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

[This corrects the article DOI: 10.1371/journal.pone.0279619.].

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

Stigma and mental health challenges among adolescents living with HIV in selected adolescent-specific antiretroviral therapy clinics in Zomba District, Malawi.

BACKGROUND: Of the 1.8 million adolescents between the ages of 10 and 19 living with HIV globally in 2020; approximately 1.5 million of these live in sub-Saharan Africa. These adolescents living with HIV (ALHIV) are at higher risk of experiencing mental health problems than those without; in Malawi, 18.9% have a depressive disorder. ALHIV can face numerous psychosocial challenges, but little is known about how ALHIV in Malawi perceive these stressors. Understanding psychosocial challenges of ALHIV is a key step in ensuring good mental health care. The aim of this study was to assess the psychosocial challenges faced by ALHIV attending adolescent-specific ART program in Zomba, Malawi. METHODS: Between April and May 2019, we engaged a purposive sample of ALHIV ages 12-18 (n = 80) in a series of eight focus groups drawing from four Teen Clubs linked to an adolescent-specific ART program. Data were analyzed inductively and deductively to identify themes related to ALHIV psychosocial experiences. RESULTS: Two themes that emerged from the study include: 1) stigma and discrimination within communities and families; 2) non-adherence to medications. HIV-related stigma was associated with increased psychological distress; physical and emotional/verbal abuse; low social support, isolation, and a feeling of rejection; and risky health behaviors such as medication hiding and non-adherence to ART. Discriminatory actions were manifested in a form of being given separate utensils for their meals and mistreatment at school. Furthermore, some parents did not allow their children to play with the participants out of fear that HIV transmission. CONCLUSIONS: Stigma and discrimination are overlooked potential barriers to HIV treatment and care. If HIV services are to effectively meet ALHIVs' needs, mental health interventions are needed to prevent and manage depression and improve adherence to ART. These findings highlight the crucial need to develop culturally relevant mental interventions aimed at helping ALHIV to cope with these diverse challenges.

Probable perinatal depression and social support among women enrolled in Malawi's Option B+ Program: A longitudinal analysis.

BACKGROUND: Malawi's PMTCT Option B+ program has expanded the reach of ART services among pregnant and breastfeeding women, but retention in lifelong HIV care remains challenging. Given that depression can undermine retention, it is important to understand how depression changes over the perinatal period, varies across treatment and retention groups, and could be buffered by social support. METHODS: Data are from an observational study conducted among women enrolled in Malawi's PMTCT Option B+ program. We used multilevel generalized linear models to estimate the odds of probable depression by time, treatment and retention group, and social support. Probable depression was assessed with the Edinburgh Postnatal Depression Scale and Patient Health Questionnaire-9. RESULTS: Of 468 women, 15% reported probable depression at antenatal enrollment and prevalence differed across newly diagnosed individuals, second line therapy users, and previous defaulters (18%, 21%, 5%, p = 0.001). Odds of probable perinatal depression decreased over time (OR per month: 0.87, 95% CI: 0.82-0.92) but were higher among those newly diagnosed (OR: 3.25, 95% CI: 1.59-6.65) and on second line therapy (OR: 3.39, 95% CI: 1.44-7.99) as compared to previous defaulters. Odds of probable postpartum depression were lower for participants with high social support (OR: 0.19, 95% CI: 0.09-0.39). LIMITATIONS: Lack of diagnostic psychiatric evaluation precludes actual diagnosis of depression. CONCLUSIONS: Probable depression varied across the perinatal period and across treatment and retention groups. Social support was protective for postpartum depression among all participants. Depression screening and provision of social support should be considered in PMTCT programs.

Barriers and facilitators to implementing the HEADSS psychosocial screening tool for adolescents living with HIV/AIDS in teen club program in Malawi: health care providers perspectives.

