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Abstract Background In Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes. Methods Design: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam. Participants: Sexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35). Intervention: Study participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use. Outcomes: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders. Discussion This proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings. Trial registration NCT06094634 on clinicaltrials.gov. Registered 16 October 2023.

Abstract Background In Malawi, approximately 25% of adolescents living with HIV (ALWH) also suffer from depression. Not only is HIV stigma a major contributor to depression but it also adversely impacts HIV care engagement. ALWH can experience HIV stigma as stereotyping, social exclusion, low social support, and abuse, and these experiences are associated with poor mental health. Despite recognition of the deleterious effects of HIV stigma, we have limited knowledge of how stigma is experienced by ALWH with comorbid depression. Guided by the Health Stigma and Discrimination Framework, we describe stigma faced by ALWH and comorbid depression in Malawi and its implications for future interventions. Methods As part of a larger formative study to adapt a mental health counseling intervention, we conducted in-depth interviews, social support mapping sessions, and focus-group discussions with 25 ALWH, 4 caregivers of ALWH, 3 HIV providers, and 5 participants and 5 staff of a prior mental health counseling intervention. After analyzing the stigma codes, we used the Health Stigma and Discrimination Framework to organize the data into four key domains: drivers, manifestations, outcomes, and health and social impacts. Results Major drivers of HIV stigma included fear of HIV transmission, negative effects of antiretroviral therapy (ART), association with death, inaccurate knowledge, and negative attitudes towards ALWH. The most common manifestations of HIV stigma were gossip, insults and mocking, and physical and social distancing. Decreased ART adherence and missed HIV appointments were commonly cited outcomes of HIV stigma. Broader health impacts of HIV stigma were notable for mental health comorbidities including depression, anxiety, substance use, and suicidality. Identified resilience strategies included support for HIV care engagement and psychosocial support from family and friends. Conclusions This study systematically describes the stigmatization process faced by ALWH and experiencing depressive symptoms in Malawi. Notably, HIV stigma continues to disrupt HIV care and detrimentally impacts mental health during adolescent development. Further studies focused specifically on stigma are needed to better characterize this process and identify additional resilience factors. Investment in stigma-reduction interventions for ALWH is needed to avert poor mental health and HIV outcomes.

Abstract Background Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians’ attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians’ knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use. Methods Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians’ alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI. Participants: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months. Outcomes: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff’s alcohol use and clinic-level alcohol expectations in the EBAI arm. Discussion This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases. Trial Registration NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885 .

Abstract Background Mental disorders are common among people with HIV (PWH) and are associated with poor HIV outcomes. Despite high unmet mental health needs among PWH, use of evidence-based mental health screening and treatment protocols remains limited at HIV treatment facilities across low-resource settings. Integrating mental health services into HIV care can reduce this gap. This study’s objective was to explore factors that influence integration of mental health screening and treatment into HIV clinics in Cameroon. Methods We analyzed 14 in-depth interviews with clinic staff supporting PWH at three urban HIV treatment clinics in Cameroon. Interviews focused on current processes, barriers and facilitators, and types of support needed to integrate mental health care into HIV care. Interviews were recorded and transcribed. French transcripts were translated into English. We used thematic analysis to identify factors that influence integration of mental health screening and treatment into HIV care in these settings. Ethical review boards in the United States and Cameroon approved this study. Results Respondents discussed a lack of standardized mental health screening processes in HIV treatment facilities and generally felt ill-equipped to conduct mental health screening. Low community awareness about mental disorders, mental health-related stigma, limited physical space, and high clinic volume affected providers’ ability to screen clients for mental disorders. Providers indicated that better coordination and communication were needed to support client referral to mental health care. Despite these barriers, providers were motivated to screen clients for mental disorders and believed that mental health service provision could improve quality of HIV care and treatment outcomes. All providers interviewed said they would feel more confident screening for mental disorders with additional training and resources. Providers recommended community sensitization, training or hiring additional staff, improved coordination to manage referrals, and leadership buy-in at multiple levels of the health system to support sustainable integration of mental health screening and treatment into HIV clinics in Cameroon. Conclusions Providers reported enthusiasm to integrate mental health services into HIV care but need more support and training to do so in an effective and sustainable manner.

Abstract 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 .

