Browsing by Subject "Adherence"

Now showing 1 - 18 of 18
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    A retrospective study of patients with biologics treatment at Groote Schuur and Red Cross Children's War Memorial Hospitals
    (2020) Ahmed, Mohammed Awad Eltoum; Hodkinson, Bridget; Gcelu, Ayanda
    Introduction. The high cost and concern of adverse events, particularly infections, limit the use of biologic disease-modifying anti-rheumatic (bDMARD) therapies. We undertook this retrospective study to document their use for immune-mediated diseases (IMDs) and explore the efficacy, safety, adherence and screening practices prior to initiating bDMARDs in a tertiary referral hospital. Methods. A folder review of all adult and paediatric patients treated for IMDs with bDMARDs at Groote Schuur and Red Cross Hospitals between January 2013 and December 2019. Clinico-demographic particulars, details of bDMARD therapy, and adverse events were collated. Changes in disease activity were measured by diseasespecific tools at 6, 12, 24-months and at the last available visit, and patient adherence to bDMARDs was explored by folder and pharmacy record review. Results. We studied 151 folders, with 182 bDMARDs uses (29 patients used more than 1 bDMARD). Patients were from rheumatology (n= 38: 13 rheumatoid arthritis; 10 spondyloarthritis, 5 Systemic Lupus Erythematosus (SLE) , 5 inflammatory myositis and 5 other conditions); gastroenterology (n=31; 26 Crohn`s and 5 Ulcerative Colitis), dermatology (n=9; psoriasis), neurology (n=4, ophthalmology (n= 25; 6 scleritis, 18 uveitis, 1 optic neuritis), and paediatrics (n= 45, 26 juvenile idiopathic arthritis , 12 SLE, 7 other conditions). The bDMARDs used were TNF inhibitors (112), rituximab (55), tocilizumab (10), anakinra (3), abatacept (1), and tofacitinib (1). The vast majority of patients had an excellent response and were in low disease activity or remission at their last available visit. Adverse events included severe infection (4), tuberculosis (TB) (2), mild infection (4), severe allergic reaction (3), mild skin reaction (14), elevated liver enzymes (2), and worsening interstitial lung disease ILD (1). bDMARD Therapy was discontinued in 18 patients, most commonly due to adverse reaction (9), lack of response (3), poor adherence (2), or remission (1). bDMARD Therapy was changed to alternative therapy in 29 patients, most commonly because of poor response (14), or adverse effects (9) or poor adherence (3). Poor adherence or patients lost to follow-up was noted in 18/182 (9.9%). Complete latent TB infection screening with chest x-ray and TB skin test was performed in only 55 (36.4 %) but INH prophylaxis was given to 51/88 (57.9%) of patients prescribed TNFi therapy. Hepatitis B screening performed in 93 (61.6 %) patients, but most patients (72.2 %) were not tested for Hepatitis B core ab. Hepatitis C screening was performed in 81 (53.6 %) patients. Only 88 (58.3%) patients had a recent HIV test. The majority (17.2%) received the influenza vaccine, but only 24 (15.8 %) received pneumococcal vaccination. Discussion and Conclusion. bDMARD therapy was an effective treatment, and the most common adverse effect was infection (7.2%), with 2 TB infections. Vaccination and screening for TB, viral hepatitis and HIV was suboptimal. Of concern, poor adherence to bDMARDs was frequently encountered.
