Using digital platforms to promote a healthcare provider community of practice for abortion care in Uganda.

BACKGROUND: A community of practice (CoP) is defined as a group of people who share a concern, set of problems, or a passion about a topic, and who deepen their knowledge and expertise by interacting on an ongoing basis. The paper presents a case study on the design, implementation and management of a CoP. The objective is to share experiences, opportunities, challenges and lessons learnt in using digital platforms for clinical mentorships to establish a CoP that promotes enhanced service provision of abortion care. METHODS: We employed competence-based training and ongoing virtual mentorship for abortion care, employing the abortion harm reduction model, and using several digital platforms to create and nurture community of practice for abortion care. Using the Capability-Opportunity-Motivation for Behavior (COM-B) model and textual data analysis, we evaluated the performance of the CoP as a tool to support abortion care, using data from in-depth interviews and information shared on the platforms. The data was analyzed by thematic analysis using text data analytical approach. RESULTS: CoPs have much unrealized potential for networking to improve abortion care, as they are more inclusive, interactive and equalizing than typical webinars, yet less expensive and can complement (though not replace) physical mentorships. CoPs' focus on sharing best practices and creating new knowledge to advance professional practice, faces challenges of maintaining regular interaction on an ongoing basis. CoP members need to share a passion for their practice and mutual trust is key to success. CONCLUSION: Though it faced initial challenges of connectivity, and limited interaction, the CoP approach using digital platforms promoted shared experiences, personal connections, communication, collaboration and application of knowledge for improved abortion care.

Ethics of Adaptive Designs for Randomized Controlled Trials.

Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in-depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.

Challenges and opportunities from using abortion harm reduction and value clarification and attitude transformation engagements for safe abortion advocacy in Uganda.

BACKGROUND: From 2018, the International Federation of Gynecologists and Obstetricians (FIGO) implemented the Advocating Safe Abortion project to support national obstetrics and gynecology (Obs/gyn) societies from ten member countries to become leaders of Sexual and Reproductive Health and Rights (SRHR). We share experiences and lessons learnt about using value clarification and attitude transformation (VCAT) and abortion harm reduction (AHR) as strategies for our advocacy engagements. METHODS: The advocacy goal of ending abortion-related deaths followed predefined pathways from an extensive needs assessment prior to the project. These pathways were strengthening capacity of the Obs/gyn society as safe abortion advocates; establishing a vibrant network of partners; transforming social and gender norms; raising awareness of the legal and policy environment regarding abortion, and promoting the generation and use abortion data for evidence-informed policy and practice. Our advocacy targeted multiple stakeholders including media, policy makers judicio-legal, political and religious leaders, health workers and the public. RESULTS: During each engagement, facilitators required audiences to identify what roles they can play along the continuum of strategies that can reduce maternal death from abortion complications. The audiences acknowledged abortion complications as a major problem in Uganda. Among the root causes for the abortion context, audiences noted absence of an enabling environment for abortion care, which was characterized by low awareness about the abortion laws and policy, restricted abortion laws, cultural and religious beliefs, poor quality of abortion care services and abortion stigma. CONCLUSION: VCAT and AHR were critical in enabling us to develop appropriate messages for different stakeholders. Audiences were able to recognize the abortion context, distinguish between assumptions, myths and realities surrounding unwanted pregnancy and abortion; recognize imperative to address conflict between personal and professional values, and identify different roles and values which inform empathetic attitudes and behaviors that mitigate abortion harms. The five pathways of the theory of change reinforced each other. Using the AHR model, we delineate strategies and activities which stakeholders could use to end abortion deaths. VCAT enables critical reflection of views, beliefs and values versus professional obligations and responsibilities, and promotes active attitude and behavior change and commitment to end abortion-related deaths.

Early discontinuation of long-acting reversible contraceptives and associated factors among women discontinuing long-acting reversible contraceptives at national referral hospital, Kampala-Uganda; a cross-sectional study.