Abstract Introduction Little is known about the effects of universal test and treat (UTT) policies on HIV care outcomes among youth living with HIV (YLHIV). Moreover, there is a paucity of information regarding when YLHIV are most susceptible to disengagement from care under the newest treatment guidelines. The longitudinal HIV care continuum is an underutilized tool that can provide a holistic understanding of population-level HIV care trajectories and be used to compare treatment outcomes across groups. We aimed to explore effects of the UTT policy on longitudinal outcomes among South African YLHIV and identify temporally precise opportunities for re-engaging this priority population in the UTT era. Methods Using medical record data, we conducted a retrospective cohort study among youth aged 18–24 diagnosed with HIV from August 2015-December 2018 in nine health care facilities in South Africa. We used Fine and Gray sub-distribution proportional hazards models to characterize longitudinal care continuum outcomes in the population overall and stratified by treatment era of diagnosis. We estimated the proportion of individuals in each stage of the continuum over time and the restricted mean time spent in each stage in the first year following diagnosis. Sub-group estimates were compared using differences. Results A total of 420 YLHIV were included. By day 365 following diagnosis, just 23% of individuals had no 90-or-more-day lapse in care and were virally suppressed. Those diagnosed in the UTT era spent less time as ART-naïve (mean difference=-19.3 days; 95% CI: -27.7, -10.9) and more time virally suppressed (mean difference = 17.7; 95% CI: 1.0, 34.4) compared to those diagnosed pre-UTT. Most individuals who were diagnosed in the UTT era and experienced a 90-or-more-day lapse in care disengaged between diagnosis and linkage to care or ART initiation and viral suppression. Conclusions Implementation of UTT yielded modest improvements in time spent on ART and virally suppressed among South African YLHIV— however, meeting UNAIDS’ 95-95-95 targets remains a challenge. Retention in care and re-engagement interventions that can be implemented between diagnosis and linkage to care and between ART initiation and viral suppression (e.g., longitudinal counseling) may be particularly important to improving care outcomes among South African YLHIV in the UTT era.

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.

Abstract Background This study explored the relationship between specific types of potentially traumatic events (PTEs) and symptoms of mental health disorders among people with HIV (PWH) in Cameroon. Methods We conducted a cross-sectional study with 426 PWH in Cameroon between 2019–2020. Multivariable log binominal regression was used to estimate the association between exposure (yes/no) to six distinct types of PTE and symptoms of depression (Patient Health Questionnaire-9 score > 9), PTSD (PTSD Checklist for DSM-5 score > 30), anxiety (Generalized Anxiety Disorder-7 scale score > 9), and hazardous alcohol use (Alcohol Use Disorders Identification Test score > 7 for men; > 6 for women). Results A majority of study participants (96%) reported exposure to at least one PTE, with a median of 4 PTEs (interquartile range: 2–5). The most commonly reported PTEs were seeing someone seriously injured or killed (45%), family members hitting or harming one another as a child (43%), physical assault or abuse from an intimate partner (42%) and witnessing physical assault or abuse (41%). In multivariable analyses, the prevalence of PTSD symptoms was significantly higher among those who reported experiencing PTEs during childhood, violent PTEs during adulthood, and the death of a child. The prevalence of anxiety symptoms was significantly higher among those who reported experiencing both PTEs during childhood and violent PTEs during adulthood. No significant positive associations were observed between specific PTEs explored and symptoms of depression or hazardous alcohol use after adjustment. Conclusions PTEs were common among this sample of PWH in Cameroon and associated with PTSD and anxiety symptoms. Research is needed to foster primary prevention of PTEs and to address the mental health sequelae of PTEs among PWH.

Abstract 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.

