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The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi.

ABSTRACT: BACKGROUND:Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. METHODS:This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load

SUBMITTER: Kim MH

PROVIDER: S-EPMC7031891 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi.

Kim Maria H MH Tembo Tapiwa A TA Mazenga Alick A Yu Xiaoying X Myer Landon L Sabelli Rachael R Flick Robert R Hartig Miriam M Wetzel Elizabeth E Simon Katie K Ahmed Saeed S Nyirenda Rose R Kazembe Peter N PN Mphande Mtisunge M Mkandawire Angella A Chitani Mike J MJ Markham Christine C Ciaranello Andrea A Abrams Elaine J EJ

Trials 20200219 1

<h4>Background</h4>Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial pro ...[more]

PMID: 32075677

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Project description:BACKGROUND:Persons with human immunodeficiency virus (HIV) who get and keep a suppressed viral load are unlikely to transmit HIV. Simple, practical interventions to help achieve HIV viral suppression that are easy and inexpensive to administer in clinical settings are needed. We evaluated whether a brief video containing HIV-related health messages targeted to all patients in the waiting room improved treatment initiation, medication adherence, and retention in care. METHODS AND FINDINGS:In a quasi-experimental trial all patients (N = 2,023) attending two HIV clinics from June 2016 to March 2017 were exposed to a theory-based, 29-minute video depicting persons overcoming barriers to starting treatment, taking medication as prescribed, and keeping medical appointments. New prescriptions at index visit, HIV viral load test results, and dates of return visits were collected through review of medical records for all patients during the 10 months that the video was shown. Those data were compared with the same variables collected for all patients (N = 1,979) visiting the clinics during the prior 10 months (August 2015 to May 2016). Among patients exposed to the video, there was an overall 10.4 percentage point increase in patients prescribed treatment (60.3% to 70.7%, p< 0.01). Additionally, there was an overall 6.0 percentage point improvement in viral suppression (56.7% to 62.7%, p< 0.01), however mixed results between sites was observed. There was not a significant change in rates of return visits (77.5% to 78.8%). A study limitation is that, due to the lack of randomization, the findings may be subject to bias and secular trends. CONCLUSIONS:Showing a brief treatment-focused video in HIV clinic waiting rooms can be effective at improving treatment initiation and may help patients achieve viral suppression. This feasible, low resource-reliant video intervention may be appropriate for adoption by other clinics treating persons with HIV. TRIAL REGISTRATION:http://www.ClinicalTrials.gov (NCT03508310).

Project description:INTRODUCTION:Definitions of retention-in-care in Prevention of Mother-to-Child Transmission of HIV (PMTCT) vary substantially between studies and programmes. Some definitions are based on visits missed/made, others on a minimum total number of visits, or attendance at a final clinic visit at a specific time. An agreed definition could contribute to developing evidence-based interventions for improving retention-in-care. In this paper, we estimated retention-in-care rates according to different definitions, and we quantified and visualized the degree of agreement between definitions. METHODS:We calculated retention in care rates using nine definitions in the six INSPIRE PMTCT intervention studies, conducted in three sub-Saharan African countries between 2013 and 2017. With data from one of the studies (E4E), we estimated the agreement between definitions using Gwet's agreement coefficient (AC1) and concordance. We calculated positive predictive values (PPV) and negative predictive values (NPV) for all definitions considering successively each definition as the reference standard. Finally, we used a Multiple Correspondence Analysis (MCA) to examine clustering of the way different definitions handle retention-in-care. RESULTS:Retention-in-care rates among 5107 women ranged from 30% to 76% in the complete dataset with Gwet's AC1 being 0.56 [0.53; 0.59] indicating a moderate agreement between all definitions together. Two pairs of definitions with high inner concordance and agreement had either very high PPV or very high NPV, and appeared distinct from the other five definitions on the MCA figures. These pairs of definitions were also the ones resulting in the lowest and highest estimates of retention-in-care. The simplest definition, that only required a final clinic visit to classify women as retained in care, and classified 55% of women as retained in care, had a PPV ranging from 0.7 to 1 and a NPV ranging from 0.69 to 0.98 when excluding the two pairs afore-mentioned; it resulted in a moderate to substantial agreement and a 70% to 90% concordance with all other definitions. CONCLUSIONS:Our study highlights the variability of definitions in estimating retention-in-care. Some definitions are very stringent which may be required in some instances. A simple indicator such as attendance at a single time point may be sufficient for programme planning and evaluation.

