Friendship Bench Intervention to Address Depression and Improve HIV Care Engagement Among Adolescents Living with HIV in Malawi: Study Protocol for a Pilot Randomized Controlled Trial.

Background: Adolescents in Sub-Saharan Africa are disproportionately affected by the HIV epidemic. Comorbid depression is prevalent among adolescents living with HIV (ALWH) and poses numerous challenges to HIV care engagement and retainment. We present a pilot trial designed to investigate feasibility, fidelity, and acceptability of an adapted and an enhanced Friendship Bench intervention (henceforth: AFB and EFB) in reducing depression and improving engagement in HIV care among ALWH in Malawi. Methods: Design:: Participants will be randomized to one of three conditions: the Friendship Bench intervention adapted for ALWH (AFB, n=35), the Friendship Bench intervention enhanced with peer support (EFB, n=35), or standard of care (SOC, n=35). Recruitment is planned for early 2024 in four clinics in Malawi.Participants:: Eligibility criteria (1) aged 13-19; (2) diagnosed with HIV (vertically or horizontally); (3) scored ≥ 13 on the self-reported Beck's Depression Inventory (BDI-II); (4) living in the clinic's catchment area with intention to remain for at least 1 year; and (5) willing to provide informed consent.Interventions:: AFB includes 6 counseling sessions facilitated by young, trained non-professional counselors. EFB consists of AFB plus integration of peer support group sessions to facilitate engagement in HIV care. SOC for mental health in public facilities in Malawi includes options for basic supportive counseling, medication, referral to mental health clinics or psychiatric units at tertiary care hospitals for more severe cases.Outcomes:: The primary outcomes are feasibility, acceptability, and fidelity of the AFB and EFB assessed at 6 months and 12 months and compared across 3 arms. The secondary outcome is to assess preliminary effectiveness of the interventions in reducing depressive symptoms and improving HIV viral suppression at 6 months and 12 months. Discussion: This pilot study will provide insights into youth-friendly adaptations of the Friendship Bench model for ALWH in Malawi and the value of adding group peer support for HIV care engagement. The information gathered in this study will lead to a R01 application to test our adapted intervention in a large-scale cluster randomized controlled trial to improve depression and engagement in HIV care among ALWH.

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.

Phone-based psychosocial counseling for people living with HIV: Feasibility, acceptability and impact on uptake of psychosocial counseling services in Malawi.

People living with HIV experience psychosocial needs that often are not addressed. We designed an innovative low-resource model of phone-based psychosocial counseling (P-PSC). We describe cohort characteristics, acceptability, feasibility and utilization of P-PSC at health facilities supported by Baylor Foundation Malawi. Staff were virtually oriented at 120 sites concurrently. From facility-based phones, people with new HIV diagnosis, high viral load, treatment interruption or mental health concerns were referred without identifiable personal information to 13 psychosocial counselors via a WhatsApp group. Routine program data were retrospectively analyzed using univariate approaches and regressions with interrupted time series analyses. Clients utilizing P-PSC were 63% female, 25% youth (10-24 y) and 9% children (<10 y). They were referred from all 120 supported health facilities. Main referral reasons included new HIV diagnosis (32%), ART adherence support (32%) and treatment interruption (21%). Counseling was completed for 99% of referrals. Counseling sessions per month per psychosocial counselor increased from 77 before P-PSC to 216 in month 1 (95% CI = 82, 350, p = 0.003). Total encounters increased significantly to 31,642 in year 1 from ~6,000 during the 12 prior months, an over fivefold increase. P-PSC implementation at 120 remote facilities was acceptable and feasible with immediate, increased utilization despite few psychosocial counselors in Malawi.

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 .

Psychosis Recovery Orientation in Malawi by Improving Services and Engagement (PROMISE) protocol.

Malawi has a population of around 20 million people and is one of the world's most economically deprived nations. Severe mental illness (largely comprising psychoses and severe mood disorders) is managed by a very small number of staff in four tertiary facilities, aided by clinical officers and nurses in general hospitals and clinics. Given these constraints, psychosis is largely undetected and untreated, with a median duration of untreated psychosis (DUP) of around six years. Our aim is to work with people with lived experience (PWLE), caregivers, local communities and health leaders to develop acceptable and sustainable psychosis detection and management systems to increase psychosis awareness, reduce DUP, and to improve the health and lives of people with psychosis in Malawi. We will use the UK Medical Research Council guidance for developing and evaluating complex interventions, including qualitative work to explore diverse perspectives around psychosis detection, management, and outcomes, augmented by co-design with PWLE, and underpinned by a Theory of Change. Planned deliverables include a readily usable management blueprint encompassing education and community supports, with an integrated care pathway that includes Primary Health Centre clinics and District Mental Health Teams. PWLE and caregivers will be closely involved throughout to ensure that the interventions are shaped by the communities concerned. The effect of the interventions will be assessed with a quasi-experimental sequential implementation in three regions, in terms of DUP reduction, symptom remission, functional recovery and PWLE / caregiver impact, with quality of life as the primary outcome. As the study team is focused on long-term impact, we recognise the importance of having embedded, robust evaluation of the programme as a whole. We will therefore evaluate implementation processes and outcomes, and cost-effectiveness, to demonstrate the value of this approach to the Ministry of Health, and to encourage longer-term adoption across Malawi.

