scholarly journals A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients’ economic outcomes in Eswatini

eLife ◽  
2020 ◽  
Vol 9 ◽  
Author(s):  
Janina Isabel Steinert ◽  
Shaukat Khan ◽  
Khudzie Mlambo ◽  
Fiona J Walsh ◽  
Emma Mafara ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Time Use ◽  
Living Standards ◽  
Hiv Positive ◽  
Stepped Wedge ◽  
Household Expenditures ◽  
Trial Number ◽  
Art Initiation ◽  
Source Type ◽  
Clinical Trials Registry

Background:Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients' lives remains unknown.Methods:We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the ‘Early Initiation of ART for All’ (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.Results:A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households’ asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients’ sex, age, education, timing of HIV diagnosis and ART initiation.Conclusions:Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.Funding:Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.Clinical trial number:NCT02909218 and NCT03789448.

scholarly journals Identification of human glucocorticoid response markers using integrated multi-omic analysis from a randomized crossover trial

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Dimitrios Chantzichristos ◽  
Per-Arne Svensson ◽  
Terence Garner ◽  
Camilla AM Glad ◽  
Brian R Walker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Council ◽  
Mononuclear Cells ◽  
University Hospital ◽  
Medical Society ◽  
Serious Adverse Events ◽  
Peripheral Blood Mononuclear ◽  
Disease Etiology ◽  
Trial Number ◽  
Clinical Trials Registry

Background:Glucocorticoids are among the most commonly prescribed drugs, but there is no biomarker that can quantify their action. The aim of the study was to identify and validate circulating biomarkers of glucocorticoid action.Methods:In a randomized, crossover, single-blind, discovery study, 10 subjects with primary adrenal insufficiency (and no other endocrinopathies) were admitted at the in-patient clinic and studied during physiological glucocorticoid exposure and withdrawal. A randomization plan before the first intervention was used. Besides mild physical and/or mental fatigue and salt craving, no serious adverse events were observed. The transcriptome in peripheral blood mononuclear cells and adipose tissue, plasma miRNAomic, and serum metabolomics were compared between the interventions using integrated multi-omic analysis.Results:We identified a transcriptomic profile derived from two tissues and a multi-omic cluster, both predictive of glucocorticoid exposure. A microRNA (miR-122-5p) that was correlated with genes and metabolites regulated by glucocorticoid exposure was identified (p=0.009) and replicated in independent studies with varying glucocorticoid exposure (0.01 ≤ p≤0.05).Conclusions:We have generated results that construct the basis for successful discovery of biomarker(s) to measure effects of glucocorticoids, allowing strategies to individualize and optimize glucocorticoid therapy, and shedding light on disease etiology related to unphysiological glucocorticoid exposure, such as in cardiovascular disease and obesity.Funding:The Swedish Research Council (Grant 2015-02561 and 2019-01112); The Swedish federal government under the LUA/ALF agreement (Grant ALFGBG-719531); The Swedish Endocrinology Association; The Gothenburg Medical Society; Wellcome Trust; The Medical Research Council, UK; The Chief Scientist Office, UK; The Eva Madura’s Foundation; The Research Foundation of Copenhagen University Hospital; and The Danish Rheumatism Association.Clinical trial number:NCT02152553.

Peer assisted HIV self-testing increases positivity rates among key populations in Burundi: descriptive analysis of routine programmatic data (Preprint)

2020 ◽  
Author(s):  
Tiffany Lillie ◽  
Dorica Boyee ◽  
Gloriose Kamariza ◽  
Alphonse Nkunzimana ◽  
Dismas Gashobotse ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Sex Workers ◽  
Descriptive Analysis ◽  
Case Finding ◽  
Hiv Positive ◽  
Key Populations ◽  
Standard Testing ◽  
Art Initiation ◽  
Treatment Standard ◽  
Self Testing

