Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system.

OBJECTIVE: To evaluate the feasibility of conducting a large clinical trial within the Rwandan mental healthcare system that would establish the safety, efficacy and benefit of paliperidone palmitate once-monthly (PP1M) and once-every-3-months (PP3M) long-acting injectable formulations in adults with schizophrenia. STUDY DESIGN: An open-label, prospective feasibility study. SETTING/PARTICIPANTS: 33 adult patients with schizophrenia were enrolled at 3 sites across Rwanda. INTERVENTIONS: The study design included 3 phases of treatment: an oral run-in to establish tolerability to risperidone (1 week), lead-in treatment with flexibly dosed PP1M to identify a stable dose (17 weeks) and maintenance treatment with PP3M (24 weeks). PRIMARY AND SECONDARY OUTCOME MEASURES: Feasibility endpoints included compliance with governmental and institutional requirements, acceptable supply chain delivery and proper onsite administration of risperidone/PP1M/PP3M, adequate site infrastructure, adequate training of clinical staff and successful completion of study procedures and scales. A variety of study scales were administered to assess outcomes relevant to patients, caregivers, clinicians and payers in Rwanda and other resource-limited settings. RESULTS: This study was terminated early by the sponsor because certain aspects of study conduct needed to be addressed to maintain Good Clinical Practice requirements and meet regulatory standards. Results identified areas for improvement in study execution, including study governance, site infrastructure, study preparation and conduct of procedures, study budget and study assessments. Despite the identification of areas in need of adjustment, none of these limitations were considered insurmountable. CONCLUSIONS: This work was designed to strengthen global research in schizophrenia by building the capacity of researchers to prepare and conduct pharmaceutical trials in resource-limited settings. Although the study was ended early, modifications motivated by the results will facilitate the successful design and completion of more comprehensive studies, including an ongoing, follow-up interventional trial of PP1M/PP3M in a larger population of patients in Rwanda. TRIAL REGISTRATION NUMBER: NCT03713658.

Prevalence of mental disorders, associated co-morbidities, health care knowledge and service utilization in Rwanda - towards a blueprint for promoting mental health care services in low- and middle-income countries?

BACKGROUND: In order to respond to the dearth of mental health data in Rwanda where large-scale prevalence studies were not existing, Rwanda Mental Health Survey was conducted to measure the prevalence of mental disorders, associated co-morbidities and knowledge and utilization of mental health services nationwide within Rwanda. METHODS: This cross-sectional study was conducted between July and August 2018, among the general population, including survivors of the 1994 Genocide against the Tutsi. Participants (14-65 years) completed the Mini-International Neuropsychiatric Interview (Version 7.0.2), sociodemographic and epilepsy-related questionnaires. General population participants were selected first by random sampling of 240 clusters, followed by systematic sampling of 30 households per cluster. Genocide survivors within each cluster were identified using the 2007-2008 Genocide Survivors Census. RESULTS: Of 19,110 general survey participants, most were female (n = 11,233; 58.8%). Mental disorders were more prevalent among women (23.2%) than men (16.6%) (p < 0.05). The most prevalent mental disorders were major depressive episode (12.0%), panic disorder (8.1%) and post-traumatic stress disorder (PTSD) (3.6%). Overall, 61.7% had awareness of mental health services while only 5.3% reported to have used existing services. Of the 1271 genocide survivors interviewed, 74.7% (n = 949) were female; prevalence of any mental disorder was 53.3% for women and 48.8% for men. Most prevalent disorders were major depressive episode (35.0%), PTSD (27.9%) and panic disorder (26.8%). Among genocide survivors, 76.2% were aware of availability of mental health services, with 14.1% reported having used mental health services. CONCLUSIONS: Despite high prevalence of mental disorders among the general population and genocide survivors, utilization of available mental health services was low. A comprehensive approach to mental health is needed for prevention of mental illness and to promote mental healthcare services.

Co-creation and Evaluation of Nationwide Remote Training Service for Mental Health Education of Community Health Workers in Rwanda.

