scholarly journals Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036147
Author(s):  
Lindsey K Reif ◽  
Marie Elmase Belizaire ◽  
Grace Seo ◽  
Vanessa Rouzier ◽  
Patrice Severe ◽  
...  
Keyword(s):  
Viral Load ◽  
Viral Suppression ◽  
Point Of Care ◽  
Randomised Trial ◽  
Art Adherence ◽  
Test Results ◽  
Standard Laboratory ◽  
Adherence Counselling ◽  
Youth Living With Hiv ◽  
Living With Hiv

IntroductionAdolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.Methods and analysisThis non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10–24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.Ethics and disseminationThis study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.Trial registration numberNCT03288246.

scholarly journals Importance of support groups to the health and well-being of vulnerable children and young people living with HIV: a case study of the Kids Clubs program in Haiti

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Susan K. Settergren ◽  
Robert Philippe ◽  
Joanne St. Louis ◽  
Nathaniel Segaren ◽  
Sylvie Boisson ◽  
...  
Keyword(s):  
Viral Load ◽  
Medication Adherence ◽  
Young People ◽  
Support Groups ◽  
Viral Suppression ◽  
People Living With Hiv ◽  
Art Adherence ◽  
Vulnerable Children ◽  
Children And Young People ◽  
Living With Hiv

Abstract Background Although access to antiretroviral therapy (ART) among children and young people living with HIV has increased in recent years, adherence to medication and viral suppression remain challenges. Evidence of benefits of support groups is growing and reflects a range of models and approaches. Since 2014, hospital-linked psychosocial support groups for children and young people living with HIV, known as Kids Clubs, have been established throughout Haiti. The program provides safe spaces for them to meet with peers, supports medication adherence, delivers health and life skills education, and facilitates linkages with clinic visits and social services. This study describes program enrollment and participant engagement, ART adherence and viral suppression among participants, and other outcomes attributed to the program by participants, caregivers, and program implementers. Methods Our mixed methods study included quantitative analysis of program monitoring data on rollout and attendance, and medication adherence and viral load results extracted from medical records. We collected qualitative data from club members, caregivers, and implementers about their experiences with the clubs and the impact of participation. Results From January 2014–December 2018, 1330 individuals aged 8–29 were enrolled in the program; over three-quarters participated for at least 12 months. In 2018, 1038 members attended at least one club meeting; more than half missed three or fewer monthly meetings. Three-quarters of ever-enrolled members reported consistent medication use at their most recent clinic visit; 64.2% (600/935) of those with a recent viral load test were virally suppressed. Level of club attendance was positively associated with ART adherence (p < 0.01) and viral suppression (p < 0.05). Club members, caregivers, and implementers noted the value of the clubs to participants’ retention in care and medication adherence, health knowledge, and capacity to deal with peer pressure, stigma, shyness, and depression. Conclusions The Kids Club program has been successful in scaling HIV support services to highly vulnerable children and young people through peer-based groups, and program participation has led to a range of benefits. Efforts to innovate, evaluate, and scale support strategies for vulnerable young populations must be accelerated in order to ensure that they survive, thrive, and reach their full potential.

scholarly journals Simplifying TREAtment and Monitoring for HIV (STREAM HIV): protocol for a randomised controlled trial of point-of-care urine tenofovir and viral load testing to improve HIV outcomes

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e050116
Author(s):  
Ashley R Bardon ◽  
Jienchi Dorward ◽  
Yukteshwar Sookrajh ◽  
Fathima Sayed ◽  
Justice Quame-Amaglo ◽  
...  
Keyword(s):  
Viral Load ◽  
Viral Suppression ◽  
Clinical Decision Making ◽  
Point Of Care ◽  
Scale Up ◽  
Standard Of Care ◽  
Resistance Testing ◽  
People Living With Hiv ◽  
Art Adherence ◽  
Randomised Controlled