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    Brief psychotherapy administered by non-specialised health workers to address risky substance use in patients with multidrug-resistant tuberculosis: a feasibility and acceptability study
    (2021-01-19) Calligaro, Gregory L; de Wit, Zani; Cirota, Jacqui; Orrell, Catherine; Myers, Bronwyn; Decker, Sebastian; Stein, Dan J; Sorsdahl, Katherine; Dawson, Rodney
    Background Only 55% of multidrug-resistant tuberculosis (MDR-TB) cases worldwide complete treatment, with problem substance use a risk for default and treatment failure. Nevertheless, there is little research on psychotherapeutic interventions for reducing substance use amongst MDR-TB patients, in general, and on their delivery by non-specialist health workers in particular. Objectives To explore the feasibility and acceptability of a non-specialist health worker-delivered 4-session brief motivational interviewing and relapse prevention (MI-RP) intervention for problem substance use and to obtain preliminary data on the effects of this intervention on substance use severity, depressive symptoms, psychological distress and functional impairment at 3 months after hospital discharge. Methods Between December 2015 and October 2016, consenting MDR-TB patients admitted to Brewelskloof Hospital who screened at moderate to severe risk for substance-related problems on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) were enrolled, and a baseline questionnaire administered. In the 4 weeks prior to planned discharge, trained counsellors delivered the MI-RP intervention. The baseline questionnaire was re-administered 3 months post-discharge and qualitative interviews were conducted with a randomly selected sample of participants (n = 10). Results Sixty patients were screened: 40 (66%) met inclusion criteria of which 39 (98%) were enrolled. Of the enrolled patients, 26 (67%) completed the counselling sessions and the final assessment. Qualitative interviews revealed participants’ perceptions of the value of the intervention. From baseline to follow-up, patients reported reductions in substance use severity, symptoms of depression, distress and functional impairment. Conclusion In this feasibility study, participant retention in the study was moderate. We found preliminary evidence supporting the benefits of the intervention for reducing substance use and symptoms of psychological distress, supported by qualitative reports of patient experiences. Randomised studies are needed to demonstrate efficacy of this intervention before considering potential for wider implementation. Trial registration South African National Clinical Trials Register ( DOH-27-0315-5007 ) on 01/04/2015 ( http://www.sanctr.gov.za )
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    Comparison of six methods to estimate adherence in an ART-naïve cohort in a resource-poor setting: which best predicts virological and resistance outcomes?
    (2017) Orrell, Catherine; Cohen, Karen; Leisegang, Rory; Bangsberg, David R; Wood, Robin; Maartens, Gary
    BACKGROUND: Incomplete adherence to antiretroviral therapy (ART) results in virologic failure and resistance. It remains unclear which adherence measure best predicts these outcomes. We compared six patient-reported and objective adherence measures in one ART-naïve cohort in South Africa. METHODS: We recruited 230 participants from a community ART clinic and prospectively collected demographic data, CD4 count and HIV-RNA at weeks 0, 16 and 48. We quantified adherence using 3-day self-report (SR), clinic-based pill count (CPC), average adherence by pharmacy refill (PR-average), calculation of medication-free days (PR-gaps), efavirenz therapeutic drug monitoring (TDM) and an electronic adherence monitoring device (EAMD). Associations between adherence measures and virologic and genotypic outcomes were modelled using logistic regression, with the area under the curve (AUC) from the receiver operator characteristic (ROC) analyses derived to assess performance of adherence measures in predicting outcomes. RESULTS: At week 48 median (IQR) adherence was: SR 100% (100-100), CPC 100% (95-107), PR-average 103% (95-105), PR-gaps 100% (95-100) and EAMD 86% (59-94), and efavirenz concentrations were therapeutic (>1 mg/L) in 92%. EAMD, PR-average, PR-gaps and CPC best predicted virological outcome at week 48 with AUC ROC of 0.73 (95% CI 0.61-0.83), 0.73 (95% CI 0.61-0.85), 0.72 (95% CI 0.59-0.84) and 0.64 (95% CI 0.52-0.76) respectively. EAMD, PR-gaps and PR-average were highly predictive of detection of resistance mutations at week 48, with AUC ROC of 0.92 (95% CI 0.87-0.97), 0.86 (0.67-1.0) and 0.83 (95% CI 0.65-1.0) respectively. SR and TDM were poorly predictive of outcomes at week 48. CONCLUSION: EAMD and both PR measures predicted resistance and virological failure similarly. Pharmacy refill data is a pragmatic adherence measure in resource-limited settings where electronic monitoring is unavailable. Trial registration The trial was retrospectively registered in the Pan African Clinical Trials Registry, number PACTR201311000641402, on the 13 Sep 2013 ( www.pactr.org ). The first participant was enrolled on the 12th July 2012. The last patient last visit (week 48) was 15 April 2014.
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    Comparison of six methods to estimate adherence in an ART-naïve cohort in a resource-poor setting: which best predicts virological and resistance outcomes?