Objective: Johnson & Johnson Global Public Health and the Ministry of Health of Rwanda strengthened the mental health awareness by providing an innovative, low-cost, easily accessible, and scalable remote training service (RTS) on mental health for Community Health Workers (CHWs). Methods: The RTS consisted of eight training modules shared via simple feature phones over a 4-week period. Quiz questions and baseline/endline assessments were included to assess the feasibility and acceptability of the training platform, the knowledge and self-confidence gained by the CHWs, and prospects for the sustainability of the platform. Results: Ninety-three percent of the CHWs completed at least four of the eight training modules, and 42% of the CHWs improved with a higher end score. The training content was considered interesting, easy to understand, and helpful to intervene appropriately to refer patients with signs of mental illness to a hospital and to provide community and family education on mental health topics. Conclusion: The RTS is feasible and acceptable for the delivery of mental health training on a large scale and contributed to strengthening the capacity in delivering mental health care at community level.

Addressing the mental health needs of children affected by HIV in Rwanda: validation of a rapid depression screening tool for children 7-14 years old.

BACKGROUND: Depression in children presents a significant health burden to society and often co-exists with chronic illnesses, such as human immunodeficiency virus (HIV). Research has demonstrated that 10-37% of children and adolescents living with HIV also suffer from depression. Low-and-middle income countries (LMICs) shoulder a disproportionate burden of HIV among other health challenges, but reliable estimates of co-morbid depression are lacking in these settings. Prior studies in Rwanda, a LMIC of 12 million people in East Africa, found that 25% of children living with HIV met criteria for depression. Though depression may negatively affect adherence to HIV treatment among children and adolescents, most LMICs fail to routinely screen children for mental health problems due to a shortage of trained health care providers. While some screening tools exist, they can be costly to implement in resource-constrained settings and are often lacking a contextual appropriateness. METHODS: Relying on international guidelines for diagnosing depression, Rwandan health experts developed a freely available, open-access Child Depression Screening Tool (CDST). To validate this tool in Rwanda, a sample of 296 children with a known diagnosis of HIV between ages 7-14 years were recruited as study participants. In addition to completing the CDST, all participants were evaluated by a mental health professional using a structured clinical interview. The validity of the CDST was assessed in terms of sensitivity, specificity, and a receiver operating characteristic (ROC) curve. RESULTS: This analysis found that depression continues to be a co-morbid condition among children living with HIV in Rwanda. For identifying these at-risk children, the CDST had a sensitivity of 88.1% and specificity of 96.5% in identifying risk for depression among children living with HIV at a cutoff score of 6 points. This corresponded with an area under the ROC curve of 92.3%. CONCLUSIONS: This study provides evidence that the CDST is a valid tool for screening depression among children affected by HIV in a resource-constrained setting. As an open-access and freely available tool in LMICs, the CDST can allow any health practitioner to identify children at risk of depression and refer them in a timely manner to more specialized mental health services. Future work can show if and how this tool has the potential to be useful in screening depression in children suffering from other chronic illnesses.

Burden of post-traumatic stress disorder in postgenocide Rwandan population following exposure to 1994 genocide against the Tutsi: A meta-analysis.

BACKGROUND: The 1994 genocide against Tutsi resulted in a massive death toll that reached one million people. Despite the tremendous efforts made to mitigate the adverse effects of the genocide, a substantial burden of mental health disorders still exists including the notably high prevalence of post-traumatic stress disorder (PTSD) among genocide survivors. However, a synthesized model of PTSD vulnerability in this population is currently lacking. METHODS: A meta-analysis of 19 original research studies that reported PTSD prevalence (n = 12,610). Medline-PubMed and Science.gov were key search engines. Random-Effects Model (k = 19; tau^2 estimator: DL) was applied. Data extraction, synthesis, and meta-analysis were carried out using R. RESULTS: The total of 2957 out of 11,746 individuals suffered from PTSD. The summary proportion is 25% (95% CI=0.16,0.36). The tau^2 is 0.06 (95% CI=0.03,0.14) in the absence of subgroups, and the Q-statistic is 2827.65 (p<0.0001), all of which suggests high heterogeneity in the effect sizes. Year of data collection and Year of publication were significant moderators. PTSD pooled prevalence in the genocide survivor category was estimated at 37% (95% CI=0.21,0.56). CONCLUSION: The PTSD prevalence among genocide survivors is considerably higher compared to the general Rwandan population. The burden of PTSD in the general Rwandan population declined significantly over time, likely due to treatment of symptoms through strong national mental health programs, peace building and resolution of symptoms over time. To the best of our knowledge little evidence has reported the burden of PTSD prevalence in African post conflict zones particularly in Rwanda. LIMITATION: Limitations of our review include the use of retrospective studies and studies with very small sample sizes, as well as language criterion.

