SUNScholar - Browsing by Author "Zunza, Moleen"

Browsing by Author "Zunza, Moleen"

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A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS : impact on alcohol use, general functional ability, quality of life and adherence to HAART
(BioMed Central, 2017-01-28) Madhombiro, Munyaradzi; Dube-Marimbe, Bazondlile; Dube, Michelle; Chibanda, Dixon; Zunza, Moleen; Rusakaniko, Simbarashe; Stewart, David; Seedat, Soraya
ENGLISH SUMMARY : Background: Interventions for alcohol use disorders (AUDs) in HIV infected individuals have been primarily targeted at HIV risk reduction and improved antiretroviral treatment adherence. However, reduction in alcohol use is an important goal. Alcohol use affects other key factors that may influence treatment course and outcome. In this study the authors aim to administer an adapted intervention for AUDs to reduce alcohol use in people living with HIV/AIDS (PLWHA). Methods: This study is a cluster randomised controlled trial at 16 HIV care clinics. A motivational interviewing and cognitive behavioural therapy based intervention for AUDs, developed through adaptation and piloted in Zimbabwe, will be administered to PLWHA with AUDs recruited at HIV clinics. The intervention will be administered over 16 sessions at 8 HIV clinics. This intervention will be compared with an equal attention control in the form of the World Health Organization Mental Health Gap Action Programme (WHO mhGAP) guide, adapted for the Zimbabwean context. General function, quality of life, and adherence to highly active antiretroviral treatment (HAART) will be secondary outcomes. Booster sessions will be administered to both groups at 3 and 6 months respectively. The primary outcome measure will be the Alcohol Use Disorder Identification Test (AUDIT) score. The World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0), World Health Organisation Quality of Life (WHOQoL) HIV, viral load, and CD4 counts will be secondary outcome measures. Outcome assessments will be administered at baseline, 3, 6, and 12 months. Moderating factors such as perceived social support, how people cope with difficult situations and post-traumatic exposure and experience will be assessed at baseline. Trained research assistants will recruit participants. The outcome assessors who will be trained in administering the outcome and moderating tools will be blinded to the treatment arms allocated to the participants. However, the principal investigator, participants and intervention staff will be unblinded. Data will be analysed using STATA Version 14. Primary and secondary outcomes will be measured at four time points that is; at baseline, 3, 6, and 12 months respectively. All participants will be included in the analysis of primary and secondary outcome measures. The mean AUDIT scores will be compared between groups using student t-tests. Multilevel logistic regression analysis will be performed for binominal variables and multilevel linear regression for continuous variables. Descriptive statistics will be computed for baseline and follow-up assessments. Discussion: The study will be the first to address problematic alcohol use in PLWHA in Zimbabwe. It seeks to use local resources in delivering a modified, brief, evidence-based, and culturally contextualised intervention. The study results will determine the effectiveness of adapting psychological interventions for AUDs in HIV infected adults using a task-sharing framework.
Combination antiretroviral treatment use in prevention of mother-to-child transmission programmes : 6-week HIV prevalence and relationship to time of antiretroviral treatment initiation and mixed feeding
(AOSIS, 2019) Ndarukwa, Victoria; Zunza, Moleen
Background: In Zimbabwe, 16% of pregnant women aged 15–49 years are infected with HIV. More than 90% of HIV infection in children is through mother-to-child transmission (MTCT). We investigated the effectiveness of the Option B+ in reducing HIV infection and factors associated with HIV transmission among infants born to mothers enrolled in the prevention of mother-to-child transmission (PMTCT) programme. Methods: We randomly selected 1204 early infant HIV diagnosis test results for HIV-exposed infants and linked these results to maternal clinical records at primary healthcare clinics in Harare to estimate the prevalence of MTCT and to determine the clinical factors associated with MTCT of HIV at 6 weeks. Results: Of the 1204 infants in the study, 2.5% (95% confidence interval [CI], 1.7–3.5) were infected with HIV at 6 weeks post-delivery. Antiretroviral adherence reduced the odds of HIV infection by about 99% (odds ratio [OR] 0.01 [95% CI, 0.00–0.06]). Both mixed feeding (OR 3.89 [95% CI, 0.92–16.50]) and late initiation of antiretroviral treatment (ART) (after delivery) (OR 3.18 [95% CI, 0.42–23.94]) increased the odds of HIV infection. Conclusion: Early initiation of combination ART reduces 6-week MTCT of HIV in PMTCT programmes to levels similar to those found in controlled trial settings. Exclusive breastfeeding remains important even in the presence of ART.
