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.

The longitudinal association of stressful life events with depression remission among SHARP trial participants with depression and hypertension or diabetes in Malawi.

Depressive disorders are leading contributors to morbidity in low- and middle-income countries and are particularly prevalent among people with non-communicable diseases (NCD). Stressful life events (SLEs) are risk factors for, and can help identify those at risk of, severe depressive illness requiring more aggressive treatment. Yet, research on the impact of SLEs on the trajectory of depressive symptoms among NCD patients indicated for depression treatment is lacking, especially in low resource settings. This study aims to estimate the longitudinal association of SLEs at baseline with depression remission achievement at three, six, and 12 months among adults with either hypertension or diabetes and comorbid depression identified as being eligible for depression treatment. Participants were recruited from 10 NCD clinics in Malawi from May 2019-December 2021. SLEs were measured by the Life Events Survey and depression remission was defined as achieving a Patient Health Questionaire-9 (PHQ-9) score <5 at follow-up. The study population (n = 737) consisted predominately of females aged 50 or higher with primary education and current employment. At baseline, participants reported a mean of 3.5 SLEs in the prior three months with 90% reporting ≥1 SLE. After adjustment, each additional SLE was associated with a lower probability of achieving depression remission at three months (cumulative incidence ratio (CIR) 0.94; 95% confidence interval: 0.90, 0.98, p = 0.002), six months (0.95; 0.92, 0.98, p = 0.002) and 12 months (0.96; 0.94, 0.99, p = 0.011). Re-expressed per 3-unit change, the probability of achieving depression remission at three, six, and 12 months was 0.82, 0.86, and 0.89 times lower per 3 SLEs (the median number of SLEs). Among NCD patients identified as eligible for depression treatment, recent SLEs at baseline were associated with lower probability of achieving depression remission at three, six, and 12 months. Findings suggest that interventions addressing SLEs during integrated NCD and depression care interventions (e.g., teaching and practicing SLE coping strategies) may improve success of depression treatment among adult patient populations in low-resource settings and may help identify those at risk of severe and treatment resistant depression.

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.

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.

Estimating the effect of anticipated depression treatment-related stigma on depression remission among people with noncommunicable diseases and depressive symptoms in Malawi.

PURPOSE: While mental health stigma research is sparse in Malawi, research in other settings suggests that stigma represents a barrier to mental health treatment and recovery. Accordingly, we conducted an analysis to understand the role of treatment-related stigma in depression care in Malawi by estimating the effect of patients' baseline anticipated treatment-related stigma on their 3-month probability of depression remission when newly identified with depression. METHODS: We conducted depression screening and treatment at 10 noncommunicable disease (NCD) clinics across Malawi from April 2019 through December 2021. Eligible cohort participants were 18-65 years with depressive symptoms indicated by a PHQ-9 score ≥5. Questionnaires at the baseline and 3-month interviews included a vignette-based quantitative stigma instrument that measured treatment-related stigma, i.e., concerns about external stigma because of receiving depression treatment. Using inverse probability weighting to adjust for confounding and multiple imputation to account for missing data, this analysis relates participants' baseline levels of anticipated treatment stigma to the 3-month probability of achieving depression remission (i.e., PHQ-9 score < 5). RESULTS: Of 743 included participants, 273 (37%) achieved depression remission by their 3-month interview. The probability of achieving depression remission at the 3-month interview among participants with high anticipated treatment stigma (0.31; 95% Confidence Interval [CI]: 0.23, 0.39)) was 10 percentage points lower than among the low/neutral stigma group (risk: 0.41; 95% CI: 0.36, 0.45; RD: -0.10; 95% CI: -0.19, -0.003). CONCLUSION: In Malawi, a reduction in anticipated depression treatment-related stigma among NCD patients initiating depression treatment could improve depression outcomes. Further investigation is necessary to understand the modes by which stigma can be successfully reduced to improve mental health outcomes and quality of life among people living with depression.

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.

The feasibility and acceptability of a task-shifted intervention for perinatal depression among women living with HIV in Malawi: a qualitative analysis.

BACKGROUND: Perinatal depression (PND) is prevalent and negatively impacts HIV care among women living with HIV (WLHIV), yet PND remains under-identified in Malawian WLHIV. Accordingly, this formative study explored perceptions of the feasibility and acceptability of an integrated, task-shifted approach to PND screening and treatment in maternity clinics. METHODS: We completed consecutive PND screenings of HIV+ women attending pre- or post-natal appointments at 5 clinics in Lilongwe district, Malawi. We conducted in-depth interviews with the first 4-5 women presenting with PND per site (n = 24 total) from July to August 2018. PND classification was based on a score ≥ 10 on the Edinburgh Postnatal Depression Scale (EPDS). We conducted 10 additional in-depth interviews with HIV and mental health providers at the 5 clinics. RESULTS: Most participants endorsed the feasibility of integrated PND screening, as they believed that PND had potential for significant morbidity. Among providers, identified barriers to screening were negative staff attitudes toward additional work, inadequate staffing numbers and time constraints. Suggested solutions to barriers were health worker training, supervision, and a brief screening tool. Patient-centered counselling strategies were favored over medication by WLHIV as the acceptable treatment of choice, with providers supporting the role of medication to be restricted to severe depression. Providers identified nurses as the most suitable health workers to deliver task-shifted interventions and emphasized further training as a requirement to ensure successful task shifting. CONCLUSION: Improving PND in a simple, task-shifted intervention is essential for supporting mental health among women with PND and HIV. Our results suggest that an effective PND intervention for this population should include a brief, streamlined PND screening questionnaire and individualized counselling for those who have PND, with supplemental support groups and depression medication readily available. These study results support the development of a PND intervention to address the gap in treatment of PND and HIV among WLHIV in Malawi.

