Directly Observed Therapy Research Articles

Experience and challenges delivering hepatitis C virus treatment for people who inject drugs in Kenya.

Despite having a higher risk of hepatitis C virus (HCV) infections, people who inject drugs (PWID) in sub-Saharan Africa (SSA) have limited access to HCV treatment. There is scarce literature on treatment delivery modalities that overcome logistical and financial barriers. We utilized different service delivery modalities to provide direct-acting antivirals (DAAs) to PWIDs infected with HCV through methadone clinics and needle and syringe program (NSP) sites in Kenya. In collaboration with Kenya's National AIDS and STI Control Programme (NASCOP), we enrolled individuals with active HCV infection confirmed by HCV RNA detection from methadone and NSP sites in Nairobi, Mombasa, and Kilifi counties. Liver function and hepatitis B virus (HBV) status were assessed at baseline. Those eligible for treatment were offered ledipasvir-sofosbuvir treatment provided by NASCOP through directly observed therapy (DOT). Participants completed a follow-up visit 12 weeks after completing treatment to measure sustained viral response (SVR-12). Challenges faced while delivering HCV treatment at participating sites included the limited availability and reliability of laboratory assays, and financial constraints faced by PWIDs to attend daily DOT. Based on our experience, strategies to deliver HCV treatment for PWID in Kenya should consider improving the availability of laboratory tests and prioritizing treatment through methadone centers to achieve good outcomes.

Video-observed therapy (VOT) vs directly observed therapy (DOT) for tuberculosis treatment: A systematic review on adherence, cost of treatment observation, time spent observing treatment and patient satisfaction.

Tuberculosis (TB) treatment demands strict adherence to multidrug regimens. Directly Observed Therapy (DOT) poses challenges, especially regarding adherence. With the popularization of smartphones, Video-Observed Therapy (VOT) has emerged as a promising alternative, allowing healthcare providers to remotely supervise patients taking their medications via video calls. This systematic review critically assesses VOT's effectiveness compared to DOT, focusing on adherence, treatment costs, time spent supervising treatment, and patient satisfaction, aiming to optimize TB supervision methods worldwide. Only studies that met the following criteria were eligible for inclusion in the systematic review: randomized trials; studies that compared VOT to DOT; studies involving patients diagnosed with pulmonary or extrapulmonary tuberculosis; studies that reported any of the desired outcomes; full-text articles available for review; and studies conducted in the English language. We excluded studies with the following attributes: studies that lacked a control group; case series or case reports; and previous systematic reviews. The search engines and databases MEDLINE, Embase, and Cochrane were used to find studies comparing Video-Observed Therapy (VOT) to Directly Observed Therapy (DOT). The following search phrases were used to look for papers that contained them in their title or abstract: ("Electronic Directly Observed Therapy" OR "Video-observed therapy" OR "Telemedicine" OR "Wirelessly observed therapy" OR "Smartphone-enabled video-observed") AND ("TUBERCULOSIS"). A systematic review of the literature revealed the following findings: in all Randomized Controlled Trials (RCTs), video-observed therapy (VOT) demonstrated non-inferiority in terms of treatment adherence compared to traditional directly observed therapy (DOT); VOT reduced costs where these outcomes were assessed in the RCTs; the use of VOT reduced the amount of time healthcare professionals spent supervising treatment in RCTs evaluating this aspect; VOT contributed to higher treatment satisfaction in RCTs where this outcome was measured. In this systematic review we emphasize the importance of Video-Observed Therapy (VOT) in the digital age for patients that have access to internet. Our findings show that VOT is comparable to DOT in terms of treatment adherence, but it is also cost-effective, improves patient satisfaction and takes less time for healthcare professionals to supervise.