BACKGROUND: High levels of unmet need for contraception and unwanted pregnancies are high in developing countries despite efforts to reduce them. Long-acting reversible contraceptive (LARC) methods are more than 99% effective in preventing pregnancy. Discontinuation of LARC within the first year of initiation contributes to the high levels of unmet need. This study aimed to determine the prevalence and factors associated with the first-year discontinuation of LARC at Kawempe National Referral hospital. METHODS: A facility-based cross-sectional study was conducted from February 2020 to June 2021. We consecutively recruited 354 participants who discontinued a LARC (intrauterine device {IUD} and sub-dermal implant) during the study period after informed written consent. Data on duration of use, reasons for discontinuation, and factors associated were collected using a face-to-face interviewer-administered questionnaire and review of client records. Early LARC discontinuation was defined as the termination of the contraception within the first 12 months of use. Data were entered using SPSS version 14/0 and analyzed in STATA version 15. Prevalence was expressed as a proportion while logistic regression was used to assess factors associated with early LARC discontinuation. Variables with a p-value of < 0.05 were considered statistically significant. RESULTS: The proportion of first-year discontinuation of LARC was 29%. Women Age less than 25 years (OR = 5.07; 95% CI: 1.1-24.8) and those who desired a family size of fewer than four children (OR = 3.19; 95%CI: 1.2-8.7 ) were more likely to discontinue the LARC within 12 months of initiation after multivariate analysis. Method-related reasons for removal were painful menstrual cramps for implants, recurrent infections for IUDs, and a non-side effect reason was the desire to get pregnant. CONCLUSION: A high proportion of women discontinue LARC within 12 months following initiation. Young adults and those who desire small families are more likely to have first-year discontinuation of LARC. We recommend age-specific counseling for patients receiving the LARC and further studies looking at the depth analysis of reasons for the first-year discontinuation.

Prediction of pre-eclampsia at St. Mary's hospital lacor, a low-resource setting in northern Uganda, a prospective cohort study.

BACKGROUND: Pre-eclampsia is the second leading cause of maternal death in Uganda. However, mothers report to the hospitals late due to health care challenges. Therefore, we developed and validated the prediction models for prenatal screening for pre-eclampsia. METHODS: This was a prospective cohort study at St. Mary's hospital lacor in Gulu city. We included 1,004 pregnant mothers screened at 16-24 weeks (using maternal history, physical examination, uterine artery Doppler indices, and blood tests), followed up, and delivered. We built models in RStudio. Because the incidence of pre-eclampsia was low (4.3%), we generated synthetic balanced data using the ROSE (Random Over and under Sampling Examples) package in RStudio by over-sampling pre-eclampsia and under-sampling non-preeclampsia. As a result, we got 383 (48.8%) and 399 (51.2%) for pre-eclampsia and non-preeclampsia, respectively. Finally, we evaluated the actual model performance against the ROSE-derived synthetic dataset using K-fold cross-validation in RStudio. RESULTS: Maternal history of pre-eclampsia (adjusted odds ratio (aOR) = 32.75, 95% confidence intervals (CI) 6.59-182.05, p = 0.000), serum alkaline phosphatase(ALP) < 98 IU/L (aOR = 7.14, 95% CI 1.76-24.45, p = 0.003), diastolic hypertension ≥ 90 mmHg (aOR = 4.90, 95% CI 1.15-18.01, p = 0.022), bilateral end diastolic notch (aOR = 4.54, 95% CI 1.65-12.20, p = 0.003) and body mass index of ≥ 26.56 kg/m2 (aOR = 3.86, 95% CI 1.25-14.15, p = 0.027) were independent risk factors for pre-eclampsia. Maternal age ≥ 35 years (aOR = 3.88, 95% CI 0.94-15.44, p = 0.056), nulliparity (aOR = 4.25, 95% CI 1.08-20.18, p = 0.051) and white blood cell count ≥ 11,000 (aOR = 8.43, 95% CI 0.92-70.62, p = 0.050) may be risk factors for pre-eclampsia, and lymphocyte count of 800 - 4000 cells/microliter (aOR = 0.29, 95% CI 0.08-1.22, p = 0.074) may be protective against pre-eclampsia. A combination of all the above variables predicted pre-eclampsia with 77.0% accuracy, 80.4% sensitivity, 73.6% specificity, and 84.9% area under the curve (AUC). CONCLUSION: The predictors of pre-eclampsia were maternal age ≥ 35 years, nulliparity, maternal history of pre-eclampsia, body mass index, diastolic pressure, white blood cell count, lymphocyte count, serum ALP and end-diastolic notch of the uterine arteries. This prediction model can predict pre-eclampsia in prenatal clinics with 77% accuracy.

