Comparing harm reduction and overdose response services between community-based and public health department syringe service programmes using a national cross-sectional survey.

Background: Syringe services programmes (SSPs) are an evidence-based strategy to reduce infectious diseases and deliver overdose prevention interventions for people who use drugs. They face regulatory, administrative, and funding barriers that limit their implementation in the US, though the federal government recently began providing funding to support these efforts. In this study we aim to understand whether the organisational characteristics of SSPs are associated with the provision of syringe and other overdose response strategies. Methods: We examine four outcomes using the National Survey of Syringe Services Programs (NSSSP) (N = 472): syringe distribution, naloxone distribution, fentanyl test strip (FTS) availability, and buprenorphine implementation. These outcomes are assessed across three organizational categories of SSPs-those operated by public health departments (DPH), community-based organizations (CBOs) with government funding, and CBOs without government funding-while adjusting for community-level confounders. Findings: The proportion of SSPs by organizational category was 36% DPH, 42% CBOs with government funding, and 22% CBOs without government funding. Adjusting for community-level differences, we found that CBO SSPs with government funding had significantly higher provision of all four syringe and overdose response services as compared to DPH SSPs and across three of the four services as compared to CBO SSPs without government funding. CBO SSPs without government funding still had significantly higher provision of three of the four services as compared to programmes maintained by the DPH. Interpretation: CBO SSPs have strong potential to expand overdose response services nationally, particularly if provided with sustained and adequate funding. Communities should aim to provide funding that does not hinder SSP innovation so they can remain flexible in responding to local needs. Funding: This study was supported by Arnold Ventures (20-05172).

Funding and Delivery of Syringe Services Programs in the United States, 2022.

Objectives. To describe the current financial health of syringe services programs (SSPs) in the United States and to assess the predictors of SSP budget levels and associations with delivery of public health interventions. Methods. We surveyed all known SSPs operating in the United States from February to June 2022 (n = 456), of which 68% responded (n = 311). We used general estimating equations to assess factors influencing SSP budget size and estimated the effects of budget size on multiple measures of SSP services. Results. The median SSP annual budget was $100 000 (interquartile range = $20 159‒$290 000). SSPs operating in urban counties and counties with higher levels of opioid overdose mortality had significantly higher budget levels, while SSPs located in counties with higher levels of Republican voting in 2020 had significantly lower budget levels. SSP budget levels were significantly and positively associated with syringe and naloxone distribution coverage. Conclusions. Current SSP funding levels do not meet minimum benchmarks. Increased funding would help SSPs meet community health needs. Public Health Implications. Federal, state, and local initiatives should prioritize sustained SSP funding to optimize their potential in addressing multiple public health crises. (Am J Public Health. 2024;114(4):435-443. https://doi.org/10.2105/AJPH.2024.307583).

Two implementation strategies to support the integration of depression screening and treatment into hypertension and diabetes care in Malawi (SHARP): parallel, cluster-randomised, controlled, implementation trial.

BACKGROUND: Although evidence-based treatments for depression in low-resource settings are established, implementation strategies to scale up these treatments remain poorly defined. We aimed to compare two implementation strategies in achieving high-quality integration of depression care into chronic medical care and improving mental health outcomes in patients with hypertension and diabetes. METHODS: We conducted a parallel, cluster-randomised, controlled, implementation trial in ten health facilities across Malawi. Facilities were randomised (1:1) by covariate-constrained randomisation to either an internal champion alone (ie, basic strategy group) or an internal champion plus external supervision with audit and feedback (ie, enhanced strategy group). Champions integrated a three-element, evidence-based intervention into clinical care: universal depression screening; peer-delivered psychosocial counselling; and algorithm-guided, non-specialist antidepressant management. External supervision involved structured facility visits by Ministry officials and clinical experts to assess quality of care and provide supportive feedback approximately every 4 months. Eligible participants were adults (aged 18-65 years) seeking hypertension and diabetes care with signs of depression (Patient Health Questionnaire-9 score ≥5). Primary implementation outcomes were depression screening fidelity, treatment initiation fidelity, and follow-up treatment fidelity over the first 3 months of treatment, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03711786, and is complete. FINDINGS: Five (50%) facilities were randomised to the basic strategy and five (50%) to the enhanced strategy. Between Oct 1, 2019, and Nov 30, 2021, in the basic group, 587 patients were assessed for eligibility, of whom 301 were enrolled; in the enhanced group, 539 patients were assessed, of whom 288 were enrolled. All clinics integrated the evidence-based intervention and were included in the analyses. Of 60 774 screening-eligible visits, screening fidelity was moderate (58% in the enhanced group vs 53% in the basic group; probability difference 5% [95% CI -38% to 47%]; p=0·84) and treatment initiation fidelity was high (99% vs 98%; 0% [-3% to 3%]; p=0·89) in both groups. However, treatment follow-up fidelity was substantially higher in the enhanced group than in the basic group (82% vs 20%; 62% [36% to 89%]; p=0·0020). Depression remission was higher in the enhanced group than in the basic group (55% vs 36%; 19% [3% to 34%]; p=0·045). Serious adverse events were nine deaths (five in the basic group and four in the enhanced group) and 26 hospitalisations (20 in the basic group and six in the enhanced group); none were treatment-related. INTERPRETATION: The enhanced implementation strategy led to an increase in fidelity in providers' follow-up treatment actions and in rates of depression remission, consistent with the literature that follow-up decisions are crucial to improving depression outcomes in integrated care models. These findings suggest that external supervision combined with an internal champion could offer an important advance in integrating depression treatment into general medical care in low-resource settings. FUNDING: The National Institute of Mental Health.