IntroductionSubstantial improvements in viral suppression among people living with HIV (PLHIV) are needed to end the HIV epidemic, requiring extensive scale-up of low-cost HIV monitoring services. Point-of-care (POC) tests for monitoring antiretroviral therapy (ART) adherence and viral load (VL) may be efficient and effective tools for real-time clinical decision making. We aim to evaluate the effects of a combined intervention of POC ART adherence and VL testing compared with standard-of-care on ART adherence, viral suppression and retention at 6 and 18 months post-ART initiation among PLHIV.Methods and analysisSimplifying TREAtment and Monitoring for HIV (STREAM HIV) is a two-arm, open-label, randomised controlled superiority trial of POC urine tenofovir (POC TFV) and VL monitoring in PLHIV. We aim to enrol 540 PLHIV initiating a first-line ART regimen at a public HIV clinic in South Africa. Participants will be randomised 1:1 to the intervention or control arm. Intervention arm participants will receive monthly POC TFV testing for the first 5 months and POC VL testing at months 6 and 12. Intervention arm participants will also receive reflex POC TFV testing if viraemic and reflex HIV drug resistance testing for those with viraemia and detectable TFV. Control arm participants will receive standard-of-care, including laboratory-based VL testing at months 6 and 12. Primary outcomes include ART adherence (TFV-diphosphate concentration) at 6 months and viral suppression and retention at 18 months. Secondary outcomes include viral suppression and retention at 6 months, TFV-diphosphate concentration at 18 months, cost and cost-effectiveness of the intervention and acceptability of the intervention among PLHIV and healthcare workers.Ethics and disseminationSTREAM HIV has received ethical approval from the University of Washington Institutional Review Board (STUDY00007544), University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC/00000833/2019) and Division of AIDS Regulatory Support Center (38509). Findings will be disseminated at international conferences and in peer-reviewed journals.Trial registration numberNCT04341779.

scholarly journals Linkage to intensive adherence counselling among HIV-positive persons on ART with detectable viral load in Gomba district, rural Uganda

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Rita Nakalega ◽  
Nelson Mukiza ◽  
Henry Debem ◽  
George Kiwanuka ◽  
Ronald Makanga Kakumba ◽  
...  
Keyword(s):  
Viral Load ◽  
Health Center ◽  
Health Facility ◽  
Transmission Risk ◽  
World Health ◽  
Hiv Positive ◽  
Art Adherence ◽  
Detectable Viral Load ◽  
Adherence Support ◽  
Adherence Counselling

Abstract Background Antiretroviral therapy (ART) adherence is a primary determinant of sustained viral suppression, HIV transmission risk, disease progression and death. The World Health Organization recommends that adherence support interventions be provided to people on ART, but implementation is suboptimal. We evaluated linkage to intensive adherence counselling (IAC) for persons on ART with detectable viral load (VL). Methods Between January and December 2017, we conducted a retrospective chart review of HIV-positive persons on ART with detectable VL (> 1000 copies/ml), in Gomba district, rural Uganda. We abstracted records from eight HIV clinics; seven health center III’s (facilities which provide basic preventive and curative care and are headed by clinical officers) and a health center IV (mini-hospital headed by a medical doctor). Linkage to IAC was defined as provision of IAC to ART clients with detectable VL within three months of receipt of results at the health facility. Descriptive statistics and multivariable logistic regression analyses were used to evaluate factors associated with linkage to IAC. Results Of 4,100 HIV-positive persons on ART for at least 6 months, 411 (10%) had detectable VL. The median age was 32 years (interquartile range [IQR] 13–43) and 52% were female. The median duration on ART was 3.2 years (IQR 1.8–4.8). A total of 311 ART clients (81%) were linked to IAC. Receipt of ART at a Health Center level IV was associated with a two-fold higher odds of IAC linkage compared with Health Center level III (adjusted odds ratio [aOR] 1.78; 95% CI 1.00–3.16; p = 0.01). Age, gender, marital status and ART duration were not related to IAC linkage. Conclusions Linkage to IAC was high among persons with detectable VL in rural Uganda, with greater odds of linkage at a higher-level health facility. Strategies to optimize IAC linkage at lower-level health facilities for persons with suboptimal ART adherence are needed.

