RESUMEN
BACKGROUND: Improving treatment success rates among multi drug-resistant tuberculosis (MDR-TB) patients is critical to reducing its incidence and mortality, but adherence poses an important challenge. Video-based direct observed therapy (vDOT) may provide adherence benefits, while addressing the time and cost burden associated with community treatment supporter (CTS)-DOT. This study explored experiences of patients, family members and healthcare workers with different DOT modalities for adherence support in Eswatini. METHODS: Between April 2021 and May 2022, thirteen men and five women with MDR-TB, ten healthcare workers, and nine caregivers were purposively sampled to include a range of characteristics and experiences with DOT modalities. Data were generated through individual in-depth interviews and a smartphone messaging application (WhatsApp). Data coding was undertaken iteratively, and thematic analysis undertaken, supported by Nvivo. RESULTS: Four themes emerged that reflected participants' experiences with different DOT modalities, including stigma, efficiency, perceived risks of TB acquisition, and patient autonomy. vDOT was appreciated by patients for providing them with privacy and shielding them from stigmatisation associated with being seen in TB clinics or with community treatment supporters. vDOT was also seen as more efficient than CTS-DOT. Health workers acknowledged that it saved time, allowing them to attend to more patients, while many patients found vDOT more convenient and less expensive by removing the need to travel for in-person consultations. Health workers also appreciated vDOT because it reduced risks of TB acquisition by minimising exposure through virtual patient monitoring. Although many patients appreciated greater autonomy in managing their illness through vDOT, others preferred human contact or struggled with making video recordings. Most family members appreciated vDOT, although some resented feeling removed from the process of supporting loved ones. CONCLUSIONS: vDOT was generally appreciated by MDR-TB patients, their family members and health workers as it addressed barriers to adherence which could contribute to improved treatment completion rates and reduced workplace exposure. However, patients should be offered an alternative to vDOT such as CTS-DOT if this modality does not suit their circumstances or preferences.
Asunto(s)
Antituberculosos , Terapia por Observación Directa , Cumplimiento de la Medicación , Investigación Cualitativa , Tuberculosis Resistente a Múltiples Medicamentos , Humanos , Masculino , Femenino , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológico , Adulto , Antituberculosos/uso terapéutico , Antituberculosos/administración & dosificación , Persona de Mediana Edad , Esuatini , Personal de Salud/psicología , Adulto Joven , Estigma Social , Cuidadores/psicologíaRESUMEN
BACKGROUND: Adherence to pharmacotherapy and use of the correct inhaler technique are important basic principles of asthma management. Video- or remote-direct observation of therapy (v-DOT) could be a feasible approach to facilitate monitoring and supervising therapy, supporting the delivery of standard care. OBJECTIVE: To explore the utility and the feasibility of v-DOT to monitor inhaler technique and adherence to treatment in adults attending the asthma outpatient service in a tertiary hospital in Northern Ireland. METHOD: The project evaluated use of the technology with 10 asthma patients. Patient and clinician feedback was obtained, in addition to measures of patient engagement and disease-specific clinical markers to assess the feasibility and utility of v-DOT technology in this group of patients. RESULTS: The engagement rate with v-DOT for participating patients averaged 78% (actual video uploads vs expected video uploads) over a median 7 week usage period. Although 50% of patients reported a technical issue at some stage during the usage period, all patients and clinicians reported that the technology was easy to use and that they were satisfied with the outcomes. A range of positive impacts were observed, including optimised inhaler technique and an observed improvement in lung function. An increase in asthma control test scores aligned with clinical aims to promote adherence and alleviate symptoms. CONCLUSION: The v-DOT technology was shown to be a feasible method of assessing inhaler technique and monitoring adherence in this small group of adult asthma patients. A range of positive impacts for participating patients and clinicians were observed. Not all patients invited to join the project agreed to participate or engage with using the technology, highlighting that in this setting, digital modes of delivering care provide only one of the approaches in the necessary "tool kit" for clinicians and patients.
Asunto(s)
Asma , Humanos , Asma/tratamiento farmacológico , Asma/terapia , Adulto , Femenino , Masculino , Proyectos Piloto , Persona de Mediana Edad , Irlanda del Norte , Tecnología Digital/métodos , Tecnología Digital/estadística & datos numéricos , Grabación en Video/métodos , Grabación en Video/estadística & datos numéricos , Terapia por Observación Directa , Nebulizadores y Vaporizadores/estadística & datos numéricosRESUMEN
BACKGROUND: Extra- pulmonary tuberculosis ( EPTB) contributes to the burden of Tuberculosis (TB) especially in developing countries. Despite this fact, information on the prevalence of EPTB is scarce. The aim of this study is to determine the five-year prevalence of EPTB among patients diagnosed with tuberculosis (TB) that attended and received treatment for TB at directly observed treatment short course (DOTS) clinic of Abubakar Tafawa Balewa University Teaching Hospital (ATBUTH), Bauchi, North-eastern Nigeria. METHODOLOGY: This is a retrospective review of all patients' records diagnosed with TB that attended and received treatment at the TB DOTS clinic of ATBUTH, Bauchi from January, 2017 to December, 2021. Extracted data was analyzed using IBM SPSS version 23.0 software. RESULT: There were 676 patients comprising of 389 (57.5%) males and 287 (42.5%) females and out of these, 208 had EPTB. The estimated five-year prevalence of EPTB in the studied cases was 30.8%. Tuberculosis of the spine was the predominant form of EPTB in this study with 117 (56.3%) cases. This was followed by TB Lymph nodes 40 (19.2%), TB Abdomen 36 (17.3%), TB Pleura 6 (2.9%), TB Pericardium 3 (1.4%), 2 (1.0%) each of TB Breast and CNS, and 1 (0.5%) each of TB Testicle and Upper arm. Seventy-eight (11.5%) patients were HIV positive, 549 (81.2%) were HIV-negative and the HIV status of 49 (7.2%) patients was unknown. CONCLUSION: The study showed prevalence of EPTB is still high as reported in some literature. Tuberculosis of spine was the commonest form of EPTB. These findings underscore the need for continued screening of EPTB to reduce the burden of TB in resource-poor countries.