Understanding the impact of pandemics on long-term medication adherence: directly observed therapy in a tuberculosis treatment cohort pre- and post-COVID-19 lockdowns

BackgroundThe COVID-19 pandemic negatively impacted tuberculosis (TB) treatment services, including directly observed therapy (DOT) programs used to promote medication adherence. We compared DOT adherence embedded in a research study before and after COVID-19 lockdowns in South Africa.MethodsWe analyzed data from 263 observational study participants undergoing drug susceptible (DS)-TB DOT between May 2017 to March 2022. Participants enrolled before October 2019 were considered ‘pre-COVID-19’ and those enrolled after September 2020 were considered ‘post-COVID-19 lockdown groups. Negative binomial regression models were used to compare DOT non-adherence rates between the two lockdown groups. We then conducted a sensitivity analysis which only included participants enrolled in the immediate period following the first COVID-19 lockdown.ResultsDOT non-adherence rate was higher in the post-COVID-19 lockdown group (aIRR = 1.42, 95% CI = 1.04–1.96; p = 0.028) compared to pre-COVID-19 lockdown period, adjusting for age, sex, employment status, household hunger, depression risk, and smoked substance use. DOT non-adherence was highest immediately following the initial lockdown (aIRR = 1.74, 95% CI = 1.17–2.67; p = 0.006).ConclusionThe COVID-19 lockdowns adversely effected adherence to TB DOT in the period after lockdowns were lifted. The change in DOT adherence persisted even after adjusting for socioeconomic and behavioral variables. We need a better understanding of what treatment adherence barriers were exacerbated by COVID-19 lockdowns to improve outcomes in post-pandemic times.Trial registrationClinicalTrials.gov Registration Number: NCT02840877. Registered on 19 July 2016.

APERFEIÇOAMENTO SOBRE O RASTREIO DA TUBERCULOSE PARA OS AGENTES COMUNITÁRIOS DE SAÚDE DA ESTRATÉGIA DE SAÚDE DA FAMÍLIA DO NASCENTE I E II EM ARARIPINA-PE.

Tuberculosis (TB), a disease formerly described as typhus, was known in the 19th century as the white plague, decimating hundreds of thousands of people around the world. TB can be caused by any of the seven species that make up the Mycobacterium tuberculosis complex: M. tuberculosis, M. bovis, M. africanum, M. canetti, M. microti, M. pinnipedi and M. caprae. M. tuberculosis is transmitted by air, from a person with pulmonary or laryngeal TB, who eliminates bacilli in the environment (source case), to another person, by inhaling aerosols from coughing, talking or sneezing. Primary pulmonary TB usually occurs after the individual's first contact with the bacillus and is therefore more common in children. Its main characteristic is a dry or productive cough. Evening fever, without chills, does not usually exceed 38.5ºC. Night sweats and anorexia are common. Tuberculosis is a serious disease, but it is curable in the vast majority of cases, as long as the treatment is followed correctly. In Brazil, treatment is standardized and free of charge, provided by the National Tuberculosis Control Program (PNCT) in Health Units. In Brazil, tuberculosis treatment is standardized and consists of two phases: intensive and maintenance. The basic regimen recommended by the Ministry of Health (BRASIL, 2019) for adults and adolescents aged 10 and over includes rifampicin, isoniazid, pyrazinamide and ethambutol (RHZE). Directly Observed Treatment (DOT) is a fundamental strategy for ensuring patient adherence to tuberculosis treatment and reducing abandonment rates. Adopted by the Ministry of Health (MoH) based on WHO recommendations, DOT consists of direct observation of drug intake by health professionals. Community health workers (CHWs) are essential for tuberculosis control, from diagnosis to the outcome of cases. Their duties include Spreading the word to their community about tuberculosis as an important current public health problem. Educate the population about airborne transmission of tuberculosis and the preventive measures that can be adopted. To be aware of the main symptoms of tuberculosis (cough, fever, weight loss and night sweats) at all meetings with the community, as well as publicizing them, and referring suspected cases to the health unit.

Tuberculosis-related deaths at a tertiary hospital in Zambia: Insights into the prevalence and associated factors.

Tuberculosis (TB) mortality remains a significant public health concern globally. This study aimed to determine the prevalence of tuberculosis-related deaths and associated factors among patients at Livingstone University Teaching Hospital (LUTH) Chest Clinic, Zambia. We conducted a retrospective cross-sectional study among 694 individuals (507 adult and 187 children) diagnosed with drug susceptible TB disease between January 1, 2021, and December 31, 2022. Demographic and clinical information were collected from medical records using a data collection form. Multivariable logistic regression was used to determine factors associated with TB-related death. Statistical significance was set at p < 0.05. STATA version 15 was used for all data analysis. The prevalence of TB-related death among adults (above 19 years old) was 18.4% (n = 93) whereas that in children (below 19 years old) was 7.0% (n = 187). Living with HIV (AOR 1.75, 95% CI 1.00-3.08, p = 0.049) was positively associated with TB-related death among the adult patients while being on a family based direct observation therapy (DOT) plan was negatively associated with TB-related death both among adults and among children, (AOR 0.24, 95% CI 0.13-0.45, p <0.001) and (AOR 0.2, 95% CI 0.03-0.99, p = 0.039) respectively. This study found a high TB-related mortality rate, both among adults and children, exceeding the national target of 5% and it was significantly associated with HIV status and DOT plan. There is therefore a need to enhance strategies aimed at reducing TB-related deaths, especially among those living with HIV.