A cross-sectional descriptive study of breastfeeding behaviour and galactogogue use among private-sector patients in Cape Town, South Africa
(Health and Medical Publishing Group, 2017-05) Steyn, N.; Zunza, Moleen; Decloedt, E. H.
Background. Failure to exclusively breastfeed is often caused by a perception of insufficient breastmilk supply. Galactogogues are frequently prescribed in these circumstances, but this is supported by sparse scientific data with safety concerns for both mother and infant. The exact extent of galactogogue use in South Africa (SA) is not well known. Objectives. To assess breastfeeding behaviour, galactogogue use and perceived galactogogue side-effects among patients attending International Board Certified Lactation Consultant (IBCLC) private practices. Methods. We administered a self-developed, expert-reviewed questionnaire in five IBCLC private practices within the Cape Town Metropole, SA. All patients attending the practices during an 8-week period were invited to participate. Results. Data from 104 participants were included in the study. An exclusive breastfeeding rate of slightly more than 50%, associated with greater parity (p=0.029), was found. Perceived lack of breastmilk predicted galactogogue use (p=0.013). There was a high prevalence of galactogogue use (54%), with 80% of these participants using non-prescription medication. Sulpiride was the most common prescription medication used. Increased milk production was reported by 41% (n=23) of galactogogue users, while 30% (n=17) reported no effect. Most reported side-effects were minor. Conclusions. Prevalence of galactogogue use exceeded other published data. Sulpiride was most frequently prescribed, despite not being recommended during breastfeeding. A large group of participants reported poor efficacy. The effect of vaginal delivery and immediate skin-to-skin contact after delivery on milk production might be smaller than previously reported in mothers who are personally motivated to breastfeed. Healthcare practitioners should acknowledge breastfeeding mothers’ concerns regarding insufficient milk supply and emphasise correct breastfeeding technique.
Determinants of poor adherence to antiretroviral treatment using a combined effect of age and education among human immunodeficiency virus infected young adults attending care at Letaba Hospital HIV Clinic, Limpopo Province, South Africa
(Pan African Medical Journal, 2019-01-18) Mabunda, Kuhlula; Ngamasana, Emery Ladi; Babalola, Joseph Omoniyi; Zunza, Moleen; Nyasulu, Peter
Introduction: sustained viral suppression using antiretroviral treatment (ART) occurs with adherence to treatment of at least 95%. Non-adherence promotes the development of drug-resistance and treatment failure in individuals infected with Human Immunodeficiency Virus. In Limpopo Province, the adherence rate is approximately 61%, but the prevalence and the factors associated with adherence at Letaba hospital HIV clinic are not well established. Therefore, the aim of this study was to identify the factors associated with adherence among HIV-infected young adults, aged 18-35 years, attending the clinic. Methods: a cross-sectional survey was conducted in Letaba HIV clinic among young adults of 18-35 years old. Logistic regression analysis was performed to determine factors associated with ART adherence. We reported odds ratios with the corresponding 95% confidence intervals and p-values. A p-value < 0.1 was considered as statistically significant. ART adherence was defined as taking more than 95% of the prescribed treatment, 3 days prior to completion of the questionnaire. Results: a total of 281 participants were enrolled with 163 (58.0%) females and more than three quarter, 222 (79.0%) between the ages of 18 and 29 years. The overall ART adherence stood at (87.2%) (95% CI: 63.0%-89.0%) representing 245 participants. Non-adherers to treatment, 36 (12.8%): patients reported no reason (3.9%), forgetting (3.2%), feeling good (3.2%), fear and running out of treatment (2.5%) as some of the reasons for not taking treatment within the three days prior to data collection. The following factors: tertiary education (p = 0.07), age (30-35; p-value: 0.07), drug availability (p-value: 0.07), were only marginally significantly associated with ART adherence. Conclusion: the study found unsatisfactory ART adherence among our participants. Our study suggests that factors other than sociodemographic and clinical factors might better explain differences in adherence. This highlights the need for a more complex study that would look at the entire system in which these patients are navigating as well as their mental models.
Effects of postnatal interventions for the reduction of vertical HIV transmission on infant growth and non-HIV infections : a systematic review
(BioMed Central, 2013-12-20) Zunza, Moleen; Mercer, Gareth D.; Thabane, Lehana; Esser, Monika; Cotton, Mark F.