CONTEXTE: La tuberculose extra-pulmonaire (TEP) contribue au fardeau de la tuberculose (TB), en particulier dans les pays en développement. Malgré ce fait, les informations sur la prévalence de la TEP sont rares. Le but de cette étude est de déterminer la prévalence sur cinq ans de la TEP chez les patients diagnostiqués avec la tuberculose (TB) qui ont fréquenté et reçu un traitement pour la TB au centre de traitement de courte durée sous observation directe (DOTS) de l'hôpital universitaire Abubakar Tafawa Balewa (ATBUTH), Bauchi, Nord-Est du Nigéria. MÉTHODOLOGIE: Il s'agit d'une revue rétrospective de tous les dossiers des patients diagnostiqués avec la TB qui ont fréquenté et reçu un traitement au centre de traitement DOTS de l'ATBUTH, Bauchi, de janvier 2017 à décembre 2021. Les données extraites ont été analysées à l'aide du logiciel IBM SPSS version 23.0. RÉSULTAT: Il y avait 676 patients comprenant 389 (57,5%) hommes et 287 (42,5%) femmes, dont 208 avaient une TEP. La prévalence estimée sur cinq ans de la TEP dans les cas étudiés était de 30,8%. La tuberculose de la colonne vertébrale était la forme prédominante de TEP dans cette étude avec 117 (56,3%) cas. Cela a été suivi par la TB des ganglions lymphatiques 40 (19,2%), la TB abdominale 36 (17,3%), la TB pleurale 6 (2,9%), la TB péricardique 3 (1,4%), 2 (1,0%) cas chacun de TB du sein et du SNC, et 1 (0,5%) cas chacun de TB testiculaire et du bras supérieur. Soixante-dix-huit (11,5%) patients étaient séropositifs, 549 (81,2%) étaient séronégatifs et le statut VIH de 49 (7,2%) patients était inconnu. CONCLUSION: L'étude a montré que la prévalence de la TEP est encore élevée, comme le rapporte certaines littératures. La tuberculose de la colonne vertébrale était la forme la plus courante de TEP. Ces résultats soulignent la nécessité de poursuivre le dépistage de la TEP pour réduire le fardeau de la TB dans les pays à ressources limitées. MOTS CLÉS: Tuberculose Extra-Pulmonaire, Prévalence, Bauchi, Nord-Est du Nigéria.
Asunto(s)
Centros de Atención Terciaria , Humanos , Nigeria/epidemiología , Masculino , Femenino , Estudios Retrospectivos , Prevalencia , Adulto , Persona de Mediana Edad , Adolescente , Adulto Joven , Tuberculosis/epidemiología , Tuberculosis/diagnóstico , Terapia por Observación Directa , Niño , Anciano , Preescolar , Tuberculosis ExtrapulmonarRESUMEN
BACKGROUND: TB is treated with a six-month course of four antimicrobial drugs, and nearly all cases of TB can be cured if the medications are given and taken correctly. Due to its prolong treatment plans, there can be reasons associated with non-adherence to treatment by TB patients. Hence, the present study aimed to explore the factors associated with medication adherence among TB patients. METHOD: A cross-sectional descriptive survey was conducted among adult pulmonary tuberculosis patients enrolled under RNTCP (now NTEP) in New Delhi among 27 functional RNTCP districts. Around 200 TB patients who are enrolled in the Nikshay App and are also on treatment were considered. A structured questionnaire was prepared for the interview guide. Analysis was done using bivariate analysis, chi-square tests, and Fisher's exact tests. RESULTS: Among the total participants, 173 (86.5%) were adherent and the remaining 27 (13.5%) participants were non-adherent. The majority of the participants (91%) said they were able to follow the routine to the DOTS center, and 9% said they find it difficult to report to the DOTS center as per their schedule. Only 12.35% of non-adherent participants were seen among those who get regular reminders from their families to take medicines, as compared to 18.42% among those who did not get regular reminders from their families. More than one-fourth of the participants (25.9%) who report not getting necessary motivation from healthcare providers were non-adherent. Motivation by healthcare workers to follow drug schedules was found statistically significant to treatment compliance with a P-value of 0.0422. CONCLUSION: TB is a curable disease; this belief has turned out to be a motivational factor for patients suffering from this disease. Studies have shown that faith in the efficacy of treatment helps adherence to TB treatment while other studies describe how patient adherence was adversely affected by the belief that TB is incurable or the treatment is inefficient or that alternative treatment such as traditional medicine is better.