Abstract Background Stigma around human immunodeficiency virus (HIV), injection drug use (IDU), and mental health disorders can be co-occurring and have different impacts on the well-being of people living with HIV (PWH) who use drugs and have mental health disorders. This stigma can come from society, health professionals, and internalized stigma. A person who has more than one health condition can experience overlapping health-related stigma and levels of stigma which can prevent them from receiving necessary support and healthcare, serving to intensify their experience with stigma. This study investigates HIV, drug use, and mental health stigmas in three dimensions (social, internalized, and professional) around PWH on methadone maintenance treatment (MMT) who have common mental disorders (CMDs) including depression, anxiety, and stress-related disorders in Hanoi, Vietnam.Please check and confirm whether corresponding author's email id is correctly identified.The cooresponding author's email is correct Methods We conducted semi-structured, in-depth interviews (IDIs) (n = 21) and two focus group discussions (FGDs) (n = 10) with PWH receiving MMT who have CMD symptoms, their family members, clinic health care providers, and clinic directors. We applied thematic analysis using NVIVO software version 12.0, with themes based on IDI and FGD guides and emergent themes from interview transcripts. Results The study found evidence of different stigmas towards HIV, IDU, and CMDs from the community, family, health care providers, and participants themselves. Community and family members were physically and emotionally distant from patients due to societal stigma around illicit drug use and fears of acquiring HIV. Participants often conflated stigmas around drug use and HIV, referring to these stigmas interchangeably. The internalized stigma around having HIV and injecting drugs made PWH on MMT hesitant to seek support for CMDs. These stigmas compounded to negatively impact participants’ health. Conclusions Strategies to reduce stigma affecting PWH on MMT should concurrently address stigmas around HIV, drug addiction, and mental health. Future studies could explore approaches to address internalized stigma to improve self-esteem, mental health, and capacities to cope with stigma for PWH on MMT. Trial registration: NCT04790201, available at clinicaltrials.gov.

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

Abstract Background Transmission of malaria in sub-Saharan Africa has become increasingly stratified following decades of malaria control interventions. The extent to which environmental and land cover risk factors for malaria may differ across distinct strata of transmission intensity is not well known and could provide actionable targets to maximize the success of malaria control efforts. Methods This study used cross-sectional malaria survey data from a nationally representative cohort of school-aged children in Tanzania, and satellite-derived measures for environmental features and land cover. Hierarchical logistic regression models were applied to evaluate associations between land cover and malaria prevalence within three distinct strata of transmission intensity: low and unstable, moderate and seasonal, and high and perennial. Results In areas with low malaria transmission, each 10-percentage point increase in cropland cover was associated with an increase in malaria prevalence odds of 2.44 (95% UI: 1.27, 5.11). However, at moderate and higher levels of transmission intensity, no association between cropland cover and malaria prevalence was detected. Small associations were observed between greater grassland cover and greater malaria prevalence in high intensity settings (prevalence odds ratio (POR): 1.10, 95% UI: 1.00, 1.21), and between greater forest cover and reduced malaria prevalence in low transmission areas (POR: 0.74, 95% UI: 0.51, 1.03), however the uncertainty intervals of both estimates included the null. Conclusions The intensity of malaria transmission appears to modify relationships between land cover and malaria prevalence among school-aged children in Tanzania. In particular, greater cropland cover was positively associated with increased malaria prevalence in areas with low transmission intensity and presents an actionable target for environmental vector control interventions to complement current malaria control activities. As areas are nearing malaria elimination, it is important to re-evaluate environmental risk factors and employ appropriate interventions to effectively address low-level malaria transmission.

Abstract Extraction of natural resources through mining and logging activities provides revenue and employment across sub-Saharan Africa, a region with the highest burden of malaria globally. The extent to which mining and logging influence malaria transmission in Africa remains poorly understood. Here, we evaluate associations between mining, logging, and malaria in the high transmission setting of the Democratic Republic of the Congo using population-representative malaria survey results and geographic data for environmental features and mining and logging concessions. We find elevated malaria prevalence among individuals in rural areas exposed to mining; however, we also detect significant spatial confounding among locations. Upon correction, effect estimates for mining and logging shifted toward the null and we did not find sufficient evidence to detect an association with malaria. Our findings reveal a complex interplay between mining, logging, space, and malaria prevalence. While mining concessions alone may not drive the high prevalence, unobserved features of mining-exposed areas, such as human migration, changing vector populations, or parasite genetics, may instead be responsible.

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.