    (BioMed Central, 2017-04-04) Orrell, Catherine; Cohen, Karen; Leisegang, Rory; Bangsberg, David R; Wood, Robin; Maartens, Gary
    Background: Incomplete adherence to antiretroviral therapy (ART) results in virologic failure and resistance. It remains unclear which adherence measure best predicts these outcomes. We compared six patient-reported and objective adherence measures in one ART-naïve cohort in South Africa. Methods: We recruited 230 participants from a community ART clinic and prospectively collected demographic data, CD4 count and HIV-RNA at weeks 0, 16 and 48. We quantified adherence using 3-day self-report (SR), clinicbased pill count (CPC), average adherence by pharmacy refill (PR-average), calculation of medication-free days (PR-gaps), efavirenz therapeutic drug monitoring (TDM) and an electronic adherence monitoring device (EAMD). Associations between adherence measures and virologic and genotypic outcomes were modelled using logistic regression, with the area under the curve (AUC) from the receiver operator characteristic (ROC) analyses derived to assess performance of adherence measures in predicting outcomes. Results: At week 48 median (IQR) adherence was: SR 100% (100–100), CPC 100% (95–107), PR-average 103% (95– 105), PR-gaps 100% (95–100) and EAMD 86% (59–94), and efavirenz concentrations were therapeutic (>1 mg/L) in 92%. EAMD, PR-average, PR-gaps and CPC best predicted virological outcome at week 48 with AUC ROC of 0.73 (95% CI 0.61–0.83), 0.73 (95% CI 0.61–0.85), 0.72 (95% CI 0.59–0.84) and 0.64 (95% CI 0.52–0.76) respectively. EAMD, PR-gaps and PR-average were highly predictive of detection of resistance mutations at week 48, with AUC ROC of 0.92 (95% CI 0.87–0.97), 0.86 (0.67–1.0) and 0.83 (95% CI 0.65–1.0) respectively. SR and TDM were poorly predictive of outcomes at week 48. Conclusion: EAMD and both PR measures predicted resistance and virological failure similarly. Pharmacy refill data is a pragmatic adherence measure in resource-limited settings where electronic monitoring is unavailable. Trial registration The trial was retrospectively registered in the Pan African Clinical Trials Registry, number PACTR201311000641402, on the 13 Sep 2013 (www.pactr.org). The first participant was enrolled on the 12th July 2012. The last patient last visit (week 48) was 15 April 2014
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    Digital messaging to support control for type 2 diabetes (StAR2D): a multicentre randomised controlled trial
    (2021-10-21) Farmer, A; Bobrow, K; Leon, N; Williams, N; Phiri, E; Namadingo, H; Cooper, S; Prince, J; Crampin, A; Besada, D; Daviaud, E; Yu, L-M; N’goma, J; Springer, D; Pauly, B; Tarassenko, L; Norris, S; Nyirenda, M; Levitt, N
    Background Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes. Methods StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals. Results The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (− 0.08% (− 0.31 to 0.16) (IFCC − 0.82 mmol/mol (− 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was − 0.71% (− 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful. Conclusions Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes. Trial registration Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.
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    Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data
    (BioMed Central Ltd, 2013) Allen, Elizabeth; Chandler, Clare; Mandimika, Nyaradzo; Pace, Cheryl; Mehta, Ushma; Barnes, Karen
    BACKGROUND:Participant reports of medical histories, adverse events (AE) and non-study drugs are integral to evaluating harm in clinical research. However, interpreting or synthesizing results is complicated if studies use different methods for ascertaining and assessing these data. To explore how these data are obtained in malaria drug studies, a descriptive online survey of clinical researchers was conducted during 2012 and 2013. METHODS: The survey was advertised through e-mails, collaborators and at conferences. Questions aimed to capture the detail, rationale and application of methods used to obtain relevant data within various study designs and populations. Closed responses were analysed using proportions, open responses through identifying repeating ideas and underlying concepts. RESULTS: Of fifty-two respondents from 25 counties, 87% worked at an investigational site and 75% reported about an interventional study. Studies employed a range of methods to elicit, assess and record participant-reported AEs and related data. Questioning about AEs in 31% of interventional studies was a combination of general (open questions about health) and structured (reference to specific health-related items), 26% used structured only and 18% general only. No observational studies used general questioning alone. A minority incorporated pictorial tools. Rationales for the questioning approach included: standardization of assessment or data capture, specificity or comprehensiveness of data sought, avoidance of suggestion, feasibility, and understanding participants' perceptions. Most respondents considered the approach they reported was optimal, though several reconsidered this. Four AE grading, and three causality assessment approaches were reported. Combining general and structured questions about non-study drug use were considered useful for revealing and identifying specific medicines, while pictures could enhance reports, particularly in areas of low literacy. CONCLUSIONS: It is critical to evaluate the safety of anti-malarial drugs being deployed in large, diverse populations. Many studies would be suitable for contributing to a larger body of evidence for answering questions on harm. However this survey showed that various methods are used to obtain relevant data, which could influence study results. As the best practices for obtaining such data are unclear, anti-malarial clinical researchers should work towards consensus about the selection and/or design of optimal methods.