Asunto(s)
Antituberculosos , Terapia por Observación Directa , Cumplimiento de la Medicación , Tuberculosis Pulmonar , Humanos , Tuberculosis Pulmonar/tratamiento farmacológico , Tuberculosis Pulmonar/psicología , Femenino , Adulto , India , Masculino , Estudios Transversales , Cumplimiento de la Medicación/estadística & datos numéricos , Cumplimiento de la Medicación/psicología , Antituberculosos/uso terapéutico , Persona de Mediana Edad , Adulto Joven , Encuestas y Cuestionarios , Sistemas RecordatoriosRESUMEN
BACKGROUND: Video-enabled directly observed therapy (video-DOT) has been proposed as an additional option for treatment provision besides in-person DOT for patients with drug-resistant TB (DRTB) disease. However, evidence and implementation experience mainly originate from well-resourced contexts. This study describes the operationalization of video-DOT in a low-resourced setting in Eswatini facing a high burden of HIV and TB amid the emergence of the COVID-19 pandemic. METHODS: This is a retrospectively established cohort of patients receiving DRTB treatment during the implementation of video-DOT in Shiselweni from May 2020 to March 2022. We described intervention uptake (vs. in-person DOT) and assessed unfavorable DRTB treatment outcome (death, loss to care) using Kaplan-Meier statistics and multivariable Cox-regression models. Video-related statistics were described with frequencies and medians. We calculated the fraction of expected doses observed (FEDO) under video-DOT and assessed associations with missed video uploads using multivariable Poisson regression analysis. RESULTS: Of 71 DRTB patients eligible for video-DOT, the median age was 39 (IQR 30-54) years, 31.0% (n = 22) were women, 67.1% (n = 47/70) were HIV-positive, and 42.3% (n = 30) were already receiving DRTB treatment when video-DOT became available. About half of the patients (n = 37; 52.1%) chose video-DOT, mostly during the time when COVID-19 appeared in Eswatini. Video-DOT initiations were lower in new DRTB patients (aHR 0.24, 95% CI 0.12-0.48) and those aged ≥ 60 years (aHR 0.27, 95% CI 0.08-0.89). Overall, 20,634 videos were uploaded with a median number of 553 (IQR 309-748) videos per patient and a median FEDO of 92% (IQR 84-97%). Patients aged ≥ 60 years were less likely to miss video uploads (aIRR 0.07, 95% CI 0.01-0.51). The cumulative Kaplan-Meier estimate of an unfavorable treatment outcome among all patients was 0.08 (95% CI 0.03-0.19), with no differences detected by DOT approach and other baseline factors in multivariable analysis. CONCLUSIONS: Implementing video-DOT for monitoring of DRTB care provision amid the intersection of the HIV and COVID-19 pandemics seemed feasible. Digital health technologies provide additional options for patients to choose their preferred way to support treatment taking, thus possibly increasing patient-centered health care while sustaining favorable treatment outcomes.
Asunto(s)
COVID-19 , Terapia por Observación Directa , Tuberculosis Resistente a Múltiples Medicamentos , Humanos , Estudios Retrospectivos , Femenino , Masculino , Adulto , Persona de Mediana Edad , Esuatini/epidemiología , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológico , SARS-CoV-2 , Pandemias , Telemedicina , Antituberculosos/uso terapéutico , Infecciones por VIH/tratamiento farmacológicoRESUMEN
BACKGROUND: There are no recent studies comparing the compliance rates of both patients and observers in tuberculosis treatment between the video-observed therapy (VOT) and directly observed therapy (DOT) programs. OBJECTIVE: This study aims to compare the average number of days that patients with pulmonary tuberculosis and their observers were compliant under VOT and DOT. In addition, this study aims to compare the sputum conversion rate of patients under VOT with that of patients under DOT. METHODS: Patient and observer compliance with tuberculosis treatment between the VOT and DOT programs were compared based on the average number of VOT and DOT compliance days and sputum conversion rates in a 60-day cluster randomized controlled trial with patients with pulmonary tuberculosis (VOT: n=63 and DOT: n=65) with positive sputum acid-fast bacilli smears and 38 observers equally randomized into the VOT and DOT groups (19 observers per group and n=1-5 patients per observer). The VOT group submitted videos to observers via smartphones; the DOT group followed standard procedures. An intention-to-treat analysis assessed the compliance of both the patients and the observers. RESULTS: The VOT group had higher average compliance than the DOT group (patients: mean difference 15.2 days, 95% CI 4.8-25.6; P=.005 and observers: mean difference 21.2 days, 95% CI 13.5-28.9; P<.001). The sputum conversion rates in the VOT and DOT groups were 73% and 61.5%, respectively (P=.17). CONCLUSIONS: Smartphone-based VOT significantly outperformed community-based DOT in ensuring compliance with tuberculosis treatment among observers. However, the study was underpowered to confirm improved compliance among patients with pulmonary tuberculosis and to detect differences in sputum conversion rates. TRIAL REGISTRATION: Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/38796.