Introduction: Guidelines in resource-poor settings have progressively included interventions to reduce postnatal HIV transmission through breast milk. In addition to HIV-free survival, infant growth and non-HIV infections should be considered. Determining the effect of these interventions on infant growth and non-HIV infections will inform healthcare decisions about feeding HIV-exposed infants. We synthesize findings from studies comparing breast to formula feeding, early weaning to standard-duration breastfeeding, breastfeeding with extended antiretroviral (ARV) to short-course ARV prophylaxis, and alternative preparations of infant formula to standard formula in HIV-exposed infants, focusing on infant growth and non-HIV infectious morbidity outcomes. The review objectives were to collate and appraise evidence of interventions to reduce postnatal vertical HIV transmission, and to estimate their effect on growth and non-HIV infections from birth to two years of age among HIV-exposed infants. Methods: We searched PubMed, SCOPUS, and Cochrane CENTRAL Controlled Trials Register. We included randomized trials and prospective cohort studies. Two authors independently extracted data and evaluated risk of bias. Rate ratios and mean differences were used as effect measures for dichotomous and continuous outcomes, respectively. Where pooling was possible, we used fixed-effects meta-analysis to pool results across studies. Quality of evidence was assessed using the GRADE approach. Results and discussion: Prospective cohort studies comparing breast- versus formula-fed HIV-exposed infants found breastfeeding to be protective against diarrhoea in early life [risk ratio (RR)=0.31; 95% confidence interval (CI)=0.13 to 0.74]. The effect of breastfeeding against diarrhoea [hazard ratio (HR)=0.74; 95% CI=0.57 to 0.97] and respiratory infections (HR=0.65; 95% CI=0.41 to 1.00) was significant through two years of age. The only randomized controlled trial (RCT) available showed that breastfeeding tended to be protective against malnutrition (RR=0.63; 95% CI=0.36 to 1.12). We found no statistically significant differences in the rates of non-HIV infections or malnutrition between breast-fed infants in the extended and short-course ARV prophylaxis groups. Conclusions: Low to moderate quality evidence suggests breastfeeding may improve growth and non-HIV infection outcomes of HIV-exposed infants. Extended ARV prophylaxis does not appear to increase the risk for HIV-exposed infants for adverse growth or non-HIV infections compared to short-course ARV prophylaxis.
Equipping medical graduates to address health systems challenges in South Africa : an expressed need for curriculum change
(Health & Medical Publishing Group, 2015) Mukinda, Fidele K.; Goliath, C. D.; Willems, B.; Zunza, Moleen; Dudley, Lilian
Background: Stellenbosch University Rural Medical Education Partnership Initiative (SURMEPI) aims to enhance health systems knowledge and skills to empower medical graduates to address health systems challenges especially in rural and underserved areas. Objectives: To assess the content of health systems research (HSR) and strengthening, and understand perceptions of medical graduates and faculty about HSR in the undergraduate medical curriculum at Stellenbosch University. Methods: We defined HSR and strengthening competencies for medical graduates through a literature review and expert consultations. Learning outcomes in terms of knowledge, skill or attitude in the 64 module guides of the curriculum were compared with the competencies required. A survey of recent medical graduates assessed whether their training equipped them to address health systems challenges. Interviews with faculty assessed their views on teaching health systems competencies. Results. HSR foundational competencies were covered at a basic knowledge level, with little progression of learning levels, and several key competencies were not taught at all. Teaching was not integrated throughout the curriculum. Of 189 graduates, 63 (33.3%) agreed while 67 (35.4%) disagreed that their training prepared them to address health system challenges; 128 (67.7%) agreed on the importance of learning health systems competencies as undergraduates, and proposed learning areas of health system knowledge, leadership and management, problem solving, community service, evaluation methods and health economics. They wanted more practical, problem-oriented HSR training. Faculty supported the relevance and inclusion of HSR and strengthening in the curriculum. Conclusion: The curriculum needs adaptation to better equip students with HSR and strengthening competencies.
