Browsing by Author "Naledi, Tracey"

Now showing 1 - 8 of 8
  • Thumbnail Image
    Item
    Open Access
    Adverse drug reactions in South African patients receiving bedaquiline-containing tuberculosis treatment: an evaluation of spontaneously reported cases
    (2019-06-20) Jones, Jackie; Mudaly, Vanessa; Voget, Jacqueline; Naledi, Tracey; Maartens, Gary; Cohen, Karen
    Background Bedaquiline was recently introduced into World Health Organization (WHO)-recommended regimens for treatment of drug resistant tuberculosis. There is limited data on the long-term safety of bedaquiline. Because bedaquiline prolongs the QT interval, there are concerns regarding cardiovascular safety. The Western Cape Province in South Africa has an established pharmacovigilance programme: a targeted spontaneous reporting system which solicits reports of suspected adverse drug reactions (ADRs) in patients with HIV-1 and/or tuberculosis infection. Since 2015, bedaquiline has been included in the treatment regimens recommended for resistant tuberculosis in South Africa. We describe ADRs in patients on bedaquiline-containing tuberculosis treatment that were reported to the Western Cape Pharmacovigilance programme. Methods We reviewed reports of suspected ADRs and deaths received between March 2015 and June 2016 involving patients receiving bedaquiline-containing tuberculosis treatment. A multidisciplinary panel assessed causality, and categorised suspected ADRs using World Health Organisation-Uppsala Monitoring Centre system categories. “Confirmed ADRs” included all ADRs categorised as definite, probable or possible. Preventability was assessed using Schumock and Thornton criteria. Where a confirmed ADR occurred in a patient who died, the panel categorised the extent to which the ADR contributed to the patient’s death as follows: major contributor, contributor or non-contributor. Results Thirty-five suspected ADRs were reported in 32 patients, including 13 deaths. There were 30 confirmed ADRs, of which 23 were classified as “possible” and seven as “probable”. Bedaquiline was implicated in 22 confirmed ADRs in 22 patients. The most common confirmed ADR in patients receiving bedaquiline was QT prolongation (8 cases, 7 of which were severe). A fatal arrhythmia was suspected in 4 sudden deaths. These 4 patients were all taking bedaquiline together with other QT-prolonging drugs. There were 8 non-bedaquiline-associated ADRs, of which 7 contributed to deaths. Conclusions Confirmed ADRs in patients receiving bedaquiline reflect the known safety profile of bedaquiline. Quantifying the incidence and clinical consequences of severe QT-prolongation in patients receiving bedaquiline-containing regimens is a research priority to inform recommendations for patient monitoring in treatment programmes for drug resistant tuberculosis. Pharmacovigilance systems within tuberculosis treatment programmes should be supported and encouraged, to provide ongoing monitoring of treatment-limiting drug toxicity.
  • Thumbnail Image
    Item
    Open Access
    Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial
    (BioMed Central, 2018-03-16) Myers, Bronwyn; Lund, Crick; Lombard, Carl; Joska, John; Levitt, Naomi; Butler, Christopher; Cleary, Susan; Naledi, Tracey; Milligan, Peter; Stein, Dan J; Sorsdahl, Katherine
    Background In low- and middle-income countries (LMIC), it is uncertain whether a “dedicated” approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a “designated” approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. Methods/Design This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios. Discussion Study findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting. Trial registration Pan African Clinical Trials Registry, Trial registration number: ACTR201610001825403 . Registered 17 October 2016.
  • No Thumbnail Available
    Item
    Open Access
    Innovative Finance Week 1 Video 10 - Choosing an issue area
    (2019) Phiri, Lelemba; Giese, Sonja; Okbaselasie, Merhawi; Naledi, Tracey
    This video introduces the representaives from the case astudies. We are introduced to the different areas that the organizations focus on, which include financial inclusion, housing, education, and healthcare. we are also introduced to the perspective of the private investment group that focuses on impact investing. This is video 10/11 in week 1 of the Innovative Finance: Hacking Finance to change the World course.
  • No Thumbnail Available
    Item
    Open Access
    Innovative Finance Week 3 Video 6 - Case Study: Identifying resources
    (2019) Naledi, Tracey
    This video focuses on a case study of an organisation (Innovation Edge) and its resources. The video starts off by discussing the partners that the organisation has identified. It then talks about the core resource of the organisation when it comes to solve slum issues. The video then goes on to discuss the various sources of funding and how the core funders help run Innovation Edge. Lastly, the video reflects on the journey of the organisation and its excellent track record. This is video 6/7 in week 3 of the Innovative Finance: Hacking Finance to Change the World course.
