scholarly journals Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention (Preprint)

2018 ◽  
Author(s):  
K Rivet Amico ◽  
Amanda Dunlap ◽  
Ronald Dallas ◽  
Jane Lindsey ◽  
Barbara Heckman ◽  
...  

BACKGROUND Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. OBJECTIVE The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures—HIV viral suppression (VLS), defined as both <200 copies/ml and <50 copies/ml at 12 weeks, and (2) secondary outcome measures—VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. METHODS The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM has not been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. RESULTS Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. CONCLUSIONS Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care. CLINICALTRIAL ClinicalTrials.gov NCT03292432; https://clinicaltrials.gov/ct2/show/NCT03292432 (Archived by WebCite at http://www.webcitation.org/768J8ijjp). INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11416

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Emmanuel Bahemana ◽  
◽  
Allahna Esber ◽  
Nicole Dear ◽  
Kavitha Ganesan ◽  
...  

Abstract Introduction With increased use of antiretroviral therapy (ART), HIV mortality rates are declining and people living with HIV (PLWH) are surviving longer. We characterized CD4 recovery and viral suppression among adults aged < 50 and ≥ 50 years living with HIV who initiated ART in the African Cohort Study (AFRICOS). Methods Beginning in January 2013, PLWH at twelve clinics in Kenya, Uganda, Tanzania and Nigeria underwent medical history review, CD4 and viral load testing as part of the ongoing African Cohort Study (AFRICOS). ART-naïve PLWH who initiated ART within 30 days of enrollment and had at least one year of follow-up were included in these analyses. To compare ART response in participants < 50 years and ≥ 50 years old, changes in CD4 count and viral load suppression after ART initiation were examined at different time points using linear and binomial regression with generalized estimating equations. Variables for time since ART initiation and the interaction between age group and time on ART were included in the model to evaluate longitudinal changes in CD4 recovery and viral suppression by age. Results Between January 2013 and September 2019, 2918 PLHV were enrolled in the cohort. Of these, 443 were ART naïve and initiated on ART within 30 days of enrollment, with 90% (n = 399) aged < 50 years old at ART initiation. At ART initiation, participants aged 50 and older had a higher median CD4 count compared to participants younger than 50 years of age although it did not reach statistical significance (306 cells/mm3, IQR:130–547 vs. 277cells/mm3, IQR: 132–437). In adjusted models examining CD4 recovery and viral suppression there were no significant differences by age group over time. By the end of follow-up viral suppression was high among both groups of adults (96% of adults ≥ 50 years old and 92% of adults < 50 years old). Conclusion This study found no difference in long-term CD4 recovery or viral suppression by age at ART initiation. We found that particularly among younger adults participants had lower median CD4 counts at ART initiation, suggesting the importance of identifying and putting this population on treatment earlier in the disease course.


Author(s):  
Ashish Premkumar ◽  
Lynn M. Yee ◽  
Lia Benes ◽  
Emily S. Miller

Objective The aim of this study was to assess whether social vulnerability among foreign-born pregnant women living with HIV is associated with maternal viremia during pregnancy. Study Design This retrospective cohort study included all foreign-born pregnant women living with HIV who received prenatal care in a multidisciplinary prenatal clinic between 2009 and 2018. A licensed clinical social worker evaluated all women and kept detailed clinical records on immigration status and social support. Social vulnerability was defined as both living in the United States for less than 5 years and reporting no family or friends for support. The primary outcome was evidence of viral non-suppression after achievement of initial suppression. Secondary outcomes were the proportion of women who required > 12 weeks after starting antiretroviral therapy to achieve viral suppression, median time to first viral suppression (in weeks) after initiation of antiretroviral therapy, and the proportion who missed ≥ 5 doses of antiretroviral therapy. Bivariable analyses were performed. Results A total of 111 foreign-born women were eligible for analysis, of whom 25 (23%) were classified as socially vulnerable. Social and clinical characteristics of women diverged by social vulnerability categorization but no differences reached statistical significance. On bivariable analysis, socially-vulnerable women were at increased risk for needing > 12 weeks to achieve viral suppression (relative risk: 1.78, 95% confidence interval: 1.18–2.67), though there was no association with missing ≥ 5 doses of antiretroviral therapy or median time to viral suppression after initiation of antiretroviral therapy. Conclusion Among foreign-born, pregnant women living with HIV, markers of virologic control during pregnancy were noted to be worse among socially-vulnerable women. Insofar as maternal viremia is the predominant driver of perinatal transmission, closer clinical surveillance and support may be indicated in this population. Key Points


Cells ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 909
Author(s):  
Laura Cheney ◽  
John M. Barbaro ◽  
Joan W. Berman