Outcomes of a primary care mental health implementation program in rural Rwanda: A quasi-experimental implementation-effectiveness study.

INTRODUCTION: To address the know-do gap in the integration of mental health care into primary care in resource-limited settings, a multi-faceted implementation program initially designed to integrate HIV/AIDS care into primary care was adapted for severe mental disorders and epilepsy in Burera District, Rwanda. The Mentoring and Enhanced Supervision at Health Centers (MESH MH) program supported primary care-delivered mental health service delivery scale-up from 6 to 19 government-run health centers over two years. This quasi-experimental study assessed implementation reach, fidelity, and clinical outcomes at health centers supported by MESH MH during the scale up period. METHODS: MESH MH consisted of four strategies to ensure the delivery of the priority care packages at health centers: training; supervision and mentorship; audit and feedback; and systems-based quality improvement (QI). Implementation reach (service use) across the 19 health centers supported by MESH MH during the two year scale-up period was described using routine service data. Implementation fidelity was measured at four select health centers by comparing total clinical supervisory visits and checklists to target goals, and by tracking clinical observation checklist item completion rates over a nine month period. A prospective before and after evaluation measured clinical outcomes in consecutive adults presenting to four select health centers over a nine month period. Primary outcome assessments at baseline, 2 and 6 months included symptoms and functioning, measured by the General Health Questionnaire (GHQ-12) and the World Health Organization Disability Assessment Scale (WHO-DAS Brief), respectively. Secondary outcome assessments included engagement in income generating work and caregiver burden using a quantitative scale adapted to context. RESULTS: A total of 2239 mental health service users completed 15,744 visits during the scale up period. MESH MH facilitated 70% and 76% of supervisory visit and clinical checklist utilization target goals, respectively. Checklist item completion rates significantly improved overall, and for three of five checklist item subgroups examined. 121 of 146 consecutive service users completed outcome measurements six months after entry into care. Scores improved significantly over six months on both the GHQ-12, with median score improving from 26 to 10 (mean within-person change 12.5 [95% CI: 10.9-14.0] p< 0.0001), and the WHO-DAS Brief, with median score improving from 26.5 to 7 (mean within-person change 16.9 [95% CI: 14.9-18.8] p< 0.0001). Over the same period, the percentage of surveyed service users reporting an inability to work decreased significantly (51% to 6% (p < 0.001)), and the proportion of households reporting that a caregiver had left income-generating work decreased significantly (41% to 4% (p < 0.001)). CONCLUSION: MESH MH was associated with high service use, improvements in mental health care delivery by primary care nurses, and significant improvements in clinical symptoms and functional disability of service users receiving care at health centers supported by the program. Multifaceted implementation programs such as MESH MH can reduce the evidence to practice gap for mental health care delivery by nonspecialists in resource-limited settings. The primary limitation of this study is the lack of a control condition, consistent with the implementation science approach of the study. STUDY REGISTRATION: ISRCTN #37231.

PTSD prevalence among resident mothers and their offspring in Rwanda 25 years after the 1994 genocide against the Tutsi.