  • No Thumbnail Available
    Item
    Open Access
    Innovative Finance Week 5 Video 6 - Designing for Impact - Western Cape Government
    (2019) Naledi, Tracey
    This video focuses on the Western Cape Government's case study. The video discusses how they sought to change the way they did their community based program. It goes onto discuss how the process was originally conducted before going into how they have changed how they ran their community based programs. The video then focuses on why they were interested in the social impact bond. It touches on how it decreases the risk for those investing in the community based programs. It also discusses how the social impact bonds created incentives for those running the projects to ensure the programs succeeded. The video then discusses how the outcome based approaches resulted in them gaining private partners to assist in funding the projects. This is video 6/8 in week 5 of the Innovative Finance: Hacking Finance to Change the World course.
  • Thumbnail Image
    Item
    Open Access
    Patient outcomes and experience of a task-shared screening and brief intervention service for problem substance use in South African emergency centres: a mixed methods study
    (2021-05-12) van der Westhuizen, Claire; Malan, Megan; Naledi, Tracey; Roelofse, Marinda; Myers, Bronwyn; Stein, Dan J; Lahri, Sa’ad; Sorsdahl, Katherine
    Abstract Background Screening, brief intervention and referral to treatment (SBIRT) programmes have resulted in generally positive outcomes in healthcare settings, particularly for problem alcohol use, yet implementation is hampered by barriers such as concerns regarding the burden on healthcare professionals. In low-resourced settings, task-sharing approaches can reduce this burden by using non-professional healthcare workers, yet data are scarce regarding the outcomes and acceptability to patients within a SBIRT service. This study aims to evaluate patient-reported outcomes, patient acceptability, perceived benefits and recommendations for improving a task-shared SBIRT service in South African emergency centres (ECs). Methods This mixed methods study incorporates quantitative substance use screening and patient satisfaction data collected routinely within the service at three hospitals, and qualitative semi-structured interviews with 18 EC patient beneficiaries of the programme exploring acceptability and perceived benefits of the programme, as well as recommendations to improve the service. Approximately three months after the acute EC visit, a sub-sample of patients were followed up telephonically to assess patient-reported satisfaction and substance use outcomes. Results Of the 4847 patients eligible for the brief intervention, 3707 patients (76%) used alcohol as their primary substance and 794 (16%) used cannabis. At follow-up (n = 273), significant reductions in substance use frequency and severity were noted and over 95% of patients were satisfied with the service. In the semi-structured interviews, participants identified the non-judgemental caring approach of the counsellors, and the screening and psychoeducation components of the intervention as being the most valuable, motivating them to decrease substance use and make other positive lifestyle changes. Study participants made recommendations to include group sessions, market the programme in communities and extend the programme’s reach to include a broader age group and a variety of settings. Conclusions This task-shared SBIRT service was found to be acceptable to patients, who reported several benefits of a single SBIRT contact session delivered during an acute EC visit. These findings add to the SBIRT literature by highlighting the role of non-professional healthcare workers in delivering a low-intensity SBIRT service feasible to implement in low-resourced settings.