Addressing ethical issues related to prenatal diagnostic procedures.

BACKGROUND: For women of advanced maternal age or couples with high risk of genetic mutations, the ability to screen for embryos free of certain genetic mutations is reassuring, as it provides opportunity to address age-related decline in fertility through preimplantation genetic testing. This procedure has potential to facilitate better embryo selection, improve implantation rates with single embryo transfer and reduce miscarriage rates, among others, yet confers some risk to the embryo and additional costs of assisted reproductive technology. This raises questions whether, when and which patients should receive routine PGT-A prior to embryo transfer. DISCUSSION: Prenatal diagnostic procedures refer to tests done when one or both genetic parents has a known genetic disorder (or has worries about the disorder) and testing is performed on them, their gametes or on the embryos to determine if the latter is likely to carry a genetic disorder. PGT is used to identify genetic defects in gametes or embryos (often created through in vitro fertilization (IVF). The procedures generate immense potential to improve health and wellbeing by preventing conception or birth of babies with undesirable traits, life-limiting conditions and even lethal conditions. However, they generate a lot of information, which often may challenge decision-making ability of healthcare providers and parents, and raise ethical challenges. CONCLUSION: Prenatal diagnostic procedures have potential to address uncertainty and risk of having a child affected with a genetic disease. They, however, often raise own uncertainty and controversies, whose origin, manifestation and related ethical issues are presented. There is need to develop individual and couple decision support tools that incorporate patients' values and concerns in the decision-making process in order to promote more informed decisions, during counseling.

Navigating ethical challenges of conducting randomized clinical trials on COVID-19.

BACKGROUND: The contemporary frameworks for clinical research require informed consent for research participation that includes disclosure of material information, comprehension of disclosed information and voluntary consent to research participation. There is thus an urgent need to test, and an ethical imperative, to test, modify or refine medications or healthcare plans that could reduce patient morbidity, lower healthcare costs or strengthen healthcare systems. METHODS: Conceptual review. DISCUSSION: Although some allocation principles seem better than others, no single moral principle allocates interventions justly, necessitating combining the moral principles into multiprinciple allocation systems. The urgency notwithstanding, navigating ethical challenges related to conducting corona virus disease (COVID-19) clinical trials is mandatory, in order to safeguard the safety and welfare of research participants, ensure autonomy of participants, reduce possibilities for exploitation and ensure opportunities for research participation. The ethical challenges to can be categorized as challenges in allocation of resources for research; challenges of clinical equipoise in relation to the research questions; challenges of understanding disclosed information in potential participants; and challenges in obtaining informed consent. CONCLUSION: To navigate these challenges, stakeholders need a delicate balance of moral principles during allocation of resources for research. Investigators need to apply information processing theories to aid decision-making about research participation or employ acceptable modifications to improve the informed consent process. Research and ethics committees should strengthen research review and oversight to ensure rigor, responsiveness and transparency.

Risk factors for recurrence of pelvic organ prolapse after vaginal surgery among Ugandan women: a prospective cohort study.