Factors associated with adherence to dietary prescription among adult patients with chronic kidney disease on hemodialysis in national referral hospitals in Kenya : a mixed-methods survey
(BMC (part of Springer Nature), 2019-09-11) Opiyo, Rose Okoyo; Nyasulu, Peter Suwirakwenda; Olenja, Joyce; Zunza, Moleen; Nguyen, Kim A.; Bukania, Zipporah; Nabakwe, Esther; Mbogo, Alexander; Were, Anthony Omolo
Introduction: Adherence to dietary prescriptions among patients with chronic kidney disease is known to prevent deterioration of kidney functions and slow down the risk for morbidity and mortality. This study determined factors associated with adherence to dietary prescription among adult patients with chronic kidney disease on hemodialysis. Methods: A mixed-methods study, using parallel mixed design, was conducted at the renal clinics and dialysis units at the national teaching and referral hospitals in Kenya from September 2018 to January 2019. The study followed a QUAN + qual paradigm, with quantitative survey as the primary method. Adult patients with chronic kidney disease on hemodialysis without kidney transplant were purposively sampled for the quantitative survey. A sub-sample of adult patients and their caregivers were purposively sampled for the qualitative survey. Numeric data were collected using a structured, self-reported questionnaire using Open Data Kit “Collect software” while qualitative data were collected using in-depth interview guides and voice recording. Analysis on STATA software for quantitative and NVIV0 12 for qualitative data was conducted. The dependent variable, “adherence to diet prescription” was analyzed as a binary variable. P values < 0.1 and < 0.05 were considered as statistically significant in univariate and multivariate logistic regression models respectively. Qualitative data were thematically analyzed. Results: Only 36.3% of the study population adhered to their dietary prescriptions. Factors that were independently associated with adherence to diet prescriptions were “flexibility in the diets” (AOR 2.65, 95% CI 1.11–6.30, P 0.028), “difficulties in following diet recommendations” (AOR 0.24, 95% CI 0.13–0.46, P < 001), and “adherence to limiting fluid intake” (AOR 9.74, 95% CI 4.90–19.38, P < 0.001). Conclusions: For patients with chronic kidney disease on hemodialysis, diet prescriptions with less restrictions and requiring minimal extra efforts and resources are more likely to be adhered to than the restrictive ones. Patients who adhere to their fluid intake restrictions easily follow their diet prescriptions. Prescribed diets should be based on the individual patient’s usual dietary habits and assessed levels of challenges in using such diets. Additionally, diet adherence messages should be integrated with fluid limitation messages. Further research on understanding patients’ adherence to fluid restriction is also suggested.
The impact of family physician supply on district health system performance, clinical processes and clinical outcomes in the Western Cape Province, South Africa (2011–2014)
(AOSIS, 2018-04) Chinhoyi, Rekai L.; Zunza, Moleen; Von Pressentin, Klaus B.
Background: A revised family physician (FP) training programme was introduced in South Africa in 2007. A baseline assessment (2011) of the impact of FP supply on district health system performance was performed within the Western Cape Province, South Africa. The impact of an increased FP supply within this province required re-evaluation. Aim: To assess the impact of FP supply on indicators of district health system performance, clinical processes and clinical outcomes in the Western Cape Province. The objectives were to determine the impact of FPs, nurses, medical officers (MOs) and other specialists. Setting: The study sample included all five rural districts and eight urban subdistricts of the Western Cape Province. Methods: A secondary analysis was performed on routinely collected data from the Western Cape Department of Health from 01 March 2011 until 30 April 2014. Results: The FP supply did not significantly impact the indicators analysed. The supply of nurses and MOs had an impact on some of the indicators analysed. Conclusion: This study did not replicate the positive associations between an increase in FP supply and improved health indicators, as described previously for high-income country settings. The impact of FP supply on clinical processes, health system performance and outcome indicators in the Western Cape Province was not statistically significant. Future re-evaluation is recommended to allow for more time and an increase in FP supply.
Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa : study protocol for a randomized controlled trial
(BioMed Central, 2017-07-17) Zunza, Moleen; Cotton, Mark F.; Mbuagbaw, Lawrence; Lester, Richard; Thabane, Lehana
Background: South Africa recently phased out access to free formula milk in the public sector in support of breastfeeding for women living with HIV. Few women living with HIV in South Africa choose breastfeeding and among those who do, many stop breastfeeding early. We sought to explore the feasibility of using mobile phone text messaging coupled with motivational interviewing to enhance adherence to breastfeeding practices. Methods and design: A randomized, parallel group, single-center pilot trial. Electronic sequence generation and random allocation will be done centrally. Women of low socioeconomic status, from Cape Town, South Africa will be randomly assigned within 24 h of giving birth at a primary healthcare clinic to a structured weekly text message plus motivational interviewing and usual standard of care, using a permutation of different block sizes. Criteria for feasibility success will include: five participants recruited per week (over 12 weeks), about 75% of all eligible participants consent for study participation, complete evaluation of outcomes in at least 70% of all recruited participants, breastfeeding adherence rates of at least 70% in the intervention group, six months after delivery. Participants will be evaluated soon after giving birth and post-delivery at weeks 2, 6, 10, and 24. Primary analysis will follow the “intention-to-treat” principle. Sub-group analysis will be used to assess sub-group effects. Discussion: This pilot trial will evaluate the feasibility of conducting a larger trial on communication and support approaches to improve adherence to breastfeeding by HIV-infected women. Text messaging and motivational interviewing are simple interventions which may allow participants to access personalized adherence advice and support. Trial registration: ClinicalTrials.gov: NCT02949713. Registered on 26 October 2016; Pan African Clinical Trial Registry PACTR201611001855404. Registered on 8 November 2016.
