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.

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.

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.

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 .

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.

"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.

Association Between Depression and HIV Care Engagement Outcomes Among Patients Newly Initiating ART in Lilongwe, Malawi.

As in other sub-Saharan countries, the burden of depression is high among people living with HIV in Malawi. However, the association between depression at ART initiation and two critical outcomes-retention in HIV care and viral suppression-is not well understood. Prior to the launch of an integrated depression treatment program, adult patients were screened for depression at ART initiation at two clinics in Lilongwe, Malawi. We compared retention in HIV care and viral suppression at 6 months between patients with and without depression at ART initiation using tabular comparison and regression models. The prevalence of depression among this population of adults newly initiating ART was 27%. Those with depression had similar HIV care outcomes at 6 months to those without depression. Retention metrics were generally poor for those with and without depression. However, among those completing viral load testing, nearly all achieved viral suppression. Depression at ART initiation was not associated with either retention or viral suppression. Further investigation of the relationship between depression and HIV is needed to understand the ways depression impacts the different aspects of HIV care engagement.

Risk factors for readmission among a cohort of psychiatric inpatients in Lilongwe, Malawi.

Objectives: Inpatient psychiatric capacity is limited in Malawi and no published studies have assessed psychiatric readmissions there. Information about factors associated with readmission may help guide strategies to reduce readmission rates and keep patients stabilised in the community. Our goal was to determine factors associated with readmission among a cohort of psychiatric inpatients in Lilongwe, Malawi.Methods: We conducted a retrospective chart review of all patients admitted to an inpatient psychiatric unit in Lilongwe, Malawi from January 1 to December 31, 2011. We used logistic regression to test for associations between readmissions during the study period and patient variables.Results: 419 patients were hospitalised during the study period. Twenty-nine patients (6.9%) were readmitted at least once during the study period. Readmission was associated only with intentional medication non-adherence at home (aOR: 3.33, p = 0.02).Conclusions: Intentional medication non-adherence is a potentially modifiable behaviour associated with psychiatric readmission. Efforts to improve medication adherence among patients following hospital discharge may help decrease the risk of readmission.KEY POINTSThe prevalence of readmission among psychiatric inpatients in Lilongwe, Malawi was 6.9% during the 1-year study period.Readmission was associated with intentional medication non-adherence at home.Future research efforts in Malawi should focus on improving medication adherence among psychiatric patients in the community to help decrease rates of readmission.

The Role of Depression Screening and Treatment in Achieving the UNAIDS 90-90-90 Goals in Sub-Saharan Africa.

Despite widespread HIV screening and treatment programs across sub-Saharan Africa, many countries are not on course to meet the Joint United Nations Program on HIV/AIDS 90-90-90 targets. As mental health disorders such as depression are prevalent among people living with HIV, investment in understanding and addressing comorbid depression is increasing. This manuscript aims to assess depression and HIV management in sub-Saharan Africa using a 90-90-90 lens through a discussion of: depression and the HIV care continuum; the state of depression screening and treatment; and innovations such as task-shifting strategies for depression management. Due to the lack of mental health infrastructure and human resources, task-shifting approaches that integrate mental health management into existing primary and community health programs are increasingly being piloted and adopted across the region. Greater integration of such mental health care task-shifting into HIV programs will be critical to realizing the 90-90-90 goals and ending the HIV epidemic.

The validity of the patient health Questionnaire-9 to screen for depression in patients with type-2 diabetes mellitus in non-communicable diseases clinics in Malawi.

BACKGROUND: Depression is a global problem, affecting populations worldwide, but is too often under-diagnosed. The identification of depression among patients with diabetes is important because depression is prevalent in this group and can complicate diabetes management. OBJECTIVES: The aim of the study was to determine the sensitivity and specificity of the PHQ-9 in the detection of depression among patients with type-2 diabetes mellitus attending non-communicable diseases (NCD) clinics in Malawi. METHODS: We conducted a validation study of the Patient Health Questionnaire (PHQ-9) among 323 patients with type-2 diabetes mellitus who attended two NCD clinics in one of the 28 districts of Malawi. The participants were screened consecutively using the nine-item PHQ-9 in Chichewa by a research assistant and completed a diagnostic interview using the Structured Clinical Interview for DSM-IV (SCID) for depression with a mental health clinician. We evaluated both content validity based on expert judgement and criterion validity of the Patient Health Questionnaire (PHQ-9) based on performance against the SCID. The PHQ-9 cutpoint that maximized sensitivity plus specificity was selected to report test characteristics. RESULTS: Using the SCID for depression, the prevalence of minor or major depression was 41% (133/323). The internal consistency estimate for the PHQ-9 was 0.83, with an area under the receiver operator curve (AUC) of 0.93 (95% CI, [0.91-0.96]). Using the optimal cut-point of ≥9, the PHQ-9 had a sensitivity of 64% and a specificity of 94% in detecting both minor and major depression, with likelihood ratio-positive = 10.1 and likelihood ratio negative =0.4 as well as overall correct classification (OCC) rate of 81%. CONCLUSIONS: This is the first validation study of the PHQ-9 in NCD clinics in Malawi. Depression was highly prevalent in this sample. The PHQ-9 demonstrated reasonable accuracy in identifying cases of depression and is a useful screening tool in this setting. Health care workers in NCD clinics can use the PHQ-9 to identify depression among their patients with those having a positive screen followed up by additional diagnostic assessment to confirm diagnosis. TRIAL REGISTRATION: PACTR201807135104799 . Retrospectively registered on 12 July 2018.