Implementation strategies to build mental health-care capacity in Malawi: a health-economic evaluation.

BACKGROUND: Depression is a major contributor to morbidity and mortality in sub-Saharan Africa. Due to low system capacity, three in four patients with depression in sub-Saharan Africa go untreated. Despite this, little attention has been paid to the cost-effectiveness of implementation strategies to scale up evidence-based depression treatment in the region. In this study, we investigate the cost-effectiveness of two different implementation strategies to integrate the Friendship Bench approach and measurement-based care in non-communicable disease clinics in Malawi. METHODS: The two implementation strategies tested in this study are part of a trial, in which ten clinics were randomly assigned (1:1) to a basic implementation package consisting of an internal coordinator acting as a champion (IC-only group) or to an enhanced package that complemented the basic package with quarterly external supervision, and audit and feedback of intervention delivery (IC + ES group). We included material costs, training costs, costs related to project-wide meetings, transportation and medication costs, time costs related to internal champion activities and depression screening or treatment, and costs of external supervision visits if applicable. Outcomes included the number of patients screened with the patient health questionnaire 2 (PHQ-2), cases of remitted depression at 3 and 12 months, and disability-adjusted life-years (DALYs) averted. We compared the cost-effectiveness of both packages to the status quo (ie, no intervention) using a micro-costing-informed decision-tree model. FINDINGS: Relative to the status quo, IC + ES would be on average US$10 387 ($1349-$17 365) more expensive than IC-only but more effective in achieving remission and averting DALYs. The cost per additional remission would also be lower with IC + ES than IC-only at 3 months ($119 vs $223) and 12 months ($210 for IC + ES; IC-only dominated by the status quo at 12 months). Neither package would be cost-effective under the willingness-to-pay threshold of $65 per DALY averted currently used by the Malawian Ministry of Health. However, the IC + ES package would be cost-effective in relation to the commonly used threshold of three times per-capita gross domestic product per DALY averted. INTERPRETATION: Investing in supporting champions might be an appropriate use of resources. Although not currently cost-effective by Malawian willingness-to-pay standards compared with the status quo, the IC + ES package would probably be a cost-effective way to build mental health-care capacity in resource-constrained settings in which decision makers use higher willingness-to-pay thresholds. FUNDING: National Institute of Mental Health.

Effectiveness of trauma-focused cognitive behavioral therapy compared to psychosocial counseling in reducing HIV risk behaviors, substance use, and mental health problems among orphans and vulnerable children in Zambia: a community-based randomized controlled trial.

Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts.Clinical Trials Number: NCT02054780.

Improving integrated depression and non-communicable disease care in Malawi through engaged leadership and supportive implementation climate.