Abstract Background Common mental health disorders (CMDs), including depression, anxiety and post-traumatic stress disorder (PTSD) may worsen both HIV and drug use outcomes, yet feasible tools to accurately identify CMDs have received limited study in this population. We aimed to validate the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder screen (GAD-7) and Primary Care PTSD screen for DSM-5 (PC-PTSD-5) in a methadone maintenance therapy (MMT) patient population in Hanoi, Vietnam. Methods We conducted a cross-sectional survey. The PHQ-9, GAD-7, and PC-PTSD-5 were administered to MMT patients. A blinded interviewer administered the Mini-International Neuropsychiatric Interview (MINI) as the reference gold standard. Total scores of each tool were compared with the MINI diagnoses using a receiver operating characteristic curves, and we identified the optimal respective cut-off scores using the Youden’s Index. Results We enrolled 400 MMT patients. Approximately 99.3% were male (n = 397) and 21.8% (n = 87) were HIV positive. The prevalence of major depressive disorder, generalized anxiety disorder and PTSD, respectively, was 10.5, 4 and 2%. Optimal cut-off scores for the PHQ-9, GAD-7 and PC-PTSD were ≥ 5, ≥3, and ≥ 4 with a sensitivity/specificity of 95.2%/91.9, 93.8%/87.5, and 62.5%/95.2%. Conclusions The prevalence of CMDs in the MMT population was lower than expected. A lower cut-off score may be considered when screening for CMDs in this population. Further research should investigate the validity of somatic symptom-based screening tools among other drug-using or MMT populations.

Abstract Background Injection drug use drives HIV transmission in Southeast Asia, where around a quarter of users are living with HIV. Vietnam developed Methadone Maintenance Therapy (MMT) programs to reduce unsafe drug abuse. Common mental health disorders (CMD), including depression, anxiety and post-traumatic stress disorder (PTSD), can worsen MMT outcomes and are highly prevalent among people living with HIV (PLH). We aimed to characterize HIV and CMD among MMT patients and assess the impact of HIV and CMD on MMT engagement outcomes in Hanoi, Vietnam. Methods This cross-sectional study was conducted at an urban MMT clinic in Hanoi. Participants were screened for CMD with the relevant sections of the Mini International Neuropsychiatric Interview (MINI). Tabular comparisons and regression models were used to understand the association of HIV and CMD with substance use and methadone compliance. Results Of the 400 MMT participants, 22% were living with HIV, 11% a CMD, 27% reported injection drug use, and 27% reported methadone noncompliance. Around 17% of those with HIV also had a CMD. Reporting non injection and injection drug use were each higher among those with CMD regardless of HIV status. In addition, reporting any drug use was much higher among those with both HIV and CMD than among those with neither (73% vs 31%, p value 0.001). While methadone noncompliance was lower among PLH than among those without HIV (16.3% vs 30.1%, p value 0.010), noncompliance was higher among those with CMD than among those without (40.5% vs 25.6%, p value 0.045). Among those without HIV, noncompliance was higher among those with CMD than among those without, but among those with HIV, the opposite relationship was observed. Conclusion There is complex overlap between substance use and methadone noncompliance among MMT patients living with HIV, CMD or both. In this population, we found a high prevalence of CMD and substance use among PLH, and a high prevalence of substance use and methadone noncompliance among those with CMD. Prioritizing provision of mental health care services to MMT patients living with HIV can help improve engagement with substance use disorder treatment and reduce the risk of HIV transmission.

Asymptomatic malaria infections contribute to transmission. Here, Sumner et al. infer participant-to-mosquito transmission by sampling naturally-fed mosquitoes from households in Western Kenya and find that asymptomatic infections more than double the odds of transmission to a mosquito compared to symptomatic infections.

Abstract Background Depression is associated with chronic physical illnesses and negatively affects health outcomes. However, it often goes undiagnosed and untreated. We investigated the prevalence of depression among adult type 2 diabetes mellitus (T2DM) patients attending non-communicable diseases (NCD) clinics in Lilongwe, Malawi, and estimated the level of routine detection by NCD clinicians. This study set out to determine the prevalence of major depression and its detection among adult type 2 diabetes mellitus (T2DM) patients attending NCD clinics in Lilongwe, Malawi. Methods In a cross-sectional study design, 323 T2DM patients aged ≥ 18 years were screened for depression with the Patient Health Questionnare-9 (PHQ-9) followed by diagnostic assessment with the Structured Clinical Interview for DSM-IV (SCID). We analysed the association between presence of major depression and sociodemographic factors using logistic regression. Results Three quarters of the participants (76%) were females. The participants’ ages ranged from 21–79 years. Of the 323 participants, 58 (18%) met criteria for DSM-IV major depression. None of the cases of major depression had been identified by the NCD clinicians. Major depression was found not to be significantly associated with any of the sociodemographic factors. Conclusions We found that depression is common among NCD clinic attendees with T2DM in Malawi, and poorly detected by NCD clinicians. Given the high prevalence and challenges in clinical identification, integration of depression screening with a standardized validated tool should be a high priority so as to link patients to appropriate services.