Knowledge, attitude and perceived barriers related to directly observed treatment, short-course among patients and caregivers attending tuberculosis clinics: a cross-sectional survey.

Tuberculosis (TB) is a major worldwide health problem, particularly in India, where it accounts for a quarter of infections. Adherence to the directly observed treatment, short-course (DOTS), which is necessary for TB treatment, is difficult in resource-limited circumstances. This study addressed the knowledge, attitude, and perceived barriers related to TB and DOTS adherence among patients and caregivers. A cross-sectional survey was undertaken at the selected TB clinics between November 2023 and March 2024. Purposive sample yielded 180 patients and 217 caregivers. Data were obtained using validated, self-structured questionnaires that assessed knowledge, attitude, and perceived barriers to TB and DOTS adherence. Statistical analysis was carried out with IBM SPSS version 23.0. The study found that caregivers had considerably greater TB knowledge than patients (p<0.05). Many patients misunderstood the cause of TB (50.6%) and embraced various misconceptions about the disease, such as TB spreading by shaking hands or sharing food, swimming in a holy river to cure diseases, and TB being the result of sin or karmic retribution. Distance to treatment facilities (95.6%), the necessity to take time off from work (91.7%), and social stigma (65.0%) were identified as the top three barriers to DOTS adherence. The study highlighted considerable gaps in knowledge, distant healthcare facilities, busy work schedules, and social stigma as barriers to TB treatment adherence in Deoghar, Jharkhand. Addressing these challenges via focused education and support activities is essential for enhancing DOTS adherence and TB treatment outcomes.

Tuberculosis patients’ satisfaction with directly observed treatment short course strategy and associated factors in Southern Ethiopia: a mixed method study

AabstractBackgroundTuberculosis (TB) is a second major global public health problem and the leading infectious cause of death in Ethiopia. Patients under directly observed treatment short-courses (DOTs) have a higher treatment success rate and reduced drug resistance. A successful treatment outcome and adherence to the treatment are related to patient satisfaction with the DOT strategy. Client satisfaction is one of the indicators of the quality of care. In this perspective, there were limited studies in Ethiopia related to patient satisfaction with the DOTs strategy in the prevention and control of TB to achieve the ‘’END TB Strategy.’’ Therefore, this study was aimed at identifying the TB patients’ satisfaction with the DOTs strategy and associated factors in Gamo Zone, Southern Ethiopia.MethodsAn institutional-based cross-sectional study design for quantitative data and a phenomenological approach were employed for qualitative data. The calculated sample size was 374. A systematic random sampling method was used to select study participants. A pre-tested structured interviewer-administered questionnaire for quantitative data and focus group discussions (FGDs) for qualitative data were used for data collection. Bivariable and multivariable analyses were used. The determinants with a p-value < 0.05 were declared to have a significant association with the outcome variable, and an adjusted odd ratio with a 95% confidence interval (CI) was used.ResultsA total of 358 patients participated in the study, with a response rate of 95.72%. The majority of study participants’ ages ranged between 25 and 34 years. The tuberculosis DOT satisfaction rate was 61.17% [56.10-66.25%, 95%CI]. The TB patients who took treatment for 20 weeks or more were 3.97 times [AOR = 3.97; 95% CI (1.55–10.16)] more likely to be satisfied with the DOTs service provided. However, the participants who perceived transport costs as high were 79% [AOR = 0.21; 95% CI (0.06–0.71)] less likely to be satisfied with DOTs. Qualitatively, the participants reported that there was a major problem with laboratory services, which resulted in delays and long appointments to get the results in addition to lack of clean toilets and safe water to swallow medications.ConclusionThe satisfaction rate for tuberculosis DOTs observed in this study appears to be relatively lower in comparison to other studies. Availing DOTs service nearby patients to enhance the accessibility of the service is crucial to improving patients’ satisfaction with DOTs service. Reducing laboratory result delays by improving laboratory service is essential to enhancing patients’ satisfaction with DOTs. Moreover, improving toilet services, and availing safe water to swallow medications is recommended to enhancing patients’ satisfaction with DOTs service.

Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration

ABSTRACT Pre-exposure prophylaxis (PrEP) adherence remains a challenge among young men who have sex with men (MSM). We developed and tested a smartphone application (“app”), “DOT Diary”, which combines automated directly observed therapy (DOT) with information about PrEP protection levels, pill-taking reminders, a sexual behavior diary, and a PrEP dosing calendar. To contextualize trial results, we qualitatively explored participants’ app experiences. The trial enrolled 100 young MSM in San Francisco and Atlanta. Participants were randomized 2:1 to DOT Diary versus standard-of-care and followed for 24 weeks. Interviews were conducted with 24 intervention participants. Data were analyzed using a memo-writing approach. Most expressed overall satisfaction with the app (“it was good for its purpose”), despite concerns about technical glitches. The most popular app features were the monthly calendar showing days PrEP was taken and information about level of protection based on pills taken. The DOT component helped participants establish PrEP routines. The reminders were “annoying but effective” at motivating dosing. Opinions about the sexual behavior diary varied. Overall, DOT Diary was acceptable; participants were willing to use it daily to record pill-taking. Critical components included the information about PrEP protection levels and calendar, while others may be modified to improve future success. Trial registration: ClinicalTrials.gov identifier: NCT03771638.

Evaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial.

Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We conducted an inductive thematic analysis and aligned the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as required enabled acceptance for patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, and collaboration among HCPs enabled, whereas initial concerns about 3HP safety among HCPs delayed 3HP adoption and implementation. SAT was maintained post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up.

The Impact of Directly Observed Therapy of Weekly Iron Supplementation Program in Female Adolescent Hemoglobin Status

In adolescents, nutrition is an important factor in the growth and development process, especially during the growth spurt period that occurs in early adolescence and is characterized by physical, cognitive, and reproductive organ growth and maturation of reproductive organs. Inadequate nutrition during adolescence will cause various problems, one of which is anemia. Anemia has negative impacts, including impaired growth and development, decreased learning achievement, and impaired immunity, thus increasing the occurrence of infections and reproductive disorders. This research is quasi-experimental with a one-group pretest-posttest approach. The research was conducted at Muhammadiyah I Lamongan Vocational School with a total of 44 female students. The sampling technique used in this research was total sampling. Research data analysis was carried out using the paired T-test statistical test. The results of the study showed that carrying out Directly Observed Therapy (DOT) while administering Fe tablets for 12 weeks was able to significantly increase Fe levels in adolescents, with a p-value of 0.000 (p&lt;0.05).

Adverse events reported during weekly isoniazid-rifapentine (3HP) tuberculosis preventive treatment among people living with HIV in Uganda.

Short-course tuberculosis (TB) prevention regimens, including 12 weeks of isoniazid and rifapentine (3HP), are increasingly used in high TB-burden countries. Despite established safety and tolerability in efficacy trials, 3HP-related adverse events (AE) could differ in routine settings. Real-world data on AE type, frequency, and timing is crucial for health systems considering 3HP programmatic scale-up. We reviewed AEs among people living with HIV (PLHIV) participating in a pragmatic implementation trial of facilitated 3HP taken by directly observed therapy (DOT) or self-administered therapy (SAT) in Kampala, Uganda, and classified them using the Common Terminology Criteria for Adverse Events. We assessed AE timing and summarized related clinical actions including lab tests, diagnoses made, medications prescribed, and treatment interruptions. Among 1655 PLHIV treated between July 2020-September 2022, 270 (16.3%) reported 451 events; main issues included general (7%), nervous system (6%), musculoskeletal (5%), gastrointestinal (5%), and dermatologic (3%) disorders. Most (61%) occurred within 6 weeks of initiating 3HP. Among those with events, 211 (78%) required further clinician evaluation, 202 (75%) required laboratory testing, 102 (38%) had medications prescribed, 40 (15%) had treatment paused, and 14 (5%) discontinued 3HP. Women, those multidimensionally impoverished, and DOT recipients were more likely to report an AE. SAT users and later enrollees were more likely to have 3HP interrupted or stopped due to an AE. In a routine setting, 3HP was safe with 16% of PLHIV reporting AEs and only 3% requiring temporary or permanent treatment interruption. These findings support 3HP expansion in routine HIV/AIDS care settings for TB prevention.