INTRODUCTION AND HYPOTHESIS: This study was aimed at determining the recurrence rate and risk factors for the recurrence of pelvic organ prolapse (POP), at 1 year post-vaginal reconstructive surgery in a resource-limited setting. METHODS: We enrolled women who underwent vaginal surgery for POP at the urogynecology unit of Mbarara Regional Referral Hospital (MRRH) in southwestern Uganda between December 2018 and February 2020. The surgeries that were performed include anterior colporrhaphy for cystocele, posterior colporrhaphy for rectocele, vaginal hysterectomy with vault suspension for uterine prolapse, and cervicopexy in those with uterine prolapse where uterine-sparing surgery was desired. The women were followed up for a period of 1 year after surgery. Pelvic examinations in lithotomy position under maximum strain were carried out to assess for recurrence using the Pelvic Organ Quantification (POP-Q) system. Recurrence was defined as a prolapse of ≥POP-Q stage II. Descriptive analyses and multivariate log binomial regression were performed to determine risk factors for recurrence. RESULTS: Of the 140 participants enrolled, 127 (90.7%) completed the follow-up at 1 year. The recurrence rate was 25.2% (32 out of 127). Most (56.3%) of the recurrences occurred in the anterior compartment and in the same site previously operated. Women aged <60 years (RR = 2.34; 95% CI: 1.16-4.72; p = 0.018) and those who had postoperative vaginal cuff infection (RR = 2.54; 95% CI: 1.5-4.3; p = 0.001) were at risk of recurrence. CONCLUSION: Recurrence of POP was common. Younger women, and those with postoperative vaginal cuff infection, were more likely to experience recurrent prolapse after vaginal repair.

Early contraceptive implants removal and its associated factors among women using implants at a National Referral Hospital, Kampala Uganda.

BACKGROUND: Early discontinuation of implant contraceptive methods and reasons for discontinuation remains a major concern for family planning programs. Early discontinuation is related to higher rates of the overall fertility rate, unwanted pregnancies leading to possibly induced abortion. There is paucity of data on the practice of discontinuation of contraceptives in developing countries. The objective of the study was to determine the magnitude of early implants discontinuation among women receiving implants services in the study area and the factors associated with it. METHODS: A cross-sectional study was conducted from 2nd January to 3rd March 2020. Data were collected from 207 women who had come to remove implants on socio-demographic characteristics, obstetric history, duration of implant, and reasons for wanting to remove the implant. We computed the proportion of those who removed the implant before 18 months (early discontinuation). To assess the factors associated with early discontinuation, we estimated the prevalence ratios with a generalized linear model of the poisson family with a log link and robust error variance. RESULTS: The proportion of early implant discontinuation was 87/207(42%). Factor associated with early implant discontinuation included; experience of side effects (PR = 1.1; 95% CI 1.03-1.24; P = 0.001), not having received pre-insertion counseling about the benefits and side effects of contraceptive implants (PR = 1.5; 95% CI 1.02-1.30; P = 0.019) and staying in rural areas (PR = 1.1; 95% CI 1.03-1.27; P = 0.014). CONCLUSION: Nearly one in every two mothers have early discontinuation of contraceptive implants. Factors associated with early implant removal include; experience of side effects, lack of counseling services, and staying in rural areas. There is a need for intervention to address high prevalence of early contraceptive removal through improving on counselling services about possible side effects.

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda.

BACKGROUND: Informed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized clinical trials (RCTs). METHODS: This was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process. RESULTS: Respondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research. CONCLUSION: Respondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation.

Impact of surgery on quality of life of Ugandan women with symptomatic pelvic organ prolapse: a prospective cohort study.

