12 to 18 years) with the Adolescent Adherence Patient Tool (ADAPT). METHODS:The ADAPT intervention consisted of an app for patients, which was connected to a management system for their pharmacist. The aim of the ADAPT intervention was to improve medication adherence and, therefore, the app contained multiple functionalities: questionnaires to monitor symptoms and adherence, medication reminders, short movies, pharmacist chat, and peer chat. For this study, data of the ADAPT study and a cluster randomized controlled trial were used. Adolescents with asthma had 6 months' access to the ADAPT intervention, and all app usage was securely registered in a log file. RESULTS:In total, 86 adolescents (mean age 15.0, SD 2.0 years) used the ADAPT app 17 times (range 1-113) per person. Females used the app more often than males (P=.01) and for a longer period of time (P=.03). On average, 3 different functionalities were used, and 13% of the adolescents used all functionalities of the app. The questionnaires to monitor symptoms and adherence were used by most adolescents. The total app use did not affect adherence; however, activity in the pharmacist chat positively affected medication adherence (P=.03), in particular, if patients sent messages to their pharmacist (P=.01). CONCLUSIONS:mHealth apps for adolescents with asthma should contain different functionalities to serve the diverging needs and preferences of individual patients. Suggested key functionalities to promote use and effectiveness in adolescents with asthma are questionnaires to monitor symptoms and a health care provider chat.

Project description:Introduction:Youth in Uganda are disproportionately impacted by HIV and report significant barriers to ART adherence. We asked participants how fixed versus flexible adherence target setting for incentive interventions, in combination with other support systems, could help HIV-positive youth in Uganda reach medication adherence targets. Methods:Four focus groups conducted in Luganda were audiotaped, transcribed, and translated into English; the transcriptions were then coded using Dedoose software. Two members of the research team read the text and identified the basic topics covered. A codebook was developed that detailed inclusion and exclusion criteria for each topic area, as well as typical entries for each code. A directed content analysis was used to identify key themes. Results:Several themes were common across groups. Participants consistently maintained that they preferred to set their own adherence targets. But regardless of how adherence targets were assigned, participants noted that missing their target was disappointing. They commented positively on the use of Medication Event Monitoring System (MEMS) caps, noting that knowing their adherence information was being tracked often encouraged them to take their medications. Participants reported that receiving text messages further motivated them to take their medications; however, on occasions when they reported not doing well, they wanted intensive follow-up by staff. Participants said that the prize drawing alone did not motivate their ART adherence and that receiving 'zero' in the drawing was disheartening. Conclusion:We found that participants preferred to set their own adherence targets and that doing so increased a sense of ownership in achieving them. All participants enjoyed using MEMS caps and expressed disappointment at needing to return the device at the study's completion. Participants noted that text message reminders may be a useful way to help patients stay motivated between clinic visits; however, ongoing engagement and support are needed from providers and counselors. Finally, our participants stressed the importance of including incentives with a small, positive value rather than 0 when designing the lowest prize.

Project description:IntroductionMiddle East and North Africa (MENA) has a rising rate of new HIV infections and AIDS-related mortality. Consistent adherence to antiretroviral therapy (ART) leads to viral suppression, preventing HIV transmission and treatment failure. mHealth interventions can improve ART adherence by providing tailored support and directing patients to existing healthcare services. HamRaah (Persian for 'together-in-path') is the first mHealth-based intervention in a MENA country and is designed to improve adherence through two-way mobile messaging for people recently diagnosed with HIV in Tehran, Iran. The objectives of this pilot randomised controlled trial (RCT) are to examine the feasibility, acceptability and preliminary effectiveness of HamRaah, and to develop an explanatory theory for any observed effects through a nested realist evaluation.MethodsA feasibility study and two-arm RCT of HamRaah, with an embedded realist evaluation will be conducted. Participants will be randomised 1:1 to HamRaah or routine care for a 6-month intervention. The initial effectiveness of HamRaah will be assessed through the primary outcome of self-reported ART adherence and several secondary outcomes: retention in care, CD4 count and viral suppression. A theory-driven realist evaluation framework will be used to develop an explanatory theory regarding what works, for whom, how and in what context.Ethics and disseminationThe study received ethical clearance from Tehran University of Medical Sciences Ethics Committee and Oxford Tropical Research Ethics Committee People living with HIV in Tehran and key country stakeholders in HIV policy and programming have been involved in the development of HamRaah and this pilot trial. Participants will provide informed consent prior to study enrolment. The results will be disseminated to all stakeholders and presented in peer-reviewed journal publications and conferences.Trial registration numberIRCT20100601004076N23; Pre-results.

