Experiences and ethical issues during shared decision-making in healthcare at rural health facilities in Uganda: An exploratory qualitative study.

Background: Shared decision-making in healthcare is a collaborative process where patients are supported to make informed decisions according to their preferences. Healthcare decisions affect patients' lives which necessitates patients to participate in decisions concerning their health. This study explored experiences and ethical issues related to shared decision-making in a rural healthcare setting. Methods: An exploratory qualitative study was conducted at Budumba Health Centre III and Butaleja Health Centre III in rural Eastern Uganda. In this study, 23 in-depth interviews were conducted among 12 healthcare providers and 11 patients. Data was analyzed thematically using NVivo-12 plus software. Results: Four themes emerged which included: experiences, challenges, strategies for improvement, and ethical issues. Patients at both facilities expressed the need to be involved in decision-making processes. However, many stressed that they are not engaged in decision-making about their health. Many healthcare providers noted that shared decision-m aking could improve patient prognosis but are faced with challenges related to low male involvement and the influence of cultural and religious practices, including myths and patriarchal attitudes which impact effective patient engagement.Ethical issues included concerns about informed consent, privacy and confidentiality, deception, and harm. This study highlighted the need for better sensitization of patients and comprehensive training for HCPs to minimize and resolve ethical issues that emerge during shared decision-making processes. Conclusions: There is a need for targeted interventions to enhance decision-making processes in rural healthcare including but not limited to developing shared decision-making manual and continuous training of healthcare providers to ethically engage patients. Further research is needed to explore larger facilities with a bigger scope including patients under 18 years of age and and their surrogates.

Practices and attitudes of herbalists regarding informed consent in Uganda: a qualitative study.

BACKGROUND: Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. METHODS: To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were conducted. The data were analyzed thematically using NVivo version 12 software. RESULTS: Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine. CONCLUSION: This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists' practices and attitudes toward informed consent.

The remote provision of pharmaceutical products and services by retail pharmacies in Kampala, Uganda; practices and challenges.

BACKGROUND: The COVID-19 pandemic significantly increased the demand for remote healthcare services delivery, including remote access to medications. This study explored the practices and challenges associated with remote provision of pharmaceutical products and services in Kampala, Uganda. METHODS: A cross-sectional study was conducted from July to September 2022, enrolling 174 out of 198 sampled retail pharmacies. Data was collected using a pre-tested questionnaire on remote service provision, platforms used, products offered, delivery methods, and challenges faced. RESULTS: Over 58% of pharmacies provided remote services, primarily through social media (especially WhatsApp) and phone calls. OTCs and POMs were the most commonly dispensed products remotely. Key challenges identified included high internet costs, labor shortages, poor internet quality, and a lack of specific regulations for remote provision of pharmaceutical products and services. CONCLUSION: The proportion of retail pharmacies providing pharmaceutical products and services remotely is significant in Kampala, but they face challenges that need to be addressed. Regulations are crucial to ensure responsible dispensing practices and rational medicine use. Addressing internet affordability and quality, staffing issues, and delivery logistics is essential for sustainable and effective remote pharmaceutical products and services.

Exploration of clinical ethics consultation in Uganda: a case study of Uganda Cancer Institute.

INTRODUCTION: Globally, healthcare providers (HCPs), hospital administrators, patients and their caretakers are increasingly confronted with complex moral, social, cultural, ethical, and legal dilemmas during clinical care. In high-income countries (HICs), formal and informal clinical ethics support services (CESSs) have been used to resolve bioethical conflicts among HCPs, patients, and their families. There is limited evidence about mechanisms used to resolve these issues as well as experiences and perspectives of the stakeholders that utilize them in most African countries including Uganda. METHODS: This phenomenological qualitative study utilized in-depth interviews (IDIs) and focus group discussions (FGDs) to collect data from Uganda Cancer Institute (UCI) staff, patients, and caretakers who were purposively selected. Data was analyzed deductively and inductively yielding themes and sub-themes that were used to develop a codebook. RESULTS: The study revealed there was no formal committee or mechanism dedicated to resolving ethical dilemmas at the UCI. Instead, ethical dilemmas were addressed in six forums: individual consultations, tumor board meetings, morbidity and mortality meetings (MMMs), core management meetings, rewards and sanctions committee meetings, and clinical departmental meetings. Participants expressed apprehension regarding the efficacy of these fora due to their non-ethics related agendas as well as members lacking training in medical ethics and the necessary experience to effectively resolve ethical dilemmas. CONCLUSION: The fora employed at the UCI to address ethical dilemmas were implicit, involving decisions made through various structures without the guidance of personnel well-versed in medical or clinical ethics. There was a strong recommendation from participants to establish a multidisciplinary clinical ethics committee comprising members who are trained, skilled, and experienced in medical and clinical ethics.