Analysis of the Vulnerability Profile of tuberculosis co-infection in people living with HIV

Introduction: studies that seek to identify and outline the vulnerability profile contribute to directing necessary interventions to be carried out in people with tuberculosis (TB) and HIV (acronym in English for human immunodeficiency virus) co-infection, to achieve the end of TB. Objective: to describe the profile of people with tuberculosis and HIV co-infection, from 2016 to 2018, in Espírito Santo, Brazil. Methods: this is a cross-sectional descriptive study, using secondary data from the Notifiable Diseases Information System (SINAN) for TB and HIV, through a methodological process of database preparation and descriptive data analysis, the information was encoded and stored anonymously in a database in Excel for Windows®; Afterwards, the STATA statistical package, version 16 (Stata Corp LP, College Station, TX, USA) was used to carry out descriptive analyses with identification of relative and absolute values, and tables were generated for data analysis. The study was approved by the Research Ethics Committee of the Health Sciences Center of the Federal University of Espírito Santo (CEP/CCS/UFES) under opinion number 4022892 on 05/12/2020. Results: of a total of 4,428 cases, 325 cases were TB-HIV co-infection, 322 cases were located in the SINAN-TB database and three cases were located after linking with the SINAN-HIV database that presented a record of negative results for the diagnostic test of HIV in the SINAN-TB database. There was a profile with a predominance of men (71%), young people (20 to 39 years old) (52%), mixed race (59%), up to 8 years of schooling (25%), of which 29% reported alcohol consumption, 26% used illicit drugs, and 37% were smokers, who had the pulmonary form of the disease (66%), they reported adherence to antiretroviral therapy (65%) and only 44% had a cure outcome at closure and 20% stopped treatment; the majority of cases (61%) did not undergo directly observed treatment and only 6.9% of cases reported receiving assistance from the government’s income transfer program. Conclusion: in order to ensure greater coverage of tuberculosis control in PLHIV patients, it is necessary to expand the dialogue between health and social support policies; enable access to health services such as antiretroviral treatment for all people diagnosed with HIV, and timely directly observed treatment (DOT) for people who present this vulnerability profile. Carrying out new studies is essential to contribute to technological advancement and planning in health service actions.

Knowledge, Attitude and Factors Associated with Depression in Tuberculosis Patients Attending Directly Observed Treatment Short-course (DOTS) Centers in South-West Nigeria

Knowledge, Attitude and Factors Associated with Depression in Tuberculosis Patients Attending Directly Observed Treatment Short-course (DOTS) Centers in South-West Nigeria

Impact of HIV coinfection on tuberculosis treatment outcomes in Ethiopia: a systematic review and meta-analysis

ObjectivesDespite the implementation of a short-term direct observation treatment programme, HIV coinfection is one of the main determinants of tuberculosis (TB) treatment success. This meta-analysis was conducted to report the...

Exploring the Biochemical Mechanisms of Fluoroquinolone Compounds against Tuberculosis by Utilizing Molecular Docking and Quantitative Structure-amino Acid Relationship

Background: Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis (Mtb). It is one of the leading causes of death of 1.5 million people each year. TB can be treated by directly observed treatment short course (DOTS), but due to multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis, consequences can be devastating if the single DOTS dose is missed by the patient. MDR and XDR-TB require much more attention and time to control the infection. The longer period of tuberculosis treatment has side effects and it is expensive. Objectives: This alarming condition demands the development of novel processes to diagnose the disease in its early stage as well as to produce more promising antimicrobial chemotherapeutics. The current study aimed to explore molecular mechanisms involving docking simulation-based quantitative structureamino acid relationship (QSAAR) in order to have a better understanding of the interactions between the fluoroquinolones and Mtb DNA gyrase. Methods: In this study, 24 fluoroquinolone (FQ) compounds present in the literature were selected and docked against the Mtb DNA gyrase. Further, the relationship between the minimum inhibitory concentration of the compounds and interacting amino acids was assessed using QSAAR. Results: The study has established a novel method of formulating a quantitative structure-amino acid relationship. A significant correlation (R-value=0.829) between biological activity and the docked amino acid residues responsible for producing anti-tubercular activities has been obtained. Conclusion: The predicted residues captured in the developed model have been explored to report the Mtb virulence.