Asunto(s)
Terapia por Observación Directa , Teléfono Inteligente , Humanos , Femenino , Masculino , Adulto , Persona de Mediana Edad , Teléfono Inteligente/instrumentación , Teléfono Inteligente/estadística & datos numéricos , Cumplimiento y Adherencia al Tratamiento/estadística & datos numéricos , Cumplimiento y Adherencia al Tratamiento/psicología , Cooperación del Paciente/estadística & datos numéricos , Tuberculosis Pulmonar/terapia , Tuberculosis Pulmonar/tratamiento farmacológico , Análisis por ConglomeradosRESUMEN
BACKGROUND: Tuberculosis (TB) treatment delay is one of the major challenges of TB care in many low-income countries. Such cases may contribute to an increased TB transmission and severity of illness. The aim of this study was to determine the magnitude of patient delay in TB treatment, and associated factors in Dale District and Yirgalem Town administration of Sidama Region, Southern Ethiopia. METHODS: Between January 1-Augst 30/ 2022, we studied randomly selected 393 pulmonary TB cases on Directly Observed Treatment Short course (DOTS) in Dale District and Yirgalem Town Administration. After conducting a pretest, we interviewed participants on sociodemographic, health seeking behavior and clinical factors and reviewed the TB registry. Trained enumerators interviewed to collect data. We entered data in to EPI-info 7 version 3.5.4 and then exported to the Statistical Package for Social Science (SPSS) version 23 for analysis. Multivariable logistic regression was used to identify associated factors of TB and statistical significance was defined using the 95% confidence interval. RESULT: A total of 393 (98%) participants involved in the study. The magnitude of delay in TB treatment among the study participants was 223 (56.7%) (95% CI (51.8 - 61.6%)). Distance of the health facility from home, (adjusted odds ratio (AOR) = 2.04, 95% CI (1.3, 3.2)), seeking antibiotic treatment before being diagnosed for TB (AOR = 2.1, 95% CI (1.3, 3.5)) and the knowledge of TB prevention and treatments (AOR = 5.9, 95% CI (3.6, 9.8)), were factors associated with delay in TB treatment. CONCLUSION: The prevalence of TB treatment delay among pulmonary TB patients in the study setting was high. Delay in TB treatment was associated with knowledge, behavioral and accessibility related factors. Providing health education and active case finding of TB would help in minimizing the delay.
Asunto(s)
Tuberculosis Pulmonar , Humanos , Etiopía/epidemiología , Femenino , Masculino , Adulto , Tuberculosis Pulmonar/tratamiento farmacológico , Tuberculosis Pulmonar/epidemiología , Persona de Mediana Edad , Adulto Joven , Adolescente , Instituciones de Salud/estadística & datos numéricos , Aceptación de la Atención de Salud/estadística & datos numéricos , Antituberculosos/uso terapéutico , Estudios Transversales , Terapia por Observación Directa , Tiempo de Tratamiento/estadística & datos numéricos , Retraso del TratamientoRESUMEN
BACKGROUND: Tuberculosis (TB) remains a significant global health challenge, especially prevalent in the WHO African region. The WHO's End TB Strategy emphasises effective treatment approaches such as directly observed therapy (DOT), yet the optimal implementation of DOT, whether through health facility-based (HF DOT) or community-based (CB DOT) approaches, remains uncertain. OBJECTIVE: To conduct a systematic comparison of the effectiveness and cost-effectiveness of Community-Based Directly Observed Treatment (CB DOT) versus Health Facility-Based Directly Observed Treatment (HF DOT) for tuberculosis (TB) treatment in African settings. METHODS: We will conduct a systematic review and meta-analysis following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, Embase, Web of Science, Scopus and the Cochrane Library for articles published up to 30 March 2023, without date restrictions. Eligible studies must be full economic evaluations conducted in African countries, comparing CB DOT to HF DOT regarding treatment outcomes and costs. Exclusion criteria include non-English, non-peer-reviewed or studies lacking caregiver involvement in CB DOT, health facility-based DOT comparison, direct comparability between CB DOT and HF DOT, significant selection bias or non-economic evaluations. Data extraction will be performed independently by reviewers, and meta-analyses will use STATA software. To pool the data, a random-effect model will be applied, and quality assessment of the studies will be conducted. ETHICS AND DISSEMINATION: Ethical approval is not required as the study will use previously published articles available publicly. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42023443260.
Asunto(s)
Análisis Costo-Beneficio , Terapia por Observación Directa , Metaanálisis como Asunto , Revisiones Sistemáticas como Asunto , Tuberculosis , Humanos , África , Tuberculosis/tratamiento farmacológico , Tuberculosis/economía , Tuberculosis/terapia , Instituciones de Salud/economía , Servicios de Salud Comunitaria/economía , Proyectos de Investigación , Antituberculosos/uso terapéutico , Antituberculosos/economíaRESUMEN
INTRODUCTION: Tuberculosis (TB) causes over 1 million deaths annually. Providing effective treatment is a key strategy for reducing TB deaths. In this study, we identified factors associated with unsuccessful treatment outcomes among individuals treated for TB in Brazil. METHODS: We obtained data on individuals treated for TB between 2015 and 2018 from Brazil's National Disease Notification System (SINAN). We excluded patients with a history of prior TB disease or with diagnosed TB drug resistance. We extracted information on patient-level factors potentially associated with unsuccessful treatment, including demographic and social factors, comorbid health conditions, health-related behaviors, health system level at which care was provided, use of directly observed therapy (DOT), and clinical examination results. We categorized treatment outcomes as successful (cure, completed) or unsuccessful (death, regimen failure, loss to follow-up). We fit multivariate logistic regression models to identify factors associated with unsuccessful treatment. RESULTS: Among 259,484 individuals treated for drug susceptible TB, 19.7% experienced an unsuccessful treatment outcome (death during treatment 7.8%, regimen failure 0.1%, loss to follow-up 11.9%). The odds of unsuccessful treatment were higher with older age (adjusted odds ratio (aOR) 2.90 [95% confidence interval: 2.62-3.21] for 85-100-year-olds vs. 25-34-year-olds), male sex (aOR 1.28 [1.25-1.32], vs. female sex), Black race (aOR 1.23 [1.19-1.28], vs. White race), no education (aOR 2.03 [1.91-2.17], vs. complete high school education), HIV infection (aOR 2.72 [2.63-2.81], vs. no HIV infection), illicit drug use (aOR 1.95 [1.88-2.01], vs. no illicit drug use), alcohol consumption (aOR 1.46 [1.41-1.50], vs. no alcohol consumption), smoking (aOR 1.20 [1.16-1.23], vs. non-smoking), homelessness (aOR 3.12 [2.95-3.31], vs. no homelessness), and immigrant status (aOR 1.27 [1.11-1.45], vs. non-immigrants). Treatment was more likely to be unsuccessful for individuals treated in tertiary care (aOR 2.20 [2.14-2.27], vs. primary care), and for patients not receiving DOT (aOR 2.35 [2.29-2.41], vs. receiving DOT). CONCLUSION: The risk of unsuccessful TB treatment varied systematically according to individual and service-related factors. Concentrating clinical attention on individuals with a high risk of poor treatment outcomes could improve the overall effectiveness of TB treatment in Brazil.