BACKGROUND: Pelvic organ prolapse (POP) is a significant public health issue that negatively affects the Quality of Life (QOL) of women in both low and high-income countries. About 20% of women will undergo surgery for POP over their lifetime. However, there is a paucity of information on the effect of surgery on QOL especially in resource-limited settings. We therefore assessed the QOL among women with symptomatic POP living in rural southwestern Uganda and the impact of surgery on their quality of life. METHODS: We conducted a prospective cohort study among 120 women with symptomatic POP scheduled for surgery at the urogynecology unit of Mbarara Regional Referral Hospital. The QOL at baseline and at 1 year after surgery in the domains of physical performance, social interaction, emotional state, sexual life, sleep quality, personal hygiene and urinary bladder function was determined using a King's Quality of Life questionnaire. A paired t-test was used to compare the difference in mean scores at baseline and at 1-year post-surgery. RESULTS: Of the 120 participants that were enrolled at baseline, 117(98%) completed the follow-up period of 1 year. The baseline QOL was poor. The domains with the poorest QOL were physical, social, sexual, emotional and sleep quality. The mean QOL scores in all the domains and the overall QOL significantly improved 1 year after surgery (p < 0.001). The overall QOL improved by 38.9% after surgery (p < 0.001). CONCLUSIONS: The QOL was poor among women with symptomatic POP and surgery improved the QOL in all the domains of life. We recommend that surgery as an option for treatment of symptomatic POP should be scaled up to improve on the QOL of these women.

Transition to adult care: Exploring factors associated with transition readiness among adolescents and young people in adolescent ART clinics in Uganda.

BACKGROUND: Transition readiness refers to a client who knows about his/her illness and oriented towards future goals and hopes, shows skills needed to negotiate healthcare, and can assume responsibility for his/ her treatment, and participate in decision-making that ensures uninterrupted care during and after the care transition to adult HIV care. There is a paucity of research on effective transition strategies. This study explored factors associated with adolescent readiness for the transition into adult care in Uganda. METHODS: A cross-sectional study was conducted among 786 adolescents, and young people living with HIV randomly selected from 9 antiretroviral therapy clinics, utilizing a structured questionnaire. The readiness level was determined using a pre-existing scale from the Ministry of Health, and adolescents were categorized as ready or not ready for the transition. Bivariate and multivariate analyses were conducted. RESULTS: A total of 786 adolescents were included in this study. The mean age of participants was 17.48 years (SD = 4). The majority of the participants, 484 (61.6%), were females. Most of the participants, 363 (46.2%), had no education. The majority of the participants, 549 (69.8%), were on first-line treatment. Multivariate logistic regression analysis found that readiness to transition into adult care remained significantly associated with having acquired a tertiary education (AOR 4.535, 95% CI 1.243-16.546, P = 0.022), trusting peer educators for HIV treatment (AOR 16.222, 95% CI 1.835-143.412, P = 0.012), having received counselling on transition to adult services (AOR 2.349, 95% CI 1.004-5.495, P = 0.049), having visited an adult clinic to prepare for transition (AOR 6.616, 95% CI 2.435-17.987, P = < 0.001) and being satisfied with the transition process in general (AOR 0.213, 95% CI 0.069-0.658, P = 0.007). CONCLUSION: The perceived readiness to transition care among young adults was low. A series of individual, social and health system and services factors may determine successful transition readiness among adolescents in Uganda. Transition readiness may be enhanced by strengthening the implementation of age-appropriate and individualized case management transition at all sites while creating supportive family, peer, and healthcare environments.

Ethical challenges of the healthcare transition to adult antiretroviral therapy (ART) clinics for adolescents and young people with HIV in Uganda.

BACKGROUND: Whereas many adolescents and young people with HIV require the transfer of care from paediatric/adolescent clinics to adult ART clinics, this transition is beset with a multitude of factors that have the potential to hinder or facilitate the process, thereby raising ethical challenges of the transition process. Decisions made regarding therapy, such as when and how to transition to adult HIV care, should consider ethical benefits and risks. Understanding and addressing ethical challenges in the healthcare transition could ensure a smooth and successful transition. The purpose of this study was to analyze the ethical challenges of transitioning HIV care for adolescents into adult HIV clinics. METHODS: Data presented were derived from 191 adolescents attending nine different health facilities in Uganda, who constituted 18 focus group discussions. In the discussions, facilitators and barriers regarding adolescents transitioning to adult HIV clinics were explored. Guided by the Silences Framework for data interpretation, thematic data analysis was used to analyze the data. The principles of bioethics and the four-boxes ethics framework for clinical care (patient autonomy, medical indications, the context of care, and quality of life) were used to analyze the ethical issues surrounding the transition from adolescent to adult HIV care. RESULTS: The key emerging ethical issues were: reduced patient autonomy; increased risk of harm from stigma and loss of privacy and confidentiality; unfriendly adult clinics induce disengagement and disruption of the care continuum; patient preference to transition as a cohort, and contextual factors are critical to a successful transition. CONCLUSION: The priority outcomes of the healthcare transition for adolescents should address ethical challenges of the healthcare transition such as loss of autonomy, stigma, loss of privacy, and discontinuity of care to ensure retention in HIV care, facilitate long-term self-care, offer ongoing all-inclusive healthcare, promote adolescent health and wellbeing and foster trust in the healthcare system. Identifying and addressing the ethical issues related to what hinders or facilitates successful transitions with targeted interventions for the transition process may ensure adolescents and young people with HIV infection remain healthy across the healthcare transition.