The effect of a health education programme on Tuberculosis infection prevention and control practices among HIV-positive patients at three tertiary hospitals in Ogun state, southwest Nigeria

Objective: This research evaluated the impact of a peer-support health education programme on tuberculosis infection prevention and control practices among HIV-positive patients receiving anti-retroviral therapy (ART) in a tertiary hospital. Methods: A quasi-experimental design was used for this study. Forty respondents were randomly selected between January and April 2023. Two tertiary health institutions in Ogun State, Nigeria with Direct Observation Treatment Shortcut programme were purposively selected. Systematic sampling was used to select the participants from the selected facilities and they were grouped into one experimental group (EG) and one control Group (CG). The intervention was implemented for six weeks and data were collected at baseline, immediate post-intervention and at 12th-week follow-up. Results: At the 12th-week follow-up, the peer-supported health education intervention had a significant effect (t78=14.21, effect size =3.09, p &lt;0.05) on the Intervention Group with a mean score (X̅) of 6.85±0.86 compared to the Control Group (CG) with a mean score (X̅) of 3.95±0.96. Furthermore, among the Intervention Group, there is a significant difference (t39=19.0, effect size =3.06, p &lt;0.05) in the effect of the peer-supported health education intervention program on TB infection prevention practices of participants at baseline (X̅ =3.98±0.73) and also at 12th weeks follow-up (X̅ =6.90±0.71). Conclusion: There was a significant association between the intervention and improvement in TB infection prevention and control practices. More focus should be placed on peer-supported health education TB prevention interventions among HIV patients. Also, the National Tuberculosis Control Programme should adopt peer-supported health education interventions to improve prevention practices.

Effectiveness, Safety, and Acceptability of Primaquine Mass Drug Administration in Low-Endemicity Areas in Southern Thailand: Proof-of-Concept Study.

A challenge in achieving the malaria-elimination target in the Greater Mekong Subregion, including Thailand, is the predominance of Plasmodium vivax malaria, which has shown extreme resilience to control measures. This proof-of-concept study aimed to provide evidence for implementing primaquine mass drug administration (pMDA) as a strategy for P. vivax elimination in low-endemicity settings. The study employed a mixed-methods trial to thoroughly evaluate the effectiveness, safety, acceptability, and community engagement of pMDA. The quantitative part was designed as a 2-period cluster-crossover randomized controlled trial. The intervention was pMDA augmented to the national prevention and control standards with directly observed treatment (DOT) by village health volunteers. The qualitative part employed in-depth interviews and brainstorming discussions. The study involved 7 clusters in 2 districts of 2 southern provinces in Thailand with persistently low P. vivax transmission. In the quantitative part, 5 cross-sectional blood surveys were conducted in both the pMDA and control groups before and 3 months after pMDA. The effectiveness of pMDA was determined by comparing the proportions of P. vivax infections per 1000 population between the 2 groups, with a multilevel zero-inflated negative binomial model adjusted for cluster and time as covariates and the interaction. The safety data comprised adverse events after drug administration. Thematic content analysis was used to assess the acceptability and engagement of stakeholders. In the pre-pMDA period, the proportions of P. vivax infections in the pMDA (n=1536) and control (n=1577) groups were 13.0 (95% CI 8.2-20.4) and 12.0 (95% CI 7.5-19.1), respectively. At month 3 post-pMDA, these proportions in the pMDA (n=1430) and control (n=1420) groups were 8.4 (95% CI 4.6-15.1) and 5.6 (95% CI 2.6-11.5), respectively. No statistically significant differences were found between the groups. The number of malaria cases reduced in all clusters in both groups, and thus, the impact of pMDA was inconclusive. There were no major safety concerns. Acceptance among the study participants and public health care providers at local and national levels was high, and they believed that pMDA had boosted awareness in the community. pMDA was associated with high adherence, safety, and tolerability, but it may not significantly impact P. vivax transmission. As this was a proof-of-concept study, we decided not to scale up the intervention with larger clusters and samples. An alternative approach involving a targeted primaquine treatment strategy with primaquine and DOT is currently being implemented. We experienced success regarding effective health care workforces at point-of-care centers, effective collaborations in the community, and commitment from authorities at local and national levels. Our efforts boosted the acceptability of the malaria-elimination initiative. Community engagement is recommended to achieve elimination targets. Thai Clinical Trials Registry TCTR20190806004; https://www.thaiclinicaltrials.org/show/TCTR20190806004.

Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial.

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. 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. 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. 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). 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. Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh. RR2-10.2196/38796.

Tuberculosis and HIV/AIDS coinfection in patients attending Directly Observed Treatment Short-course (DOTS) centers in Anambra State, Nigeria: A retrospective study.

This study retrospectively assessed the prevalence of TB and human immunodeficiency virus (HIV)/AIDScoinfection among patients that attended the Directly Observed Treatment Short-course (DOTS) centers in Anambra State, Southeast, Nigeria, between 2013 and 2017. The study adopted a descriptive and retrospective epidemiological survey design. A total of 1443 case files of patients aged 15-60 who were treated in DOTS centers selected from Anambra State's 21 Local Government Areas between 2013 and 2017 were investigated. The uniform data form, a standardized instrument used in Anambra State's health facilities for data collection, was used to collect data from case files of all those identified as coinfected with TB and HIV/AIDS. The mean prevalence rate of TB and HIV/AIDS coinfection in the state during the 5-year period (2013-2017) was 20.00%. The highest annual prevalence of TB and HIV/AIDS coinfection was recorded in 2014 (23.84%). The state's prevalence of TB and HIV/AIDS coinfection increased dramatically from 13.17% in 2013to 23.84% in 2014, followed by a slight downward trend to 22.80% in 2015, 20.17% in 2016, and 20.03% in 2017. In terms of gender, age, marital status, and occupation, females (59.5%), those aged 15 to 25 years (30.7%), married people (43.90%), and traders/business owners (50.7%), respectively, had the highest rates of tuberculosis and HIV/AIDS coinfection during the study period. The findings of this study show that young people, females, married people, and traders/business owners appear to be the most vulnerable groups affected by TB and HIV/AIDS coinfection, accounting for the majority of the disease burden in the state. To address the high prevalence of TB and HIV/AIDS coinfection in the Anambra State, novel intervention and control programs should be developed and implemented, and existing intervention frameworks should be strengthened.

Perception, acceptability and challenges of digital adherence technology among TB healthcare workers

&lt;sec&gt;&lt;title&gt;INTRODUCTION&lt;/title&gt;Successful treatment of TB requires high levels of adherence to treatment. This has been found to be below optimal with directly observed therapy (DOT), and digital adherence technologies (DATs) offer a promising approach to non-adherence to medication and improving treatment outcomes. This study explores the perception, acceptability, and challenges of DATs among healthcare workers (HCWs).&lt;/sec&gt;&lt;sec&gt;&lt;title&gt;METHODS&lt;/title&gt;The study was conducted in eight states in Nigeria among Health Care workers involved in treating patients with TB. This was a descriptive cross-sectional study using an open questionnaire and analysed using IBM SPSS v25.&lt;/sec&gt;&lt;sec&gt;&lt;title&gt;RESULTS&lt;/title&gt;Twenty-three HCWs (95.8%) agreed that DATs helped them provide better support and counselling to their patients. All of them would recommend DATs to their patients and found it easy to explain them. Eleven (45.8%) of them were not able to use DATs on a few occasions; their reasons were poor network (n = 9, 37.5%) and (n = 1, 4.2%) power failure.&lt;/sec&gt;&lt;sec&gt;&lt;title&gt;CONCLUSION&lt;/title&gt;DATs help HCWs provide better support and care regarding real-time tracking of their patients’ adherence to treatment and possibly reduction of attrition. This implies that DATs are a suitable alternative to DOT to help HCWs provide the best care and support to their patients towards achieving the End TB targets.&lt;/sec&gt;