BACKGROUND: The 1994 Genocide against the Tutsi was a major traumatic event affecting nearly all Rwandans. Significant psychological sequels continue to occur in the population 25 years after, with a high prevalence of posttraumatic stress disorder (PTSD) found in women. Three groups are typically designated with regard to the Genocide against the Tutsi: those who were targeted and categorized as genocide "survivors," those who were in the country during the genocide and were the "non-targeted" group, and those who were outside of the country, referred to as the "1959 returnees." Each group experienced various traumatic events during and in the aftermath of the genocide. Offspring of the designated groups, currently exhibit symptoms of PTSD disregarding of being born in the years following the genocide. A number of studies have described the prevalence of PTSD in the general adult population. There is a lack of research comparing the prevalence of PTSD in women and their offspring among these three target groups, therefore, this study aimed to bridge the gap. METHODS: We conducted a comparative cross-sectional study with a sample of 432 mothers and 432 children in three categories: genocide survivors, in country non-targeted and 1959 returnees. Participant ages for children were between 14 to 22 years and for mothers, between the ages of 32 to 87 years. The UCLA-PTSD DSM-5, PTSD Check list-5 and Life events Checklist-5 were translated from English to Kinyarwanda and were used to assess exposure to trauma and the prevalence of PTSD symptoms in Rwandan mothers and their offspring. RESULTS: Key Results yield a PTSD rate of 18.8, 6.2, 5.2% within survivors, in country non-targeted, and returnees respectively with an average PTSD rate of 43.8% for parents, and 16.5% for offspring. CONCLUSION: PTSD among the mothers' groups and their offspring have been found, specifically in the offspring of genocide survivors. Considering these adolescents were not born at the time of the 1994 Genocide against the Tutsi, the results suggest future studies should explore the precipitating factors contributing to the PTSD symptoms within this specific group.

Evaluating process and clinical outcomes of a primary care mental health integration project in rural Rwanda: a prospective mixed-methods protocol.

INTRODUCTION: Integrating mental healthcare into primary care can reduce the global burden of mental disorders. Yet data on the effective implementation of real-world task-shared mental health programmes are limited. In 2012, the Rwandan Ministry of Health and the international healthcare organisation Partners in Health collaboratively adapted the Mentoring and Enhanced Supervision at Health Centers (MESH) programme, a successful programme of supported supervision based on task-sharing for HIV/AIDS care, to include care of neuropsychiatric disorders within primary care settings (MESH Mental Health). We propose 1 of the first studies in a rural low-income country to assess the implementation and clinical outcomes of a programme integrating neuropsychiatric care into a public primary care system. METHODS AND ANALYSIS: A mixed-methods evaluation will be conducted. First, we will conduct a quantitative outcomes evaluation using a pretest and post-test design at 4 purposively selected MESH MH participating health centres. At least 112 consecutive adults with schizophrenia, bipolar disorder, depression or epilepsy will be enrolled. Primary outcomes are symptoms and functioning measured at baseline, 8 weeks and 6 months using clinician-administered scales: the General Health Questionnaire and the brief WHO Disability Assessment Scale. We hypothesise that service users will experience at least a 25% improvement in symptoms and functioning from baseline after MESH MH programme participation. To understand any outcome improvements under the intervention, we will evaluate programme processes using (1) quantitative analyses of routine service utilisation data and supervision checklist data and (2) qualitative semistructured interviews with primary care nurses, service users and family members. ETHICS AND DISSEMINATION: This evaluation was approved by the Rwanda National Ethics Committee (Protocol #736/RNEC/2016) and deemed exempt by the Harvard University Institutional Review Board. Results will be submitted for peer-reviewed journal publication, presented at conferences and disseminated to communities served by the programme.

Correction: Ethics in Community-Based Research with Vulnerable Children: Perspectives from Rwanda.

[This corrects the article DOI: 10.1371/journal.pone.0157042.].

Mental Health and Antiretroviral Adherence Among Youth Living With HIV in Rwanda.