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    Factors influencing user adherence towards privacy standards in the usage of Internet of Things devices in South Africa
    (2022) Bazanye, Kizito Philip; Uys, Walter; Chigona, Wallace
    Background: The Internet of Things (IoT) is considered an essential element of the Fourth Industrial Revolution (4IR). IoT devices are vulnerable to attacks. These vulnerabilities affect all aspects of daily life including retail and home automation interconnected by basic networking. The vulnerable end nodes may be machines, human to machine interactions, and the integration points of human-to-human communication. Problem statement: The onset of the Covid-19 pandemic ushered in increased use of IoT devices. The increased use of IoT devices perpetuated negligent use and therefore cyber-attacks exposed South African IoT users' data harvested through these devices. Purpose of research: The objective of the study is to conceptualise and understand what factors influence IoT device users to adhere to recommended IoT device privacy standards in South Africa. Design/methodology/approach: This qualitative, interpretivist, cross-sectional exploratory research was guided by a three-phase approach using Activity Theory. The ontological stance adopted is subjectivism. The interview questions were derived from the Activity Theory model and themes identified in the literature reviewed. The qualitative data collected from the semistructured interviews was analysed using deductive thematic analysis by linking of elements to the six components of Activity Theory. Findings: The lack of privacy adherence is driven by a lack of trust in IoT devices and service providers as well as convenience and health factors. Additionally, users' personality, awareness and surroundings are major influencers to IoT device privacy standards' adherence. Contribution and implication: This study conceptualises how IoT device privacy standards adherence can further be promoted with the increased adoption of such technologies. Further research may need to examine the specific impact of legislation on users and IoT device privacy. Additionally, the impact of third-party IoT service providers on IoT privacy models in South Africa needs to be investigated.
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    ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial
    (2022-08-18) Sikkema, K J; Rabie, S; King, A; Watt, M H; Mulawa, M I; Andersen, L S; Wilson, P A; Marais, A; Ndwandwa, E; Majokweni, S; Orrell, C; Joska, J A
    Background Addressing sexual trauma in the context of HIV care is essential to improve clinical outcomes and mental health among women in South Africa. Women living with HIV (WLH) report disproportionately high levels of sexual trauma and have higher rates of posttraumatic stress disorder. Adherence to antiretroviral therapy (ART) may be difficult for traumatized women, as sexual trauma compounds the stress associated with managing HIV and is often comorbid with other mental health disorders, further compromising care engagement and adherence. ART initiation represents a unique window of opportunity for intervention to enhance motivation, increase care engagement, and address the negative effects of trauma on avoidant coping behaviors. Mental health interventions delivered by non-specialists in low- and middle-income countries have potential to treat depression, trauma, and effects of intimate partner violence among WLH. This study will examine the effectiveness of Improving AIDS Care after Trauma (ImpACT +), a task-shared, trauma-focused coping intervention, to promote viral suppression among WLH initiating ART in a South African clinic setting. Methods This study will be conducted in Khayelitsha, a peri-urban settlement situated near Cape Town, South Africa. Using a hybrid type 1 effectiveness-implementation design, we will randomize 350 WLH initiating ART to the ImpACT + experimental condition or the control condition (three weekly sessions of adapted problem-solving therapy) to examine the effectiveness of ImpACT + on viral suppression, ART adherence, and the degree to which mental health outcomes mediate intervention effects. ImpACT + participants will receive six once-a-week coping intervention sessions and six monthly maintenance sessions over the follow-up period. We will conduct mental health and bio-behavioral assessments at baseline, 4, 8, and 12 months, with care engagement data extracted from medical records. We will explore scalability using the Consolidated Framework for Implementation Research (CFIR). Discussion This trial is expected to yield important new information on psychologically informed intervention models that benefit the mental health and clinical outcomes of WLH with histories of sexual trauma. The proposed ImpACT + intervention, with its focus on building coping skills to address traumatic stress and engagement in HIV care and treatment, could have widespread impact on the health and wellbeing of individuals and communities in sub-Saharan Africa. Trial registration Clinicaltrials.gov NCT04793217 . Retrospectively registered on 11 March 2021.