Abstract Background People who inject drugs (PWID) bear a disproportionate burden of HIV infection and experience poor outcomes. A randomized trial demonstrated the efficacy of an integrated System Navigation and Psychosocial Counseling (SNaP) intervention in improving HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality. There is limited evidence about how to effectively scale such intervention. This protocol presents a hybrid type III effectiveness-implementation trial comparing two approaches for scaling-up SNaP. We will evaluate the effectiveness of SNaP implementation approaches as well as cost and the characteristics of HIV testing sites achieving successful or unsuccessful implementation of SNaP in Vietnam. Methods Design: In this cluster randomized controlled trial, two approaches to scaling-up SNaP for PWID in Vietnam will be compared. HIV testing sites (n = 42) were randomized 1:1 to the standard approach or the tailored approach. Intervention mapping was used to develop implementation strategies for both arms. The standard arm will receive a uniform package of these strategies, while implementation strategies for the tailored arm will be designed to address site-specific needs. Participants: HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months. Site directors and staff at each of the 42 HIV testing sites will complete surveys at baseline, 12, and 24 months. Outcomes: Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms. To measure incremental costs, we will conduct an empirical costing study of each arm and the actual process of implementation from a societal perspective. Qualitative and quantitative site-level data will be used to explore key characteristics of HIV testing sites that successfully or unsuccessfully implement the intervention for each arm. Discussion Scaling up evidence-based interventions poses substantial challenges. The proposed trial contributes to the field of implementation science by applying a systematic approach to designing and tailoring implementation strategies, conducting a rigorous comparison of two promising implementation approaches, and assessing their incremental costs. Our study will provide critical guidance to Ministries of Health worldwide regarding the most effective, cost-efficient approach to SNaP implementation. Trial registration NCT03952520 on Clinialtrials.gov. Registered 16 May 2019.

Abstract Background Ending the HIV epidemic requires that women living with HIV (WLWH) have access to structurally competent HIV-related and other health care. WLWH may not regularly engage in care due to inadequate quality; however, women’s perspectives on the quality of care they receive are understudied. Methods We conducted 12 focus groups and three in-depth interviews with Black (90%) and Latina (11%) WLWH enrolled in the Women’s Interagency HIV Study in Atlanta, GA, Birmingham, AL, Brooklyn, NY, Chapel Hill, NC, Chicago, IL, and Jackson, MS from November 2017 to May 2018 (n = 92). We used a semi-structured format to facilitate discussions about satisfaction and dissatisfaction with health care engagement experiences, and suggestions for improvement, which were audio-recorded, transcribed, and coded using thematic analysis. Results Themes emerged related to women’s health care satisfaction or dissatisfaction at the provider, clinic, and systems levels and across Institute of Medicine-defined quality of care domains (effectiveness, efficiency, equity, patient-centeredness, safety and timeliness). Women’s degree of care satisfaction was driven by: 1) knowledge-based care resulting in desired outcomes (effectiveness); 2) coordination, continuity and necessity of care (efficiency); 3) perceived disparities in care (equity); 4) care delivery characterized by compassion, nonjudgment, accommodation, and autonomous decision-making (patient-centeredness); 5) attention to avoiding side effects and over-medicalization (safety); and 6) limited wait time (timeliness). Conclusions Quality of care represents a key changeable lever affecting engage in care among WLWH. The communities most proximally affected by HIV should be key stakeholders in HIV-related quality assurance. Findings highlight aspects of the health care experience valued by WLWH, and potential participatory, patient-driven avenues for improvement.

Background Among people who inject drugs (PWID), depression burden is high and may interfere with HIV prevention efforts. Although depression is known to affect injecting behaviors and HIV treatment, its overall impact on HIV transmission has not been quantified. Using mathematical modeling, we sought to estimate secondary HIV transmissions and identify differences by depression among PWID. Methods We analyzed longitudinal data from 455 PWID living with HIV in Vietnam during 2009–2013. Using a Bernoulli process model with individual-level viral load and behavioral data from baseline and 6-month follow-up visits, we estimated secondary HIV transmission events from participants to their potentially susceptible injecting partners. To evaluate differences by depression, we compared modeled transmissions per 1,000 PWID across depressive symptom categories (severe, mild, or no symptoms) in the three months before each visit. Results We estimated a median of 41.2 (2.5th, 97.5th percentiles: 33.2–49.2) secondary transmissions from all reported acts of sharing injection equipment with 833 injecting partners in the three months before baseline. Nearly half (41%) of modeled transmissions arose from fewer than 5% of participants in that period. Modeled transmissions per 1,000 PWID in that period were highest for severe depressive symptoms (100.4, 80.6–120.2) vs. mild (87.0, 68.2–109.4) or no symptoms (78.9, 63.4–94.1). Transmission estimates fell to near-zero at the 6-month visit. Conclusions Secondary transmissions were predicted to increase with depression severity, although most arose from a small number of participants. Our findings suggest that effective depression interventions could have the important added benefit of reducing HIV transmission among PWID.

Abstract Background The HIV epidemic in Vietnam has been primarily driven by injection drug use. HIV-infected people who inject drugs (PWID) in Vietnam have very high rates of mental health problems, which can accelerate progression to AIDS and increase mortality rates. No research has explored the barriers and facilitators of mental health care for HIV-infected PWID in Vietnam. Methods We conducted 28 in-depth interviews among HIV-infected PWID (n = 16), HIV and MMT (methadone maintenance treatment) providers (n = 8), and health officials (n = 4) in Hanoi. We explored participants’ perceptions of mental health disorders, and barriers and facilitators to seeking and receiving mental health care. Results HIV-infected PWID were perceived by both PWID, HIV/MMT providers, and health officials to be vulnerable to mental health problems and to have great need for mental health care. Perceived social, physical, and economical barriers included stigma towards HIV, injection drug use, and mental illnesses; lack of awareness around mental health issues; lack of human resources, facilities and information on mental health services; and limited affordability of mental health services. Social support from family and healthcare providers was a perceived facilitator of mental health care. Conclusions Interventions should raise self-awareness of HIV-infected PWID about common mental health problems; address social, physical, economic barriers to seeking mental health services; and increase social support for patients.

Objectives: Many orphaned children in low- and middle-income countries live with family. Yet, their household composition and its stability are not well-characterized, nor is impact of stability on longer-term outcomes.Methods: We used the longitudinal, multi-country Positive Outcomes for Orphans cohort to describe adult family living with orphans. Stability was measured by changes in presence of six familial relations over time, and related to three outcomes: 1) incident abuse, 2) cognitive functioning, 3) emotional difficulties. Associations were estimated using generalized linear models fit with generalized estimating equations. For abuse, Poisson regression estimated risk ratios. For continuous scores of cognitive functioning and emotional difficulties, linear models estimated mean differences (MDs) with 95% confidence intervals.Results: Among 1,359 orphans, 53–61% reported living with their mother each year; 7–13% with father; nearly 60% reported ≥1 change in composition over follow-up. Compared to 0 changes, difficulties increased with 1 change [MD: 0.23 (−0.33, 0.79)], 2 changes [MD: 0.57 (0.00, 1.16)] and ≥3 changes [MD: 0.73 (0.18, 1.29)]. No associations were found with abuse or cognitive functioning.Conclusion: Orphan well-being may be improved through supports stabilizing household composition or targeting emotional resilience.

Abstract 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.

Abstract 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.