Lay persons' perception of the requirements for research in emergency obstetric and newborn care.

BACKGROUND: Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons' understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. METHODS: This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6-8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis. RESULTS: Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making. CONCLUSIONS: Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent.

Factors associated with the uptake of immediate postpartum intrauterine contraceptive devices (PPIUCD) in Rwanda: a mixed methods study.

BACKGROUND: Rwanda has a high unmet need for family planning which could be reduced by improving access to postpartum intrauterine contraceptives device (PPIUCD) insertion. The objective of the study was to assess the prevalence and factors associated with the uptake of PPIUCD among postpartum women in Muhima Hospital. METHODS: A concurrent mixed-method study was used. Three hundred eight three (383) immediate postpartum mothers, and 10 health services providers were interviewed using a structured questionnaire and in-depth interviews respectively. Logistics regression was done to assess for factors associated with PPIUCD uptake and thematic analysis was used for qualitative data. RESULTS: The prevalence for PPIUCD use was 28.1%, women who had spontaneous vaginal delivery were more likely to take up PPIUCD (Adjusted Odds Ratio (AOR) 2.623, 95% CI = 2.017-6.507 compared to those who had cesarean section; women who received PPIUCD counselling during the antenatal period were more likely to use PPIUCD ((AOR 2.072, 95% CI = 1.018-4.218) as compared to those who didn't receive any form of counselling; mothers who received spouse approval were more likely to use PPIUCD (AOR 2.591,95% CI = 1.485-4.492); as compared to those who didn't receive any spousal approval; women who had more than one child were more likely to use PPIUCD (AOR =2.265, 95% CI = 1.472-3.163) as compared to prime gravida; Mothers with birth to pregnancy interval less than two years were more likely to use PPIUCD (AOR =2.123, CI =1.477-2.706) as compared to those who had birth to pregnancy interval more than 2 years. From the qualitative findings, health education of mothers and partners on PPIUCD, training of health care providers, and availability of supplies to provide PPIUCD influenced the use of PPIUCD. CONCLUSION: The acceptability to use for PPIUCD was high in this population. PPIUCD uptake was associated with normal birth, PPIUCD counselling, spousal approval, parity, birth interval, level of education. Health education of mothers and partners on PPIUCD, training of health providers, and availability of supplies to provide PPIUCD influenced uptake of PPIUCD.

Barriers and facilitators for transitioning of young people from adolescent clinics to adult ART clinics in Uganda: unintended consequences of successful adolescent ART clinics.