Pathways to care for psychosis in Malawi.

People with psychosis in Malawi have very limited access to timely assessment and evidence-based care, leading to a long duration of untreated psychosis and persistent disability. Most people with psychosis in the country consult traditional or religious healers. Stigmatising attitudes are common and services have limited capacity, particularly in rural areas. This paper, focusing on pathways to care for psychosis in Malawi, is based on the Wellcome Trust Psychosis Flagship Report on the Landscape of Mental Health Services for Psychosis in Malawi. Its purpose is to inform Psychosis Recovery Orientation in Malawi by Improving Services and Engagement (PROMISE), a longitudinal study that aims to build on existing services to develop sustainable psychosis detection systems and management pathways to promote recovery.

Preferences for enhanced treatment options to address HIV care engagement among women living with HIV and perinatal depression in Malawi.

BACKGROUND: Option B + offers lifelong ART to pregnant or breastfeeding mothers, but postpartum loss to HIV care, partially driven by perinatal depression (PND), threatens the impact of this policy. This study aims to understand women's and providers' preferences for developing a feasible intervention to address PND and support engagement in HIV care among women living with PND and HIV. METHODS: We conducted a total of 6 focus group discussions (FGDs) involving 4 clinics in Lilongwe District from December 2018 through February 2019. We conducted 2 FGDs each among 3 stakeholder groups: clinical staff, prenatal women, and postnatal women. Perinatal participants were living with HIV and screened positively for PND using the validated Edinburgh Postnatal Depression Scale (EPDS). Clinical staff were nurses who were trained antiretroviral therapy (ART) providers. Interviewers led FGDs in Chichewa using a semi-structured guide. Data were analyzed using deductive and inductive coding in NVivo 12 software. RESULTS: Women favored ART linkage services, but providers said they already offered such services, with mixed results. Individual counselling was universally supported. A perceived benefit of group counselling was peer support, but there were concerns among women regarding confidentiality and stigma. Women liked mobile appointment reminders but identified low phone ownership as a barrier. Participants recommended home visits as an additional care engagement strategy. Women consistently discussed the need for social support from family members and friends to address PND and support engagement in HIV care. CONCLUSION: This study highlights the importance of peer encouragement to support perinatal HIV care engagement among women with HIV and PND. The results from this study can be used to support intervention development to increase HIV care engagement and improve long-term HIV outcomes in women with PND.

Depressive disorder at the household level: prevalence and correlates of depressive symptoms among household members.

BACKGROUND: Globally, an estimated five percent of adults have major depressive disorder. However, little is known about the relationship between these individuals' depressive symptoms and their household members' mental health and well-being. OBJECTIVES: We aimed to investigate the prevalence and predictors of depressive symptoms among adult household members of patients living with major depressive disorder in Neno District, Malawi. METHODS: As part of a cluster randomized controlled trial providing depression care to adults with major depressive disorder, we conducted surveys with patients' household members (n = 236) and inquired about their overall health, depressive symptoms, disability, and social support. We calculated prevalence rates of depressive disorder and conducted multivariable linear regression and multivariable logistic regression analyses to assess correlates of depressive symptom severity and predictors of having depressive disorder (PHQ-9), respectively, among household members. RESULTS: We observed that roughly one in five household members (19%) screened positive for a depressive disorder (PHQ-9 > 9). More than half of household members endorsed six or more of the nine symptoms, with 68% reporting feeling 'down, depressed, or hopeless' in the prior two weeks. Elevated depression symptom severity was associated with greater disability (ß = 0.17, p < 0.001), less social support (ß = -0.04, p = 0.016), and lower self-reported overall health (ß = 0.54, p = 0.001). Having depressive disorder was also associated with greater disability (adjusted Odds Ratio [aOR] = 1.12, p = 0.001) and less social support (aOR = 0.97, p = 0.024). CONCLUSIONS: In the Malawian context, we find that depressive disorder and depression symptoms are shared attributes among household members. This has implications for both screening and treatment, and it suggests that mental health should be approached from the vantage point of the broader social ecology of the household and family unit. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04777006) - March 2, 2021.

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.

An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.

Perinatal depression (PND) is common and an important barrier to engagement in HIV care for women living with HIV (WLHIV). Accordingly, we adapted and enhanced The Friendship Bench, an evidence-based counseling intervention, for perinatal WLHIV. In a pilot randomized trial (NCT04143009), we evaluated the feasibility, acceptability, fidelity, and preliminary efficacy of the Enhanced Friendship Bench (EFB) intervention to improve PND and engagement in HIV care outcomes. Eighty pregnant WLHIV who screened positive for PND symptoms on the Self-Report Questionnaire (≥ 8) were enrolled, randomized 1:1 to EFB or usual care, and followed through 6 months postpartum. Overall, 100% of intervention participants were satisfied with the intervention and 93% found it beneficial to their overall health. Of 82 counseling sessions assessed for fidelity, 83% met or exceeded the fidelity threshold. At 6 months postpartum, intervention participants had improved depression remission (59% versus 36%, RD 23%, 95% CI 2%, 45%), retention in HIV care (82% versus 69%, RD 13%, -6%, 32%), and viral suppression (96% versus 90%, RD 7%, -7%, 20%) compared to usual care. Adverse events did not differ by arm. These results suggest that EFB intervention should be evaluated in a fully powered randomized trial to evaluate its efficacy to improve PND and engagement in HIV care outcomes for WLHIV.

The acceptability of antidepressant treatment in people living with HIV in Malawi: A patient perspective.

Depression is common among people living with HIV (PLWH). Measurement-based care models that measure depression severity and antidepressant side effects, and use an algorithm to guide antidepressant prescription by non-specialized health workers represent an evidence-based treatment for severe depression in sub-Saharan Africa. We conducted in-depth interviews from June to December 2018 with eleven patients enrolled in Project SOAR-Mental Health, a pilot project integrating depression treatment into HIV care in Malawi. Patients treated with amitriptyline or fluoxetine participated in interviews exploring antidepressant acceptability through patient knowledge, side effect severity, pill burden, adherence, perceived efficacy, and tolerability. Patients described a lack of detailed antidepressant education from their providers. Variable, typically self-limiting side effects were reported from both amitriptyline and fluoxetine. While most side effects were mild, three patients reported functional impairment. Patients reported high adherence, though the additional pill burden was a challenge. Most patients found the antidepressants efficacious, tolerable, beneficial and acceptable. Although patient psychoeducation is notably lacking as a facet of clinical management, antidepressant prescription by primary care providers appears acceptable for comorbid severe depression in PLWH initiating HIV care in sub-Saharan Africa. Health workers should be mindful of dosing to minimise side effects and considerate of the additional pill burden.Trial registration: ClinicalTrials.gov ID [NCT03555669]. Retrospectively registered on 13 June 2018.

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.

Prevalence and correlates of internalized stigma among adults with HIV and major depressive disorder in rural Malawi.

Internalized stigma is common among individuals with sexually transmitted infections such as HIV and among those with mental health conditions such as major depressive disorder (MDD). As part of a cluster randomized trial, we investigated the prevalence and correlates of internalized stigma among adults living with comorbid HIV and MDD in rural Malawi (n = 339). We found heightened stigma toward HIV and mental illness among those in the cohort: more than half of respondents (54%) endorsed negative perceptions associated with each health condition. Internalized HIV-related stigma was higher among those with no education (p = 0.04), younger adults (p = 0.03), and those with less social support (p = 0.001). Mental illness-related stigma was elevated among those with no source of income (p = 0.001), and it was also strongly associated with HIV-related stigma (p < 0.001). Our findings highlight potential avenues for reducing internalized stigma associated with high-prevalence health conditions in Malawi.Trial registration: ClinicalTrials.gov identifier: NCT04777006.

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.

The relationship between adverse childhood experiences and common mental disorders among pregnant women living with HIV in Malawi.

INTRODUCTION: Adverse childhood experiences (ACEs) have been linked to common mental disorders (CMDs) such as anxiety and depressive thoughts. We examined the prevalence of ACEs and their association with CMDs among pregnant women living with HIV (PWLHIV) in Malawi-an HIV endemic resource-limited setting. METHODS: This is a cross-sectional study of 798 PWLHIV enrolled in the VITAL Start trial in Malawi (10/2018 to 06/2021) (NCT03654898). ACE histories were assessed using WHO's Adverse Childhood Experiences International Questionnaire (ACE-IQ) tool. Depressive symptoms (somatic complaints, reduced vital energy, anxiety, and depressive thoughts) were assessed using WHO's Self Reporting Questionnaire 20-Item (SRQ-20) tool. Log-binomial regressions were used to examine the association between cumulative ACEs and each depressive symptom, as well as identify ACEs driving this association. RESULTS: The mean age of our sample was 27.5 years. Over 95 % reported having experienced ≥1 ACE. On average, each participant reported four ACEs; 11 % reported sexual abuse. About 52 % and 44 % reported anxiety and depressive thoughts, respectively. In regressions, cumulative ACE scores were significantly associated with depressive symptoms-even after adjusting for multiple testing. This association was primarily driven by reports of sexual abuse. LIMITATIONS: Data on maternal ACEs were self-reported and could suffer from measurement error because of recall bias. CONCLUSIONS: ACEs are widespread and have a graded relationship with depressive symptoms in motherhood. Sexual abuse was found to be a primary driver of this association. Earlier recognition of ACEs and provision of trauma-informed interventions to improve care in PWLHIV may reduce negative mental health sequelae.