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    Improving adherence in mental health service users with severe mental illness in South Africa: a pilot randomized controlled trial of a treatment partner and text message intervention vs. treatment as usual
    (BioMed Central, 2017-11-09) Sibeko, Goodman; Sibeko, Goodman; Mall, Sumaya; Williams-Ashman, Peter; Thornicroft, Graham; Susser, Ezra S; Lund, Crick; Stein, Dan J; Milligan, Peter D
    Objectives: Medication non-adherence is a significant problem in treatment of severe mental disorders and is associated with poor clinical outcomes and increased demand on services. Task-shifting interventions incorporating mobile health may improve adherence in mental health service users in low- and middle-income countries. Seventy-seven participants were recruited from a psychiatric hospital in Cape Town, with 42 randomized to receive the intervention and 35 to treatment as usual. Intervention pairs underwent treatment-partner contracting and psychoeducation, and received monthly text message reminders of clinic appointments. Primary outcomes were intervention acceptability and feasibility. Secondary outcome for efficacy were adherence to clinic visit; relapse; quality of life; symptomatic relief and medication adherence. Results: Treatment partner and psychoeducation components were acceptable and feasible. The text message component was acceptable but not feasible in its current form. Efficacy outcomes favoured the intervention but did not reach statistical significance. A treatment-partner intervention is acceptable and feasible in a low- and middle-income setting. Work is needed to ensure that additional components of such interventions are tailored to the local context. Appropriately powered efficacy studies are needed. Trial Registration PACTR PACTR201610001830190, Registered 21 October 2016 (Retrospectively registered)
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    Improving treatment adherence for blood pressure lowering via mobile phone SMS-messages in South Africa: a qualitative evaluation of the SMS-text Adherence SuppoRt (StAR) trial
    (2015) Leon, Natalie; Surender, Rebecca; Bobrow, Kirsty; Muller, Jocelyn; Farmer, Andrew
    BACKGROUND:Effective use of proven treatments for high blood pressure, a preventable health risk, is challenging for many patients. Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment, though more research is needed on impact and patient perceptions of such support interventions, especially in low-resource settings.METHOD:An individually-randomised controlled trial in a primary care clinic in Cape Town (2012-14), tested the effect of an adherence support intervention delivered via SMS-texts, on blood pressure control and adherence to medication, for hypertensive patients. (Trial registration: ClinicalTrials.gov NCT02019823). We report on a qualitative evaluation that explored the trial participants' experiences and responses to the SMS-text messages, and identified barriers and facilitators to delivering adherence support via patients' own mobile phones. Two focus groups and fifteen individual interviews were conducted. We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three researchers. RESULTS: Most participants were comfortable with the technology of using SMS-text messages. Messages were experienced as acceptable, relevant and useful to a broad range of participants. The SMS-content, the respectful tone and the delivery (timing of reminders and frequency) and the relational aspect of trial participation (feeling cared for) were all highly valued. A subgroup who benefitted the most, were those who had been struggling with adherence due to high levels of personal stress. The intervention appeared to coincide with their readiness for change, and provided practical and emotional support for improving adherence behaviour. Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility. Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours. CONCLUSION: Adherence support for treatment of raised blood pressure, delivered via SMS-text message on the patient's own phone, was found to be acceptable, relevant and helpful, even for those who already had their own reminder systems in place. Our findings begin to identify for whom and what core elements of the SMS-text message intervention appear to work best in a low-resource operational setting, issues that future research should explore in greater depth.
