Study protocol for the SMART2D adaptive implementation trial: a cluster randomised trial comparing facility-only care with integrated facility and community care to improve type 2 diabetes outcomes in Uganda, South Africa and Sweden

INTRODUCTION Type 2 diabetes (T2D) is increasingly contributing to the global burden of disease. Health systems in most parts of the world are struggling to diagnose and manage T2D, especially in low-income and middle-income countries, and among disadvantaged populations in high-income countries. The aim of this study is to determine the added benefit of community interventions onto health facility interventions, towards glycaemic control among persons with diabetes, and towards reduction in plasma glucose among persons with prediabetes. METHODS AND ANALYSIS An adaptive implementation cluster randomised trial is being implemented in two rural districts in Uganda with three clusters per study arm, in an urban township in South Africa with one cluster per study arm, and in socially disadvantaged suburbs in Stockholm, Sweden with one cluster per study arm. Clusters are communities within the catchment areas of participating primary healthcare facilities. There are two study arms comprising a facility plus community interventions arm and a facility-only interventions arm. Uganda has a third arm comprising usual care. Intervention strategies focus on organisation of care, linkage between health facility and the community, and strengthening patient role in selfmanagement, community mobilisation and a supportive environment. Among T2D participants, the primary outcome is controlled plasma glucose; whereas among prediabetes participants the primary outcome is reduction in plasma glucose. ETHICS AND DISSEMINATION The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. Trial registration number ISRCTN11913581; Pre-results

Integrated approach to malaria prevention at household level in rural communities in Wakiso district, Uganda: impact evaluation of a pilot project

Background: The integrated approach to malaria prevention, which advocates for the use of several malaria prevention methods at households, is being explored to complement other existing strategies. We implemented a pilot project that promoted the integrated approach to malaria prevention in two rural communities in Wakiso district, Uganda. Objectives: This paper presents the impact evaluation findings of the project carried out 2 years after implementation with a focus on changes in knowledge and practices on malaria prevention. Methods: The project evaluation was cross-sectional in design and employed both quantitative and qualitative data collection methods. The quantitative survey was conducted among 540 households (household heads being participants) while the qualitative component involved 4 focus group discussions among community health workers (CHWs). Chi-square test was used to compare quantitative results from the evaluation with those of the baseline while thematic analysis was employed for qualitative data. Results: There was a statistically significant positive change in malaria prevention practices in the evaluation compared with the baseline regarding indoor residual spraying (χ2 = 7.9, p = 0.019), mosquito screening of windows and ventilators (χ2 = 62.3, p = 0.001), and closing windows of houses before 6:00 pm (χ2 = 60.2, p < 0.001). The CHWs trained during the project were found to be highly knowledgeable on the various malaria prevention methods in the integrated approach, and continued to promote their use in the community. Conclusion: Findings of the impact evaluation give promise that utilisation of integrated malaria prevention can be enhanced if use of multiple methods is promoted in communities

Tobacco use and associated factors among Adults in Uganda: Findings from a nationwide survey

Introduction Tobacco use and the exposure to tobacco smoke is one of the most preventable causes of death and disability globally. The risk is even higher among daily tobacco users. The World Health Organization (WHO) has recommended that surveillance of major risk factors for Non Communicable Diseases (NCDs) such as tobacco use is imperative to predict the future burden of NCDs, identify interventions to reduce future burden and monitor emerging patterns and trends. In 2014 the first Uganda nation-wide NCD risk factor survey was carried out to estimate the prevalence of major NCD risk factors. We analyzed data from this survey to estimate the prevalence of daily tobacco use and associated risk factors. Material and Methods A nationally representative sample was drawn stratified by the four regions of the country. The WHO’s STEPwise tool was used to collect data on demographic and behavioral characteristics including tobacco use, physical and biochemical measurements. Tobacco use was divided into three categories; daily tobacco use, daily smoked tobacco use and daily smokeless tobacco use. Weighted logistic regression analysis was used to identify factors associated with daily tobacco use. Results Of the 3983 participants, 9.2 % (366) were daily tobacco users, 7.4 % (294) were daily smoked tobacco users and 2.9 % (115) were daily smokeless tobacco users. Male participants were more likely to be daily tobacco users compared with female participants AOR 5.51 [3.81–7.95]. Compared with participants aged 18–29 years, those aged 30–49 years were more likely to be daily tobacco users AOR 2.47 [1.54–3.94] as were those aged 50–69 years AOR 2.82 [1.68–4.74]. Compared with participants without any education, those with primary education were less likely to be daily tobacco users AOR 0.43 [0.29–0.65], as were those with secondary education AOR 0.21 [0.14–0.33] and those with university level of education AOR 0.23 [0.11–0.48]. Compared with participants in the central region, those in the eastern region were more likely to be daily tobacco users AOR 2.14 [1.33–3.45] as were those in the northern region AOR 4.31 [2.79–6.45] and those in the western region AOR 1.87 [1.18–2.97]. Participants who were underweight were more likely to be daily tobacco users compared with people with normal BMI AOR 2.19 [1.48–3.24]. Conclusions In agreement with previous surveys on tobacco use, there is a high prevalence of tobacco use in Uganda with almost 1 in every 10 Ugandans using tobacco products daily. Being older, male, having no formal education, residing in the east, north and western regions and having low BMI were significantly associated with daily tobacco use. This information provides a useful benchmark to the National Tobacco Control Program for the designing of public health interventions for the control and prevention of tobacco use in Uganda

Integrated approach to malaria prevention at household level in rural communities in Wakiso district, Uganda: impact evaluation of a pilot project

