Transition to an in-facility electronic Tuberculosis register: Lessons from a South African pilot project

Myburgh, Hanlie; Peters, Remco P. H.; Hurter, Theunis; Grobbelaar, Cornelius J.; Hoddinott, Graeme

doi:10.4102/sajhivmed.v21i1.1025

Cited by 6 publications

(4 citation statements)

References 22 publications

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“…We initially planned a confirmatory second data source for the primary outcome using clinic-maintained TB registers from which study personnel abstracted the total number of TB cases diagnosed by that clinic each month. However, during the period of study implementation, clinic-based TB registers were replaced with an electronic system, Tier.net [ 29 ]. It was apparent that clinic TB registers were not standardized; some did not differentiate between patients diagnosed in the clinic and those initially diagnosed elsewhere and referred to the clinic, or between laboratory and clinically diagnosed patients.…”

Section: Methodsmentioning

confidence: 99%

Evaluating systematic targeted universal testing for tuberculosis in primary care clinics of South Africa: A cluster-randomized trial (The TUTT Trial)

Martinson¹,

Genade²,

Berhanu³

et al. 2023

PLoS Med

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Background The World Health Organization (WHO) recommends systematic symptom screening for tuberculosis (TB). However, TB prevalence surveys suggest that this strategy does not identify millions of TB patients, globally. Undiagnosed or delayed diagnosis of TB contribute to TB transmission and exacerbate morbidity and mortality. We conducted a cluster-randomized trial of large urban and rural primary healthcare clinics in 3 provinces of South Africa to evaluate whether a novel intervention of targeted universal testing for TB (TUTT) in high-risk groups diagnosed more patients with TB per month compared to current standard of care (SoC) symptom-directed TB testing. Methods and findings Sixty-two clinics were randomized; with initiation of the intervention clinics over 6 months from March 2019. The study was prematurely stopped in March 2020 due to clinics restricting access to patients, and then a week later due to the Coronavirus Disease 2019 (COVID-19) national lockdown; by then, we had accrued a similar number of TB diagnoses to that of the power estimates and permanently stopped the trial. In intervention clinics, attendees living with HIV, those self-reporting a recent close contact with TB, or a prior episode of TB were all offered a sputum test for TB, irrespective of whether they reported symptoms of TB. We analyzed data abstracted from the national public sector laboratory database using Poisson regression models and compared the mean number of TB patients diagnosed per clinic per month between the study arms. Intervention clinics diagnosed 6,777 patients with TB, 20.7 patients with TB per clinic month (95% CI 16.7, 24.8) versus 6,750, 18.8 patients with TB per clinic month (95% CI 15.3, 22.2) in control clinics during study months. A direct comparison, adjusting for province and clinic TB case volume strata, did not show a significant difference in the number of TB cases between the 2 arms, incidence rate ratio (IRR) 1.14 (95% CI 0.94, 1.38, p = 0.46). However, prespecified difference-in-differences analyses showed that while the rate of TB diagnoses in control clinics decreased over time, intervention clinics had a 17% relative increase in TB patients diagnosed per month compared to the prior year, interaction IRR 1.17 (95% CI 1.14, 1.19, p < 0.001). Trial limitations were the premature stop due to COVID-19 lockdowns and the absence of between-arm comparisons of initiation and outcomes of TB treatment in those diagnosed with TB. Conclusions Our trial suggests that the implementation of TUTT in these 3 groups at extreme risk of TB identified more TB patients than SoC and could assist in reducing undiagnosed TB patients in settings of high TB prevalence. Trial registration South African National Clinical Trials Registry DOH-27-092021-4901.

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Section: Methodsmentioning

confidence: 99%

Evaluating systematic targeted universal testing for tuberculosis in primary care clinics of South Africa: A cluster-randomized trial (The TUTT Trial)

Martinson¹,

Genade²,

Berhanu³

et al. 2023

PLoS Med

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“… 9 Complete trust of electronic systems to have the ability to perform tasks appropriately and efficiently so as to satisfy the end users is sometimes unachievable. 10 Some researchers also expressed fears of reliance on an electronic system for updates especially in case of a system breakdown. Fears or uncertainties about the future of information systems have been reported in low resource settings.…”