Intervention for alcohol use disorders at an HIV care clinic in Harare : a pilot and feasibility study
(BMC (part of Springer Nature), 2019) Madhombiro, Munyaradzi; Dube, Bazondlile; Dube, Michelle; Zunza, Moleen; Chibanda, Dixon; Rusakaniko, Simbarashe; Seedat, Soraya, 1966-
Background: Alcohol use in HIV infected patients is associated with risky sexual behaviour, poor adherence to Highly Active Antiretroviral Therapy, treatment failure and increased physiologic harm. The objectives of the study were to pilot the outcome assessments to be used in the trial proper, assess the feasibility of delivery of a brief MI/CBT intervention compared to an WHO mhGAP intervention for problematic alcohol use in PLWH in Zimbabwe, and pilot the effectiveness (on alcohol use, functionality and CD4 count) of these interventions at 3 months in a randomised controlled trial design. Methods: An intervention for HIV infected patients with problematic alcohol use, developed through adaptation of existing evidence based psychological treatments, was assessed for its feasibility at a tertiary HIV care clinic in Zimbabwe. Registered general nurses, using a manualised protocol, delivered the intervention. Forty patients were recruited and randomised to receive either an MI/CBT intervention or the WHO mhGAP Intervention Guide for AUDs (n = 20 patients per group). Results: Out of 40 participants enrolled, 31 were successfully followed up for 3 months with a loss to follow-up rate of 23%. There was a statistically significant decrease in AUDIT score over time in both groups (p < 0.001), however no statistically significant group difference with a mean difference of 0.80, standard error of 2.07 and p = 0.70. For the CD4 count, the median and interquartile ranges at baseline for MI/CBT and WHO mhGAP IG groups were 218 (274) and 484 (211.50), respectively. At follow-up, median and interquartile ranges for the CD4 count for MI/CBT and WHO mhGAP IG groups were 390 (280) and 567 (378), respectively, indicative of improvement in immunological parameters in both arms. Conclusion: The findings from this pilot study suggests that a brief MI/CBT delivered by Registered General Nurses for problematic alcohol use is feasible in this population but will require the implementation of additional measures to improve retention. However, mechanisms to improve retention need special attention.
Isoniazid for preventing tuberculosis in HIV-infected children
(John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration, 2017) Zunza, Moleen; Gray, Diane M.; Young, Taryn; Cotton, Mark; Zar, Heather J.
Background: Tuberculosis (TB) is an important cause of illness and death in HIV‐positive children living in areas of high TB prevalence. We know that isoniazid prophylaxis prevents TB in HIV‐negative children following TB exposure, but there is uncertainty related to its role in TB preventive treatment in HIV‐positive children. Objectives: To summarise the effects of TB preventive treatment versus placebo in HIV‐positive children with no known TB contact on active TB, death, and reported adverse events. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE/PubMed, Embase and two trial registers up to February 2017. Selection criteria: We included trials of HIV‐positive children with and without known TB exposure, randomized to receive TB preventive treatment or placebo. Data collection and analysis: Two review authors independently used the study selection criteria, assessed risk of bias, and extracted data. We assessed effects using risk, incidence rate and hazard ratios and assessed the certainty of evidence using GRADE. Main results: We included three trials, involving 991 participants, below the age of 13 years, from South Africa and Botswana. Children were randomized to isoniazid prophylaxis or placebo, given daily or three times weekly. The median length of follow‐up ranged from 5.7 to 34 months; some were on antiretroviral therapy (ART). In HIV‐positive children not on ART, isoniazid prophylaxis may reduce the risk of active TB (hazard ratio (HR) 0.31, 95% confidence interval (CI) 0.11 to 0.87; 1 trial, 240 participants, low certainty evidence), and death (HR 0.46, 95% CI 0.22 to 0.95; 1 trial, 240 participants, low certainty evidence). One trial (182 participants) reported number of children with laboratory adverse events, which was similar between the isoniazid prophylaxis and placebo groups. No clinical adverse events were reported. In HIV‐positive children on ART, we do not know if isoniazid prophylaxis reduces the risk of active TB (risk ratio (RR) 0.76, 95% CI 0.50 to 1.14; 3 trials, 737 participants, very low certainty evidence) or death (RR 1.45, 95% CI 0.78 to 2.72; 3 trials, 737 participants, very low certainty evidence). Two trials (714 participants) reported number of clinical adverse events and three trials (795 participants) reported number of laboratory adverse events; for both categories, the number of adverse events were similar between the isoniazid prophylaxis and placebo groups. Authors' conclusions: Isoniazid prophylaxis given to all children diagnosed with HIV may reduce the risk of active TB and death in HIV‐positive children not on ART in studies from Africa. For children on ART, no clear benefit was detected.