Project description:Patient Selection: Three hospitals were involved in the study: Dong Thap Provincial and An Giang Provincial hospitals, both located in the Mekong Delta Region of Vietnam where most of the Typhoid patients were admitted, and the Hospital for Tropical Diseases, Ho Chi Minh City, where the malarial patients were admitted. Infection status of each patient was determined by blood culture for the Typhoid patients and by microscopic examination of stained thick and thin peripheral-blood slides for the patients suspected of having Malaria. Patients with blood cultures positive for S. Typhi or S. enterica serovar Paratyphi A (S. Paratyphi A) (samples designated ST) or peripheral blood smears positive for Plasmodium falciparum or Plasmodium vivax (samples designated PF) were consented and enrolled in the study. A total of 28 S. Typhi positive patients and one S. Paratyphi A positive patient were enrolled in the first phase of the study and a further 9 S. Typhi and one S. Paratyphi A positive patient were enrolled in the second phase. Nine patients with Malaria caused by P. falciparum and one caused by P. vivax were enrolled. Sixteen uninfected healthy individuals (samples designated HC) were also enrolled in the study (one sample each). The Typhoid patients were randomly chosen to receive either Azithromycin or Gatifloxicin (20mg/kg/day for 7 days) antibiotics. Uncomplicated malaria patients were treated for 3 days with Artekin (dihydroartemisinin with piperaquine phosphate). Venous blood (2.5ml) was collected for total RNA extraction into PaxGene RNA collection tubes (Qiagen) at various times. The first sample (T1) was taken immediately on admission or entry into the study, then samples were collected, 3 (T3), 6-9 (T9 for Typhoid, T7 for Malaria), and 28-45 (T28) days following entry into the study and an average of 9 months (T9M) later. The PaxGene tubes were stored at 4degC until RNA was extracted as per the manufacturers instructions. Purified RNA was shipped on dry ice to Stanford University, CA for use in Microarray analyses. Microarrays: Experimental and reference samples (Human Universal RNA reference {Stratagene}) were amplified using the MessageAmp II aRNA Kit (Ambion) as per the manufacturer's instructions. Four micrograms amplified RNA was labeled through indirect incorporation of Cy5 (experimental) and Cy3 (reference) dyes (protocols can be found at http://cmgm.stanford.edu/pbrown/protocols/index.html). The labeled probes were then mixed and hybridized to Stanford Human cDNA arrays with 42 K features. Arrays were scanned using a Genepix 4000A laser scanner and data extracted with Genepix Pro Software version 5.1 (Axon Instruments). The data were then uploaded into the Stanford Microarray Database (SMD). A disease state experiment design type is where the state of some disease such as infection, pathology, syndrome, etc is studied. Compound Based Treatment: Drugs used for treatment Disease State: Malaria, Typhoid or Healthy Controls Keywords: disease_state_design

Project description:IntroductionAchieving optimal adherence to antiretroviral therapy (ART) among adolescents living with HIV (ALWHIV) is challenging, especially in low-resource settings. To help accurately determine who is at risk of poor adherence, we developed and internally validated models comprising multi-level factors that can help to predict the individualized risk of poor adherence among ALWHIV in a resource-limited setting such as Uganda.MethodsWe used data from a sample of 637 ALWHIV in Uganda who participated in a longitudinal study, "Suubi+Adherence" (2012 to 2018). The model was developed using the Least Absolute Shrinkage and Selection Operator (LASSO) penalized regression to select the best subset of multi-level predictors (individual, household, community or economic-related factors) of poor adherence in one year's time using 10-fold cross-validation. Seventeen potential predictors included in the model were assessed at 36 months of follow-up, whereas adherence was assessed at 48 months of follow-up. Model performance was evaluated using discrimination and calibration measures.ResultsFor the model predicting poor adherence, five of the 17 predictors (adherence history, adherence self-efficacy, family cohesion, child poverty and group assignment) were retained. Its ability to discriminate between individuals with and without poor adherence was acceptable; area under the curve (AUC) = 69.9; 95% CI: 62.7, 72.8. There was no evidence of possible areas of miscalibration (test statistic = 1.20; p = 0.273). The overall performance of the model was good.ConclusionsOur findings support prediction modelling as a useful tool that can be leveraged to improve outcomes across the HIV care continuum. Utilizing information from multiple sources, the risk prediction score tool applied here can be refined further with the ultimate goal of being used in a screening tool by practitioners working with ALWHIV. Specifically, the tool could help identify and provide early interventions to adolescents at the highest risk of poor adherence and/or viral non-suppression. However, further fine-tuning and external validation may be required before wide-scale implementation.

Project description:Medication adherence is an important but highly complex set of behaviors, which for life-threatening and infectious diseases such as HIV carry critical consequences for individual and public health. There is growing evidence that mobile phone text messaging interventions (mHealth) connecting providers with patients positively impact medication adherence, particularly two-way engagement platforms that require bidirectional communication versus one-way in which responses are not mandatory. However, mechanisms of action have not been well defined. The Behavior Change Wheel is a comprehensive framework for behavior change that includes an all-encompassing model of behavior known as Capability Opportunity Motivation-Behavior and is complemented by a taxonomy of behavior change techniques. Evaluating mHealth interventions for medication adherence using these tools could provide useful insights that may contribute to optimizing their integration into the healthcare system and successful scaling-up.This study aimed to help address the current knowledge gap regarding how two-way mHealth interventions for medication adherence may work by applying the Behavior Change Wheel to characterize WelTel: an interactive digital health outreach platform with robust evidence for improving adherence to antiretroviral therapy.To characterize how WelTel may promote medication adherence, we applied the Behavior Change Wheel to systematically (1) generate a behavioral diagnosis through mapping known antiretroviral therapy adherence barriers onto the Capability Opportunity Motivation-Behavior model of behavior, (2) specify the behavior change techniques that WelTel delivers, (3) link identified behavior change techniques to corresponding intervention functions of the Behavior Change Wheel, and (4) connect these behavior change techniques and intervention functions to respective Capability Opportunity Motivation-Behavior influences on behavior to determine potential mechanisms of action.Our evaluation of WelTel using the Behavior Change Wheel suggests that most of its impact is delivered primarily through its personalized communication component, in which 8 different behavior change techniques were identified and linked with 5 intervention functions (environmental restructuring, enablement, education, persuasion, and training). Its mechanisms of action in promoting antiretroviral therapy adherence may involve addressing all Capability Opportunity Motivation-Behavior influences on behavior (physical and psychological capability, physical and social opportunity, reflective and automatic motivation).Systematically unpacking the potential active ingredients of effective interventions facilitates the creation and implementation of more parsimonious, tailored, and targeted approaches. Evaluating WelTel using the Behavior Change Wheel has provided valuable insights into how and why such interactive two-way mHealth interventions may produce greater impact than one-way in addressing both nonintentional and intentional forms of nonadherence. The application of the Behavior Change Wheel for evidence synthesis across mHealth interventions targeting various conditions would contribute to strengthening the knowledge base regarding how they may work to impact medication adherence behavior.

Project description:INTRODUCTIONThere are two million HIV-positive adolescents in southern Africa, and this group has low retention in care and high mortality. There is almost no evidence to identify which healthcare factors can improve adolescent self-reported retention. This study examines factors associated with retention amongst antiretroviral therapy (ART)-initiated adolescents in South Africa.METHODSWe collected clinical records and detailed standardized interviews (n = 1059) with all 10- to 19 year-olds ever initiated on ART in all 53 government clinics of a health subdistrict, and community traced to include lost-to-follow-up (90.1% of eligible adolescents interviewed). Associations between full self-reported retention in care (no past-year missed appointments and 85% past-week adherence) and health service factors were tested simultaneously in sequential multivariate regression and marginal effects modelling, controlling for covariates of age, gender, urban/rural location, formal/informal housing, maternal and paternal orphanhood, vertical/horizontal HIV infection, overall health, length of time on ART and type of healthcare facility.RESULTSAbout 56% of adolescents had self-reported retention in care, validated against lower detectable viral load (AOR: 0.63, CI: 0.45 to 0.87, p = 0.005). Independent of covariates, five factors (STACK) were associated with improved retention: clinics Stocked with medication (OR: 3.0, CI: 1.6 to 5.5); staff with Time for adolescents (OR: 2.7, CI: 1.8 to 4.1); adolescents Accompanied to the clinic (OR: 2.3, CI: 1.5 to 3.6); enough Cash to get to clinic safely (OR: 1.4, CI: 1.1 to 1.9); and staff who are Kind (OR: 2.6, CI: 1.8 to 3.6). With none of these factors, 3.3% of adolescents reported retention. With all five factors, 69.5% reported retention.CONCLUSIONSThis study identifies key intervention points for adolescent retention in HIV care. A basic package of clinic and community services has the potential to STACK the odds for health and survival for HIV-positive adolescents.

Dataset Information

The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam.

Publications

The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam.

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