Project description:BackgroundSexually transmitted disease (STD) prevention remains a public health priority. Simple, practical interventions to reduce STD incidence that can be easily and inexpensively administered in high-volume clinical settings are needed. We evaluated whether a brief video, which contained STD prevention messages targeted to all patients in the waiting room, reduced acquisition of new infections after that clinic visit.Methods and findingsIn a controlled trial among patients attending three publicly funded STD clinics (one in each of three US cities) from December 2003 to August 2005, all patients (n = 38,635) were systematically assigned to either a theory-based 23-min video depicting couples overcoming barriers to safer sexual behaviors, or the standard waiting room environment. Condition assignment alternated every 4 wk and was determined by which condition (intervention or control) was in place in the clinic waiting room during the patient's first visit within the study period. An intent-to-treat analysis was used to compare STD incidence between intervention and control patients. The primary endpoint was time to diagnosis of incident laboratory-confirmed infections (gonorrhea, chlamydia, trichomoniasis, syphilis, and HIV), as identified through review of medical records and county STD surveillance registries. During 14.8 mo (average) of follow-up, 2,042 patients (5.3%) were diagnosed with incident STD (4.9%, intervention condition; 5.7%, control condition). In survival analysis, patients assigned to the intervention condition had significantly fewer STDs compared with the control condition (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.84 to 0.99).ConclusionsShowing a brief video in STD clinic waiting rooms reduced new infections nearly 10% overall in three clinics. This simple, low-intensity intervention may be appropriate for adoption by clinics that serve similar patient populations.Trial registrationhttp://www.ClinicalTrials.gov (#NCT00137670).

Project description:Our objective was to evaluate the efficacy of the Sitting Together and Reaching to Play (START-Play) intervention in young infants with neuromotor disorders. This randomized controlled trial compared usual care early intervention (UC-EI) with START-Play plus UC-EI. Analyses included 112 infants with motor delay (55 UC-EI, 57 START-Play) recruited at 7 to 16 months of age across 5 sites. START-Play included twice-weekly home visits with the infant and caregiver for 12 weeks provided by physical therapists trained in the START-Play intervention; UC-EI was not disrupted. Outcome measures were the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley); the Gross Motor Function Measure; reaching frequency; and the Assessment of Problem Solving in Play (APSP). Comparisons for the full group as well as separate comparisons for infants with mild motor delay and infants with significant motor delay were conducted. Piecewise linear mixed modeling estimated short- and long-term effects. For infants with significant motor delay, positive effects of START-Play were observed at 3 months for Bayley cognition, Bayley fine motor, and APSP and at 12 months for Bayley fine motor and reaching frequency outcomes. For infants with mild motor delay, positive effects of START-Play for the Bayley receptive communication outcome were found. For the UC-EI group, the only difference between groups was a positive effect for the APSP outcome, observed at 3 months. START-Play may advance reaching, problem solving, cognitive, and fine motor skills for young infants with significant motor delay over UC-EI in the short term. START-Play in addition to UC-EI may not improve motor/cognitive outcomes for infants with milder motor delays over and above usual care. Concepts of embodied cognition, applied to early intervention in the START-Play intervention, may serve to advance cognition and motor skills in young infants with significant motor delays over usual care early intervention. If you have a young infant with significant delays in motor skills, your physical therapist can work with you to develop play opportunities to enhance your child's problem solving, such as that used in the START-Play intervention, in addition to usual care to help your child advance cognitive and motor skills.

Project description:BackgroundA lifesaving treatment for myocardial infarction is the placement of a stent in a closed or obstructed coronary artery. The largest modifiable risk factor after receiving a stent is medication adherence to Dual AntiPlatelet Therapy, a combination of P2Y12 inhibitors and aspirin.ObjectiveThis study aimed to determine the acceptability of a protocol and an intervention using the My Interventional Drug-Eluting Stent Educational App (MyIDEA) and to evaluate medication adherence using the proportion of days covered (PDC) and platelet activation tests in a multisite randomized controlled trial.MethodsPotential participants who received a post percutaneous coronary intervention (PCI) procedure with a drug-eluting stent were approached. All patients older than 50 years and who spoke English were recruited. Participants were recruited, baseline demographics were collected, and the Hospital Anxiety and Depression Scale (HADS), Rapid Estimate of Adult Literacy in Medicine-Short Form, Burden-Benefit questionnaire, 36-Item Short Form Health Survey, and PCI knowledge questionnaire were administered. Block randomization was used to randomize participants to either usual care or MyIDEA supplementation. MyIDEA is a personalized educational intervention based on the Kolb experiential learning theory using patient narratives for education. During the visits, participants' blood was collected to measure platelet suppression from medication. During the second and third encounters, the Morisky medication adherence score and cardiology outcomes were measured. The study was conducted at the University of Illinois Hospital and John H Stroger Jr Cook County Hospital with appropriate ethical approvals. Platelet suppression was measured through aspirin reactive units and P2Y12 reactive units. Medication adherence was measured using the PDC. The analysis team was blinded to the participants' group membership. The primary outcome was a feasibility analysis of recruitment and retention.ResultsThe mean age of participants was 60.4 years (SD 7.1); the majority of patients were black and non-Hispanic. The majority of patients' reading levels were seventh grade or above, and they were not very familiar with other electronic devices for information and communication. The number of control subjects was 21, and the number of participants in the interventional arm was 24. The interventional group was able to use MyIDEA in both the hospital and outpatient setting. However, there was no significant difference in platelet suppression or medication adherence between groups. There were also differences between the groups in terms of depression and anxiety, initially, as measured by HADS. No documented adverse event associated with the intervention was found.ConclusionsElderly patients are willing to use tablet devices to be educated about health conditions. Additional studies are required to measure the effectiveness and determine the most suitable timing and location for patient education.Trial registrationClinicalTrials.gov NCT04439864; https://clinicaltrials.gov/ct2/show/NCT04439864.

Dataset Information

The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi.

Publications

The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi.

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