BACKGROUND AND OBJECTIVES: In Rwanda, significant progress has been made in advancing access to antiretroviral therapy (ART) among youth. As availability of ART increases, adherence is critical for preventing poor clinical outcomes and transmission of HIV. The goals of the study are to (1) describe ART adherence and mental health problems among youth living with HIV aged 10 to 17; and (2) examine the association between these factors among this population in rural Rwanda. METHODS: A cross-sectional analysis was conducted that examined the association of mental health status and ART adherence among youth (n = 193). ART adherence, mental health status, and related variables were examined based on caregiver and youth report. Nonadherence was defined as ever missing or refusing a dose of ART within the past month. Multivariate modeling was performed to examine the association between mental health status and ART adherence. RESULTS: Approximately 37% of youth missed or refused ART in the past month. In addition, a high level of depressive symptoms (26%) and attempt to hurt or kill oneself (12%) was observed in this population of youth living with HIV in Rwanda. In multivariate analysis, nonadherence was significantly associated with some mental health outcomes, including conduct problems (odds ratio 2.90, 95% confidence interval 1.55-5.43) and depression (odds ratio 1.02, 95% confidence interval 1.01-1.04), according to caregiver report. A marginally significant association was observed for youth report of depressive symptoms. CONCLUSIONS: The findings suggest that mental health should be considered among the factors related to ART nonadherence in HIV services for youth, particularly for mental health outcomes, such as conduct problems and depression.

Ethics in Community-Based Research with Vulnerable Children: Perspectives from Rwanda.

A "risk of harm" protocol to identify youth in need of immediate emergency assistance in a study on mental health and HIV in Rwanda among 680 youth ages 10-17 is described. Cases are presented that describe the experience in using this protocol to ensure safety of participants, with ethical and logistical challenges considered. Among the population of the study, 3.2% were deemed "risk of harm." The most prevalent presenting problem was non-fatal suicidal behavior (91% of risk of harm cases), with 36% having a history of a reported previous attempt. Challenges included: acute food insecurity/significant poverty; lack of support/adequate supervision from family members; family violence; alcohol abuse; and HIV-related stigma. Development of a "risk of harm" protocol and collaboration between study staff, community leadership, health authorities, and health workers are critical to ensuring participants' safety in research among vulnerable populations.

Validating the Children's Depression Inventory in the context of Rwanda.

BACKGROUND: Depression is often co-morbid with chronic conditions, and when combined with HIV it can increase progression and reduce survival. A brief and accurate screening tool for depression among children living with HIV is necessary to increase access to mental health care and improve HIV-related outcomes in the long-term. METHODS: A validation study was conducted, comparing the Children's Depression Inventory (CDI) with a structured clinical assessment as the gold standard among children living with HIV ages 7-14 years in Rwanda. The response rate was 87 % and the analysis was performed among 100 study participants. RESULTS: Twenty-five percent of children had a diagnosis of depression based on the clinical interview. Sensitivity of the CDI ranged from 44 to 76 % and specificity was 92 to 100 % for cut-off scores from 5 to 9. The area under the curve (AUC) for receiver operating characteristic analysis, an estimate of overall accuracy, was 0.87 (95 % confidence interval: 0.77 - 0.97). CONCLUSIONS: The significant prevalence of depression among children living with HIV in Rwanda reflects a critical need to advance mental health care in this population. Although overall accuracy of the CDI is reasonable in this context, further research needs to be done to develop a more sensitive measure of depression in this vulnerable population. Development of a highly sensitive screening measure will be a fundamental step towards improving access to mental health care among children living with HIV, potentially improving health outcomes and quality of life in the long-term as this vulnerable population transitions into adulthood.

HIV and child mental health: a case-control study in Rwanda.

BACKGROUND: The global HIV/AIDS response has advanced in addressing the health and well-being of HIV-positive children. Although attention has been paid to children orphaned by parental AIDS, children who live with HIV-positive caregivers have received less attention. This study compares mental health problems and risk and protective factors in HIV-positive, HIV-affected (due to caregiver HIV), and HIV-unaffected children in Rwanda. METHODS: A case-control design assessed mental health, risk, and protective factors among 683 children aged 10 to 17 years at different levels of HIV exposure. A stratified random sampling strategy based on electronic medical records identified all known HIV-positive children in this age range in 2 districts in Rwanda. Lists of all same-age children in villages with an HIV-positive child were then collected and split by HIV status (HIV-positive, HIV-affected, and HIV-unaffected). One child was randomly sampled from the latter 2 groups to compare with each HIV-positive child per village. RESULTS: HIV-affected and HIV-positive children demonstrated higher levels of depression, anxiety, conduct problems, and functional impairment compared with HIV-unaffected children. HIV-affected children had significantly higher odds of depression (1.68: 95% confidence interval [CI] 1.15-2.44), anxiety (1.77: 95% CI 1.14-2.75), and conduct problems (1.59: 95% CI 1.04-2.45) compared with HIV-unaffected children, and rates of these mental health conditions were similar to HIV-positive children. These results remained significant after controlling for contextual variables, there were no significant differences on mental health outcomes groups, reflecting a potential explanatory role of factors such as daily hardships, caregiver depression, and HIV-related stigma [corrected]. CONCLUSIONS: The mental health of HIV-affected children requires policy and programmatic responses comparable to HIV-positive children.