Practices and attitudes of herbalists regarding informed consent in Uganda: A qualitative study.

Background: Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. Methods: To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were also conducted. The data were analyzed thematically using NVivo version 12 software. Results: Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine. Conclusion: This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists' practices and attitudes toward informed consent.

Exploration of Clinical Ethics Consultation in Uganda: A case study of Uganda Cancer Institute.

Introduction: Globally, healthcare providers (HCPs), hospital administrators, patients and their caretakers are increasingly confronted with complex moral, social, cultural, ethical, and legal dilemmas during clinical care. In high-income countries (HICs), formal and informal clinical ethics support services (CESS) have been used to resolve bioethical conflicts among HCPs, patients, and their families. There is limited evidence of mechanisms used to resolve these issues as well as experiences and perspectives of the stakeholders that utilize them in most African countries including Uganda. Methodology: This qualitative study utilized in-depth-interviews (IDIs) and focus group discussions (FGDs) to collect data from Uganda Cancer Institute (UCI) staff, patients, and caretakers, who were purposively selected. Data was analyzed deductively and inductively yielding themes and sub-themes that were used to develop a codebook. Results: There was no formal committee nor mechanism utilized to resolve ethical dilemmas at the UCI. The study uncovered six fora where ethical dilemmas were addressed: individual consultations, tumor board meetings, morbidity and mortality meetings, core management meetings, rewards and sanctions committee meetings, and clinical departmental meetings. Participants expressed apprehension regarding the efficacy of these fora due to their non-ethics related agendas as well as members lacking training in medical ethics and the necessary experience to effectively resolve ethical dilemmas. Conclusion: The fora employed at the UCI to address ethical dilemmas were implicit, involving decisions made through various structures without the guidance of personnel well-versed in medical or clinical ethics. There was a strong recommendation from participants to establish a multidisciplinary clinical ethics committee comprising members who are trained, skilled, and experienced in medical and clinical ethics.

Compliance of public health facilities with essential medicines and health supplies redistribution guidelines in Mbale district, Eastern Uganda: a mixed-methods study.

INTRODUCTION: Redistribution of essential medicines and health supplies (EMHS) is a mechanism to address supply chain uncertainty by moving excess stock of health commodities from health facilities that are overstocked to health facilities with shortages, where it is most needed. It prevents the wastage of scarce resources and improves efficiency within a health supply chain system. Many public health facilities in Uganda experience stock-outs, overstocking, and expiry of essential medicines. This study assessed the compliance of public health facilities with the Uganda Ministry of Health redistribution strategy for EMHS in Mbale district, Eastern Uganda. METHODS: A mixed-methods study was conducted among 55 respondents at public health facility level and five key informants at the district level. Audio-recorded data were transcribed and coded to develop themes. Thematic analysis was performed using ATLAS.ti Version 8.5. Quantitative data were analysed using IBM SPSS Version 24.0. RESULTS: About a third (33%) of the surveyed health facilities complied with EMHS redistribution guidelines. Respondents agreed that EMHS redistribution had helped reduce health commodity expiries and stock-outs in health facilities. Respondents who did not know about the timely release of funds for redistribution were 68% less likely to comply, and those who said the guidelines were never shared were 88% less likely to comply with the guidelines. CONCLUSIONS: Compliance with the EMHS redistribution guidelines was low and associated with failure to share the guidelines with staff and inadequate awareness about release funds for EMHS redistribution. The district local government should allocate more funds to the EMHS redistribution.

Cold chain management practices of non-vaccine commodities in public health facilities of Rwenzori Region, Western Uganda.