Asunto(s)
Antituberculosos , Insuficiencia del Tratamiento , Tuberculosis , Humanos , Brasil/epidemiología , Masculino , Femenino , Adulto , Persona de Mediana Edad , Antituberculosos/uso terapéutico , Adulto Joven , Adolescente , Tuberculosis/tratamiento farmacológico , Tuberculosis/epidemiología , Anciano , Terapia por Observación Directa , Niño , Preescolar , Factores de Riesgo , Lactante , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Resultado del Tratamiento , Anciano de 80 o más AñosRESUMEN
Asunto(s)
Terapia por Observación Directa , Derivación y Consulta , Humanos , Masculino , Femenino , España , Persona de Mediana Edad , Estudios Prospectivos , Adulto , Derivación y Consulta/estadística & datos numéricos , Antituberculosos/administración & dosificación , Tuberculosis/tratamiento farmacológico , Insuficiencia del Tratamiento , Personas con Mala Vivienda/estadística & datos numéricos , Estudios de Seguimiento , Factores de Riesgo , Adulto Joven , Anciano , Infecciones por VIH/tratamiento farmacológicoRESUMEN
BACKGROUND: Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled Plasmodium falciparum infection in a phase 1 trial. Whether a monoclonal antibody administered subcutaneously can protect children from P. falciparum infection in a region where this organism is endemic is unclear. METHODS: We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 years of age over a 6-month malaria season. In part A of the trial, safety was assessed at three dose levels in adults, followed by assessment at two dose levels in children. In part B of the trial, children were randomly assigned, in a 1:1:1 ratio, to receive 150 mg of L9LS, 300 mg of L9LS, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first P. falciparum infection, as detected on blood smear performed at least every 2 weeks for 24 weeks. A secondary efficacy end point was the first episode of clinical malaria, as assessed in a time-to-event analysis. RESULTS: No safety concerns were identified in the dose-escalation part of the trial (part A). In part B, 225 children underwent randomization, with 75 children assigned to each group. No safety concerns were identified in part B. P. falciparum infection occurred in 36 participants (48%) in the 150-mg group, in 30 (40%) in the 300-mg group, and in 61 (81%) in the placebo group. The efficacy of L9LS against P. falciparum infection, as compared with placebo, was 66% (adjusted confidence interval [95% CI], 45 to 79) with the 150-mg dose and 70% (adjusted 95% CI, 50 to 82) with the 300-mg dose (P<0.001 for both comparisons). Efficacy against clinical malaria was 67% (adjusted 95% CI, 39 to 82) with the 150-mg dose and 77% (adjusted 95% CI, 55 to 89) with the 300-mg dose (P<0.001 for both comparisons). CONCLUSIONS: Subcutaneous administration of L9LS to children was protective against P. falciparum infection and clinical malaria over a period of 6 months. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT05304611.).
Asunto(s)
Anticuerpos Monoclonales Humanizados , Malaria Falciparum , Adulto , Niño , Femenino , Humanos , Masculino , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Enfermedades Endémicas/prevención & control , Inyecciones Subcutáneas , Estimación de Kaplan-Meier , Malaria Falciparum/tratamiento farmacológico , Malaria Falciparum/epidemiología , Malaria Falciparum/prevención & control , Malí/epidemiología , Plasmodium falciparum , Resultado del Tratamiento , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Terapia por Observación Directa , Combinación Arteméter y Lumefantrina/administración & dosificación , Combinación Arteméter y Lumefantrina/uso terapéutico , Adulto Joven , Persona de Mediana EdadRESUMEN
BACKGROUND: People in underserved groups have higher rates of tuberculosis (TB) and poorer treatment outcomes compared with people with no social risk factors. OBJECTIVES: This scoping review aimed to identify interventions that improve TB treatment adherence or completion rates. ELIGIBILITY CRITERIA: Studies of any design focusing on interventions to improve adherence or completion of TB treatment in underserved populations in low incidence countries. SOURCES OF EVIDENCE: MEDLINE, Embase and Cochrane CENTRAL were searched (January 2015 to December 2023). CHARTING METHODS: Piloted data extraction forms were used. Findings were tabulated and reported narratively. Formal risk of bias assessment or synthesis was not undertaken. RESULTS: 47 studies were identified. There was substantial heterogeneity in study design, population, intervention components, usual care and definition of completion rates. Most studies were in migrants or refugees, with fewer in populations with other risk factors (eg, homelessness, imprisonment or substance abuse). Based on controlled studies, there was limited evidence to suggest that shorter treatment regimens, video-observed therapy (compared with directly observed therapy), directly observed therapy (compared with self-administered treatment) and approaches that include tailored health or social support beyond TB treatment may lead to improved outcomes. This evidence is mostly observational and subject to confounding. There were no studies in Gypsy, Roma and Traveller populations, or individuals with mental health disorders and only one in sex workers. Barriers to treatment adherence included a lack of knowledge around TB, lack of general health or social support and side effects. Facilitators included health education, trusted relationships between patients and healthcare staff, social support and reduced treatment duration. CONCLUSIONS: The evidence base is limited, and few controlled studies exist. Further high-quality research in well-defined underserved populations is needed to confirm the limited findings and inform policy and practice in TB management. Further qualitative research should include more people from underserved groups.
