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

Shisha use among students in a private university in Kigali city, Rwanda: prevalence and associated factors

Abstract Background All over the globe shisha smoking is fast growing among different age brackets. Shisha use has been reported to be increasing among youths in African major cities. Its use is documented to result in health effects such as lung cancer, cardiovascular and respiratory conditions, periodontal diseases, keratoacanthoma which are also associated with cigarette smoking. In Kigali, Rwanda’s capital, reports indicate that shisha use is increasing among the youths, particularly the university students. The study aimed at determining the prevalence, and establishing factors associated with shisha use among students in a university in Kigali Rwanda, which will be a significant step in stemming shisha fame among youths in Rwanda as there was no previously documented evidence-based study. Methods A total of 427 students were selected for this cross-sectional study using stratified sampling method. A questionnaire was used to collect data on shisha use, knowledge about shisha, attitude towards shisha, and factors associated with use of shisha. The association between the independent variables and shisha use was assessed using chi-square p value < 0.05. Binary logistic regression was used to determine variables that were independently associated with shisha smoking. Results Prevalence of ever smoking shisha among the university students was 26.1% and that of those that smoked in the last month (30 days) was 20.8%. About 40 % (39.9%) of the participants that had heard about shisha before demonstrated low level of knowledge, and 41.6% of these reported shisha use in the last 30 days. Logistic regression revealed that the followings were independently associated with shisha smoking: always drink alcohol (p = 0.003); drink alcohol occasionally (p = 0.045); having friend(s) who smoke shisha (p = 0.001); being aware of shisha’s availability in cafes, bars and restaurants in Kigali (p = 0.022); positive attitude towards shisha smoking (p < 0.001) and participants with age < 20 years (p = 0.039). Conclusions There is a relative high prevalence of shisha smoking and a poor knowledge about its impact on health among these university students. Regular medical education and health promotion targeting the youths could improve knowledge and practices about shisha use. Shisha laws and regulations should be enacted, and fines imposed on individuals or group who flout them

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 NCT0371365