BACKGROUND: Despite the evidence that cold chain management practices affect the potency and effectiveness of both vaccines and non-vaccine commodities, most of the researches in Uganda focus on vaccines. This study assessed the cold chain management practices of non-vaccine cold chain commodities in public health facilities of the Rwenzori Region, Uganda. METHODS: A cross-sectional study was conducted in a random sample of 69 level III and IV health facilities. The respondents were store managers at health facilities. Data on stock and storage management practices and level of knowledge on cold chain management were assessed. Data were collected and entered into Microsoft excel 2017, cleaned, and later exported into IBM SPSS version 26 for analysis. The management practices were graded as poor (< 50% score), fair (50-75% score), or good (> 75% score). RESULTS: Results from the 69 facilities indicated that the stock management practices were graded as fair for lesser than half of the facilities 28 (40.6%). Few facilities were correctly filling stock cards 20 (29%) and conducting physical inventories 19 (27.5%). The refrigerator storage management practices were fair for nearly half of the facilities 32 (46.4%). Among the facilities that had a refrigerator 53 (76.8%), 39 (70.9%) utilized it for storing both vaccines and non-vaccine commodities. The cold chain management practices at service delivery points were fair for 32 (46.4%) health centers. A larger proportion of the participants 69 (65%) had knowledge of cold chain storage. Most of the participants 47 (67.8%) were knowledgeable about the heat sensitivity of the cold chain commodities, however, almost half (48.1%) of them lacked knowledge on refrigerator use. CONCLUSION: The management practices for non-vaccine cold chain commodities in health centers were fair. More than a third of the facility store managers lacked knowledge on cold chain management practices for non-vaccine commodities. There is a need to strengthen the capacity of the facilities' store managers and provide equipment specific for non-vaccine cold chain commodities.

Empowering local research ethics review of antibacterial mass administration research.

BACKGROUND: Recent studies using mass drug administration (MDA) of antibiotics to entire communities have focused global attention on the unique ethical challenges of MDA of antibiotics in research and public health interventions. However, there is no specific guidance for Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) to review such trials. We surveyed the literature to identify the unique ethical challenges and to strengthen the competencies of RECs or IRBs in low- and middle-income countries (LMICs) in their ethical reviews of these trials. METHODS: We employed a desk review. We searched PubMed, Web of Science, and Google Scholar, combining terms for "mass drug administration" with terms for "research ethics committees," "institutional review boards," and "ethics." We reviewed citations of search results to retrieve additional articles. Only articles published and indexed in the above databases up to 6 January 2022 in English were included. Abstracts (without full articles), books and articles that had exclusive veterinary and environmental focus were excluded. We synthesized the literature to identify particularly challenging ethical issues relevant to antibacterial MDA trials in LMICs. RESULTS: The most challenging ethical issues can be categorised into four broad domains: determining the social value of MDA, assessing risks and benefits, engaging all stakeholders meaningfully, and study design-related ethical challenges. These four domains interact and impact each other. Together, they reveal the need for RECs/IRBs to review MDA studies through a broader lens than that of clinical trials per se. From our findings, we propose a framework to guide the RECs and IRBs in LMICs to perform the initial and continuing review of antibiotic MDA trials. We also recommend strengthening the competencies of LMIC RECs or IRBs through ongoing training and collaboration with RECs or IRBs from high-income countries. CONCLUSIONS: REC/IRB review of research using MDA of antibiotics plays a critical role in assuring the ethical conduct of MDA studies. Local RECs/IRBs should be empowered to review MDA studies comprehensively and competently in order to advance scientific knowledge about MDA and promote improved global health.

Evaluation of the Clinical Use of Ceftriaxone among In-Patients in Selected Health Facilities in Uganda.

Ceftriaxone has a high propensity for misuse because of its high rate of utilization. In this study, we aimed at assessing the appropriateness of the clinical utilization of ceftriaxone in nine health facilities in Uganda. Using the World Health Organization (WHO) Drug Use Evaluation indicators, we reviewed a systematic sample of 885 patients' treatment records selected over a three (3)-month period. Our results showed that prescriptions were written mostly by medical officers at 53.3% (470/882). Ceftriaxone was prescribed mainly for surgical prophylaxis at 25.3% (154/609), respiratory tract infections at 17% (104/609), and sepsis at 11% (67/609), as well as for non-recommended indications such as malaria at 7% (43/609) and anemia at 8% (49/609). Ceftriaxone was mostly prescribed once daily (92.3%; 817/885), as a 2 g dose (50.1%; 443/885), and for 5 days (41%; 363/885). The average score of inappropriate use of ceftriaxone in the eight indicators was 32.1%. Only 58.3% (516/885) of the ceftriaxone doses prescribed were administered to completion. Complete blood count and culture and sensitivity testing rates were 38.8% (343/885) and 1.13% (10/885), respectively. Over 85.4% (756/885) of the patients improved and were discharged. Factors associated with appropriate ceftriaxone use were gender, pregnancy status, days of hospitalization, health facility level of care, health facility type, and type of prescriber.