The cross-sectional association of stressful life events with depression severity among patients with hypertension and diabetes in Malawi.

Depressive disorders are a leading cause of global morbidity and remain disproportionately high in low- and middle-income settings. Stressful life events (SLEs) are known risk factors for depressive episodes and worsened depressive severity, yet are under-researched in comparison to other depression risk factors. As depression is often comorbid with hypertension, diabetes, and other noncommunicable diseases (NCDs), research into this relationship among patients with NCDs is particularly relevant to increasing opportunities for integrated depression and NCD care. This study aims to estimate the cross-sectional association between SLEs in the three months preceding baseline interviews and baseline depressive severity among patients with at least mild depressive symptoms who are seeking NCD care at 10 NCD clinics across Malawi. SLEs were measured by the Life Events Survey and depressive severity (mild vs. moderate to severe) was measured by the Patient Health Questionnaire-9. The study population (n = 708) was predominately currently employed, grand multiparous (5-8 children) women with a primary education level. Two thirds (63%) had mild depression while 26%, 8%, and 3% had moderate, moderately severe, and severe depression, respectively. Nearly all participants (94%) reported at least one recent SLE, with the most common reported SLEs being financial stress (48%), relationship changes (45%), death of a family member or friend (41%), or serious illness of a family member or friend (39%). Divorce/separation, estrangement from a family member, losing source of income, and major new health problems were significant predictors of greater (moderate or severe) depressive severity compared to mild severity. Having a major new health problem or experiencing divorce/separation resulted in particularly high risk of more severe depression. After adjustment, each additional SLE was associated with a 9% increased risk of moderate or worse depressive severity compared to mild depressive severity (RR: 1.09; (95% CI: 1.05, 1.13), p<0.0001). Among patients with NCDs with at least mild depressive symptoms, SLEs in the prior 3 months were associated with greater depressive severity. While many SLEs may not be preventable, this research suggests that assessment of SLEs and teaching of positive coping strategies when experiencing SLEs may play an important role in integrated NCD and depression treatment models.

Arbovirus risk perception as a predictor of mosquito-bite preventive behaviors in Ponce, Puerto Rico.

Mosquito-borne arboviruses are an important cause of morbidity and mortality in the Caribbean. In Puerto Rico, chikungunya, dengue, and Zika viruses have each caused large outbreaks during 2010-2022. To date, the majority of control measures to prevent these diseases focus on mosquito control and many require community participation. In 2018, the U.S. Centers for Disease Control and Prevention launched the COPA project, a community-based cohort study in Ponce, Puerto Rico, to measure the impact of novel vector control interventions in reducing arboviral infections. Randomly selected households from 38 designated cluster areas were offered participation, and baseline data were collected from 2,353 households between May 2018 and May 2019. Household-level responses were provided by one representative per home. Cross-sectional analyses of baseline data were conducted to estimate 1) the association between arboviral risk perception and annual household expenditure on mosquito control, and 2) the association between arboviral risk perception and engagement in ≥3 household-level risk reduction behaviors. In this study, 27% of household representatives believed their household was at high risk of arboviruses and 36% of households engaged in at least three of the six household-level preventive behaviors. Households where the representative perceived their household at high risk spent an average of $35.9 (95% confidence interval: $23.7, $48.1) more annually on mosquito bite prevention compared to households where the representative perceived no risk. The probability of engaging in ≥3 household-level mosquito-preventive behaviors was 10.2 percentage points greater (7.2, 13.0) in households where the representatives perceived high risk compared to those in which the representatives perceived no risk. Paired with other research, these results support investment in community-based participatory approaches to mosquito control and providing accessible information for communities to accurately interpret their risk.

"Thandi should feel embarrassed": describing the validity and reliability of a tool to measure depression-related stigma among patients with depressive symptoms in Malawi.

PURPOSE: There are no validated tools in Malawi to measure mental health stigma. Accordingly, this study evaluates the validity and reliability of a short quantitative instrument to measure depression-related stigma in patients exhibiting depressive symptoms in Malawi. METHODS: The SHARP study began depression screening in 10 NCD clinics across Malawi in April 2019; recruitment is ongoing. Eligible participants were 18-65 years, had a patient health questionnaire (PHQ-9) score ≥ 5, and were new or current diabetes or hypertension patients. Participants completed a baseline questionnaire that measured depression-related stigma, depressive symptoms, and sociodemographic information. The stigma instrument included a vignette of a depressed woman named Thandi, and participants rated their level of agreement with statements about Thandi's situation in nine prompts on a 5-point Likert scale. Inter-item reliability was assessed with Cronbach's alpha. Exploratory factor analysis (EFA) was used to assess structural validity, and OLS regression models were used to assess convergent and divergent validity between measured levels of depression-related stigma and covariates. RESULTS: The analysis of patient responses (n = 688) to the stigma tool demonstrated acceptable inter-item reliability across all scales and subsequent subscales of the instrument, with alpha values ranging from 0.70 to 0.87. The EFA demonstrated clustering around three domains: negative affect, treatment carryover, and disclosure carryover. Regression models demonstrated convergence with several covariates and demonstrated divergence as expected. CONCLUSION: This study supports the reliability and validity of a short stigma questionnaire in this population. Future studies should continue to assess the validity of this stigma instrument in this population.