Asunto(s)
Tuberculosis , Humanos , Incidencia , Tuberculosis/tratamiento farmacológico , Terapia por Observación Directa , Atención a la Salud , Factores de RiesgoRESUMEN
BACKGROUND: Despite improvements in antiretroviral therapy (ART) availability, suboptimal adherence is common among youth with HIV (YWH) and can increase drug resistance and poor clinical outcomes. Our study examined an innovative mobile app-based intervention that used automated directly observed therapy (aDOT) using artificial intelligence, along with conditional economic incentives (CEIs) to improve ART adherence and enhance viral suppression among YWH. SETTING: We conducted a pilot study of the aDOT-CEI intervention, informed by the operant framework of Key Principles in Contingency Management Implementation, to improve ART adherence among YWH (18-29) in California and Florida who had an unsuppressed HIV viral load. METHODS: We recruited 28 virally unsuppressed YWH from AIDS Healthcare Foundation clinics, who used the aDOT platform for 3 months. Study outcomes included feasibility and acceptability, self-reported ART adherence, and HIV viral load. RESULTS: Participants reported high satisfaction with the app (91%), and 82% said that it helped them take their medication. Comfort with the security and privacy of the app was moderate (55%), and 59% indicated the incentives helped improve daily adherence. CONCLUSIONS: Acceptability and feasibility of the aDOT-CEI intervention were high with potential to improve viral suppression, although some a priori metrics were not met. Pilot results suggest refinements which may improve intervention outcomes, including increased incentive amounts, provision of additional information, and reassurance about app privacy and security. Additional research is recommended to test the efficacy of the aDOT-CEI intervention to improve viral suppression in a larger sample.
Asunto(s)
Inteligencia Artificial , Terapia por Observación Directa , Infecciones por VIH , Cumplimiento de la Medicación , Carga Viral , Humanos , Proyectos Piloto , Infecciones por VIH/tratamiento farmacológico , Masculino , Femenino , Adulto , Adulto Joven , Adolescente , Motivación , Fármacos Anti-VIH/uso terapéutico , Aplicaciones Móviles , Florida , CaliforniaRESUMEN
BACKGROUND: The Directly Observed Treatment-Short Course (DOTS) Programme was implemented by WHO and includes a combination of four anti-tuberculosis (TB) drugs (isoniazid, pyrazinamide, ethambutol and rifampicin) for a period of six months to eradicate the TB infection completely. Diabetes mellitus (DM) is recognized as one of a strong contributor of TB according to World Health Organization (WHO). The presence of diabetes mellitus type 2 (DM type 2) makes TB treatment complicated. Thus, the objective of the current meta-analysis was to identify and quantify the impact of type 2 DM on treatment outcomes of TB patients treated under the DOTS Programme. METHODS: This meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Through a systematic review of relevant literature, we focused on studies investigating treatment outcomes including extended treatment duration and recurrence for individuals with both TB and DM undergoing DOTS therapy. The extracted information included study designs, sample sizes, patient characteristics and reported treatment results. RESULTS: In 44 studies from different parts of the world, the pooled HR for the impact of DM on extended treatment duration and reoccurrence were HR 0.72, 95% CI 0.56-0.83, p < .01 and HR 0.93, 95% CI 0.70-1.04, p = .08, respectively. The pooled HR for impact of DM on composite TB treatment outcomes was calculated as 0.76 (95% CI 0.60-0.87), p < .01 with an effect size of 41.18. The heterogeneity observed among the included studies was moderate (I2 = 55.79%). CONCLUSIONS: A negative impact of DM was found on recurrence and extended treatment duration in TB patients treated with DOTS therapy. DM type 2 is responsible for the TB treatment prolongation and TB recurrence rates. By implementing effective management strategies and advancing research, the challenges can be mitigated, arising due to the complex interaction between DM and TB.