BACKGROUND: Low- and middle-income countries often lack access to mental health services, leading to calls for integration within other primary care systems. In sub-Saharan Africa, integration of depression treatment in non-communicable disease (NCD) settings is feasible, acceptable, and effective. However, leadership and implementation climate challenges often hinder effective integration and quality of services. The aim of this study was to identify discrete leadership strategies that facilitate overcoming barriers to the integration of depression care in NCD clinics in Malawi and to understand how clinic leadership shapes the implementation climate. METHODS: We conducted 39 in-depth interviews with the District Medical Officer, the NCD coordinator, one NCD provider, and the research assistant from each of the ten Malawian NCD clinics (note one District Medical Officer served two clinics). Based on semi-structured interview guides, participants were asked their perspectives on the impact of leadership and implementation climate on overcoming barriers to integrating depression care into existing NCD services. Thematic analysis used both inductive and deductive approaches to identify emerging themes and compare among participant type. RESULTS: The results revealed how engaged leadership can fuel a positive implementation climate where clinics had heightened capacity to overcome implementation barriers. Effective leaders were approachable and engaged in daily operations of the clinic and problem-solving. They held direct involvement with and mentorship during the intervention, providing assistance in patient screening and consultation with treatment plans. Different levels of leadership utilized their respective standings and power dynamics to influence provider attitudes and perceptions surrounding the intervention. Leaders acted by informing providers about the intervention source and educating them on the importance of mental healthcare, as it was often undervalued. Lastly, they prioritized teamwork and collective ownership for the intervention, increasing provider responsibility. CONCLUSION: Training that prioritizes leadership visibility and open communication will facilitate ongoing Malawi Ministry of Health efforts to scale up evidence-based depression treatment within NCD clinics. This proves useful where extensive and external monitoring may be limited. Ultimately, these results can inform successful strategies to close implementation gaps to achieve integration of mental health services in low-resource settings through improved leadership and implementation climate. TRIAL REGISTRATION: These findings are reported from ClinicalTrials.gov, NCT03711786. Registered on 18/10/2018. https://clinicaltrials.gov/ct2/show/NCT03711786 .

Systems analysis and improvement approach to improve naloxone distribution within syringe service programs: study protocol of a randomized controlled trial.

BACKGROUND: More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone's ability to improve naloxone distribution in general and among BIPOC specifically. METHODS: We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone's ability to improve SSPs' naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness. DISCUSSION: This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.

Champion and audit and feedback strategy fidelity and their relationship to depression intervention fidelity: A mixed method study.

Background: Globally, mental health disorders rank as the greatest cause of disability. Low and middle-income countries (LMICs) hold a disproportionate share of the mental health burden, especially as it pertains to depression. Depression is highly prevalent among those with non-communicable diseases (NCDs), creating a barrier to successful treatment. While some treatments have proven efficacy in LMIC settings, wide dissemination is challenged by multiple factors, leading researchers to call for implementation strategies to overcome barriers to care provision. However, implementation strategies are often not well defined or documented, challenging the interpretation of study results and the uptake and replication of strategies in practice settings. Assessing implementation strategy fidelity (ISF), or the extent to which a strategy was implemented as designed, overcomes these challenges. This study assessed fidelity of two implementation strategies (a 'basic' champion strategy and an 'enhanced' champion + audit and feedback strategy) to improve the integration of a depression intervention, measurement based care (MBC), at 10 NCD clinics in Malawi. The primary goal of this study was to assess the relationship between the implementation strategies and MBC fidelity using a mixed methods approach. Methods: We developed a theory-informed mixed methods fidelity assessment that first combined an implementation strategy specification technique with a fidelity framework. We then created corresponding fidelity indicators to strategy components. Clinical process data and one-on-one in-depth interviews with 45 staff members at 6 clinics were utilized as data sources. Our final analysis used descriptive statistics, reflexive-thematic analysis (RTA), data merging, and triangulation to examine the relationship between ISF and MBC intervention fidelity. Results: Our mixed methods analysis revealed how ISF may moderate the relationship between the strategies and MBC fidelity. Leadership engagement and implementation climate were critical for clinics to overcome implementation barriers and preserve implementation strategy and MBC fidelity. Descriptive statistics determined champion strategy fidelity to range from 61 to 93% across the 10 clinics. Fidelity to the audit and feedback strategy ranged from 82 to 91% across the 5 clinics assigned to that condition. MBC fidelity ranged from 54 to 95% across all clinics. Although correlations between ISF and MBC fidelity were not statistically significant due to the sample of 10 clinics, associations were in the expected direction and of moderate effect size. A coefficient for shared depression screening among clinicians had greater face validity compared to depression screening coverage and functioned as a proximal indicator of implementation strategy success. Conclusion: Fidelity to the basic and enhanced strategies varied by site and were influenced by leadership engagement and implementation climate. Champion strategies may benefit from the addition of leadership strategies to help address implementation barriers outside the purview of champions. ISF may moderate the relationship between strategies and implementation outcomes.