Conducting an ongoing HIV clinical trial during the COVID-19 pandemic in Uganda: a qualitative study of research team and participants' experiences and lessons learnt.

OBJECTIVE: To explore the experiences and lessons learnt by the study team and participants of the Workplace-based HIV self-testing among Men trial during the COVID-19 pandemic in Uganda. DESIGN: An explorative qualitative study comprising two virtual focus group discussions (FGDs) with 12 trial team members and 32 in-depth participant interviews (N=44). Data were collected via telephone calls for in-depth interviews or Zoom for FGDs and manually analysed by inductive content analysis. SETTING: Fourteen private security companies in two Uganda districts. PARTICIPANTS: Members of the clinical trial study team, and men working in private security companies who undertook workplace-based HIV testing. RESULTS: The key themes for participants experiences were: 'challenges in accessing HIV treatment and care, and prevention services', 'misinformation' and 'difficulty participating in research activities'. The effects on HIV treatment and prevention resulted from; repercussions of the COVID-19 restrictions, participants fear of coinfection and negative experiences at health facilities. The difficulty in participating in research activities arose from: fear of infection with COVID-19 for the participants who tested HIV negative, transport difficulties, limited post-test psychosocial support and lack of support to initiate pre-exposure prophylaxis. The key study team reflections focused on the management of the clinical trial, effects of the local regulations and government policies and the need to adhere to ethical principles of research. CONCLUSIONS: Findings highlight the need to organise different forms of HIV support for persons living with HIV during a pandemic. Additionally, the national research regulators and ethics committees or review boards are strongly urged to develop policies and guidelines for the continuity of research and clinical trials in the event of future shocks. Furthermore, this study calls on the appropriate government agencies to ensure public and researchers' preparedness through continuing education and support. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT04164433; Pre-results.

Nature and history of the CIOMS International Ethical Guidelines and implications for local implementation: A perspective from East Africa.

The theme of the 10th Annual Research Ethics Conference organized by the Uganda National Council for Science and Technology (2018) was "Evolution of Research Ethics in Uganda and the Region: Past, Present and Future". We were asked to address the topic: "The History of CIOMS and the recent changes in the international ethics guidelines: implications for local research". The thrust of the conference was to track progress in ensuring ethical conduct of research, highlight challenges encountered, and to propose strategies for effective and meaningful implementation of international ethical guidelines in local contexts. Consequently, the purpose of this paper is to comment on the implications of the history of CIOMS ethical guidelines and suggest strategies for their effective and meaningful implementation in the East African region, and perhaps the whole of Sub-Saharan Africa. Inferring from the 'evolutionary', 'flexible', and 'general' nature of the CIOMS guidelines, we proposed a six-point strategy for ensuring their effective and meaningful implementation in local contexts. This strategy is in the form of obligations for local research regulators and researchers, the fulfillment of which will go a long way towards their smooth and meaningful implementation in local contexts. These obligations are: ensuring evidence-based adaptation of each individual guideline; ensuring sufficiently judicious and motivated RECs membership; acting proactively to ensure harmony between bioethics and local legal regimes; cultivating a 'bioethics culture' among the public; moving towards regional bioethics governance; and playing an active and meaningful role in future revisions of these guidelines.

Factors associated with occupancy of pharmacist positions in public sector hospitals in Uganda: a cross-sectional study.