Rwanda 20 years on: investing in life.

Two decades ago, the genocide against the Tutsis in Rwanda led to the deaths of 1 million people, and the displacement of millions more. Injury and trauma were followed by the effects of a devastated health system and economy. In the years that followed, a new course set by a new government set into motion equity-oriented national policies focusing on social cohesion and people-centred development. Premature mortality rates have fallen precipitously in recent years, and life expectancy has doubled since the mid-1990s. Here we reflect on the lessons learned in rebuilding Rwanda's health sector during the past two decades, as the country now prepares itself to take on new challenges in health-care delivery.

Validating the Center for Epidemiological Studies Depression Scale for Children in Rwanda.

OBJECTIVE: We assessed the validity of the Center for Epidemiological Studies Depression Scale for Children (CES-DC) as a screen for depression in Rwandan children and adolescents. Although the CES-DC is widely used for depression screening in high-income countries, its validity in low-income and culturally diverse settings, including sub-Saharan Africa, is unknown. METHOD: The CES-DC was selected based on alignment with local expressions of depression-like problems in Rwandan children and adolescents. To examine criterion validity, we compared CES-DC scores to depression diagnoses on a structured diagnostic interview, the Mini International Neuropsychiatric Interview for Children (MINI KID), in a sample of 367 Rwandan children and adolescents aged 10 through 17 years. Caregiver and child or adolescent self-reports endorsing the presence of local depression-like problems agahinda kenshi (persistent sorrow) and kwiheba (severe hopelessness) were also examined for agreement with MINI KID diagnosis. RESULTS: The CES-DC exhibited good internal reliability (α = .86) and test-retest reliability (r = .85). The area under the receiver operating characteristic curve for the CES-DC was 0.825 when compared to MINI KID diagnoses, indicating a strong ability to distinguish between depressed and nondepressed children and adolescents in Rwanda. A cut point of≥30 corresponded with a sensitivity of 81.9% and a specificity of 71.9% in this referred sample. MINI KID diagnosis was well aligned with local expressions of depression-like problems. CONCLUSION: The CES-DC demonstrates good psychometric properties for clinical screening and evaluation in Rwanda, and should be considered for use in this and other low-resource settings. Population samples are needed to determine a generalizable cut point in nonreferred samples.

Interrelatedness of child health, protection and well-being: an application of the SAFE model in Rwanda.

This study examines the core components of children's basic security and well-being in order to examine issues central to improving child protection in Rwanda. Sources of data included 15 focus groups with adults, 7 focus groups with children ages 10-17, and 11 key informant interviews with child protection stakeholders, including representatives from international NGOs, community-based groups, and the Rwandan Government, all of which took place in April and May of 2010. Participants painted a complex picture of threats to children's basic security in Rwanda. Three key themes were pervasive across all interviews: (1) deterioration of social and community cohesion in post-genocide Rwanda; (2) the cascading effects of poverty; and (3) the impact of caregiver illness and death on the caregiving environment. Consistent with the SAFE (Safety/freedom from harm; Access to basic physiological needs and healthcare; Family and connection to others; Education and economic security) model of child protection, participants rarely elaborated on a child protection threat independent of other basic security needs and rights. Findings suggest a need for integrated approaches to child protection that recognize this interrelatedness and extend beyond issue-specific child protection responses. This study contributes to a growing body of work highlighting the interrelated nature of child protection threats and the implications of adaptive and dangerous survival strategies that children and families engage in to meet their basic security needs. Analysis of this interrelatedness provides a roadmap for improving policies and implementing integrated and robust child protection strategies in Rwanda and other settings.