Evaluating the validity of depression-related stigma measurement among diabetes and hypertension patients receiving depression care in Malawi: A mixed-methods analysis.

Mental illness stigma research is sparse in Malawi. Our team previously analyzed the reliability and statistical validity of a quantitative tool to measure depression-related stigma among participants with depressive symptoms using quantitative psychometric methods. This analysis aims to further evaluate the content validity of the stigma tool by comparing participants' quantitative responses with qualitative data. The SHARP project conducted depression screening and treatment at 10 noncommunicable disease clinics across Malawi from April 2019 through December 2021. Eligible participants were 18-65 years with depressive symptoms indicated by a PHQ-9 score ≥5. Questionnaires at each study timepoint included a vignette-based quantitative stigma instrument with three thematic domains: disclosure carryover (i.e., concerns about disclosure), treatment carryover (i.e., concerns about external stigma because of receiving depression treatment), and negative affect (i.e., negative attitudes about people having depression). Sub-scores were aggregated for each domain, with higher scores indicating greater stigma. To better understand participants' interpretation of this quantitative stigma questionnaire, we asked a subset of six participants a parallel set of questions in semi-structured qualitative interviews in a method similar to cognitive interviewing. Qualitative responses were linked with participants' most recent quantitative follow-up interviews using Stata 16 and NVivo software. Participants with lower quantitative stigma disclosure sub-scores had qualitative responses that indicated less stigma around disclosure, while participants with higher quantitative stigma sub-scores had qualitative responses indicating greater stigma. Similarly, in the negative affect and treatment carryover domains, participants had parallel quantitative and qualitative responses. Further, participants identified with the vignette character in their qualitative interviews, and participants spoke about the character's projected feelings and experiences based on their own lived experiences. The stigma tool was interpreted appropriately by participants, providing strong evidence for the content validity of the quantitative tool to measure these stigma domains.

Assessing suicidality during the SARS-CoV-2 pandemic: Lessons learned from adaptation and implementation of a telephone-based suicide risk assessment and response protocol in Malawi.

The SARS-CoV-2 pandemic led to the rapid transition of many research studies from in-person to telephone follow-up globally. For mental health research in low-income settings, tele-follow-up raises unique safety concerns due to the potential of identifying suicide risk in participants who cannot be immediately referred to in-person care. We developed and iteratively adapted a telephone-delivered protocol designed to follow a positive suicide risk assessment (SRA) screening. We describe the development and implementation of this SRA protocol during follow-up of a cohort of adults with depression in Malawi enrolled in the Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building (SHARP) randomized control trial during the COVID-19 era. We assess protocol feasibility and performance, describe challenges and lessons learned during protocol development, and discuss how this protocol may function as a model for use in other settings. Transition from in-person to telephone SRAs was feasible and identified participants with suicidal ideation (SI). Follow-up protocol monitoring indicated a 100% resolution rate of SI in cases following the SRA during this period, indicating that this was an effective strategy for monitoring SI virtually. Over 2% of participants monitored by phone screened positive for SI in the first six months of protocol implementation. Most were passive risk (73%). There were no suicides or suicide attempts during the study period. Barriers to implementation included use of a contact person for participants without personal phones, intermittent network problems, and pre-paid phone plans delaying follow-up. Delays in follow-up due to challenges with reaching contact persons, intermittent network problems, and pre-paid phone plans should be considered in future adaptations. Future directions include validation studies for use of this protocol in its existing context. This protocol was successful at identifying suicide risk levels and providing research assistants and participants with structured follow-up and referral plans. The protocol can serve as a model for virtual SRA development and is currently being adapted for use in other contexts.

"We start where we are": a qualitative study of barriers and pragmatic solutions to the assessment and reporting of implementation strategy fidelity.

BACKGROUND: Fidelity measurement of implementation strategies is underdeveloped and underreported, and the level of reporting is decreasing over time. Failing to properly measure the factors that affect the delivery of an implementation strategy may obscure the link between a strategy and its outcomes. Barriers to assessing and reporting implementation strategy fidelity among researchers are not well understood. The aims of this qualitative study were to identify barriers to fidelity measurement and pragmatic pathways towards improvement. METHODS: We conducted in-depth interviews among researchers conducting implementation trials. We utilized a theory-informed interview approach to elicit the barriers and possible solutions to implementation strategy fidelity assessment and reporting. Reflexive-thematic analysis guided coding and memo-writing to determine key themes regarding barriers and solutions. RESULTS: Twenty-two implementation researchers were interviewed. Participants agreed that implementation strategy fidelity was an essential element of implementation trials and that its assessment and reporting should improve. Key thematic barriers focused on (1) a current lack of validated fidelity tools with the need to assess fidelity in the short term, (2) the complex nature of some implementation strategies, (3) conceptual complications when assessing fidelity within mechanisms-focused implementation research, and (4) structural issues related to funding and publishing. Researchers also suggested pragmatic solutions to overcome each barrier. Respondents reported using specification and tracking data in the short term until validated tools become available. Participants suggested that researchers with strategy-specific content expertise lead the way in identifying core components and setting fidelity requirements for them. Addressing the third barrier, participants provided examples of what pragmatic prospective and retrospective fidelity assessments might look like along a mechanistic pathway. Finally, researchers described approaches to minimize costs of data collection, as well as more structural accountability like adopting and enforcing reporting guidelines or changing the structure of funding opportunities. DISCUSSION: We propose short- and long-term priorities for improving the assessment and reporting of implementation strategy fidelity and the quality of implementation research. CONCLUSIONS: A better understanding of the barriers to implementation strategy fidelity assessment may pave the way towards pragmatic solutions.

Consumer perspectives on acceptability of trauma-focused cognitive behavioral therapy in Tanzania and Kenya: A mixed methods study.

Background: There is a substantial mental health treatment gap globally. Increasingly, mental health treatments with evidence of effectiveness in western countries have been adapted and tested in culturally and contextually distinct countries. Findings from these studies have been promising, but to better understand treatment outcome results and consider broader scale up, treatment acceptability needs to be assessed and better understood. This mixed methods study aimed to examine child and guardian acceptability of trauma-focused cognitive behavioral therapy (TF-CBT) in two regions in Tanzania and Kenya and to better understand how TF-CBT was perceived as helpful for children and guardians. Methods: Participants were 315 children (7-13), who experienced the death of one or both parents and 315 guardians, both of whom participated in TF-CBT as part of a randomized controlled trial conducted in Tanzania and Kenya. The study used mixed methods, with quantitative evaluation from guardian perspective (N=315) using the Treatment Acceptability Questionnaire (TAQ) and the Client Satisfaction Questionnaire-8 (CSQ-8). Acceptability was assessed qualitatively from both guardian and child perspectives. Qualitative evaluation involved analysis using stratified selection to identify 160 child and 160 guardian interviews, to allow exploration of potential differences in acceptability by country, setting (urban/rural), and youth age (younger/older). Results: Guardians reported high acceptability on the TAQ and, using an interpretation guide from U.S.-based work, medium acceptability on the CSQ-8. Guardians and children noted high acceptability in the qualitative analysis, noting benefits that correspond to TF-CBT's therapeutic goals. Analyses exploring differences in acceptability yielded few differences by setting or child age but suggested some potential differences by country. Conclusion: Quantitative and qualitative data converged to suggest high acceptability of TF-CBT from guardian and child perspectives in Tanzania and Kenya. Findings add to accumulating evidence of high TF-CBT acceptability from Zambia and other countries (United States, Norway, Australia).Plain Language Summary: Evidence-based treatments have been shown to be effective in countries and regions that are contextually and culturally distinct from where they were developed. But, perspectives of consumers on these treatments have not been assessed regularly or thoroughly. We used open-ended questions and rating scales to assess guardian and youth perspectives on a group-based, cognitive behavioral treatment for children impacted by parental death, in regions within Tanzania and Kenya. Our findings indicate that both guardians and youth found the treatment to be very acceptable. Nearly all guardians talked about specific benefits for the child, followed by benefits for the family and themselves. Eighty percent of youth mentioned benefits for themselves and all youth said they would recommend the program to others. Benefits mentioned by guardians and youth corresponded to treatment goals (improved mood/feelings or behavior, less distress when thinking about the parent/s' death). Both guardians and children named specific aspects of the treatment that they liked and found useful. Dislikes and challenges of the treatment were less frequently mentioned, but point to areas where acceptability could be further improved. Recommendations from participants also offer areas where acceptability could be improved, namely guardians' recommendation that the treatment also address non-mental health needs and offer some follow-up or opportunity to participate in the program again. Our study provides an example of how to assess acceptability and identify places to further enhance acceptability.

The case for prioritizing implementation strategy fidelity measurement: benefits and challenges.

Implementation strategies are systematic approaches to improve the uptake and sustainability of evidence-based interventions. They frequently focus on changing provider behavior through the provision of interventions such as training, coaching, and audit-and-feedback. Implementation strategies often impact intermediate behavioral outcomes like provider guideline adherence, in turn improving patient outcomes. Fidelity of implementation strategy delivery is defined as the extent to which an implementation strategy is carried out as it was designed. Implementation strategy fidelity measurement is under-developed and under-reported, with the quality of reporting decreasing over time. Benefits of fidelity measurement include the exploration of the extent to which observed effects are moderated by fidelity, and critical information about Type-III research errors, or the likelihood that null findings result from implementation strategy fidelity failure. Reviews of implementation strategy efficacy often report wide variation across studies, commonly calling for increased implementation strategy fidelity measurement to help explain variations. Despite the methodological benefits of rigorous fidelity measurement, implementation researchers face multi-level challenges and complexities. Challenges include the measurement of a complex variable, multiple data collection modalities with varying precision and costs, and the need for fidelity measurement to change in-step with adaptations. In this position paper, we weigh these costs and benefits and ultimately contend that implementation strategy fidelity measurement and reporting should be improved in trials of implementation strategies. We offer pragmatic solutions for researchers to make immediate improvements like the use of mixed methods or innovative data collection and analysis techniques, the inclusion of implementation strategy fidelity assessment in reporting guidelines, and the staged development of fidelity tools across the evolution of an implementation strategy. We also call for additional research into the barriers and facilitators of implementation strategy fidelity measurement to further clarify the best path forward.

Facilitators, barriers and potential solutions to the integration of depression and non-communicable diseases (NCDs) care in Malawi: a qualitative study with service providers.

BACKGROUND: Integration of depression services into infectious disease care is feasible, acceptable, and effective in sub-Saharan African settings. However, while the region shifts focus to include chronic diseases, additional information is required to integrate depression services into chronic disease settings. We assessed service providers' views on the concept of integrating depression care into non-communicable diseases' (NCD) clinics in Malawi. The aim of this analysis was to better understand barriers, facilitators, and solutions to integrating depression into NCD services. METHODS: Between June and August 2018, we conducted nineteen in-depth interviews with providers. Providers were recruited from 10 public hospitals located within the central region of Malawi (i.e., 2 per clinic, with the exception of one clinic where only one provider was interviewed because of scheduling challenges). Using a semi structured interview guide, we asked participants questions related to their understanding of depression and its management at their clinic. We used thematic analysis allowing for both inductive and deductive approach. Themes that emerged related to facilitators, barriers and suggested solutions to integrate depression assessment and care into NCD clinics. We used CFIR constructs to categorize the facilitators and barriers. RESULTS: Almost all providers knew what depression is and its associated signs and symptoms. Almost all facilities had an NCD-dedicated room and reported that integrating depression into NCD care was feasible. Facilitators of service integration included readiness to integrate services by the NCD providers, availability of antidepressants at the clinic. Barriers to service integration included limited knowledge and lack of training regarding depression care, inadequacy of both human and material resources, high workload experienced by the providers and lack of physical space for some depression services especially counseling. Suggested solutions were training of NCD staff on depression assessment and care, engaging hospital leaders to create an NCD and depression care integration policy, integrating depression information into existing documents, increasing staff, and reorganizing clinic flow. CONCLUSION: Findings of this study suggest a need for innovative implementation science solutions such as reorganizing clinic flow to increase the quality and duration of the patient-provider interaction, as well as ongoing trainings and supervisions to increase clinical knowledge. Trial registration This study reports finding of part of the formative phase of "The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building-A Clinic-Randomized Trial of Strategies to Integrate Depression Care in Malawi" registered as NCT03711786.

Locally contextualizing understandings of depression, the EPDS, and PHQ-9 among a sample of postpartum women living with HIV in Malawi.