BACKGROUND: There is a growing number of adolescents and young adults living with HIV (YPLHIV) who require the transfer of care from pediatric/ adolescent clinics to adult Antiretroviral therapy (ART) clinics. A successful transition is critical for optimum health outcomes, yet facilities may lack infrastructure, human resources (with appropriate knowledge and skills), and a supportive environment, as only 3% of clinics in Uganda caring for YPLHIV have a process for supporting this critical transition from pediatric to adult care, and, facilitators and barriers of a successful transition are not well documented. The purpose of this study was to explore the facilitators and barriers of transitioning among adolescents from adolescent clinics to adult ART clinics. METHOD: Eighteen focus group discussions were held in nine health facilities with 174 adolescents and YPLHIV to assess barriers and facilitators regarding transitioning to adult clinics. The focus group discussions were audio-recorded and transcribed. The Silences Framework using a thematic approach guided the analysis. RESULTS: The key emerging issues were: Unfriendly adults in adult clinics, Care provided in the adolescent clinics, fear of stigma from health care providers, Congestion and long waiting time, fear to lose friends were barriers to transitioning. Transitioning preparation is key to a successful transition, moving as a cohort facilitates transition, and care in adult clinics offers new opportunities, could facilitate readiness and transition. CONCLUSION: YPLHIV expressed fear to transition to adult clinics mainly because of the perceived better care provided in the adolescent clinic, thus constituting a barrier to smooth transition A range of individual, social and health system and services-related factors hindered transitioning. The expectation of transitioning as a group, assurance of similar care as in the adolescent clinic, and guarantees of confidentiality, privacy, and autonomy in decision-making for care was perceived as facilitators. Understanding barriers and facilitators can enable the Ministry of Health to improve the quality of life of YPLHIV through linkage to care, adherence, retention, and viral suppression. There is a need to better planning and preparation for clinical providers and YPLHIV with a focus on age-appropriate and individualized case management transition as well as focus on improving both clinical and psychosocial support throughout the process.

Why 'understanding' of research may not be necessary for ethical emergency research.

BACKGROUND: Randomized controlled trials (RCTs) are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented. METHODS: Conceptual review. DISCUSSION: Research is necessary to identify how the illnesses may be prevented, to explore the causes, and to investigate what medications could be used to manage such illness. Voluntary informed consent requires that prospective participants understand the disclose information about the research, and use this to make autonomous informed decision about participation, in line with their preferences and values. Yet the emergency context affects how information may be disclosed to prospective research participants, how much participants may comprehend, and how participants may express their voluntary decision to participate, all of which pose a threat to the validity of the informed consent. I challenge the claim that the 'understanding' of research is always necessary for ethical informed consent for research during emergency care. I argue for reconceptualization of the value of understanding, through recognition of other values that may be equally important. I then present a reflective perspective that frames moral reflection about autonomy, beneficence and justice in research in emergency research. CONCLUSION: While participant 'understanding' of research is important, it is neither necessary nor sufficient for a valid informed consent, and may compete with other values with which it needs to be considered.

The moral imperative to approve pregnant women's participation in randomized clinical trials for pregnancy and newborn complications.

BACKGROUND: There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence about how to effectively and safely prevent illness or treat sick people. This manuscripts present a conceptual analysis of the ethicality of clinical trials in 3 scenarios: where the pregnant is involved in clinical trials as a participant during pregnancy for data that addresses pregnancy complications, where the pregnant woman consents to clinical trial participation for an unborn baby that has complications, to generate data on complications at this stage of life, and where the mother may consent for participation of their newborn child in clinical trials. METHODS: Conceptual analysis. FINDINGS: Investigators often choose to exclude pregnant women and newborns from research, even where there is possibility for them to benefit from the study intervention. Objections include vulnerability of pregnant women, altered pharmacokinetics and risk of adverse effects, with a need to balance potential maternal and fetal risks and benefits of research participation. While the objections may be valid, not performing research magnifies what should be a carefully controlled risk during research, pushing this risk into the clinical setting, and subsequently posing a challenge to clinicians who are faced with making treatment decisions for pregnant patients with limited evidence of efficacy and safety. The potential benefits of fair inclusion in clinical trials outweigh the potential risks. CONCLUSION: Research involving pregnant women is necessary to provide women with effective treatment during pregnancy, to promote fetal safety (such as by avoiding the clinical use of drugs that may be harmful to the developing fetus), and to reduce avoidable harm from suboptimal care (such as from underdosing) and to provide pregnant women, their fetuses and newborns (with access to potential benefits of research participation).

The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.

BACKGROUND: Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. DISCUSSION: The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. CONCLUSION: The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight.