Evaluating the delivery of Problem Management Plus in primary care settings in rural Rwanda: a study protocol using a pragmatic randomised hybrid type 1 effectiveness-implementation design.

INTRODUCTION: Evidence-based low-intensity psychological interventions such as Problem Management Plus (PM+) have the potential to expand treatment access for depression and anxiety, yet these interventions are not yet effectively implemented in rural, public health systems in resource-limited settings. In 2017, Partners In Health adapted PM+ for delivery by primary care nurses in rural Rwanda and began integrating PM+ into health centres in collaboration with the Rwandan Ministry of Health, using established implementation strategies for mental health integration into primary care (Mentoring and Enhanced Supervision at Health Centers for Mental Health (MESH MH)). A gap in the evidence regarding whether low-intensity psychological interventions can be successfully integrated into real-world primary care settings and improve outcomes for common mental disorders remains. In this study, we will rigorously evaluate the delivery of PM+ by primary care nurses, supported by MESH MH, as it is scaled across one rural district in Rwanda. METHODS AND ANALYSIS: We will conduct a hybrid type 1 effectiveness-implementation study to test the clinical outcomes of routinely delivered PM+ and to describe the implementation of PM+ at health centres. To study the clinical effectiveness of PM+, we will use a pragmatic, randomised multiple baseline design to determine whether participants experience improvement in depression symptoms (measured by the Patient Health Questionnaire-9) and functioning (measured by the WHO-Disability Assessment Scale Brief 2.0) after receiving PM+. We will employ quantitative and qualitative methods to describe and evaluate PM+ implementation outcomes using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, using routinely collected programme data and semistructured interviews. ETHICS AND DISSEMINATION: This evaluation was approved by the Rwanda National Ethics Committee (Protocol #196/RNEC/2019) and deemed exempt by the Harvard University Institutional Review Board. The results from this evaluation will be useful for health systems planners and policy-makers working to translate the evidence base for low-intensity psychological interventions into practice.

Adapting Problem Management Plus for Implementation: Lessons Learned from Public Sector Settings Across Rwanda, Peru, Mexico and Malawi.

Problem Management Plus (PM+) is a low-intensity psychological intervention developed by the World Health Organization that can be delivered by nonspecialists to address common mental health conditions in people affected by adversity. Emerging evidence demonstrates the efficacy of PM+ across a range of settings. However, the published literature rarely documents the adaptation processes for psychological interventions to context or culture, including curriculum or implementation adaptations. Practical guidance for adapting PM+ to context while maintaining fidelity to core psychological elements is essential for mental health implementers to enable replication and scale. This paper describes the process of contextually adapting PM+ for implementation in Rwanda, Peru, Mexico and Malawi undertaken by the international nongovernmental organization Partners In Health. To our knowledge, this initiative is among the first to adapt PM+ for routine delivery across multiple public sector primary care and community settings in partnership with Ministries of Health. Lessons learned contribute to a broader understanding of effective processes for adapting low-intensity psychological interventions to real-world contexts.

Decentralized, primary-care delivered epilepsy services in Burera District, Rwanda: Service use, feasibility, and treatment.

BACKGROUND: Integrating epilepsy care into primary care settings could reduce the global burden of illness attributable to epilepsy. Since 2012, the Rwandan Ministry of Health and the international nonprofit Partners In Health have collaboratively used a multi-faceted implementation program- MESH MH-to integrate and scale-up care for epilepsy and mental disorders within rural primary care settings in Burera district, Rwanda. We here describe demographics, service use and treatment patterns for patients with epilepsy seeking care at MESH-MH supported primary care health centers. METHODS AND FINDINGS: This was a retrospective cohort study using routinely collected data from fifteen health centers in Burera district, from January 2015 to December 2016. 286 patients with epilepsy completed 3307 visits at MESH-MH participating health centers over a two year period (Jan 1st 2015 to Dec 31st 2016). Men were over twice as likely to be diagnosed with epilepsy than women (OR 2.38, CI [1.77-3.19]), and children under 10 were thirteen times as likely to be diagnosed with epilepsy as those 10 and older (OR 13.27, CI [7.18-24.51]). Carbamazepine monotherapy was prescribed most frequently (34% of patients). CONCLUSION: Task-sharing of epilepsy care to primary care via implementation programs such as MESH-MH has the potential to reduce the global burden of illness attributable to epilepsy.

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.

