Dataset Information

Randomized Controlled Trial of Daily Text Messages to Support Adherence to Preexposure Prophylaxis in Individuals at Risk for Human Immunodeficiency Virus: The TAPIR Study.

ABSTRACT: Background:Adherence is critical for efficacy of tenofovir disoproxil fumarate/emtricitabine (FTC) as preexposure prophylaxis (PrEP). Methods:Between February 2013 and February 2016, 398 men who have sex with men and transgender women were randomized 1:1 to receive individualized texting for adherence building (iTAB) or standard care (SoC) for 48 weeks. The primary endpoint was dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations at both week 12 and the last on-drug visit of >719 fmol/punch (ie, adequate adherence). Secondary outcomes included DBS TFV-DP concentrations of >1246 fmol/punch (ie, near-perfect adherence) and plasma FTC >350 ng/mL (consistent with dosing within the past 24 hours). Results:Concentrations >719 fmol/punch of TFV-DP were found in 88.6% of participants at week 12 and 82.5% at week 48. For the primary endpoint, the study arms did not differ (72.0% in iTAB and 69.2% in SoC; P > .05). For the secondary composite endpoint of >1246 fmol/punch the iTAB arm was superior to SoC (33.5% vs 24.8%; P = .06), reaching statistical significance when adjusting for age (odds ratio, 1.56 [95% confidence interval, 1.00-2.42]; P < .05). At week 48, iTAB was superior to SoC for near-perfect adherence (51.0% vs 37.4%; P = .02). At week 12, iTAB was superior to SoC for dosing in past 24 hours by plasma FTC (47.5% vs 33.3%; P = .007), but not at weeks 24, 36, and 48 (all P > .05). Conclusions:Automated text messaging is a low-burden tool that improves durability of near-perfect PrEP adherence. Clinical Trials Registration:NCT01761643.

SUBMITTER: Moore DJ

PROVIDER: S-EPMC6248545 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Randomized Controlled Trial of Daily Text Messages to Support Adherence to Preexposure Prophylaxis in Individuals at Risk for Human Immunodeficiency Virus: The TAPIR Study.

Moore David J DJ Jain Sonia S Dubé Michael P MP Daar Eric S ES Sun Xiaoying X Young Jason J Corado Katya K Ellorin Eric E Milam Joel J Collins Deborah D Blumenthal Jill J Best Brookie M BM Anderson Peter P Haubrich Richard R Morris Sheldon R SR

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20180501 10

<h4>Background</h4>Adherence is critical for efficacy of tenofovir disoproxil fumarate/emtricitabine (FTC) as preexposure prophylaxis (PrEP).<h4>Methods</h4>Between February 2013 and February 2016, 398 men who have sex with men and transgender women were randomized 1:1 to receive individualized texting for adherence building (iTAB) or standard care (SoC) for 48 weeks. The primary endpoint was dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations at both week 12 and the last on-dru ...[more]

PMID: 29228144

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Project description:ObjectiveTo understand perspectives on and preferences for preexposure prophylaxis (PrEP) for pregnant individuals who are at risk for human immunodeficiency virus (HIV) infection.MethodsIn this qualitative study, we purposively sampled and conducted in-depth interviews with pregnant participants at risk of HIV infection (indicated by a recent sexually transmitted infection [STI]) from a U.S. urban obstetrics clinic. Interview questions focused on perceived HIV risk, knowledge and perceptions of PrEP, and preferences for different PrEP formulations. We coded data using deductive and inductive codes, created matrices to explore patterns in findings, and wrote memos to interpret emergent themes.ResultsTwenty patients were enrolled. Median age of the participants was 24 years (interquartile range 19-26 years), 95.0% were African American, 65.0% were high school graduates, and 70.0% had unplanned pregnancies. Participants had low knowledge of PrEP and most saw themselves at low to no risk of HIV acquisition, despite their recent STI. Further, participants' low HIV risk perception and medication safety concerns reduced PrEP acceptability. Moreover, very few had discussed PrEP with their obstetrician-gynecologists (ob-gyns) during antenatal care, which further affected perceived acceptability. However, participants who did discuss PrEP with their ob-gyns had favorable perceptions of it. These participants indicated that they would choose a formulation based on individual preferences, which were largely shaped by perceived ease of use, acceptability, and prior experience with other medication regimens.ConclusionObstetrician-gynecologists may play an important role in increasing pregnant individuals' knowledge of and access to PrEP during pregnancy among those who are at risk of HIV acquisition. To maximize uptake and adherence during this time, PrEP formulations should be tailored to individual preferences. Prevention of HIV during this critical life transition is important not only for the long-term health and well-being of pregnant individuals and their infants, but to the plan to end the HIV epidemic in the United States by 2030.

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.

Dataset Information

Randomized Controlled Trial of Daily Text Messages to Support Adherence to Preexposure Prophylaxis in Individuals at Risk for Human Immunodeficiency Virus: The TAPIR Study.

Publications

Randomized Controlled Trial of Daily Text Messages to Support Adherence to Preexposure Prophylaxis in Individuals at Risk for Human Immunodeficiency Virus: The TAPIR Study.

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