Background Changes in white matter microstructural integrity are detectable before appearance of white matter lesions on magnetic resonance imaging as a manifestation of cerebral small‐vessel disease. The information relating poor white matter microstructural integrity to aortic stiffness, a hallmark of aging, is limited. We aimed to examine the association between aortic stiffness and white matter microstructural integrity among older adults. Methods and Results We conducted a cross‐sectional study to examine the association between aortic stiffness and white matter microstructural integrity among 1484 men and women (mean age, 76 years) at the 2011 to 2013 examination of the ARIC‐NCS (Atherosclerosis Risk in Communities Neurocognitive Study). Aortic stiffness was measured as carotid‐femoral pulse wave velocity. Cerebral white matter microstructural integrity was measured as fractional anisotropy and mean diffusivity using diffusion tensor imaging. Multivariable linear regression was used to examine the associations of carotid‐femoral pulse wave velocity with fractional anisotropy and mean diffusivity of the overall cerebrum and at regions of interest. Each 1‐m/s higher carotid‐femoral pulse wave velocity was associated with lower overall fractional anisotropy (β=−0.03; 95% CI, −0.05 to −0.02) and higher overall mean diffusivity (β=0.03; 95% CI, 0.02–0.04). High carotid‐femoral pulse wave velocity (upper 25th percentile) was associated with lower fractional anisotropy (β=−0.40; 95% CI, −0.61 to −0.20) and higher overall mean diffusivity (β=0.27; 95% CI, 0.10–0.43). Similar associations were observed at individual regions of interest. Conclusions High aortic stiffness is associated with low cerebral white matter microstructural integrity among older adults. Aortic stiffness may serve as a target for the prevention of poor cerebral white matter microstructural integrity.

Abstract 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.

Background.Integration of mental health services into nonspecialist settings is expanding in low and middle income countries (LMICs). Among many factors required for success, such programs require reliable administration of mental health screening tools. While several tools have been validated in carefully conducted research studies, few studies have assessed how reliably nonspecialist clinicians administer these tools to low-literacy LMIC populations in routine care.Methods.Ninety-seven patients accessing human immunodeficiency virus primary care in Malawi who completed Patient Health Questionnaire (PHQ)-9 depression screening with their clinician then completed a second PHQ-9 with a trained research assistant (RA) blinded to the first result.Results.Compared to clinicians, RAs identified more patients with any depressive symptoms (PHQ-9 score ⩾5: 38% v. 32%), moderate/severe symptoms (PHQ-9 ⩾ 10: 14% v. 6%), any suicidality (14% v. 4%), and active suicidality (3% v. 2%). Across these indicators, clinician and RA ratings had strong overall agreement (81–97%) but low corrected Kappa agreement (31–59%). Treating RA results as the reference standard of a carefully supervised research administration of the PHQ-9, clinician administration had high specificity (90–99%) but low sensitivity (23–68%) for these indicators.Conclusions.In routine care in LMICs, clinicians may administer validated mental health screening tools with varying quality. To ensure quality, integration programs must incorporate appropriate and ongoing training, support, supervision, and monitoring.

Abstract Background Policy-makers promote a seek, test, treat and retain (STTR) strategy to expand HIV testing, support linkage and engagement in care, and enhance the continuous use of antiretroviral therapy for those HIV-infected. This HIV prevention strategy is particularly appropriate in correctional settings where HIV screening and treatment are routinely available yet many HIV-infected individuals have difficulty sustaining sufficient linkage and engagement in care, disease management, and viral suppression after prison release. Methods/design Our research team developed Project imPACT (individuals motivated to Participate in Adherence, Care and Treatment), a multi-component approach for HIV-Infected recently incarcerated individuals that specifically targets their care linkage, retention, and medication adherence by addressing multiple barriers to care engagement after release. The ultimate goals of this intervention are to improve the health of HIV-infected individuals recently released from prison and reduce HIV transmission to their communities by maintaining viral suppression. This paper describes the intervention and technology development processes, based on best practices for intervention development and process evaluation. These processes included: 1) identifying the target population; 2) clarifying the theoretical basis for intervention design; 3) describing features of its foundational interventions; 4) conducting formative qualitative research; 5) integrating and adapting foundational interventions to create and refine intervention content based on target audience feedback. These stages along with the final intervention product are described in detail. The intervention is currently being evaluation and a two arm randomized, controlled trial in two US state prison systems. Discussion Based on a literature review, qualitative research, integration of proven interventions and behavioral theory, the final imPACT intervention focused on the transition period two to three months before and three months after prison release. It emphasized pre-release readiness, pre- and post-release supportive non-judgmental counseling, linking individuals to a HIV care clinic and technological supports through videos and text messages. This article provides a useful model for how researchers can develop, test, and refine multi-component interventions to address HIV care linkage, retention and adherence. Clinical trial registration NCT01629316 , first registered 6-4-2012; last updated 6-9-2015.