scholarly journals Tobacco Use and Sustained Viral Suppression in Youth Living with HIV

2017 ◽  
Vol 22 (6) ◽  
pp. 2018-2025 ◽  
Author(s):  
Kristi E. Gamarel ◽  
◽  
Andrew O. Westfall ◽  
Michelle A. Lally ◽  
Sybil Hosek ◽  
...  
Keyword(s):  
Tobacco Use ◽  
Viral Suppression ◽  
Sustained Viral Suppression ◽  
Youth Living With Hiv ◽  
Living With Hiv

scholarly journals 1318. Examining Multimorbidity as a Moderating Effect on the Relationship Between Substance Use and Viral Suppression Among People Living with HIV

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S476-S476
Author(s):  
Timothy N Crawford ◽  
Alice Thornton
Keyword(s):  
Substance Use ◽  
Viral Load ◽  
Chronic Conditions ◽  
Viral Suppression ◽  
Moderating Effect ◽  
Multiple Chronic Conditions ◽  
People Living With Hiv ◽  
Substance Users ◽  
Living With Hiv ◽  
The Relationship

Abstract Background Substance use and multimorbidity (≥2 chronic conditions) are highly prevalent among people living with HIV (PLWH). However, their impact on achieving viral suppression are not well understood. The purpose of this study was to examine the relationship between substance use and viral suppression and the potential moderating effect of multimorbidity. Methods A retrospective cohort study was conducted at an academic Ryan White Funded clinic in central Kentucky. Individuals were included if they were diagnosed with HIV, seeking care between 2010 and 2014, had at least one year of follow-up, and did not have a chronic condition at the time they entered care. The primary independent variable was substance use which included alcohol, nicotine use, and/or illicit drug use; the moderating variable was multimorbidity (0, 1, ≥2 chronic conditions); and outcome was viral suppression (≤50 copies/mL). A logistic regression model was developed to examine the interaction between substance use and multimorbidity on achieving viral load suppression. The model controlled for medication adherence, insurance status, age, and CD4+ cell counts. Results A total of 941 individuals were included in the study, with an average age of 43.9 ± 11.7 years. Approximately 67.0% reported substance use; 54% had ≥2 chronic conditions diagnosed. The three most prevalent conditions diagnosed were hypertension (34.6%), mental health (33.9%), and diabetes (21.5%) Approximately 61.0% of substance users had ≥2 conditions. Those with viral suppression were less likely to be substance users, but were more likely to have ≥2 conditions compared with their counterparts. There was a significant interaction between substance use and multimorbidity (P = 0.037). Stratified by multimorbidity, substance use was associated with unsuppressed viral loads; among those with ≥2 chronic conditions substance users had lower odds of achieving viral suppression compared with nonusers (OR=0.24; 95% CI=0.10–0.55). Conclusion Substance use may impede the opportunity for PLWH to achieve viral suppression, increasing their risk of transmission and progression of disease. More research is needed to understand the role substance use plays in impacting viral load, specifically among those with multiple chronic conditions. Disclosures All authors: No reported disclosures.