Asunto(s)
Antituberculosos , Diabetes Mellitus Tipo 2 , Terapia por Observación Directa , Tuberculosis , Humanos , Antituberculosos/uso terapéutico , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Tuberculosis/epidemiología , Tuberculosis/tratamiento farmacológico , Resultado del Tratamiento , Comorbilidad , Recurrencia , Rifampin/uso terapéutico , Femenino , MasculinoRESUMEN
The PROMISE study assessed revisions designed to facilitate implementation of an HIV care coordination program (CCP) addressing gaps in care and treatment engagement among people living with HIV in New York City (NYC). Through latent class analysis (LCA) of a discrete choice experiment (DCE), we explored heterogeneity of provider preferences regarding CCP features. From January-March 2020, 152 NYC CCP providers completed a DCE with 3-4 levels on each of 4 program attributes: 1) Help with Adherence to Antiretroviral Therapy (ART), 2) Help with Primary Care Appointments, 3) Help with Issues Other than Primary Care, and 4) Where Program Visits Happen. We used LCA to assess patterns of preference, and choice simulation to estimate providers' endorsement of hypothetical CCPs. LCA identified three subgroups. The two larger subgroups (n = 133) endorsed more intensive individual program features, including directly observed therapy, home visits, and appointment reminders with accompaniment of clients to their appointments. The smallest subgroup (n = 19) endorsed medication reminders only, appointment reminders without accompaniment, and meeting at the program location rather than clients' homes. Choice simulation analysis affirmed the highest degree of endorsement (62%) for hypothetical programs combining the intensive features described above. Results indicated providers' preference for intensive program features and also reinforced the need for flexible service delivery options. Provider perspectives on service delivery approaches can inform program adjustments for successful long-term implementation, which in turn can improve patient outcomes.
Asunto(s)
Terapia por Observación Directa , Visita Domiciliaria , Humanos , Análisis de Clases Latentes , Simulación por Computador , Ciudad de Nueva YorkRESUMEN
BACKGROUND: Adherence is often a barrier to curative treatment of Mycobacterium tuberculosis (TB). There have been numerous interventions focused on increasing TB treatment adherence in Southeast Asia, but it is unclear if they are effective. This systematic review and meta-analysis aimed to compile and evaluate the literature on interventions designed to increase TB treatment adherence in Southeast Asia. METHODS: We searched Cochrane Library Reviews (CDSR) and Cochrane Library Trials (CENTRAL), Medline, CINAHL, Scopus, and Web of Science from 2000 to 2022 with no language restrictions. We included studies of any design conducted in Southeast Asia that implemented interventions to increase treatment completion in people diagnosed with TB and assessed completion as an outcome. We did not require a control group. Four investigators used a standardized data collection form to collate results. The heterogeneity across studies was explored by I2 statistics. We assessed bias using the Newcastle-Ottawa Scale and Cochrane ROB 2.0. We used a random effects meta-analysis to calculate a pooled risk ratio with 95% confidence intervals. RESULTS: From 1881 abstracts, we included 14 articles. There were 7198 subjects with 3163 (44%) receiving a TB treatment adherence intervention across eight countries. Interventions included directly observed therapy, text-message reminders, food incentives, and more. The risk ratio, derived from the meta-analysis of eight included studies with a control group and 6618 participants overall, was 1.04 (95% CI 1.01,1.08; I2 = 29%), favoring the interventions over controls with little concern for heterogeneity or risk of bias. When narratively assessed, the other six studies all reported increased adherence in the intervention group. DISCUSSION: The results suggested there is a small, statistically significant benefit of using interventions to promote TB treatment completion. Future research could look at additional strategies and combinations of strategies to promote adherence.
Asunto(s)
Antituberculosos , Terapia por Observación Directa , Tuberculosis , Humanos , Asia Sudoriental , Tuberculosis/tratamiento farmacológico , Antituberculosos/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Envío de Mensajes de Texto , Sistemas Recordatorios , Tuberculosis Pulmonar/tratamiento farmacológicoRESUMEN
Digital adherence technologies are increasingly used to support tuberculosis (TB) treatment adherence. Using microcosting, we estimated healthcare system costs (in 2022 US dollars) of 2 digital adherence technologies, 99DOTS medication sleeves and video-observed therapy (VOT), implemented in demonstration projects during 2018-2021. We also obtained cost estimates for standard directly observed therapy (DOT). Estimated per-person costs of 99DOTS for drug-sensitive TB were $98 in Bangladesh (n = 719), $119 in the Philippines (n = 396), and $174 in Tanzania (n = 976). Estimated per-person costs of VOT were $1,154 in Haiti (87 drug-sensitive), $304 in Moldova (173 drug-sensitive), $452 in Moldova (135 drug-resistant), and $661 in the Philippines (110 drug-resistant). 99DOTS costs may be similar to or less expensive than standard DOT. VOT is more expensive, although in some settings, labor cost offsets or economies of scale may yield savings. 99DOTS and VOT may yield savings to local programs if donors cover infrastructure costs.
Asunto(s)
Terapia por Observación Directa , Costos de la Atención en Salud , Humanos , Bangladesh , Haití , RentaRESUMEN
BACKGROUND: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement. METHODS: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers. DISCUSSION: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities. TRIAL REGISTRATION: The trial registration number is NCT05789875.