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    Investigating the executive functioning and patterns of adherence to antiretroviral therapy among adolescents living with HIV in South Africa
    (2020) Gama, Lungile Vakele; Schrieff, Leigh; Atujuna, Millicent
    Given the pathophysiology associated with the Human Immunodeficiency Virus (HIV) and the reported predilection for frontal circuitries and deep white matter, one might expect that executive dysfunction forms part of the neurocognitive profile of people living with HIV. However, such deficits have mainly been reported for adults living with HIV. Adolescence is a period where significant growth and refinement of executive functioning occurs and therefore specific research focused on HIV-positive adolescents is needed. Adolescence is also a developmental period where poor adherence to Antiretroviral Therapy (ART) persists despite marked increases in the national roll out of ART in South Africa, which has significantly decreased HIV-related morbidity and mortality rates. Poor adherence is not only a threat to the efficacy of ART but is also linked to the emergence of drug-resistant HIV strains and identified as a key contributor in the persistence of some cognitive impairments among people living with HIV. Studies show that executive dysfunction can undermine adherence to ART particularly in adolescents, whose frontal lobes are still developing. The first aim of this study was to compare the executive function profile of a group of HIV positive adolescents with that of a matched HIV negative control group. Using P. Anderson's (2002) model, executive functions were considered along the four subdomains: attentional control, processing speed, cognitive flexibility and goal setting. A second aim of the study was to investigate the relationship between executive function and levels of adherence to ART amongst the HIV positive adolescents in the sample. This cross sectional, between-groups study used a comprehensive neuropsychology test battery which was sorted into composite domains to investigate differences in executive functioning between the two study groups of adolescents aged between 14 to 16 (n = 22 in each group) using t-tests. Correlation coefficients were further computed to establish association between adherence and executive functioning. Apart from processing speed (p = 0.42, after the removal of outliers), there were no significant between-group differences in executive functioning outcomes that emerged between the HIV-positive and HIV-negative groups. The neuropsychological test scores for both groups were largely in the borderline range. Correlations between adherence and executive functioning outcomes did not yield any significant associations for each of the executive function domains. The lack of significant between-group differences may be explained by the mitigating effects of ART in the CNS in the HIV-positive group. However, consideration should be given to social factors as these may be important mediators of cognition and may therefore confound neuropsychological performance outcomes for both groups. Although the findings in the current study did not conclusively provide evidence for the role of executive functions in adherence, given the noted limitations, further studies with larger samples should confirm such outcomes.
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    Mobile phone text messaging for promoting adherence to anti-tuberculosis treatment: a systematic review protocol
    (BioMed Central Ltd, 2013) Nglazi, Mweete; Bekker, Linda-Gail; Wood, Robin; Hussey, Gregory D; Wiysonge, Charles S
    BACKGROUND: In 2010, there were approximately 8.8 million incident cases of tuberculosis (TB) worldwide. The treatment of TB is at least six months long and may be complicated by a high pill burden. In addition, TB patients often do not take their medication on schedule simply because they forget. Mobile phone text messaging has the potential to help promote TB treatment adherence. We, therefore, propose to conduct a review of current best evidence for the use of mobile phone text messaging to promote patient adherence to TB treatment. METHODS: This is a systematic review of the literature. We will preferably include randomized controlled trials (RCTs). However, non-randomized studies (NRS) will be considered if there is an inadequate number of RCTs.We will search PubMed, EMBASE, CINAHL, CENTRAL, Science Citation Index, Africa-Wide Information, and WHOLIS electronic databases for eligible studies available by 30 November 2012 regardless of language or publication status. We will also check reference lists for additional studies, identify abstracts from conference proceedings and communicate with authors for any relevant material.At least two authors will independently screen search outputs, select studies, extract data and assess the risk of bias (using separate criteria for RCTs and NRS); resolving discrepancies by discussion and consensus. We will assess clinical heterogeneity by examining the types of participants, interventions and outcomes in each study and pool studies judged to be clinically homogenous. We will also assess statistical heterogeneity using the chi-square test of homogeneity and quantify it using the I-square statistic. If study results are found to be statistically homogeneous (that is heterogeneity P > 0.1), we will pool them using the fixed-effect meta-analysis. Otherwise, we will use random-effects meta-analysis. We will calculate risk ratios and their corresponding 95% confidence intervals for dichotomous outcomes, and mean differences for continuous outcomes. For other outcomes without quantitative data, a descriptive analysis will be used.DISCUSSION:Our results can be used by researchers and policy-makers to help inform them of the efficacy of mobile phone text messaging interventions to promote patient adherence to TB treatment.
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    'Swimming in confusion': a qualitative appraisal of factors affecting uptake and adherence to HAART through South Africa's Public Health System.