  • Thumbnail Image
    Item
    Open Access
    Perinatal psychological distress in the South African context: The road to task shifting evidence based interventions
    (2017) Spedding, Maxine F; Sorsdahl, Katherine R; Stein, Dan J; Naledi, Tracey
    Inadequate public health resources coupled with a chronically overburdened health system leave a large proportion of South Africans unable to access mental health care. Low-income pregnant women with common mental disorders (CMDs) are arguably more vulnerable to falling through the treatment gap, given the low rates of detection during pregnancy and the numerous additional barriers to care. The direct and indirect financial and personal costs associated with perinatal mental illness are substantial, while the high prevalence rates of perinatal CMDs make this an area in need of urgent attention. Integrating task shifting approaches into perinatal primary health care services is a promising solution. The first chapter introduces the thesis, providing context to the studies that are presented in later chapters and an overview of the research questions that informed them. The second chapter constitutes a systematic review of the literature relevant to the studies. Chapters 3 to 6 report on the findings of the studies, briefly described in the abstract below. The prevalence and risk factors associated with perinatal psychological distress - a plausible precursor for common mental disorders (CMDs) - are not widely understood in under-resourced settings. The first study (Chapter 3) investigates the prevalence and predictors of psychological distress in the antenatal period. Data were collected from 664 pregnant women who reported for antenatal care to any one of 11 Midwife and Obstetric Units (MOU) across the greater Cape Town area. Psychological distress was measured using the Symptom Response Questionnaire (SRQ-20; cut-off value of 7/8), while data pertaining to risk factors were collected via a demographic questionnaire, the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and the Multidimensional Scale of Perceived Social Support (MSPSS). The prevalence of antenatal psychological distress was 38.6%. Risk factors included low socio-economic status (SES) (OR = 1.45, 95% CI: 1.24-1.68); recent physical abuse and/or rape (OR = 1.94, 95% CI: 1.57-2.40); complications during a previous delivery (OR = 1.18, 95% CI: 1.01-1.38); having given birth before (OR = 1.61, 95% CI: 1.21-2.14). The high prevalence rate of psychological distress is consistent with those found in other South African studies of perinatal CMDs. Appropriate, context-specific, and effective interventions are better served by investigating a broader range of symptoms associated with perinatal CMDs in these settings. The second study (Chapter 4) examines the mental health literacy (MHL) of pregnant women, including their perceptions of the causes of mental illness during pregnancy and best treatment approaches. Understanding the factors that represent barriers to accessing care is important to the development of accessible interventions. Globally, low levels of mental health literacy have often been identified as one such treatment barrier. However, little is known about how pregnant women perceive and understand mental illness during this time, particularly in South Africa. A convenience sample of 262 pregnant women attending routine antenatal appointments at a Midwife and Obstetrics Unit (MOU) were recruited to participate in the study. Participants were presented with one of five possible vignettes, depicting a woman with perinatal mental illness, as defined by the DSM 5, including ante- and postnatal depression, panic disorder, substance dependence and schizophrenia. Participants were then asked to provide a diagnosis and completed two scales assessing aspects of mental health literacy. The results from this study showed that more than three quarters of respondents (77.4%) did not identify the signs and symptoms described in the vignettes as those consistent with mental illness. More than half of all participants (57.5%) were of the view that all the disorders depicted were "typical of a weak character", while stress was the most widely held explanation for symptoms of all disorders. Participants were most confident in the therapeutic potential of psychological services, especially consulting with a counsellor or social worker. These were closely followed by lifestyle and self-help options as the most endorsed means to addressing psychiatric symptoms during pregnancy. Notably, seeking help from a spiritual or religious advisor was comparably as popular among participants as seeking help from a psychologist or social worker. Given the elevated prevalence of perinatal mental illness, these findings are cause for concern. Developing socio-culturally nuanced understandings of how perinatal mental illness is perceived should be emphasized as central to the development of successful interventions. The third study (Chapters 5 and 6) investigates the feasibility and acceptability of, as well as the preliminary responses to an adapted Problem Solving Therapy (PST) intervention to treat psychological distress. Given the large treatment gap that exists in public mental health, support for task shifting evidence based mental health treatments is growing. However, the gaps in our knowledge are threefold. First, most research has used lay counsellors to deliver interventions. No research has used Registered Counsellors (RC) to conduct interventions. Second, very little is known about the potential outcomes of task shifting an adapted PST intervention to reduce symptoms of psychological distress. Third, data regarding the feasibility and acceptability of such interventions in South African Midwife and Obstetric Units (MOUs) is very limited. Results from the study are presented in two chapters. Chapter 5 focuses on the intervention participants. Thirty-eight women who screened positive for high CMD symptoms on the Edinburgh Postnatal Depression Scale (EPDS) at their first antenatal visit were recruited to participate in the intervention. Of these, 22 completed the preand post-intervention