BACKGROUND In Burundi, given the low testing numbers among key populations, peer assisted HIV self-testing (HIVST) was initiated for female sex workers (FSWs), men who have sex with men (MSM), and transgender people (TG) to provide another testing option. HIVST was provided by existing peer outreach workers (POWs) who were trained to provide support before, during, and after the administration of the test. People who screened reactive were referred and actively linked to confirmatory testing, and those confirmed positive were linked to treatment. Standard testing included HIV testing by clinical staff either at mobile clinics or in facilities. OBJECTIVE The objective was to improve access to HIV testing to underserved KP members, increase HIV positivity rates, and link those who were confirmed HIV positive with life-saving treatment for epidemic control. METHODS A descriptive analysis of routine programmatic data was conducted from a nine-month implementation period (June 2018-March 2019) of peer assisted HIVST among FSWs, MSM, and TG in six provinces where the USAID- and PEPFAR-funded LINKAGES Burundi project worked. Chi-squared tests were used to compare case-finding rates among individuals tested through HIVST versus standard testing. RESULTS A total of 2,198 HIVST test kits were administered (1,791 FSWs, 363 MSM, 44 TG). Three hundred and sixty-six people (17%) were reactive to HIV screening (296 FSWs, 60 MSM, 10 TG); 314 (14%) were confirmed HIV positive (257 FSWs, 47 MSM, 10 TG); and 301 (96%) (251 FSWs, 40 MSM, 10 TG) of those confirmed were initiated on treatment. HIV case-finding rates were significantly higher with HIVST compared to standard testing for FSW and MSM but not TG: FSWs (14% vs. 9%, P < .001); MSM (13% vs. 4%, P < .001); and TG (23% vs. 17%, P > .10). ART initiation rates were significantly lower for MSM confirmed HIV positive through HIVST than through standard testing (85% vs. 99%, P < .001) but not among FSWs or TG (FSWs: 98% vs. 97%, P > .10; TG: 100% vs. 100%). CONCLUSIONS The results demonstrate the potential effectiveness of HIVST in identifying individuals who are living with HIV.

scholarly journals One in 4 HIV-Positive South Africans Awaiting ART Initiation Report Condomless Sex With a Serodiscordant Partner

2016 ◽  
Vol 72 (3) ◽  
pp. e77-e79 ◽  
Author(s):  
Paul A. Shuper ◽  
Sandy Pillay ◽  
Susan MacDonald ◽  
Sarah Christie ◽  
Deborah H. Cornman ◽  
...  
Keyword(s):  
Hiv Positive ◽  
South Africans ◽  
Condomless Sex ◽  
Art Initiation

Individual and healthcare supply-related barriers to treatment initiation in HIV-positive patients enrolled in the Cameroonian antiretroviral treatment access programme

2020 ◽  
Author(s):  
Pierre-Julien Coulaud ◽  
Camélia Protopopescu ◽  
Khadim Ndiaye ◽  
Maël Baudoin ◽  
Gwenaëlle Maradan ◽  
...  
Keyword(s):  
Antiretroviral Treatment ◽  
Cox Model ◽  
Task Shifting ◽  
Hiv Positive ◽  
Treatment Access ◽  
Community Based ◽  
Related Factors ◽  
Hiv Services ◽  
Community Based Organizations ◽  
Art Initiation

Abstract Increasing demand for antiretroviral treatment (ART) together with a reduction in international funding during the last decade may jeopardize access to ART. Using data from a cross-sectional survey conducted in 2014 in 19 HIV services in the Centre and Littoral regions in Cameroon, we investigated the role of healthcare supply-related factors in time to ART initiation in HIV-positive patients eligible for ART at HIV diagnosis. HIV service profiles were built using cluster analysis. Factors associated with time to ART initiation were identified using a multilevel Cox model. The study population included 847 HIV-positive patients (women 72%, median age: 39 years). Median (interquartile range) time to ART initiation was 1.6 (0.5–4.3) months. Four HIV service profiles were identified: (1) small services with a limited staff practising partial task-shifting (n = 4); (2) experienced and well-equipped services practising task-shifting and involving HIV community-based organizations (n = 5); (3) small services with limited resources and activities (n = 6); (4) small services providing a large range of activities using task-shifting and involving HIV community-based organizations (n = 4). The multivariable model showed that HIV-positive patients over 39 years old [hazard ratio: 1.26 (95% confidence interval) (1.09–1.45), P = 0.002], those with disease symptoms [1.21 (1.04–1.41), P = 0.015] and those with hepatitis B co-infection [2.31 (1.15–4.66), P = 0.019] were all more likely to initiate ART early. However, patients in the first profile were less likely to initiate ART early [0.80 (0.65–0.99), P = 0.049] than those in the second profile, as were patients in the third profile [association only significant at the 10% level; 0.86 (0.72–1.02), P = 0.090]. Our findings provide a better understanding of the role played by healthcare supply-related factors in ART initiation. In HIV services with limited capacity, task-shifting and support from community-based organizations may improve treatment access. Additional funding is required to relieve healthcare supply-related barriers and achieve the goal of universal ART access.

