scholarly journals Switching protease inhibitors to rilpivirine in HIV‐positive individuals with complete viral suppression and without prior HIV drug resistance in a resource‐limited setting: a randomized controlled trial

2020 ◽  
Vol 23 (4) ◽  
Author(s):  
Kulissara Palanuphap ◽  
Somnuek Sungkanuparph
Keyword(s):  
Drug Resistance ◽  
Randomized Controlled Trial ◽  
Protease Inhibitors ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Hiv Positive ◽  
Hiv Drug Resistance ◽  
Randomized Controlled ◽  
Resource Limited ◽  
Limited Setting

scholarly journals Switching Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) to TDF/FTC/Rilpivirine vs Continuing TDF/FTC/EFV in HIV-Infected Patients With Virological Suppression: A Randomized Controlled Trial

2019 ◽  
Vol 6 (7) ◽  
Author(s):  
Sirichai Wiriyatanakorn ◽  
Somnuek Sungkanuparph
Keyword(s):  
Central Nervous System ◽  
Randomized Controlled Trial ◽  
Nervous System ◽  
Adverse Effects ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Virological Suppression ◽  
Randomized Controlled ◽  
Resource Limited ◽  
Limited Setting

AbstractA randomized controlled noninferiority trial was conducted in HIV-infected patients receiving tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV) with virological suppression in a resource-limited setting. Switching to TDF/FTC/rilpivirine was noninferior to continuing TDF/FTC/EFV in terms of maintaining compete viral suppression at 24 weeks and provided better lipid profiles and fewer central nervous system adverse effects.

scholarly journals Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Sebastian Linnemayr ◽  
Chad Stecher ◽  
Uzaib Saya ◽  
Sarah MacCarthy ◽  
Zachary Wagner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Behavioral Economics ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Hiv Positive ◽  
Art Adherence ◽  
Viral Loads ◽  
Present Bias ◽  
Randomized Controlled

Abstract Background Many HIV-positive patients do not appropriately adhere to their antiretroviral medication (ART). This leads to higher viral loads and greater probability of HIV transmission. Present bias—a tendency to give in to short-term temptations at the expense of long-term outcomes—is a potential driver of low adherence. In this study we test a novel intervention rooted in behavioral economics that is designed to overcome present bias and increase ART adherence. Methods/design We will enroll 330 HIV-positive patients at Mildmay Hospital in Kampala, Uganda, into a 2-year randomized controlled trial. Participants will be randomized to one of three groups. The first intervention group (T1, n = 110) will be eligible for small lottery prizes based on timely clinic visits and demonstration of viral suppression. Group 2 (T2, n = 110) will be eligible for the same lottery prizes conditional on high adherence measured by a medication event management system (MEMS) cap. The control group (n = 110) will receive the usual standard of care. Adherence will be measured continuously throughout the intervention period and for 12 months post-intervention to evaluate effect persistence. Surveys will be conducted at baseline and then every 6 months. Viral loads will be measured annually. Primary outcomes are whether the viral load is detectable and MEMS-measured adherence. Secondary outcomes are the log-transformed viral load as a continuous measure and a binary measure for whether the person took at least 90% of their ART pills. Discussion Our study is one of the first to investigate the effectiveness of lottery incentives for improving ART adherence, and in addition, it compares the relative efficacy of using electronically measured adherence versus viral load to determine lottery eligibility. MEMS caps are relatively costly, whereas viral load testing is now part of routine clinical care in Uganda. BEST will test whether directly incentivizing viral suppression (which can be implemented using readily available clinic data) is as effective as incentivizing electronically measured adherence. Cost-effectiveness analyses of the two implementation modes will also be performed. Trial registration ClinicalTrials.gov, NCT03494777. Registered on 11 April 2018.

scholarly journals Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men (Preprint)

2018 ◽  
Author(s):  
Keith J Horvath ◽  
K Rivet Amico ◽  
Darin Erickson ◽  
Alexandra M Ecklund ◽  
Aldona Martinka ◽  
...  
Keyword(s):  
New York ◽  
New York City ◽  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Hiv Positive ◽  
Art Adherence ◽  
Randomized Controlled ◽  
Sex With Men

BACKGROUND The suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented. OBJECTIVE The aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City. METHODS A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence. RESULTS Participant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019. CONCLUSIONS The efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features. CLINICALTRIAL ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6) REGISTERED REPORT IDENTIFIER RR1-10.2196/10182

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