BACKGROUND: Pharmacists are invaluable resources in health care. Their expertise in pharmacotherapy and medicine management both ensures that medicines of appropriate quality are available in health facilities at the right cost and are used appropriately. Unfortunately, some countries like Uganda have shortage of pharmacists in public health facilities, the dominant providers of care. This study investigated the factors that affect the occupancy of pharmacist positions in Uganda's public hospitals, including hiring patterns and job attraction and retention. METHODS: A cross-sectional survey of 91 registered pharmacists practicing in Uganda and desk review of records from the country's health care worker (HCW) recruiting agency was done in the months of May, June, and July, 2016. Pharmacist interviews were done using self-administered structured questionnaire and analyzed by descriptive statistics and chi-square test. RESULTS: Slight majority (53%) of the interviewed pharmacists work in two sectors. About 60% of the pharmacists had ever applied for public hospital jobs. Of those who received offers (N = 46), 30% had declined them. Among those who accepted the offers (N = 41), 41% had already quit. Meanwhile, the pace of hiring pharmacists into Uganda's public sector is too slow. Low socio-economic status of family in childhood (χ 2 = 2.77, p = 0.10), admission through matriculation and diploma scheme (χ 2 = 2.37, p = 0.12), internship in countryside hospitals (χ 2 = 2.24, p = 0.13), working experience before pharmacy school (χ 2 = 2.21, p = 0.14), salary expectation (χ 2 = 1.76, p = 0.18), and rural secondary education (χ 2 = 1.75, p = 0.19) favored attraction but in a statistically insignificant manner. Retention was most favored by zero postgraduate qualification (χ 2 = 4.39, p = 0.04), matriculation and diploma admission scheme (χ 2 = 2.57, p = 0.11), and working experience in private sector (χ 2 = 2.21, p = 0.14). CONCLUSIONS: The pace of hiring of pharmacists into Uganda's public health sector is too slow and should be stepped up. Besides work incentives, affirmative action to increase admissions into pharmacy degree training programs through matriculation and diploma schemes and for children with rural childhoods should be considered.

Research site monitoring for compliance with ethics regulatory standards: review of experience from Uganda.

BACKGROUND: On site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings. METHODS: This was a retrospective review of research site monitoring reports covering a period of four years. RESULTS: The monitoring was conducted by the Uganda National Council for Science and Technology, the National Drug Authority and the National HIV/AIDS Research and Ethics Committee over the period 2007 to 2010.The monitoring team was usually three members comprising of two experts in research ethics and an assistant. A total of 28 site monitoring visits covering 40 research projects were reviewed. 25% of the site monitoring reports revealed violation of the regulatory requirement for valid ethical approval. 36% of the site reports showed some instances of informed consent violation, 28% showed violation of the rights and welfare of research participants, 38% revealed that sites did not report SAEs to regulatory authorities and many sites lacked adequate GCP and GCLP. However, most of the sites monitored had adequate facilities to conduct the respective studies and good working practices. CONCLUSION: This model employed by the monitoring teams to evaluate research compliance is effective in auditing ethical practice. Compliance monitoring is feasible and affordable in a resource limited setting. Research protocol non compliance is still a major problem in Uganda, and there is need for a pro-active approach to this vice by all stake holders if ethical conduct of research is to be achieved.

Participatory healthcare-provider orientation to improve artemether-lumefantrine-based drug treatment of uncomplicated malaria: a cluster quasi-experimental study.

OBJECTIVES: To assess the effect of participatory healthcare-provider orientation in enhancing patient knowledge, appropriate prescribing and dispensing of artemether-lumefantrine, during drug treatment of uncomplicated malaria. METHODS: A cluster quasi-experimental study. The authors developed strategies to address challenges encountered by healthcare providers during clinical management of malaria. The primary outcome was patient knowledge on prescribed malaria drug treatment. Secondary outcomes were appropriate prescribing and provision of adequate drug dispensing information. The authors used generalised estimating equation logistic regression to investigate correlates of appropriate use of artemether-lumefantrine. RESULTS: The proportion of patients or caretakers of paediatric patients sufficiently knowledgeable about malaria treatment increased from 16/85 (18.8%) at baseline to 33/96 (34.4%) at evaluation, OR 2.26 (95% CI 1.13 to 4.49), p=0.020, in the intervention, and fell slightly from 49/134 (36.6%) to 35/114 (30.7%), OR 0.77, (95% CI 0.45 to 1.31), p=0.331 in the control district. This was enhanced by the existence of drug-dispensing standard operating procedures (adjusted OR 1.85, 95% CI 0.98 to 3.50; p=0.057). The proportion of appropriate prescriptions increased from 61/87 (70.1%) to 94/112 (83.9%) in the intervention district, OR 2.23 (95% CI 1.13 to 4.40), p=0.020 and reduced from 91/115 (79.1%) to 75/112 (67.0%) in the control district, OR 0.53, (95% CI 0.29 to 0.97), p=0.040. The frequency of adequately dispensed prescriptions increased in the intervention district (34(32.4%) to 53(45.3%), OR 1.73 (95% CI 1.00 to 2.99), p=0.050) but decreased in the control location (94 (69.6%) to 71 (52.6%), OR 0.48 (95% CI 0.29 to 0.80), p=0.004). CONCLUSIONS: Participatory healthcare-provider orientation enhanced patient knowledge, healthcare provider prescribing and dispensing of artemether-lumefantrine, bolstered by adequate medication counselling and use of drug-dispensing standard operating procedures.

Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

BACKGROUND: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. METHODS: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. RESULTS: Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. CONCLUSIONS: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

An assessment of Makerere University College of Health Sciences: optimizing health research capacity to meet Uganda's priorities.

BACKGROUND: Health research is critical to the institutional mission of the Makerere College of Health Sciences (MakCHS). Optimizing the alignment of health research capacity at MakCHS with the health needs and priorities of Uganda, as outlined in the country's Health Sector Strategic Plan (HSSP), is a deliberate priority, a responsibility, and a significant opportunity for research. To guide this strategic direction, an assessment of MakCHS's research grants and publication portfolio was conducted. METHODS: A survey of all new and ongoing grants, as well as all publications, between January 2005 and December 2009 was conducted. Research, training, and education grants awarded to MakCHS' constituent faculties and departments, were looked for through financial records at the college or by contact with funding organizations. Published manuscripts registered with PubMed, that included MakCHS faculty authors, were also analyzed. RESULTS: A total of 58 active grants were identified, of which 18 had been initiated prior to 2005 and there were an average of about eight new grants per year. Most grants funded basic and applied research, with major focus areas being HIV/AIDS (44%), malaria (19%), maternal and child health (14%), tuberculosis (11%), mental health (3%), and others (8%). MakCHS faculty were identified as Principal Investigators (PIs) in only 22 (38%) active grants. Grant funding details were only available for one third of the active grants at MakCHS. A total of 837 publications were identified, with an average of 167 publications per year, most of which (66%) addressed the country's priority health areas, and 58% had MakCHS faculty or students as first authors. CONCLUSIONS: The research grants and publications at MakCHS are generally well-aligned with the Ugandan Health Ministry priorities. Greater efforts to establish centralized and efficient grants management procedures are needed. In addition, greater efforts are needed to expand capacity for MakCHS faculty leadership of grants, as well as to continue to expand the contribution of MakCHS faculty to lead research publications.

Non-adherence to anti-TB drugs among TB/HIV co-infected patients in Mbarara Hospital Uganda: prevalence and associated factors.

BACKGROUND: Non-adherence to treatment remains a major obstacle to efficient tuberculosis control in developing countries. The dual infection of Tuberculosis and HIV presents further adherence problems because of high pill burden and adverse effects. This poses a risk of increased multi-drug resistant TB. However, the prevalence of non-adherence and its associated factors have not been studied in these patients in Uganda. OBJECTIVES: To determine the prevalence and factors associated with non-adherence to anti-TB drugs among TB/HIV co-infected patients in Mbarara hospital. METHODS: A cross-sectional study with qualitative and quantitative data collection methods was conducted among TB/HIV co-infected adults in Mbarara hospital from January to March 2008. Consecutive sampling was used to select 140 participants. Adherence was assessed over a 5-day period prior to the interview using patients self-reports. Data was collected using an interviewer administered questionnaire. Qualitative data was collected through key informant interviews using a topic guide and was analyzed manually. Quantitative data was analyzed using STATA version 8. Logistic regression was used to determine factors associated with nonadherence. RESULTS: The prevalence of non-adherence was 25% (95% CI=17.8-32%). Being on continuous phase of the TB regimen was significantly associated with non-adherence (OR=6.24, p<0.001). Alcohol consumption, being on antiretroviral therapy and smoking confounded the relationship between stage of the TB regimen and non-adherence. CONCLUSION: The prevalence of non-adherence was high. Patients that are on continuous phase of TB treatment should be supported to continue taking their drugs. In addition, patients that drink alcohol; smoke and those not on ART should be targeted with interventions to improve adherence.