Family-based promotion of mental health in children affected by HIV: a pilot randomized controlled trial.

BACKGROUND: Children affected by HIV are at risk for poor mental health. We conducted a pilot randomized controlled trial (RCT) of the Family Strengthening Intervention (FSI-HIV), a family home-visiting intervention to promote mental health and improve parent-child relationships in families with caregivers living with HIV, hypothesizing that child and family outcomes would be superior to usual care social work services. METHODS: Eighty two families (N = 170 children, 48.24% female; N = 123 caregivers, 68.29% female) with at least one HIV-positive caregiver (n = 103, 83.74%) and school-aged child (ages 7-17) (HIV+ n = 21, 12.35%) were randomized to receive FSI-HIV or treatment-as-usual (TAU). Local research assistants blind to treatment conducted assessments of child mental health, parenting practices, and family functioning at baseline, post-intervention, and 3-month follow-up. Multilevel modeling assessed effects of FSI-HIV on outcomes across three time points. TRIAL REGISTRATION: NCT01509573, 'Pilot Feasibility Trial of the Family Strengthening Intervention in Rwanda (FSI-HIV-R).' https://clinicaltrials.gov/ct2/show/;NCT01509573?term=Pilot+Feasibility+Trial+of+the+Family+Strengthening+Intervention+in+Rwanda+%28FSI-HIV-R%29&rank=1. RESULTS: At 3-month follow-up, children in FSI-HIV showed fewer symptoms of depression compared to TAU by both self-report (ß = -.246; p = .009) and parent report (ß = -.174; p = .035) but there were no significant differences by group on conduct problems, functional impairment, family connectedness, or parenting. CONCLUSIONS: Family-based prevention has promise for reducing depression symptoms in children affected by HIV. Future trials should examine the effects of FSI-HIV over time in trials powered to examine treatment mediators.

HIV Status Disclosure through Family-Based Intervention Supports Parenting and Child Mental Health in Rwanda.

INTRODUCTION: Few evidence-based interventions exist to support parenting and child mental health during the process of caregiver HIV status disclosure in sub-Saharan Africa. A secondary analysis of a randomized-controlled trial was conducted to examine the role of family-based intervention versus usual social work care (care as usual) in supporting HIV status disclosure within families in Rwanda. METHOD: Approximately 40 households were randomized to family-based intervention and 40 households to care as usual. Parenting, family unity, and child mental health during the process of disclosure were studied using quantitative and qualitative research methods. RESULTS: Many of the families had at least one caregiver who had not disclosed their HIV status at baseline. Immediately post-intervention, children reported lower parenting and family unity scores compared with those in the usual-care group. These changes resolved at 3-month follow-up. Qualitative reports from clinical counselor intervention sessions described supported parenting during disclosure. Overall findings suggest adjustments in parenting, family unity, and trust surrounding the disclosure process. CONCLUSION: Family-based intervention may support parenting and promote child mental health during adjustment to caregiver HIV status disclosure. Further investigation is required to examine the role of family-based intervention in supporting parenting and promoting child mental health in HIV status disclosure.

Exploring the potential of a family-based prevention intervention to reduce alcohol use and violence within HIV-affected families in Rwanda.

HIV-affected families report higher rates of harmful alcohol use, intimate partner violence (IPV) and family conflict, which can have detrimental effects on children. Few evidence-based interventions exist to address these complex issues in Sub-Saharan Africa. This mixed methods study explores the potential of a family-based intervention to reduce IPV, family conflict and problems related to alcohol use to promote child mental health and family functioning within HIV-affected families in post-genocide Rwanda. A family home-visiting, evidence-based intervention designed to identify and enhance resilience and communication in families to promote mental health in children was adapted and developed for use in this context for families affected by caregiver HIV in Rwanda. The intervention was adapted and developed through a series of pilot study phases prior to being tested in open and randomized controlled trials (RCTs) in Rwanda for families affected by caregiver HIV. Quantitative and qualitative data from the RCT are explored here using a mixed methods approach to integrate findings. Reductions in alcohol use and IPV among caregivers are supported by qualitative reports of improved family functioning, lower levels of violence and problem drinking as well as improved child mental health, among the intervention group. This mixed methods analysis supports the potential of family-based interventions to reduce adverse caregiver behaviors as a major mechanism for improving child well-being. Further studies to examine these mechanisms in well-powered trials are needed to extend the evidence-base on the promise of family-based intervention for use in low- and middle-income countries.