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Randomized Factorial Trial of Phone-Delivered Support Counseling and Daily Text Message Reminders for HIV Treatment Adherence.

ABSTRACT: BACKGROUND:HIV infection is clinically managed with antiretroviral therapy (ART), but only with sustained adherence. Cost-efficient interventions to improve and sustain ART adherence remain a pressing priority for populations challenged by nonadherence. The aim of this study was to test the independent and interactive effects of (1) brief phone-delivered self-regulation counseling and (2) daily phone-delivered text message medication reminders on HIV adherence and HIV viral suppression. METHOD:A randomized 2 (5 sessions of phone-delivered adherence support counseling vs. contact-matched control) × 2 (daily ART text reminders vs. no reminders) trial with primary end points of monthly phone-based unannounced pill count-determined ART adherence and HIV viral suppression monitored over 12 months. RESULTS:Self-regulation adherence counseling demonstrated significant improvements in achieving 90% ART adherence relative to the control group over the first 6 months of follow-up. Effects remained significant in sensitivity analyses conducted at 85% and 95% adherence. Counseling also demonstrated modest but significant effects on HIV suppression. There were no main effects or interactions for daily text message reminders, with some evidence for adverse effects on adherence self-efficacy. CONCLUSIONS:Brief adherence support counseling delivered by phone demonstrates clinically meaningful improvements in ART adherence and HIV suppression, although these benefits were not evidenced in all patients or in the long-term. Advancing adherence interventions along with an effective means for sustaining gains in adherence remain priorities if ART is to achieve its potential clinical and public health benefits.

SUBMITTER: Kalichman SC

PROVIDER: S-EPMC4981529 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Randomized Factorial Trial of Phone-Delivered Support Counseling and Daily Text Message Reminders for HIV Treatment Adherence.

Kalichman Seth C SC Kalichman Moira O MO Cherry Chauncey C Eaton Lisa A LA Cruess Dean D Schinazi Raymond F RF

Journal of acquired immune deficiency syndromes (1999) 20160901 1

<h4>Background</h4>HIV infection is clinically managed with antiretroviral therapy (ART), but only with sustained adherence. Cost-efficient interventions to improve and sustain ART adherence remain a pressing priority for populations challenged by nonadherence. The aim of this study was to test the independent and interactive effects of (1) brief phone-delivered self-regulation counseling and (2) daily phone-delivered text message medication reminders on HIV adherence and HIV viral suppression.< ...[more]

PMID: 27105048

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Project description:BackgroundMedication refill behavior in patients with cardiovascular diseases is suboptimal. Brief behavioral interventions called Nudges may impact medication refill behavior and can be delivered at scale to patients using text messaging.MethodsPatients who were prescribed and filled at least one medication for hypertension, hyperlipidemia, diabetes, atrial fibrillation, and coronary artery disease were identified for the pilot study. Patients eligible for the pilot (N=400) were enrolled with an opportunity to opt out. In phase I of the pilot, we tested text message delivery to 60 patients. In phase II, we tested intervention feasibility by identifying those with refill gap of ≥7 days and randomized them to intervention or control arms. Patients were texted Nudges and assessed whether they refilled their medications.ResultsOf 400 patients sent study invitations, 56 (14%) opted out. In phase I, we successfully delivered text messages to 58 of 60 patients and captured patient responses via text. In phase II, 207 of 286 (72.4%) patients had a medication gap ≥7 days for one or more cardiovascular medications and were randomized to intervention or control. Enrolled patients averaged 61.7 years old, were primarily male (69.1%) and White (72.5%) with hypertension being the most prevalent qualifying condition (78.7%). There was a trend towards intervention patients being more likely to refill at least 1 gapping medication (30.6% versus 18.0%; P=0.12) and all gapping medications (17.8% versus 10.0%; P=0.27).ConclusionsIt is possible to set up automated processes within health care delivery systems to identify patients with gaps in medication adherence and send Nudges to facilitate medication refills. Text message Nudges could potentially be a feasible and effective method to facilitate medication refills. A large multi-site randomized trial to determine the impact of text-based Nudges on overall CVD morbidity and mortality is now underway to explore this further. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03973931.

Project description:BackgroundImproved routine immunization (RI) coverage is recommended as the priority public health strategy to decrease vaccine-preventable diseases and eradicate polio in Pakistan and worldwide.ObjectiveThe objective of this study was to ascertain whether customized, automated, one-way text messaging (short message service, SMS) reminders delivered to caregivers via mobile phones when a child is due for an RI visit can improve vaccination uptake and timelines in Pakistan.MethodsThis was a randomized controlled trial, conducted in an urban squatter settlement area of Karachi, Pakistan. Infants less than 2 weeks of age with at least one family member who had a valid mobile phone connection and was comfortable receiving and reading SMS text messages were included. Participants were randomized to the intervention (standard care + one-way SMS reminder) or control (standard care) groups. The primary outcome was to compare the proportion of children immunized up to date at 18 weeks of age. Vaccine given at 6, 10, and 14 weeks schedule includes DPT-Hep-B-Hib vaccine (ie, diphtheria, pertussis, and tetanus; hepatitis B; and Haemophilus influenza type b) and oral poliovirus vaccine (OPV). Data were analyzed using chi-square tests of independence and tested for both per protocol (PP) and intention-to-treat (ITT) analyses.ResultsOut of those approached, 84.3% (300/356) of the participants were eligible for enrollment and 94.1% (318/338) of the participants had a working mobile phone. Only children in the PP analyses, who received an SMS reminder for vaccine uptake at 6 weeks visit, showed a statistically significant difference (96.0%, 86/90 vs 86.4%, 102/118; P=.03).The immunization coverage was consistently higher in the intervention group according to ITT analyses at the 6 weeks scheduled visit (76.0% vs 71.3%, P=.36). The 10 weeks scheduled visit (58.7% vs 52.7%, P=.30) and the 14 weeks scheduled visit (31.3% vs 26.0%, P=.31), however, were not statistically significant.ConclusionsAutomated simple one-way SMS reminders in local languages might be feasible for improving routine vaccination coverage. Whether one-way SMS reminders alone can have a strong impact on parental attitudes and behavior for improvement of RI coverage and timeliness needs to be further evaluated by better-powered studies and by comparing different types and content of text messages in low-and middle-income countries (LMICs).Trial registrationClinicalTrials.gov NCT01859546; https://clinicaltrials.gov/ct2/show/NCT01859546 (Archived by WebCite at http://www.webcitation.org/6xFr57AOc).

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Project description:BackgroundWe assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure.Methods and resultsIn this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure <140/90 mm Hg were 1.42 (95% confidence interval, 1.03-1.95) for information-only messaging and 1.41 (95% confidence interval, 1.02-1.95) for interactive messaging compared with usual care.ConclusionsIn this randomized trial of an automated adherence support program delivered by SMS text message in a general outpatient population of adults with high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141.

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Randomized Factorial Trial of Phone-Delivered Support Counseling and Daily Text Message Reminders for HIV Treatment Adherence.

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Randomized Factorial Trial of Phone-Delivered Support Counseling and Daily Text Message Reminders for HIV Treatment Adherence.

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