Output from the CIHR Canadian HIV Trials Network international postdoctoral fellowship for capacity building in HIV clinical trials
(Dove Medical Press, 2018) Mbuagbaw, L.; Slogrove, Amy L.; Sas, J.; Lengwe, Kunda J.; Morfaw, F.; Mukonzo, J. K.; Cao, W.; Ngomba-Kadima, G.; Zunza, Moleen; Ongolo-Zogo, P.; Nana, P. N.; Cockcroft, A.; Andersson, N.; Sewankambo, N; Cotton, M. F.; Li, T.; Young, T.; Singer, J.; Routy, J. P.; Ross, C. J. D.; Thin, K.; Thabane, L.; Anis, A. H.
ENGLISH ABSTRACT: As a response to the human immunodeficiency virus (HIV) epidemic and part of Canadian Institutes for Health Research’s mandate to support international health research capacity building, the Canadian Institutes for Health Research Canadian HIV Trial Network (CTN) developed an international postdoctoral fellowship award under the CTN’s Postdoctoral Fellowship Awards Program to support and train young HIV researchers in resource-limited settings. Since 2010, the fellowship has been awarded to eight fellows in Cameroon, China, Lesotho, South Africa, Uganda and Zambia. These fellows have conducted research on a wide variety of topics and have built a strong network of collaboration and scientific productivity, with 40 peer-reviewed publications produced by six fellows during their fellowships. They delivered two workshops at international conferences and have continued to secure funding for their research, using the fellowship as a stepping stone. The CTN has been successful in building local HIV research capacity and forming a strong network of like-minded junior low- and middle-income country researchers with high levels of research productivity. They have developed into mentors, supervisors and faculty members, who, in turn, build local capacity. The sustainability of this international fellowship award relies on the recognition of its strengths and the involvement of other stakeholders for additional resources.
Quality of abstracts of pilot trials in heart failure : a protocol for a systematic survey
(Elsevier, 2017) Isiguzo, Godsent; Zunza, Moleen; Chirehwa, Maxwell; Mayosi, Bongani M.; Thabane, Lehana
Introduction: Pilot trials are initial small-scale studies done to inform the design of larger trials. Their findings like other studies are usually disseminated as peer-reviewed journal articles. Abstracts are used to introduce the contents to readers, and give a general idea about the full reports and sometimes are the only source of information available to readers. Despite their importance, the contents of abstracts of trial reports are usually not informative enough and lack the essential details. Methods and analysis: This is a protocol for a planned systematic survey with a primary aim of analyzing the reporting quality measured as the completeness of the reporting of pilot trial abstracts in heart failure. The secondary aim will be to explore factors associated with better reporting quality. Abstracts of heart failure pilot trials in humans (journal and conference abstracts) published in the English language from 1 January 1990 to 30 November 2016 will be assessed to determine the reporting quality, based on the CONSORT 2010 statement extension to randomized pilot and feasibility trials. All non-pilot/feasibility trials and non-human pilot trials will be excluded. We will search Medline (PUBMED), Cochrane controlled trials register, Scopus and African wide information databases for pilot trials in heart failure. Title and abstracts of identified studies will be screened for inclusion and data extracted independently by two reviewers in duplicate without using the full text. Reported and unreported items on the abstracts will be presented as frequencies and percentages, a descriptive analysis will be used to interpret the reporting quality and regression analysis used for characteristics associated with greater statistical reporting at 95% confidence interval.