BACKGROUND: The Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire-9 (PHQ-9) are widely used depression screening tools, yet perceptions and understandings of their questions and of depression are not well defined in cross-cultural research. METHODS: 30 postpartum women living with HIV in Malawi were recruited from a cohort study and participated in in-depth cognitive interviews. Transcripts were evaluated following an inductive approach to identify common themes. RESULTS: Participants most frequently described looking sad or different than usual, self-isolation, 'thinking too much,' and anger as key symptoms of being depressed. HIV-associated stigma was commonly identified as a cause of depression. The EPDS and PHQ-9 were generally well understood but did not capture all the important symptoms of depression that women described. Participants sometimes requested clarification or rephrasing of certain EPDS and PHQ-9 questions when asked to explain the questions' meanings in their own words, and requested rephrasing more often for EPDS questions than PHQ-9 questions. Few women believed either tool was sufficient to detect depression. LIMITATIONS: Our results may not be generalizable, but are locally contextualized. Women suffering with depression may have been more or less likely to agree to the qualitative interview depending on their comfort level discussing any current depressive symptoms. CONCLUSIONS: Researchers and practitioners who use the EPDS and PHQ-9 should be aware of the tools' limitations in their context and population. New instruments may need to be developed or adaptations to existing tools made to improve accuracy of depression screening and diagnosis in different cultural contexts.

The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity-Building Scale-Up Trial: Study Design and Protocol.

BACKGROUND: Depression is a leading cause of death and disability worldwide, including in low- and middle-income countries (LMICs). Depression often coexists with chronic medical conditions and is associated with worse clinical outcomes. This confluence has led to calls to integrate mental health treatment with chronic disease care systems in LMICs. This article describes the rationale and protocol for a trial comparing the clinical effectiveness and cost-effectiveness of two different intervention packages to implement evidence-based antidepressant management and psychotherapy into chronic noncommunicable disease (NCD) clinics in Malawi. METHODS: Using constrained randomization, the Sub-Saharan Africa Regional Partnership (SHARP) for mental health capacity building will assign five Malawian NCD clinics to a basic implementation strategy via an internal coordinator, a provider within the chronic care clinic who champions depression services by providing training, supervision, operations, and reporting. Another five clinics will be assigned to depression services implementation via an internal coordinator along with an external quality assurance committee, which will provide a quarterly audit of intervention component delivery with feedback to providers and the health management team. RESULTS: The authors will compare key implementation outcomes (fidelity to intervention), clinical effectiveness outcomes (patient health), and cost-effectiveness and will assess characteristics of clinics that may influence uptake and fidelity. NEXT STEPS: This trial will provide key information to guide the Malawi Ministry of Health in scaling up depression management in existing NCD settings. The SHARP trial is anticipated to substantially contribute to enhancing both mental health treatment and implementation science research capacity in Malawi and the wider region.

The role of patient-provider communication: a qualitative study of patient attitudes regarding co-occurring depression and chronic diseases in Malawi.

BACKGROUND: Globally, depression is a leading cause of morbidity and mortality particularly in Low and Middle-Income Countries (LMICs). The burden of non-communicable diseases (NCDs) are also increasing in LMICs, the conditions frequently co-occur and exacerbate NCD outcomes. Depression interventions alone are not effective at improving NCD outcomes, resulting in wide-reaching calls for integrated services. Integrated services are in a nascent phase in LMICs in general and in Malawi in particular. This manuscript serves to clarify Malawian patients' attitudes and perceptions towards depression integration into routine NCD services. METHODS: Ten District Hospitals were selected for data collection and 2 participants were interviewed from each site (N = 20). An iterative approach to concept-driven coding was applied to facilitate the formation of similarities, differences, and connections between codes. RESULTS: While patients infrequently described moderate depression as a medical condition, and held various attitudes regarding treatments, they agreed on the appropriateness of integrated services. Patients' respect for their providers led them to support integration. Patients discussed how medical knowledge is highly regarded, revealing a power dynamic with their providers. Patients further acknowledged the importance of a provider's communication in shaping a patient's feelings about depression. CONCLUSIONS: Training and interventions that facilitate providers' abilities to transfer their medical knowledge, use strategies to channel their power, and engage patients in a meaningful and collaborative relationship will be key to successfully integrating depression treatment into Malawian NCD clinics. TRIAL REGISTRATION: This work served as part of formative data collection for National Institute of Mental Health (NIMH) Trail NCT03711786 registered on 10th October, 2018.

Implementing illness management and recovery within assertive community treatment teams: A qualitative study.