The effectiveness of depression management for improving HIV care outcomes in Malawi: protocol for a quasi-experimental study.

BACKGROUND: Depression, prevalent among people living with HIV (PLWH) in Malawi, is associated with negative HIV patient outcomes and likely affects HIV medical management. Despite the high prevalence of depression, its management has not been integrated into HIV care in Malawi or most low-income countries. METHODS: This study employs a pre-post design in two HIV clinics in Lilongwe, Malawi, to evaluate the effect of integrating depression management into routine HIV care on both mental health and HIV outcomes. Using a multiple baseline design, this study is examining mental health and HIV outcome data of adult (≥18 years) patients newly initiating ART who also have depression, comparing those entering care before and after the integration of depression screening and treatment into HIV care. The study is also collecting cost information to estimate the cost-effectiveness of the program in improving rates of depression remission and HIV treatment engagement and success. DISCUSSION: We anticipate that the study will generate evidence on the effect of depression management on HIV outcomes and the feasibility of integrating depression management into existing HIV care clinics. The results of the study will inform practice and policy decisions on integration of depression management in HIV care clinics in Malawi and related settings, and will help design a next-step strategy to scale-up integration to a larger scale. TRIAL REGISTRATION: ClinicalTrials.gov ID [ NCT03555669 ]. Retrospectively registered on 13 June 2018.

Factors associated with long length of stay in an inpatient psychiatric unit in Lilongwe, Malawi.

PURPOSE: Studies of factors affecting length of stay during psychiatric hospitalization in sub-Saharan Africa are sparse. A better understanding of such factors may lead to interventions resulting in quicker patient stabilization and discharge, freeing up needed psychiatric beds and reducing health care system expenditures. Therefore, we sought to identify factors associated with long length of stay in Malawi. METHODS: We reviewed the charts of 417 patients hospitalized at Kamuzu Central Hospital's Bwaila Psychiatric Unit in Lilongwe, Malawi from January 1 to December 31, 2011. Multivariate logistic regression analysis was employed to test for associations between patient factors and long length of stay (defined as more than 28 days). RESULTS: Mean length of stay was 22.08 ± 27.70 days (range 0-243). 21.82% (91/417) of patients stayed longer than 28 days. Long length of stay was associated with living outside of Lilongwe district [aOR: 3.65 (1.66-8.01), p = 0.001] and treatment for antipsychotic extrapyramidal side effects (EPS) during hospitalization [aOR: 3.45 (1.32-9.03), p = 0.012]. Patients who had more interactions with medical providers for this episode of illness prior to presentation at the unit were less likely to have a long length of stay [aOR: 0.35 (0.16-0.76), p = 0.008]. CONCLUSIONS: Our findings demonstrate areas of possible intervention to reduce length of stay, including securing means for patient transport home, rapid identification and treatment of EPS, and reducing the risk of EPS by decreased use of high potency first-generation antipsychotics.

Integrating depression management into HIV primary care in central Malawi: the implementation of a pilot capacity building program.

BACKGROUND: In Malawi, early retention in HIV care remains challenging. Depression is strongly associated with reduced anti-retroviral therapy (ART) adherence and viral suppression. Appropriate depression care for people initiating ART is likely to be supportive of early and continued engagement in the HIV care continuum. This paper aims to provide an overview of a task-shifting program that integrates depression screening and treatment into HIV care and the strategy used to evaluate this program, describes the implementation process, and discusses key challenges and lessons learned in the first phase of program implementation. METHODS: We are implementing a program integrating depression screening and treatment into HIV care initiation at two clinics in Lilongwe District, Malawi. The program's effect on patients' depression and HIV outcomes will be evaluated using a multiple baseline pre-post study. In this manuscript, we draw from our experiences as program implementers and some of the quantitative data to describe the process of implementation and key lessons learned. RESULTS: We successfully implemented the screening phase of this program at both clinics; 88.3 and 93.2% of newly diagnosed patients have been screened for depression at each clinic respectively. 25% of enrolled patients reported symptoms of mild-to-severe depression and only 6% reported symptoms of moderate-to-severe depression. Key lessons learned from the process show the importance of utilizing existing processes and infrastructure and focusing on iterative and collaborative learning. We continued to face challenges around establishing a sense of program ownership among providers, developing capacity to diagnose and manage depression, and ensuring the availability of appropriate medication. Our efforts to address these challenges provide insight into the technical and managerial support needed to prepare for, roll out, and sustain integrated models of mental health and HIV care. CONCLUSIONS: This activity demonstrates how a depression screening program can successfully be integrated into HIV care within the public health system in Malawi. While this program focuses on integrating depression management into HIV care, most of the lessons learned could apply to integration of mental health into any non-psychiatric specialist setting. TRIAL REGISTRATION: ClinicalTrials.gov ID [ NCT03555669 ]. Retrospectively registered on 13 June 2018.

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.

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.

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.

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.