Quality of pilot trial abstracts in heart failure is suboptimal : a systematic survey
(BioMed Central, 2018-05-31) Isiguzo, Godsent C.; Zunza, Moleen; Chirehwa, Maxwell; Mayosi, Bongani M.; Thabane, Lehana
Background: Pilot trials are miniature researches carried out with the sole aim of acting as the precursor for larger more definitive studies. Abstracts are used to summarize and introduce the findings to the reading audience. There is substantive empirical evidence showing that abstracts, despite their important roles, are not informative enough, lacking the necessary details. This systematic survey was designed to assess the quality of reporting of heart failure pilot trial abstracts. The quality of reporting was defined as the completeness of reporting based on adherence to the CONSORT extension for reporting of pilot trial abstracts. We also identified factors associated with reporting quality. Methods: We searched MEDLINE (PubMed), Cochrane Controlled Trials Register, Scopus, and African-wide information databases for abstracts from heart failure pilot trials in humans published from 1 January 1990 to 30 November 2016. These were assessed to determine the extent of adherence to CONSORT extension checklist for reporting of abstracts of pilot trials. We screened identified studies for inclusion based on title and abstract. Data were independently extracted by two reviewers using the checklist. We used regression analysis to assess the association between completeness of reporting (measured as the number of items in the CONSORT extension checklist for reporting of abstracts in pilot trials contained in each abstract) and factors influencing the quality of the reports. Results: Two hundred and twenty-eight (228) articles were retrieved, of which 92 met the inclusion criteria. The mean CONSORT extension score was 8.3/16 (standard deviation 1.7); the least reported items were the source of funding (1% [1/92]), trial registration (13% [12/92]), randomization sequence (13% [12/92]), number randomized to each arm (16% [15/92]), and number analyzed in each arm (16% [15/92]). Multivariable regression analysis showed that pharmacological intervention pilot trials [incidence rate ratio (IRR) = 0.88; 95% confidence interval (CI), 0.81–0.97] were significantly associated with better reporting. Other factors such as structured abstract (IRR = 1.10; 95% CI, 0.99–1.23) and CONSORT endorsement (IRR = 1.10; 95% CI, 0.99–1.23) only showed minimal relationship with better reporting quality. Conclusion: The quality of reporting of abstracts of heart failure pilot trials was suboptimal. Pharmacological intervention was significantly associated with better reporting. These findings are consistent with previous research on reporting of trials.
A review of adherence and predictors of adherence to the CONSORT Statement in the reporting of tuberculosis vaccine trials
(MDPI, 2020-12-16) Ngah, Veranyuy D.; Mazingisa, Akhona V.; Zunza, Moleen; Wiysonge, Charles S.
The statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored the quality of reporting of TB vaccine trials according to the latest version of the CONSORT statement, released in 2010. We searched PubMed and the Cochrane Central Register of Controlled Trials in August 2019. We conducted screening, study selection, and data extraction in duplicate; and resolved differences through discussion. We assessed reporting to be adequate if trials reported at least 75% of the CONSORT 2010 items. We conducted a trend analysis to assess if there was improvement in reporting over time. We also used logistic regression to assess factors associated with adequate reporting. We included 124 trials in the analyses. The mean proportion of adherence was 67.3% (95% confidence interval 64.4% to 70.1%), with only 46 (37%) trials having adequate reporting. There was a significant improvement in the quality of reporting over time (p < 0.0001). Trials published in journals with impact factors between 10 and 20 were more likely to have adequate reporting (odds ratio 9.4; 95% confidence interval 1.30 to 67.8), compared to lower-impact-factor journals. Despite advances over time, the reporting of TB vaccine trials is still inadequate and requires improvement.
Social and contextual factors affecting HIV-infected women’s feeding practices for their infants in normal practice settings : effects on growth and morbidity
(Stellenbosch : Stellenbosch University, 2016-03) Zunza, Moleen; Cotton, Mark F.; Esser, Monika; Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Paediatrics and Child Health.