BACKGROUND: Adolescents living with HIV (ALHIV) are at high risk of experiencing mental health problems. Depression is a major contributor to the burden of HIV-related disease amongst ALHIV and is significantly linked to non-adherence to anti-retroviral therapy (ART), yet it is under-recognized. In 2015, the Baylor College of Medicine International Pediatric AIDS Initiative (BIPAI) recommended that the psychosocial screening tool Home, Education, Activities, Drugs, Sexuality, Suicide/Depression (HEADSS) be used to screen ALHIV in Malawi who were part of an adolescent antiretroviral therapy program termed "Teen Club". However, the HEADSS tool has been substantially under-utilized. This study assessed barriers and facilitators to implementing HEADSS for ALHIV attending Teen Club Program in four selected health facilities in Malawi. METHODS: We conducted a qualitative study using semi-structured interviews at four program sites (one district hospital and one health center each in two districts) between April and May 2019. Twenty key informants were purposively selected to join this study based on their role and experiences. We used the five domains of the Consolidated Framework for Implementation Research (CFIR) to guide the development of the interview guides, analysis and interpretation of results. RESULTS: Barriers included inadequate planning for integration of the HEADSS approach; concerns that the HEADSS tool was too long, time consuming, lacked appropriate cultural context, and increased workload; and reports by participants that they did not have knowledge and skills to screen ALHIV using this tool. Facilitators to implementing the screening were that health care providers viewed screening as a guide to better systematic counselling, believed that screening could build better client provider relationship, and thought that it could fit into the existing work practice since it is not complex. CONCLUSIONS: A culturally adapted screening tool, especially one that can be used by non-clinicians such as lay health workers, would improve the ability to address mental health needs of ALHIV in many primary care and social service settings where resources for professional mental health staff are limited. These findings are a springboard for efforts to culturally adapt the HEADSS screening tool for detection of mental and risky behaviors among ALHIV attending ART program in Malawi.

A Mixed-Methods Process Evaluation: Integrating Depression Treatment Into HIV Care in Malawi.

BACKGROUND: Depression is highly prevalent among people living with HIV in Malawi. Depression can undermine engagement in HIV care and worsen HIV morbidity and mortality. The Ministry of Health integrated a pilot depression management program into HIV care at 2 clinics. This program included a measurement-based care protocol for prescribing antidepressants and an adapted Friendship Bench psychotherapy protocol for providing problem solving. Early evaluations indicated successful integration of the initial stages of training and depression screening, diagnosis, and treatment initiation. This follow-up mixed-method investigation contextualizes our previous findings and shares insights from the implementation experience. METHODS: We conducted a mixed-methods process evaluation drawing on both patient clinical data and qualitative interviews with patients and clinic staff. We focus on the following implementation outcomes: fidelity, acceptability, and sustainability. RESULTS: Although fidelity to depression screening and treatment initiation was high, fidelity to the follow-up treatment protocol was poor. Antidepressants and problem-solving therapy were acceptable to patients, but clinic staff found delivering treatment challenging given constrained human resources and infrastructure. The program was not sustained after the project. Key identified needs included substantial support to supervise the implementation of the program, continue to build and maintain the capacity of providers, integrate the program into the electronic medical records system, and ensure the availability of Friendship Bench counselors. CONCLUSIONS: Although initial steps were successful, sustained integration of this depression treatment program into HIV care in this setting met greater challenges. Implementation science studies that support both implementation and evaluation should recognize the potential for clinical implementers to rely on evaluation staff for clinical support and consider distancing evaluation staff from the actual program implementation. Further research is needed to test enhanced implementation strategies for integrating evidence-based mental health interventions into existing health care systems in a sustainable fashion, particularly in low-resource settings.

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial.

BACKGROUND: Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. METHODS: We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. DISCUSSION: This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.

Developing Biopsychosocial Research on Maternal Mental Health in Malawi: Community Perspectives and Concerns.

Interest in maternal mental health research is growing around the world. Maternal mental health research studies in Malawi have, for instance, sought to determine and establish the incidence and prevalence of depression and anxiety in pregnant people and the factors that contribute to experiences of these states. This article reports stakeholder perspectives on potential community concerns with biopsychosocial mental health research (which might include collecting blood samples) in Malawi. These perspectives were generated through a town hall event that featured five focus group discussions with various participants. In this article, we reflect on key themes from these discussions, demonstrating the endurance of long-standing concerns and practices around autonomy, consent, and the drawing of blood. We conclude by arguing that, while maternal mental health research conducted in Malawi could benefit Malawian women and children, consultation with community stakeholders is necessary to inform whether and how such research should be conducted.