Section: Discussionmentioning

confidence: 99%

Researchers experience of using the regulatory affairs information system (RAIS) in strengthening research compliance in a large research program: A case study of the Infectious Diseases Institute (IDI) in Uganda

et al. 2022

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Objective The aim of this study was to explore researchers’ experience of using the regulatory affairs information system (RAIS) in strengthening research compliance to national ethics guidelines through tracking ethics and regulatory approvals for research projects at the Infectious Diseases Institute. Methods We conducted a cross-sectional study using purposive sampling of 50 participants who were principal investigators (PI) and study coordinators (SC) of active projects between November 2019 and January 2020. Only 36 of them responded to the survey. We also conducted 12 key informant interviews among PI, SC, and research management at the Institute. We used STATA 13 to analyze responses to the survey. The interviews lasted between 20 and 30 min. We used NVivo 10 software to manage the transcripts and generation of themes. Results Majority 19 (52.8%) of those who participated in the survey were study coordinators, 19 (52.8%) had participated in more than 5 research studies, 28 (90.3%) had ever received a notification from the RAIS and 26 (92.9%) submitted requests for renewal of their studies approvals to Ethics committees and regulatory bodies 4 weeks prior to expiration dates. The study also examined participants’ general understanding of the regulatory requirements and all were aware that RECs and NDA grant approval for a period of 1 year, and 35 (97.2%) that UNCST grants approval for the duration of the study. Three prominent themes; researchers’ experiences, benefits, and shortcomings of RAIS were generated from the key informant interviews. Discussion Having experience in research coupled with a novel automated system provides a platform for a better understanding of research regulatory requirements, hence compliance to the national guidelines. Conclusion Our case study demonstrates that supporting researchers and research institutions in low resource settings with an automated system in tracking expiration dates for research approvals can facilitate compliance to national ethics guidelines.

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“…Young people aged 12–24 who had a documented HIV positive test result in one of the nine HDSS public healthcare facilities were recruited for study participation. Recruitment was based on HIV test results recorded in Tier.net, the national electronic HIV/ART monitoring platform [ 34 , 35 ], or the HDSS-Clinic Link System used to track patient outcomes, described below. To maximize study participation among individuals both in and out of HIV care, recruitment was conducted using a three-pronged approach: through trained study staff, area medical providers, and home-based care providers who regularly interact with YWH in their coverage areas.…”

Section: Methodsmentioning

confidence: 99%

Associations Between Key Psychosocial Stressors and Viral Suppression and Retention in Care Among Youth with HIV in Rural South Africa

et al. 2021

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Despite improvements in access to antiretroviral treatment over the past decade, sub-optimal HIV care outcomes persist among youth with HIV (YWH) in rural South Africa. Psychosocial stressors could impede improved HIV treatment outcomes within this population. We linked self-reported psychosocial health and demographic data from a cross-sectional survey conducted among YWH aged 12–24 in rural South Africa to individual medical record data, including facility visit history and viral load measurements. Poisson regression with robust standard errors was used to estimate the associations between five psychosocial stressors- heightened depressive symptoms (Center for Epidemiological Studies-Depression scale scores ≥ 16), lower social support (Medical Outcomes Social Support Scale scores ≤ 38), lower resilience (Conner-Davidson Resilience Scale scores ≤ 73), lower self-esteem (Rosenberg Self-Esteem Scale scores ≤ 21), and higher perceived stress (Sheldon Cohen Perceived Stress Scale scores ≥ 10)- and viral non-suppression (viral load ≥ 400 copies/mL) and loss to care (no documented clinic visits within the 90 days prior to survey), separately. A total of 359 YWH were included in this analysis. The median age of study participants was 21 (interquartile range: 16–23), and most were female (70.2%), single (82.4%), and attending school (54.7%). Over a quarter of participants (28.1%) had heightened depressive symptoms. Just 16.2% of all participants (n = 58) were lost to care at the time of survey, while 32.4% (n = 73) of the 225 participants with viral load data were non-suppressed. The prevalence of non-suppression in individuals with lower self-esteem was 1.71 (95% confidence interval: 1.12, 2.61) times the prevalence of non-suppression in those with higher self-esteem after adjustment. No meaningful association was observed between heightened depressive symptoms, lower social support, lower resilience, and higher perceived stress and viral non-suppression or loss to care in adjusted analyses. Retention in care and viral suppression among YWH in rural South Africa are below global targets. Interventions aimed at improving viral suppression among YWH should incorporate modules to improve participant’s self-esteem as low self-esteem is associated with viral non-suppression in this setting. Future studies should longitudinally explore the joint effects of co-occurring psychosocial stressors on HIV care outcomes in YWH and assess meaningful differences in these effects by age, gender, and route of transmission.

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Transition to an in-facility electronic Tuberculosis register: Lessons from a South African pilot project

Cited by 6 publications

References 22 publications

Evaluating systematic targeted universal testing for tuberculosis in primary care clinics of South Africa: A cluster-randomized trial (The TUTT Trial)

Evaluating systematic targeted universal testing for tuberculosis in primary care clinics of South Africa: A cluster-randomized trial (The TUTT Trial)

Researchers experience of using the regulatory affairs information system (RAIS) in strengthening research compliance in a large research program: A case study of the Infectious Diseases Institute (IDI) in Uganda

Associations Between Key Psychosocial Stressors and Viral Suppression and Retention in Care Among Youth with HIV in Rural South Africa

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