ENGLISH ABSTRACT: the significant reduction in HIV transmission through breastfeeding by antiretroviral treatment guided the current recommendations favouring breastfeeding which has to be continued until 12 months of age. Infant feeding guidelines for HIV-infected women in low-resourced settings are primarily informed by studies that spend much effort in controlling guideline adherence by investigators and participants. These studies however may not reflect the real world effects of the feeding options on important outcomes because such efforts are less enforced or rear in primary care settings. Reliable studies are lacking for predicting the real world effects of the feeding options on infant growth and morbidity to guide healthcare authorities in decision making. Social and contextual factors affecting HIV-infected women’s infant feeding practices are major barriers to uptake of infant feeding recommendations to levels that would result in a significant impact. Yet less attention is paid to these during guideline development and implementation. Methods: To address this knowledge gap we performed a longitudinal cohort study in primary healthcare settings, over a 12 months period. The objectives were to a) describe HIV-infected women’s infant feeding practices b) compare infant feeding practices of HIV-infected and HIV-uninfected breastfeeding women c) assess growth and infection-related hospitalizations among predominantly breastfed and predominantly formula-fed HIV-exposed uninfected infants. We explored infant feeding experiences of a sub-set of HIV-infected women who were followed-up for at least 6 months post-delivery in the longitudinal cohort. Results: We found that few HIV-infected women chose breastfeeding, and among those who did, many switched to formula feeding early. The proportion of women who continued predominantly breastfeeding was only slightly lower among HIV-infected compared to HIV-uninfected women (p = 0.0005). These differences were seen from about two weeks, and persisted throughout follow-up. By about four months, half of the HIV-infected women had switched to predominant formula feeding. However, the proportion of HIV-uninfected women who switched to formula feeding was also relatively high. The dual infant feeding option employed by the Western Cape PMTCT program while transitioning from formula feeding policy confused HIV-infected women who were worried that their child may contract HIV through breastmilk because of conflicting messages they received from healthcare providers, possibly explaining why some women stopped breastfeeding. Women’s interpretation of information about risks and benefits of infant feeding options, formula feeding stigma and the quality of infant feeding counselling affected women’s infant feeding practices. Mean weight velocity Z-scores (95% CI) of predominantly breastfed infants was -0.70 (-1.31 to -0.09; p = 0.024) lower than that of predominantly formula fed infants in the two to four months age interval. Protection against infections by breastfeeding was minimal and insignificant, odds ratio (OR) 0.95 (95% CI 0.33 to 2.74). In conclusion, it is important that all women, whether HIV-infected or not, be educated that breastfeeding is the feeding of choice in this setting. The potential of breastfeeding to reduce risks of infections to levels similar to those observed under highly controlled settings, involves changing women’s infant feeding practices. Strategies to promote and sustain continued breastfeeding by women, to levels that would result in a significant impact on the growth and protection against infections of their children are urgently needed. The strategies should be guided by social and contextual factors affecting women’s feeding practices
South African healthcare workers and COVID-19 : a shared responsibility to protect a precious and limited resource
(Health & Medical Publishing Group, 2020) Dramowski, Angela; Zunza, Moleen; Dube, Kopano; Parker, Mohammed; Slogrove, Amy L.
Healthcare workers (HCWs) in African countries face high risks of occupational exposure to many pathogens, including tuberculosis, measles, HIV and Ebola.[1,2] The novel coronavirus SARSCoV- 2 poses an arguably greater threat to African HCWs than any other infectious agent to date. Data from countries with established epidemics show that HCWs experience high rates of COVID-19 infection, morbidity and mortality. In the USA, 19% of COVID-19 cases whose occupational status was known were HCWs (9 282/49 000),[3] and >90 000 HCW COVID-19 infections were documented in 30 countries, with 260 deaths in nurses, by early May 2020.[4] In South Africa (SA), on 6 May, Minister Zweli Mkhize reported that 511 HCWs had tested positive for SARS-CoV-2 (7% of the national total), with nurses accounting for 53% of total HCW cases.[5] The unprecedented risk posed to HCWs by COVID-19 is clearly acknowledged by all levels of the SA government. Nationally there have been commitments, both financially and administratively, to ensure procurement and local production of personal protective equipment (PPE) and transparent reporting of HCW COVID-19 infections. To varying degrees, administrative and engineering interventions to prevent COVID-19 infections and outbreaks have been implemented in SA healthcare facilities (Table 1). Despite the early phase of the pandemic and general availability of PPE, SA is already facing high rates of HCW COVID-19 infections and exposure events. This is a concerning development reflecting both widespread community transmission (with HCW infections) and the need to strengthen ‘universal’ prevention measures in healthcare facilities, e.g. physical distancing, mask-wearing, hand hygiene, and increased cleaning/ disinfection of surfaces and equipment.
Strategies for partner notification for sexually transmitted infections, including HIV (review)
(John Wiley & Sons, 2013) Ferreira A; Young T; Mathews C; Zunza, Moleen; Low N

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