scholarly journals Correction: Impact on Patients' Treatment Outcomes of XpertMTB/RIF Implementation for the Diagnosis of Tuberculosis: Follow-Up of a Stepped-Wedge Randomized Clinical Trial

PLoS ONE ◽  
2016 ◽  
Vol 11 (5) ◽  
pp. e0156471
Author(s):  
Anete Trajman ◽  
Betina Durovni ◽  
Valeria Saraceni ◽  
Alexandre Menezes ◽  
Marcelo Cordeiro-Santos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Outcomes ◽  
Randomized Clinical Trial ◽  
Stepped Wedge

scholarly journals Factors associated with virological non-suppression among HIV-positive children receiving antiretroviral therapy at the Joint Clinical Research Centre in Lubowa, Kampala Uganda

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0246140
Author(s):  
Sarah Nabukeera ◽  
Joseph Kagaayi ◽  
Fredrick Edward Makumbi ◽  
Henry Mugerwa ◽  
Joseph K. B. Matovu
Keyword(s):  
Viral Load ◽  
Antiretroviral Therapy ◽  
Side Effects ◽  
Clinical Research ◽  
Clinical Stage ◽  
Research Centre ◽  
Hiv Positive ◽  
Factors Associated ◽  
Art Initiation ◽  
Stage 4

Background While the proportion of HIV-positive children (under 15 years) enrolled on antiretroviral therapy (ART) has increased in recent years, up to 60% of children started on ART do not achieve virological suppression. We set out to determine the factors associated with virological non-suppression among children living with HIV receiving ART at a peri-urban HIV care clinic in Kampala, Uganda. Method This was a retrospective cohort study conducted at the pediatric HIV/AIDS clinic at the Joint Clinical Research Centre (JCRC) in Kampala, Uganda. Three hundred (300) HIV-positive children (0–14 years) were randomly selected from existing medical records and data on children’s socio-demographic and clinical characteristics (age at ART initiation, WHO clinical staging, and ART-induced side effects) were abstracted using a data abstraction form. Virological non-suppression was defined as a viral load ≥1000 copies/Ml of blood after six months of ART initiation. Incident rate ratios (IRRs) were determined as a measure of association between virological non-suppression and child/patient characteristics. The IRRs were obtained via a modified Poisson regression with corresponding 95% confidence intervals (95%CI). All analyses were done using statistical package, Stata version 15. Results The overall non-suppression rate among HIV-positive children on ART was 23%. Being at WHO clinical stage 4 at ART initiation [adj. IRR 2.74; 95%CI: 1.63, 4.61] and ART-induced side effects [adj. IRR 1.77; 95%CI: 1.06, 2.97] were significantly associated with non-suppression. Older age at ART initiation (age 5–9 years: [adj. IRR 0.42; 95%CI: 0.28, 0.65]; age 10–14 years: [adj. IRR 0.34; 95%CI: 0.18, 0.64] was less likely to be associated with virological non-suppression. Conclusion Nearly a quarter of HIV-positive children on ART had a non-suppressed viral load after six months of treatment. Being at WHO clinical stage 4 at ART initiation and ART-induced side effects were significantly associated with virological non-suppression while older age at ART initiation was protective. Our findings suggest a need for age-specific interventions, particularly those targeting children below five years of age, to improve virological suppression among HIV-positive children receiving ART in this setting.

