Dataset Information

The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol.

ABSTRACT: The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya.A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message) slogan (the intervention) or current standard of care support mechanisms alone (the control). Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants. Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes.This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting.

SUBMITTER: Lester RT

PROVIDER: S-EPMC2760542 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol.

Lester Richard T RT Mills Edward J EJ Kariri Antony A Ritvo Paul P Chung Michael M Jack William W Habyarimana James J Karanja Sarah S Barasa Samson S Nguti Rosemary R Estambale Benson B Ngugi Elizabeth E Ball T Blake TB Thabane Lehana L Kimani Joshua J Gelmon Lawrence L Ackers Marta M Plummer Francis A FA

Trials 20090922

<h4>Background</h4>The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya.<h4>Methods and design</h4>A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized ...[more]

PMID: 19772596

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Project description:Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR]?=?0.71; 95% confidence interval [CI] 0.49-1.01; p?=?0.055) and 59% less likely to experience viral failure (HIV-1 RNA ?5,000 copies/ml) (HR 0.41; 95% CI 0.21-0.81; p?=?0.01) compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p?=?0.7) or viral failure (HR 0.99; 95% CI 0.53-1.84; p?=?1.0) compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution.Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.

Project description:BackgroundIncomplete adherence to antiretroviral therapy (ART) is one of the factors that contribute to HIV drug resistance, and it is a major problem for the public health system in controlling the HIV pandemic. There is emerging evidence that SMS can play an important role in health care delivery among patients with HIV on ART, especially in resource-limited settings.ObjectiveThis paper aims to assess the impact of two-way and one-way SMS text messaging on adherence to HIV treatment. We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life).MethodsA randomized controlled trial is being carried out among participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon. Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207. The interventions involved the use of mobile phone text messages. Before commencing the intervention, a focus group discussion was carried out among the participants to understand their perception about the use of SMS-based interventions to improve adherence. A total of 246 participants were randomized to receive either a one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care). Data on adherence and quality of life were collected at baseline and after 6 months and will be analyzed using SPSS version 21, while qualitative data will be analyzed using Atlas.ti 7.5.ResultsData collection began in September 2019 with focus group discussions and baseline data collection. After 1 month of baseline data collection, the intervention began in October 2019, and postintervention data were collected after 6 months (March 2020). At the end of the study, we will be able to understand the perception of patients toward SMS text messaging-based interventions and also assess the impact of one-way and two-way SMS text messages on treatment adherence among patients with HIV and on associated clinical outcomes (quality of life).ConclusionsThe impact of SMS text messaging varies across different settings. The results from this study will determine the perception of patients toward an SMS text messaging-based intervention and its impact on adherence to ART.International registered report identifier (irrid)DERR1-10.2196/16127.

Project description:BackgroundHypertension is the premier modifiable risk factor for recurrent stroke. In sub-Saharan Africa (SSA) where the stroke burden is escalating, little is known about the role of behavioral interventions in enhancing blood pressure (BP) control after stroke. Our objective is to test whether an m-Health technology-enabled, nurse-led, multilevel integrated approach is effective in improving BP control among Ghanaian stroke patients within 1 month of symptom onset compared with standard of care.MethodsThis two-arm cluster randomized controlled feasibility pilot trial will involve 60 recent-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated into four clusters of 15 patients each per physician: two clusters in the intervention arm and two in the control arm. Patients in the intervention arm will receive a simple pillbox, a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake under nurse guidance for 3 months. Tailored motivational text messages will be delivered based upon levels of adherence to the medication intake. Both groups will be followed up for 6 months to compare BP control at months 3, 6 and 9 as primary outcome measure. Physicians assessing BP control will be blinded to arms into which patients are allocated. Secondary outcome measures will include medication adherence scores and Competence and Autonomous Self-regulation Scale scores. A qualitative study is planned after follow-up to explore the lived experiences of participants in the intervention arm.DiscussionA feasible and preliminarily effective intervention would lead to a larger more definitive efficacy/effectiveness randomized controlled trial powered to look at clinical events, with the potential to reduce stroke-related morbidity and mortality in a low- to middle-income country.Trial registrationClinicalTrials.gov Identifier: NCT02568137 , registered on 13 July 2015.

Project description:BackgroundNearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral "nudges" using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.MethodsThe Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.DiscussionThe primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment.Trial registrationClinicalTrials.gov NCT03973931 . Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.

Dataset Information

The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol.

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The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol.

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