    (2008) Mills, Elizabeth
    In 2007, less than one-third of all HIV-positive South Africans in need of lifeextending highly-active antiretroviral treatment (HAART) are accessing it through the public health system. This ‘treatment gap’ poses a significant challenge to health practitioners and researchers given the complex factors that influence the provision (supply) and uptake (demand) of this public health intervention. This qualitative study, conducted in 2006, set out to explore some of the demand-side factors affecting uptake and adherence to HAART among a cohort of HIV-positive people living in the Western Cape. Two significant and interrelated findings emerged from the research: one, political equivocation influenced the use of lay and untested HIV remedies among the cohort, with lay remedies represented as ‘benign’ compared to the ‘risks’ of using biomedicine like HAART; second, psycho-social and physical factors, like hope, stigma and fear or experience of HAART’s side-effects, affected the respondents’ health seeking behaviour. This preliminary qualitative study suggests that political equivocation and national activism compound, and also obscure, nuanced personal responses to managing illness and securing health. In order for the hard-won HAART roll-out to succeed in reaching 80% of all those in need by 2011, as per the 2007 – 2011 HIV/AIDS and STI National Strategic Plan, researchers and practitioners need to consider and address both supply and demand-side factors inhibiting access and adherence to HAART in South Africa.
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    Tenofovir diphosphate in dried blood spots and HIV-1 resistance in South Africa
    (BioMed Central, 2023-09-14) Singh, Y.; Castillo-Mancilla, J.; Madimabe, R.; Jennings, L.; Ferraris, C. M.; Robbins, R. N.; Anderson, P. L.; Remien, R. H.; Orrell, C.
    Background Suboptimal antiretroviral (ART) adherence can lead to virologic failure with consequent HIV-1 resistance. Tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) is a powerful biomarker of cumulative adherence, predictive of future viremia. It has been associated with resistance in Persons With HIV (PWH) in South Africa and the US. We explored the relationship of TFV-DP concentrations with antiretroviral drug resistance at the time of treatment failure in SA. Methods Adult PWH from health clinics in Cape Town, South Africa on efavirenz-based first-line ART containing tenofovir disoproxil fumarate (TDF) with an undetectable (< 50 copies/mL) HIV-1 viral load (VL) were prospectively enrolled in an observational cohort for 12 months. Monthly study visits included blood collection for HIV-1 VL and DBS for TFV-DP. The first confirmed viral breakthrough (VB) > 400 copies/mL triggered HIV-1 genotyping at the subsequent visit. An electronic adherence (EA) device monitored ART adherence in real-time, estimated as a percent for the 30-days prior to VB. Wilcoxon rank sum test was used to compare median [IQR] TFV-DP by genotype outcome. Results Of 250 individuals, (n = 195, 78% women), 21 experienced VB, with a median of 5 [4;7] months on study, and a median EA of 33.3 [13.3;53.3]%. Demographic characteristics between those with and without VB were similar. Median VL at VB was 4.0 [3.2;4.5] log copies/mL. TFV-DP concentrations trended down towards the VB visit. Median TFV-DP concentrations were significantly higher in those HIV-1 genotype did not amplify due to being virally suppressed at the subsequent visit (n = 10; 380 [227–661] fmol/punch, p = 0.035; EA 45 [24.9; 59.2]%); than in those who were successfully genotyped with evidence of drug resistance (n = 5, 241 [150–247] fmol/punch, EA 20 [6.7;36.7]%) and in individuals who did not have resistance (n = 3, 39.9 [16.6; 93.9] fmol/punch; EA 33.3 [16–38]%). Three genotype collections were not done. Only non-nucleoside reverse transcriptase inhibitor-associated mutations were identified on resistance testing. (K103N, E138K, Y118H). Conclusion TFV-DP in DBS showed a step-wise inverse relationship with VB and drug resistance, with evidence of low cumulative ART adherence in PWH who developed antiretroviral resistance. Monitoring TFV-DP concentrations could be a valuable tool for predicting future VB and future resistance.
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    The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi
    (2020-02-19) Kim, Maria H; Tembo, Tapiwa A; Mazenga, Alick; Yu, Xiaoying; Myer, Landon; Sabelli, Rachael; Flick, Robert; Hartig, Miriam; Wetzel, Elizabeth; Simon, Katie; Ahmed, Saeed; Nyirenda, Rose; Kazembe, Peter N; Mphande, Mtisunge; Mkandawire, Angella; Chitani, Mike J; Markham, Christine; Ciaranello, Andrea; Abrams, Elaine J
    Abstract Background Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. Methods This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses. Discussion This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes. Trial registration ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.