scholarly journals Regenerative Therapy for Liver Cirrhosis Based on Intrahepatic Arterial Infusion of Autologous Subcutaneous Adipose Tissue-Derived Regenerative (Stem) Cells: Protocol for a Confirmatory Multicenter Uncontrolled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Yoshio Sakai ◽  
Shinya Fukunishi ◽  
Masayuki Takamura ◽  
Oto Inoue ◽  
Shinichiro Takashima ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cells ◽  
Adipose Tissue ◽  
Liver Cirrhosis ◽  
Data Analysis ◽  
Albumin Concentration ◽  
Safety And Efficacy ◽  
Tissue Dissociation ◽  
Primary Endpoints ◽  
Clinical Trials Registry

BACKGROUND Liver cirrhosis results from chronic hepatitis, and is characterized by advanced fibrosis due to long-term hepatic inflammation. Cirrhosis ultimately leads to manifestations of jaundice, ascites, and encephalopathy, and increases the risk of hepatocellular carcinoma. Once cirrhosis is established, resulting in hepatic failure, no effective treatment is available. Therefore, novel therapies to inhibit disease progression of cirrhosis are needed. OBJECTIVE The objective of this investigator-initiated clinical trial is to assess the safety and efficacy of autologous adipose tissue-derived regenerative (stem) cell therapy delivered to the liver via the hepatic artery in patients with liver cirrhosis. METHODS Through consultation with the Japan Pharmaceuticals and Medical Devices Agency, we designed a clinical trial to assess a therapy for liver cirrhosis based on autologous adipose tissue-derived regenerative (stem) cells, which are extracted using an adipose tissue dissociation device. The primary endpoints of the trial are the serum albumin concentration, prothrombin activity, harmful events, and device malfunction. RESULTS Enrollment and registration were initiated in November 2017, and the follow-up period ended in November 2019. Data analysis and the clinical study report will be completed by the end of March 2020. CONCLUSIONS Completion of this clinical trial, including data analysis, will provide data on the safety and efficacy of this novel liver repair therapy based on autologous adipose tissue-derived regenerative (stem) cells using an adipose tissue dissociation device. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3q INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17904

scholarly journals Multidisciplinary Evaluation of Pacifier Removal on Oro-Dentofacial Structures: A Controlled Clinical Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Kelly Guedes de Oliveira Scudine ◽  
Camila Nobre de Freitas ◽  
Kizzy Silva Germano Nascimento de Moraes ◽  
Silvana Bommarito ◽  
Rosana de Fátima Possobon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mixed Model ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Functional Changes ◽  
Mixed Model Anova ◽  
And Function ◽  
Clinical Trials Registry ◽  
Facial Anthropometry ◽  
Over Time

It is well recognized that pacifier habit leads to occlusal and orofacial functional changes in children. However, the effects of the interruption of prolonged pacifier habit on the development of the dento-facial complex has not yet been fully characterized. Thus, the aim of this study was to investigate the influence of pacifier removal on aspects of oro-dentofacial morphology and function in preschool children. For that, a pacifier group (n = 28) and a control group (n = 32) of 4-year-old children with and without pacifier habit, respectively, were followed up by a group of dentists and speech therapists at baseline, 6 and 12 months after habit removal. Bite force and lip pressure were assessed using digital systems, and the evaluation of breathing and speech functions was performed using validated protocols, together with the measurements of dental casts and facial anthropometry. The Two-way mixed model ANOVA was used in data analysis. After 12 months, a decrease in malocclusion frequency was observed in pacifier group. Additionally, a change over time was observed in facial, intermolar and palate depth measurements, as well in bite and lip forces and speech function scores, increasing in both groups (p &lt; 0.01). The upper and lower intercanine widths and breathing scores differed between groups at baseline and changed over time reducing the differences. The presence of speech distortions was more frequent in the pacifier group at baseline and decreased over time (p &lt; 0.05). The interruption of pacifier habit improved the maxillary and mandibular intercanine widths, as well as the breathing and speech functions, overcoming the oro-dentofacial changes found.Trial Registration: This clinical trial was registered in the Brazilian Clinical Trials Registry (ReBEC; http://www.ensaiosclinicos.gov.br/), protocol no. RBR-728MJ2.

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