OBJECTIVE: The study purpose was to assess the feasibility, advantages/disadvantages, and factors that hinder or facilitate the implementation of illness management and recovery (IMR) within assertive community treatment (ACT) teams. METHOD: A qualitative study was conducted with 11 ACT teams that implemented IMR. We conducted semistructured individual interviews with 17 persons enrolled in services and 55 ACT staff in individual and focus groups. Questions were designed to assess perceptions of IMR implementation, effects of IMR, staff training considerations, and recommendations. Data were analyzed using an inductive, consensus-building, thematic analysis, which included multiple research staff reviewing interview transcripts and field notes, developing and refining a codebook, constructing data summaries, and thematic synthesis. RESULTS: The analysis revealed six major themes: (a) a generally positive fit exists between the two models and population served, (b) both people with serious mental illness and staff benefited from ACT + IMR, (c) ACT teams encountered significant implementation barriers, (d) relationships and engagement with participants facilitated implementation, (e) taking a flexible approach to IMR and ACT improved implementation, and (f) programs should focus on greater integration of IMR within ACT teams. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: While there can be barriers to implementing IMR within ACT teams, there is generally a positive fit, it is feasible to implement, and it offers meaningful benefits. ACT teams should improve their recovery orientation by more widespread implementation of IMR. Future research on ACT + IMR should include mixed-methods approaches, implementation methodologies to identify barriers and facilitators, and idiographic measures that capture the individualized recovery goals of people with serious mental illness. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building: a program protocol for building implementation science and mental health research and policymaking capacity in Malawi and Tanzania.

BACKGROUND: Mental health (MH) disorders in low and middle-income countries (LMICs) account for a large proportion of disease burden. While efficacious treatments exist, only 10% of those in need are able to access care. This treatment gap is fueled by structural determinants including inadequate resource allocation and prioritization, both rooted in a lack of research and policy capacity. The goal of the Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building (SHARP), based in Malawi and Tanzania, is to address those research and policy-based determinants. METHODS: SHARP aims to (1) build implementation science skills and expertise among Malawian and Tanzanian researchers in the area of mental health; (2) ensure that Malawian and Tanzanian policymakers and providers have the knowledge and skills to effectively apply research findings on evidence-based mental health programs to routine practice; and (3) strengthen dialogue between researchers, policymakers, and providers leading to efficient and sustainable scale-up of mental health services in Malawi and Tanzania. SHARP comprises five capacity building components: introductory and advanced short courses, a multifaceted dialogue, on-the-job training, pilot grants, and "mentor the mentors" courses. DISCUSSION: Program evaluation includes measuring dose delivered and received, participant knowledge and satisfaction, as well as academic output (e.g., conference posters or presentations, manuscript submissions, grant applications). The SHARP Capacity Building Program aims to make a meaningful contribution in pursuit of a model of capacity building that could be replicated in other LMICs. If impactful, the SHARP Capacity Building Program could increase the knowledge, skills, and mentorship capabilities of researchers, policymakers, and providers regarding effective scale up of evidence-based MH treatment.

Treatment of an HIV-affected adolescent with heroin dependence in a low-income country: A clinical case study from Zambia.

INTRODUCTION: Although the World Health Organization (WHO) has recommended guidelines for the treatment of opioid dependence, there are myriad challenges to successfully implementing such guidelines in resource constrained settings, such as in low and middle-income countries (LMICs). To highlight these challenges, this paper presents a clinical case study of an adolescent study participant in a randomized controlled trial comparing two counseling programs in Lusaka, Zambia. CASE DESCRIPTION: This 15 year-old male reported smoking marijuana and heroin daily, and injecting heroin monthly (while needle sharing). The patient was linked to the only physician capable of treating heroin addiction in Zambia. The patient was placed on a 30-day detox regimen of Tramadol administered from home, as in-patient detox services are unavailable in Zambia. The patient experienced complications with out-patient detox, including a relapse that led to violent behavior and temporary incarceration. The patient's treatment regimen was altered to include Lorazepam, a mild sedative, and psychosocial counseling. After completing detox the client was prescribed Naltrexone for maintenance as Methadone is listed as a banned substance in Zambia, and Buprenorphine is not available and is cost prohibitive. CONCLUSIONS: Despite a considerable amount of time and resources expended to successfully treat the patient, the majority of WHO guidelines for opioid dependence treatment were not attainable within the Zambian context. Additional research into the effectiveness and implementation of evidence-based interventions for substance use in LMICs is warranted.