Accuracy of the CoaguChek XS for point-of-care international normalized ratio (INR) measurement in children requiring warfarin

2008 ◽  
Vol 99 (06) ◽  
pp. 1097-1103 ◽  
Author(s):  
Karina Black ◽  
Mary Massicotte ◽  
Michelle Bauman ◽  
Stefan Kuhle ◽  
Susan Howlett-Clyne ◽  
...  
Keyword(s):  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Venous Blood ◽  
International Normalized Ratio ◽  
Test Results ◽  
Standard Laboratory ◽  
Limits Of Agreement ◽  
Time Points ◽  
Coaguchek Xs ◽  
Roche Diagnostics

SummaryPoint-of-care INR (POC INR) meters can provide a safe and effective method for monitoring oral vitamin K antagonists (VKAs) in children. Stollery Children’s Hospital has a large POC INR meter loan program for children requiring oral VKAs. Our protocol requires that POC INR results be compared to the standard laboratory INR for each child on several consecutive tests to ensure accuracy of CoaguChek XS® (Roche Diagnostics, Basel Switzerland) meter. It was the objective of the study to determine the accuracy of the CoaguChek XS by comparing whole blood INR results from the CoaguChek XS to plasma INR results from the standard laboratory in children. POC INR meter validations were performed on plasma samples from two time points from 62 children receiving warfarin by drawing a venous blood sample for laboratory prothrombin (PT)-INR measurements and simultaneous INR determinations using the POC-INR meter. Agreement between CoaguChek XS INR and laboratory INR was assessed using Bland-Altman plots. Bland-Altman's 95% limits of agreement were 0.11 (-0.20; 0.42) and 0.13 (-0.22; 0.48) at the two time points, respectively. In conclusion, the CoaguChek XS meter appraisal generates an accurate and precise INR measure in children when compared to laboratory INR test results.

scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

BACKGROUND Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. OBJECTIVE This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). METHODS YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. RESULTS Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. CONCLUSIONS This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life. CLINICALTRIAL ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10791

Gaps in the continuum of care among people living with HIV in Afghanistan

2021 ◽  
pp. 095646242110552
Author(s):  
Mohammad Zubair Harooni ◽  
Abdul Alim Atarud ◽  
Ehsanullah Ehsan ◽  
Ajmal Alokozai ◽  
Willi McFarland ◽  
...  
Keyword(s):  
Viral Load ◽  
Viral Suppression ◽  
Demographic Data ◽  
Load Test ◽  
P Value ◽  
People Living With Hiv ◽  
Aged Patients ◽  
Art Initiation ◽  
Viral Load Test ◽  
Living With Hiv

Background Afghanistan adopted a “test and treat” strategy for all people living with HIV (PLWH) in 2016. In this study, we presented demographic and clinical characteristics of all people diagnosed between 2013 and 2019 and evaluated progress towards 90-90-90 UNAIDS targets and identified program gaps among PLWH in Afghanistan diagnosed in 2018. Methods We used clinical, behavioral, and demographic data from national HIV surveillance for 1394 patients diagnosed from 2013 through 2019. We also tracked 184 patients diagnosed with HIV in 2018 over 15 months to assess their enrollment in care, antiretroviral therapy (ART) initiation, retention on ART, and viral suppression. Results Of 1394 patients diagnosed from 2013 through 2019, 76.0% were male, 73.7% were older than 24 years, and 33.4% acquired HIV through heterosexual sex. Of the 184 patients diagnosed in 2018, 94.6% were enrolled in care, 88.6% received ART, 84.2% were retained on ART for at least 12 months, and 33.7% received a viral load test. Of those with a viral load test, 74.2% were virally suppressed. Patients who were 35–44 years old (52.0%, p-value .001), acquired HIV through unsafe injection (62.5%, p-value .413), were co-infected with hepatitis C virus (HCV) (60.0%, p-value .449), and with CD4 > 500 at diagnosis (64.7%, p-value .294) were less likely to be virally suppressed 12 months after diagnosis. Conclusion Nearly 95% of people diagnosed with HIV in Afghanistan in 2018 were linked to care and nearly 90% were on ART. Viral testing and viral suppression remain low with notable disparities for middle-aged patients, and possibly for those who injected drugs. Addressing barriers to HIV programs in Afghanistan, particularly for people who inject drugs (PWID), are urgently needed to reach the 90-90-90 global targets. Surveillance data on the number of people with undiagnosed HIV is needed to assess the first 90 target.

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