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    Triple comorbidity of severe mental illness, HIV infection & alcohol abuse in a female population at a community psychiatric clinic in Cape Town: Prevalence and correlates
    (2017) Mgweba-Bewana, Lihle; Joska, John A
    Introduction: Severe mental illness (SMI), Human immunodeficiency virus (HIV) infection and hazardous alcohol use are global epidemics. Each condition is independently associated with significant adverse health outcomes. The presence of two or more of these conditions in one individual may result in worse health outcomes. A key mediator of poor health outcomes are factors such as medication adherence. In resource-limited countries like South Africa, the impact of psycho-social factors may contribute further to worse health outcomes. These factors include poverty and unemployment; as well as gender. In South Africa, proportionately more women are infected with HIV than men; and they are also vulnerable to the problems of trauma and interpersonal violence. The main aim of this study was to investigate the prevalence of a triple co-morbidity of SMI, HIV infection and hazardous alcohol use in a female population at a community psychiatric clinic in Cape Town South Africa; and the impact of this triple comorbidity on medication adherence. Furthermore, we set out to identify demographic and clinical variables that are predictors of poor adherence to both psychotropic medication and ART where applicable. Methods: We conducted a cross-sectional study of female patients presenting to Gugulethu psychiatric clinic over a ten-month period. Demographics and clinical variables were explored using the Alcohol Use Disorders Identification Test (AUDIT); the adapted Morisky Scale to Assess Adherence to Psychotropic Medications; and an adherence to HIV antiretroviral treatment self-assessment instrument. A descriptive analysis of the demographic and predictor variables was undertaken to explore the prevalence of concurrent HIV infection and hazardous alcohol use in out-patients with SMI; as well as to investigate whether co-morbidity is associated with poor levels of adherence to psychotropic medication, as well as antiretroviral treatment (ART) in HIV positive patients. Results: We interviewed 127 patients, of whom 55 were HIV positive (43.3%). The overall prevalence of a triple comorbidity in this population was 7.9%. Only 20% within this triple comorbidity group were adherent to their psychotropic medication. Out of the 10 participants with a triple comorbidity, only five were on ART. Of these 5 participants, only two were adherent. Individuals with hazardous alcohol use were less adherent to psychotropic medication compared to those without. The seven respondents in the dual diagnosis group (SMI and hazardous alcohol use) had the lowest overall psychotropic adherence levels compared to the other subgroups (0%). Furthermore, concurrent hazardous alcohol use predicted poorer levels of compliance to ART for those with HIV infection. Conclusion: The presence of a triple diagnosis was not found to be a predictor of poorer medication adherence, compared to having one or two diagnoses. Nevertheless, there was evidence that concurrent hazardous drinking in SMI patients predicted poor compliance to both psychotropic and ART treatment regimens (for those living with HIV). These patients should be supported in future interventions to improve medication adherence and reduce hazardous drinking.
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    Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control
    (BioMed Central, 2018-01-23) Bobrow, Kirsten; Farmer, Andrew; Cishe, Nomazizi; Nwagi, Ntobeko; Namane, Mosedi; Brennan, Thomas P; Springer, David; Tarassenko, Lionel; Levitt, Naomi
    Background: Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description. Methods: We used a non-sequential and flexible approach guided by the 2008 MRC Framework for the development and evaluation of complex interventions. Results: We reviewed published literature and established a multi-disciplinary expert group to guide the development process. We selected health psychology theory and behaviour change techniques that have been shown to be important in adherence and persistence with chronic medications. Semi-structured interviews and focus groups with various stakeholders identified ways in which treatment adherence could be supported and also identified key features of well-regarded messages: polite tone, credible information, contextualised, and endorsed by identifiable member of primary care facility staff. Direct and indirect user testing enabled us to refine the intervention including refining use of language and testing of interactive components. Conclusions: Our experience shows that using a formal intervention development process is feasible in a low-resource multi-lingual setting. The process enabled us to pre-test assumptions about the intervention and the evaluation process, allowing the improvement of both. Describing how a multi-component intervention was developed including standardised descriptions of content aimed to support behaviour change will enable comparison with other similar interventions and support development of new interventions. Even in low-resource settings, funders and policy-makers should provide researchers with time and resources for intervention development work and encourage evaluation of the entire design and testing process. Trial registration: The trial of the intervention is registered with South African National Clinical Trials Register number (SANCTR DOH-27-1212-386; 28/12/2012); Pan Africa Trial Register (PACTR201411000724141; 14/12/2013); ClinicalTrials. gov (NCT02019823; 24/12/2013).
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    Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control
    (2018) Bobrow, Kirsten; Farmer, Andrew; Cishe, Nomazizi; Nwagi, Ntobeko; Namane, Mosedi; Brennan, Thomas P; Springer, David; Tarassenko, Lionel; Levitt, Naomi
    Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description.