Asunto(s)
Infecciones por VIH , Humanos , Adolescente , Adulto Joven , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , VIH , Motivación , Terapia por Observación Directa , Proyectos Piloto , Estudios Retrospectivos , Antirretrovirales/uso terapéutico , Cumplimiento de la MedicaciónRESUMEN
O Estágio de Natureza Profissional, inserido no II Curso de Mestrado em Enfermagem Comunitária visa a aquisição de competências para a obtenção do grau académico de Mestre e o título profissional de Enfermeiro Especialista em Enfermagem Comunitária na área de Enfermagem de Saúde Comunitária e de Saúde Pública. Neste percurso académico pretende-se a aquisição e o desenvolvimento das Competências Comuns do Enfermeiro Especialista e as Competências Especificas do Enfermeiro Especialista em Enfermagem Comunitária na área de Enfermagem de Saúde Comunitária e de Saúde Pública. Este relatório procura descrever e efetuar uma reflexão crítica, objetiva e contextualizada das atividades desenvolvidas nos estágios integrantes do referido curso, analisando os seus contributos para o desenvolvimento das competências comuns e específicas supramencionadas. Expõe ainda, uma componente de investigação baseada na prática clínica cuja finalidade é contribuir para a melhoria dos cuidados prestados aos doentes com Tuberculose e que se encontram em regime de Toma de Observação Direta (TOD). A Tuberculose mantém-se como uma emergência de saúde pública a nível mundial, apesar de todos os esforços multissectoriais. A TOD é uma das cinco estratégias lançadas pela Organização Mundial de Saúde para o controlo desta doença e visa a supervisão do tratamento preconizado, assegurando o vínculo entre doente e família e a equidade no cuidar. O Enfermeiro, em especial o Enfermeiro de cuidados de saúde primários, é o profissional de saúde de excelência para alcançar o sucesso terapêutico, antecipando as dificuldades e minimizando as barreiras que conduzem ao seu abandono (Ordem dos Enfermeiros [OE], 2013). Já o Enfermeiro Especialista em Enfermagem Comunitária, pelas competências especificas intrínsecas à sua área de intervenção no desenvolvimento das diretrizes subjacentes aos programas de saúde, tem um papel preponderante na implementação de medidas para dar resposta a um dos principais problemas de saúde pública como é a Tuberculose (OE, 2008). Com o objetivo de conhecer a perceção dos Enfermeiros que integram o Conselho Técnico de um Agrupamento de Centros de Saúde da região Norte e que exercem funções nas Unidades de Saúde Familiar/Unidades de Cuidados de Saúde Personalizados, quanto à realização da TOD nos doentes com Tuberculose, na unidade funcional que representam, desenvolveu-se um estudo descritivo, com uma abordagem qualitativa, com recurso a um questionário semiestruturado. Os dados obtidos foram sujeitos a uma análise de conteúdo, segundo Bardin (2016). Verificou-se que os participantes reconhecem os principais objetivos da TOD e identificam os benefícios e as dificuldades da sua execução nas unidades funcionais que representam. Foram ainda, elencadas um conjunto de estratégias fundamentais para facilitar a implementação da TOD nas unidades onde exercem funções, nomeadamente a formação dos profissionais, o melhoramento dos circuitos de informação e a reorganização dos serviços.
The Professional Training Course, which is part of the II Master's Degree in Community Nursing, aims at acquiring the skills required to obtain the academic degree of Master and the professional title of Nurse Specialist in Community Nursing in the area of Community Health Nursing and Public Health Nursing. This academic journey aims to acquire and develop the Common Competences of the Nurse Specialist and the Specific Competences of the Nurse Specialist in Community Nursing in the area of Community Health and Public Health Nursing. This report, pretends to describe and make a critical, objective and contextualised reflection on the activities developed in the internships which were part of this course, analysing their contributions to the development of the previously mentioned, specific competencies. It also exposes a research component based on clinical practice whose purpose is to contribute to the improvement of the care provided to patients with Tuberculosis who are on Direct Observation treatment (DOT). Tuberculosis remains a public health emergency worldwide despite all multisectoral efforts. DOT is one of the five strategies set up by the World Health Organization for the control of this disease and aims a supervising the recommended treatment, ensuring the link between patient and family and equity in care. The Nurse, particularly the Primary Health Care Nurse, is the health professional of excellence in achieving therapeutic success, anticipating difficulties and minimising the barriers that lead to abandonment (Ordem dos Enfermeiros [OE], 2013). As for the Nurse Specialist in Community Nursing, due to the specific skills intrinsic to his/her area of intervention in the development of the guidelines underlying the health programmes, he/she plays a leading role in the implementation of measures to address one of the main public health problems, such as Tuberculosis (OE, 2008). With the purpose of understanding the perception of the nurses, who are members of the Technical Board of a Health Care Cluster of the Northern Region, and work at Family Health Units/Personalized Health Care Units, about the performance of DOT in patients with Tuberculosis in the functional unit they represent, a descriptive study with a qualitative approach was developed using a semi-structured questionnaire. The data obtained were subjected to content analysis, according to Bardin (2016). It was found that participants recognise the main objectives of DOT and identify the benefits and difficulties of its implementation in the functional units they represent. They also listed a set of key strategies to facilitate the implementation of DOT in the units where they work, namely training professionals, improving information circuits and reorganising services.
Asunto(s)
Tuberculosis , Enfermeros , Enfermería en Salud Comunitaria , Terapia por Observación DirectaRESUMEN
SUMMARY: The Saharia tribe of Madhya Pradesh has a very high tuberculosis (TB) burden. However, there is no report of adverse drug reaction (ADR) available in patients receiving anti-TB chemotherapy in the community. Reporting and monitoring of ADRs among TB patients is still rare in marginalized communities. An observational prospective study was performed from November 2019 to June 2020 to assess the patterns of ADRs in 250 Saharia TB patients, who were prescribed Category-I daily DOTS (HRZE) by the physician. Both male and female participants equally experienced ADR during the treatment, but relatively more females (92.6%) than males (88.6%) reported ADR during Phase I. Out of 250 patients, 224 patients (89.6%) experienced one or more ADRs in Phase I. The central nervous system-related (75.6%) ADR was mostly reported followed by any gastrointestinal (74.4%), cardiovascular (49.2%) and any dermatological related (44.4%) ADRs. It is paramount to timely monitor and proactively manages ADRs pertaining to anti-TB drug treatment with minimal alteration in the treatment course.