Antiretroviral drugs have dramatically improved the morbidity and mortality of people living with HIV (PLWH). While current antiretroviral therapy (ART) regimens are generally well-tolerated, risks for side effects and toxicity remain as PLWH must take life-long medications. Antiretroviral drugs impact autophagy, an intracellular proteolytic process that eliminates debris and foreign material, provides nutrients for metabolism, and performs quality control to maintain cell homeostasis. Toxicity and adverse events associated with antiretrovirals may be due, in part, to their impacts on autophagy. A more complete understanding of the effects on autophagy is essential for developing antiretroviral drugs with decreased off target effects, meaning those unrelated to viral suppression, to minimize toxicity for PLWH. This review summarizes the findings and highlights the gaps in our knowledge of the impacts of antiretroviral drugs on autophagy.


2021 ◽  
pp. 095646242110240
Author(s):  
Genesis S Huerta-Vera ◽  
Manuel A Amarista ◽  
Fernando A Mejía ◽  
Ana B Graña ◽  
Elsa V Gonzalez-Lagos ◽  
...  

Due to a huge crisis extensive to health services many Venezuelan people living with HIV (PLWH) had migrated abroad, including Peru where favorable laws were in place until June 2019. We describe the health status and epidemiological trends of PLWH from Venezuela at an HIV program in Lima. We analyzed baseline and follow-up data of all Venezuelan PLWH enrolled in our HIV program from January 2017 to December 2019. A cross-sectional study in a subsample served to describe ARV adherence and context of migration. Between 2017-2019 our HIV Program registered 398 Venezuelan PLWH, representing 20% of the 2018 annual enrollments; numbers decreased since mid-2019. The median age was 30 years (IQR 26;37) and 90.5% were men. Between 2017 and 2019, the proportion with diagnosis in Peru increased from 14.3% to 60.9%; of AIDS stage at entry, from 8.8% to 27.2%. By December 2019, 182/250 (72.8%) were still in care, and 43 (10.8%) had not started ART. Viral suppression evaluated in 195, was achieved in 71.8%. From 2017 to 2019, migrant PLWH arrived in worsened clinical conditions, with increasing diagnosis in Peru; the flow of migrant PLWH entering care diminished with less favorable laws. Viral suppression rates were suboptimal.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S548-S549
Author(s):  
Joshua P Cohen ◽  
Xingzhi Wang ◽  
Rolin L Wade ◽  
Helena Diaz Cuervo ◽  
Dionne M Dionne

Abstract Background Discontinuation of first-line antiretroviral therapy (ART) may lead to poor outcomes for persons living with HIV (PLWH). While single-tablet regimens (STRs) have been associated with greater persistence compared to multi-tablet regimens (MTRs), few real-world studies have assessed persistence with current guideline-recommended ART regimens. The study aims to assess persistence among treatment-naïve PLWH initiating guideline-recommended ART regimens Methods Longitudinal pharmacy claims were extracted from IQVIA’s US LRx database for PLWH initiating ART between Jan 1, 2016 - Jul 31, 2019 (index period), with the observational period up to Jan 31, 2020. Index date was defined as the date of the first ART claim for STRs, or the date of the last filled drug of 1st set of claims for MTRs. Persistence was measured as the number of days until treatment discontinuation (≥ 90-day gap in therapy) and presented via Kaplan-Meier curves. Risk of discontinuation was assessed via Cox proportional hazards models, with BIC/FTC/TAF used as the reference ART regimen. Results Overall, 90,949 PLWH initiated STRs and 20,737 initiated MTRs. Average (SD) age was 43 (14) years, 75% were male, and 75% had commercial insurance. At 6 months of follow-up, 71% of PLWH initiating STRs and 56% initiating MTRs remained on their ART regimen. The proportion remaining on their index regimen at 6 months of follow-up was 79% for BIC/FTC/TAF, 73% for EVG/COBI/FTC/TAF, 71% for DTG/ABC/3TC, 69% for DTG + FTC/TAF, 67% for EFV/FTC/TDF, 62% for EVG/COBI/FTC/TDF, and 38% for DTG + FTC/TDF. Risk of discontinuation was higher for MTRs compared to STRs (hazard ratio [HR]: 1.63, 95% CI: 1.61 - 1.66). Compared to the referent BIC/FTC/TAF, risk of discontinuation was higher for EVG/COBI/FTC/TAF (HR: 1.54, 95% CI: 1.48 - 1.60), DTG/ABC/3TC (HR: 1.58, 95% CI: 1.52, 1.65), DTG + FTC/TAF (HR: 1.83, 95% CI: 1.74 - 1.93), EFV/FTC/TDF (HR: 2.31, 95% CI: 2.21 - 2.41), EVG/COBI/FTC/TDF (HR: 2.58, 95% CI: 2.47 - 2.70), and DTG + FTC/TDF (HR: 6.20, 95% CI: 5.83 - 6.59). Table 1. Persistence with ART by regimen for STR and MTR Figure 1. Forest Plot of Hazard Ratios for Treatment Discontinuation Conclusion Among US adult PLWH, STRs were associated with longer persistence on first-line therapy compared to MTRs. Among STRs, persistence was highest for BIC/FTC/TAF. Disclosures All Authors: No reported disclosures


2020 ◽  
Vol 7 (9) ◽  
pp. 1339
Author(s):  
S. Bhagyabati Devi ◽  
T. Jeetenkumar Singh ◽  
Kshetrimayum Birendra Singh ◽  
N. Biplab Singh ◽  
Robinson Ningshen ◽  
...  

Background: Antiretroviral therapy (ART) have changed the outlook of people living with HIV (PLHIV) by transforming the dreaded infection to a chronically manageable disease. However, there is scant of reports which analyses quantitatively the survival benefit of PLHIV under ART. Objectives of this study were to determine the survival time of adult PLHIV who are on ARV. To analyse the factors determining survival outcome of PLHIV on ARV.Methods: This was an observational study in centre of excellence (COE) ART Centre, RIMS, Imphal from April 2004 to December 2009. Details from the data entered in documents of the ART programme were followed up every 3 months for 60 months from the date of initiation of ARV. All PLHIV above 18 years of age and undergoing antiretroviral therapy were included.Results: Survival rate following initiation of ARV was found to be significantly high among PLHIV. Higher CD4 count at the time of ARV initiation had better prognosis. Mortality was high among IDUs and they had high incidence of co-infections with HCV and HBV. The currently available ARV drugs under NACO programme have better suppression of HIV, are less toxic, low pill burden. The combined regimen used in the earlier days were not much inferior to the current ARV drugs if initiated timely with proper prophylaxis of OIs, good adherence, good nutrition and timely management of toxicities and IRIS.Conclusions: Timely treatment with ARV drugs provided under the national programme with good adherence and regular follow-up improves the survival of PLHIV.  


2021 ◽  
Author(s):  
Terefe Gone Fuge ◽  
George Tsourtos ◽  
Emma R Miller

Abstract ObjectivesMaintaining optimal adherence and viral suppression in people living with HIV (PLWHA) is essential to ensure both preventative and therapeutic benefits of antiretroviral therapy (ART). Prisoners bear a particularly high burden of HIV infection and are highly likely to transmit to others during and after incarceration. However, the level of treatment adherence and viral suppression in incarcerated populations in low-income countries is unknown. This study aimed to determine the prevalence of non-adherence and viral failure, and contributing factors amongst prisoners in South Ethiopia. MethodsA prospective cohort study was conducted between June 1, 2019 and May 31, 2020 to compare the level of adherence and viral suppression between incarcerated and non-incarcerated PLWHA. The study involved 74 inmates living with HIV (ILWHA) and 296 non-incarcerated PLWHA. Background information (including sociodemographic, socioeconomic, psychosocial, behavioural, and incarceration related characteristics) was collected using a structured questionnaire. Adherence was determined based on the participants’ self-report and pharmacy refill records. Plasma viral load measurements undertaken within the study period were prospectively extracted to determine viral suppression. Univariate and multivariate regression models were used to analyse data. ResultsWhile prisoners had a significantly higher pharmacy refill adherence compared to non-incarcerated PLWHA (89% vs 75%), they had a slightly lower dose adherence (81% vs 83%). The prevalence of viral failure (VF) was also slightly higher (6%) in ILWHA compared to non-incarcerated PLWHA (4.4%). The overall dose non-adherence (NA) was significantly associated with missing ART appointments, level of satisfaction with ART services, patient’s ability to comply with a specified medication schedule and types of methods used to monitor the schedule. In ILWHA specifically, accessing ART services from a hospital compared to a health centre, an inability to always attend clinic appointments, experience of depression and a lack of social support predicted NA. VF was significantly higher in males, people of age 31to 35 years and in those who experienced social stigma, regardless of their incarceration status. ConclusionsThis study revealed that HIV-infected prisoners in South Ethiopia were more likely to be non-adherent to ART doses and to develop viral failure compared to their non-incarcerated counterparts. A multitude of factors were found to be responsible for this requiring multilevel intervention strategies focusing on the specific needs of prisoners.


PLoS ONE ◽  
2020 ◽  
Vol 15 (10) ◽  
pp. e0240817
Author(s):  
Shannan N. Rich ◽  
Robert L. Cook ◽  
Lusine Yaghjyan ◽  
Kesner Francois ◽  
Nancy Puttkammer ◽  
...  

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