interviews. Using mixed methods, preliminary responses to the threesession PST intervention, as well as participants' perceptions of the intervention's feasibility and acceptability were explored. Primary outcomes included psychological distress as measured by the Symptom Response Questionnaire (SRQ-20) and CMD symptoms, as measured by the EPDS. A short semi-structured post-intervention interview was also conducted approximately three months after each participant's last session. On the primary outcome measures, significant reductions were seen on EPDS scores (z = -3.0, p < 0.01) as well as the SRQ-20 scores (z = -3.5, p = <0.01). Several significant reductions were also seen on secondary outcomes. Reductions in impairment to functioning were also noted, with all three Sheehan disability scales reflecting less disruption to work (z = -2.3, p = 0.02), social life (z = -3.3, p < 0.01), as well as family and home responsibilities (z = -2.5, p = 0.01). Perceived Stress Scale scores were also significantly reduced (z = -3.4, p < 0.01). Significant changes were seen on two problem-solving styles, with reduced 'negative problem orientation' scores (z = -3.1, p < 0.01) and 'avoidant style' scores (z = -3.0, p < 0.01) Participants felt that the intervention was feasible and acceptable. The intervention's acceptability lay primarily in the opportunity for participants to talk confidentially to a non-judgmental and empathic person about their problems. The intervention materials seemed to serve as an extension of the therapeutic process. Factors that were identified by participants as representing potential barriers to the intervention included lack of transport or money, work commitments and stigma. Chapter 6 explores the intervention's feasibility and acceptability from the perspectives of 6 stakeholders who were involved with the project. Semi-structured interviews were conducted with each stakeholder. Data from the interviews showed that the stakeholders felt that the intervention was helpful to patients and a valuable resource for the facility to have. Some expressed concern about how stigma associated with mental illness might be a barrier to patients who need mental health care. To the staff, the project's value seemed to lie primarily in the support it provided in managing emotionally distressed patients. Having a resource to refer patients to appeared to provide overburdened staff with some relief. None of the stakeholders reported that the screening and referral procedures added to their workload. Some stakeholders felt detection of psychological problems among patients was compromised without mental health screening. Staff felt that a walk-in counselling service would serve to improve future interventions. Limitations to the first study included its cross-sectional design and use of a screening tool to measure the prevalence of psychological distress. The second study was limited by the employment of vignettes to collect data. While they are useful tools to elicit population-specific responses, their adaption for those purposes means that they are not standardised. The study was further limited by the use of a convenience sample. Finally, the third study was limited by a small sample size owing to low retention rates. However, low retention rates are not uncommon among antenatal and low-income populations, where structural barriers to accessing care are often more pronounced. The lack of a comparison group was an additional limitation. In conclusion, data from this study support task shifting evidence based treatments to Registered Counsellors to treat the highly prevalent antenatal psychological distress. Difficulties distinguishing CMD symptoms from normal pregnancy experiences may influence the uptake of counselling services and represent a barrier to care. Improving mental health literacy may be a necessary supplement to future interventions. Future research should focus on evaluating real-world models of integrated mental health in primary care settings. How psycho-education programmes might impact upon the uptake of services at antenatal care facilities will also contribute to broadening our knowledge of developing effective and appropriate interventions.
  • Thumbnail Image
    Item
    Open Access
    Readiness to change is a predictor of reduced substance use involvement: findings from a randomized controlled trial of patients attending South African emergency departments
    (BioMed Central, 2016-02-20) Myers, Bronwyn; van der Westhuizen, Claire; Naledi, Tracey; Stein, Dan J; Sorsdahl, Katherine
    Background: This study examines whether readiness to change is a predictor of substance use outcomes and explores factors associated with RTC substance use among patients at South African emergency departments. Methods: We use data from participants enrolled into a randomized controlled trial of a brief substance use intervention conducted in three emergency departments in Cape Town, South Africa. Results: In adjusted analyses, the SOCRATES “Recognition” (B = 11.6; 95 % CI = 6.2–17.0) and “Taking Steps” score (B = -9.5; 95 % CI = -15.5- -3.5) as well as alcohol problems (B = 4.4; 95 % CI = 0.9–7.9) predicted change in substance use involvement at 3 month follow-up. Severity of depression (B = 0.2; 95 % CI = 0.1–0.3), methamphetamine use (B = 3.4; 95 % CI = 0.5- 6.3) and substance-related injury (B = 1.9; 95 % CI = 0.6–3.2) were associated with greater recognition of the need for change. Depression (B = 0.1; 95 % CI = 0.04 -0.1) and methamphetamine use (B = 2.3; 95 % CI = 0.1 -4.2) were also associated with more ambivalence about whether to change. Participants who presented with an injury that was preceded by substance use were less likely to be taking steps to reduce their substance use compared to individuals who did not (B = -1.7; 95 % CI = -5.0- -0.6). Conclusion: Findings suggest that brief interventions for this population should include a strong focus on building readiness to change substance use through motivational enhancement strategies. Findings also suggest that providing additional support to individuals with depression may enhance intervention outcomes.