Background: The integrated approach to malaria prevention, which advocates for the use of several malaria prevention methods at households, is being explored to complement other existing strategies. We implemented a pilot project that promoted the integrated approach to malaria prevention in two rural communities in Wakiso district, Uganda. Objectives: This paper presents the impact evaluation findings of the project carried out 2 years after implementation with a focus on changes in knowledge and practices on malaria prevention. Methods: The project evaluation was cross-sectional in design and employed both quantitative and qualitative data collection methods. The quantitative survey was conducted among 540 households (household heads being participants) while the qualitative component involved 4 focus group discussions among community health workers (CHWs). Chi-square test was used to compare quantitative results from the evaluation with those of the baseline while thematic analysis was employed for qualitative data. Results: There was a statistically significant positive change in malaria prevention practices in the evaluation compared with the baseline regarding indoor residual spraying (\u3c72 = 7.9, p = 0.019), mosquito screening of windows and ventilators (\u3c72 = 62.3, p = 0.001), and closing windows of houses before 6:00 pm (\u3c72 = 60.2, p &lt; 0.001). The CHWs trained during the project were found to be highly knowledgeable on the various malaria prevention methods in the integrated approach, and continued to promote their use in the community. Conclusion: Findings of the impact evaluation give promise that utilisation of integrated malaria prevention can be enhanced if use of multiple methods is promoted in communities

Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial.

BACKGROUND: Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda. METHODS/DESIGN: We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. DISCUSSIONS: The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting. TRIAL REGISTRATION: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01228578

Modifiable socio-behavioural factors associated with overweight and hypertension among persons aged 35 to 60 years in eastern Uganda. PLoS One 2012

Abstract Background: Few studies have examined the behavioural correlates of non-communicable, chronic disease risk in lowincome countries. The objective of this study was to identify socio-behavioural characteristics associated with being overweight or being hypertensive in a low-income setting, so as to highlight possible interventions and target groups

Determination of circulating Mycobacterium tuberculosis strains and transmission patterns among pulmonary TB patients in Kawempe municipality, Uganda, using MIRU-VNTR

<p>Abstract</p> <p>Background</p> <p>Mycobacterial interspersed repetitive units - variable number of tandem repeats (MIRU-VNTR) genotyping is a powerful tool for unraveling clonally complex <it>Mycobacterium tuberculosis </it>(MTB) strains and detection of transmission patterns. Using MIRU-VNTR, MTB genotypes and their transmission patterns among patients with new and active pulmonary tuberculosis (PTB) in Kawempe municipality in Kampala, Uganda was determined.</p> <p>Results</p> <p>MIRU-VNTR genotyping was performed by PCR-amplification of 15 MTB-MIRU loci from 113 cultured specimens from 113 PTB patients (one culture sample per patient). To determine lineages, the genotypes were entered into the MIRU-VNTR<it>plus </it>database [<url>http://www.miru-vntrplus.org/</url>] as numerical codes corresponding to the number of alleles at each locus. Ten different lineages were obtained: Uganda II (40% of specimens), Uganda I (14%), LAM (6%), Delhi/CAS (3%), Haarlem (3%), Beijing (3%), Cameroon (3%), EAI (2%), TUR (2%) and S (1%). Uganda I and Uganda II were the most predominant genotypes. Genotypes for 29 isolates (26%) did not match any strain in the database and were considered unique. There was high diversity of MIRU-VNTR genotypes, with a total of 94 distinct patterns. Thirty four isolates grouped into 15 distinct clusters each with two to four isolates. Eight households had similar MTB strains for both index and contact cases, indicating possible transmission.</p> <p>Conclusion</p> <p>MIRU-VNTR genotyping revealed high MTB strain diversity with low clustering in Kawempe municipality. The technique has a high discriminatory power for genotyping MTB strains in Uganda.</p

Depressive and Anxiety Symptoms Predict Sustained Quality of Life Deficits in HIV-Positive Ugandan Adults Despite Antiretroviral Therapy: A Prospective Cohort Study

Abstract The impact of psychosocial status at onset of antiretroviral therapy on changes in quality of life (QOL) and subjectively rated health (SRH) among adults on highly active antiretroviral therapy (HAART) in resource-limited settings is poorly understood. Therefore, we evaluate the association between stigma, anxiety, depression, and social support and change in QOL and SRH in HIV-infected Ugandan adults during an 18-month period. Psychosocial indicators were assessed at enrollment using structured questionnaires. QOL and SRH measures were assessed at months 0, 6, 12, and 18 using the Medical Outcomes Survey-HIV. Linear mixed models determined risk estimated differences in QOL and SRH in relation to quartiles of each psychosocial status indicator. Repeated measures generalized estimating equations modeling was implemented to assess differences in likelihood of improved versus nonimproved SRH during follow-up. QOL scores and SRH improved significantly for all participants over 18 months (P < 0.0001). The gain in QOL increased dose-dependently as baseline depressive symptoms (time∗depression P < 0.001) and anxiety levels (time∗anxiety P < 0.001) declined. Lower social support was associated with worse QOL at baseline (P = 0.0005) but QOL improvement during follow-up was not dependent on baseline level of social support (time∗social support P = 0.8943) or number of stigmatizing experiences (time∗stigma P = 0.8662). Psychosocial determinants did not predict changes in SRH in this study. High levels of depression and anxiety symptoms at HAART initiation predicts lower gains in QOL for HIV-positive patients for as long as 18 months. Long-term QOL improvements in HIV-infected adults may be enhanced by implementation of psychosocial interventions to reduce depression and anxiety in HIV-infected adults