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Introduction: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs., Methods: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS., Registration: https://www.comet-initiative.org/Studies/Details/1580., Results: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life., Conclusion: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs., Prospero Registration Number: CRD42020197293., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Global health reciprocal innovation emphasizes the movement of technologies or interventions between high- and low-income countries to address a shared public health problem, in contrast to unidirectional models of "development aid" or "reverse innovation". Evidence-based interventions are frequently adapted from the setting in which they were developed and applied in a new setting, presenting an opportunity for learning and partnership across high- and low-income contexts. However, few clear procedures exist to guide researchers and implementers on how to incorporate equitable and learning-oriented approaches into intervention adaptation across settings. We integrated theories from pedagogy, implementation science, and public health with examples from experience adapting behavioral health interventions across diverse settings to develop a procedure for a bidirectional, equitable process of intervention adaptation across high- and low-income contexts. The Mutual capacity building model for adaptation (MCB-MA) is made up of seven steps: 1) Exploring: A dialogue about the scope of the proposed adaptation and situational appraisal in the new setting; 2) Developing a shared vision: Agreeing on common goals for the adaptation; 3) Formalizing: Developing agreements around resource and data sharing; 4) Sharing complementary expertise: Group originating the intervention supporting the adapting group to learn about the intervention and develop adaptations, while gleaning new strategies for intervention implementation from the adapting group; 5) Reciprocal training: Originating and adapting groups collaborate to train the individuals who will be implementing the adapted intervention; 6) Mutual feedback: Originating and adapting groups share data and feedback on the outcomes of the adapted intervention and lessons learned; and 7) Consideration of next steps: Discuss future collaborations. This evidence-informed procedure may provide researchers with specific actions to approach the often ambiguous and challenging task of equitable partnership building. These steps can be used alongside existing intervention adaptation models, which guide the adaptation of the intervention itself., (© 2024. The Author(s).)

Introduction: Adolescent girls and young women (AGYW) who may benefit from HIV pre-exposure prophylaxis (PrEP) face high levels of common mental disorders (e.g. depression, anxiety). Common mental disorders can reduce PrEP adherence and increase HIV risk, yet mental health interventions have not been well-integrated into PrEP delivery., Methods: We conducted a four-phase human-centred design process, from December 2020 to April 2022, to understand mental health challenges among AGYW in Johannesburg, South Africa and barriers to integrated mental health and PrEP services. In the "Discover" phase, we conducted in-depth interviews with AGYW and key informants (KIs) in Johannesburg. We conducted a rapid qualitative analysis, informed by the Consolidated Framework for Implementation Research (CFIR), to identify facilitators and barriers of integrated mental health and PrEP services and mapped barriers to potential implementation strategies. In the "Design" and "Build" phases, we conducted stakeholder workshops to iteratively adapt an evidence-based mental health intervention, the Friendship Bench, and refine implementation strategies for South African PrEP delivery settings. In the "Test" phase, we piloted our adapted Friendship Bench package., Results: Interviews with 70 Discover phase participants (48 AGYW, 22 KIs) revealed the importance of integrated mental health and PrEP services for South African AGYW. Interviewees described barriers and implementation strategies for mental health and PrEP services around the CFIR domains: intervention characteristics (e.g. challenges with AGYW "opening up"); outer Johannesburg setting (e.g. community stigma); inner clinic setting (e.g. judgemental healthcare providers); characteristics of counsellors (e.g. training gaps); and the implementation process (e.g. need for demand creation). The Design and Build workshops included 13 AGYW and 15 KIs. Implementation barriers related to the quality and accessibility of public-sector clinic services, lay counsellor training, and community education and demand creation activities were prioritized. This led to 12 key Friendship Bench adaptations and the specification of 10 implementation strategies that were acceptable and feasible in initial pilot testing with three AGYW., Conclusions: Using a human-centred approach, we identified determinants and potential solutions for integrating mental health interventions within PrEP services for South African AGYW. This design process centred stakeholders' perspectives, enabling rapid development of an adapted Friendship Bench intervention implementation package., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Over the past two decades there have been major advances in the development of interventions promoting mental health and well-being in low- and middle-income countries (LMIC), including delivery of care by non-specialist providers, incorporation of mobile technologies and development of multilevel community-based interventions. Growing inequities in mental health have led to calls to adopt similar strategies in high-income countries (HIC), learning from LMIC. To overcome shared challenges, it is crucial for projects implementing these strategies in different global settings to learn from one another. Our objective was to examine cases in which mental health and well-being interventions originating in or conceived for LMIC were implemented in the USA. The cases included delivery of psychological interventions by non-specialists, HIV-related stigma reduction programmes, substance use mitigation strategies and interventions to promote parenting skills and family functioning. We summarise commonly used strategies, barriers, benefits and lessons learnt for the transfer of these innovative practices among LMIC and HIC. Common strategies included intervention delivery by non-specialists and use of digital modalities to facilitate training and increase reach. Common barriers included lack of reimbursement mechanisms for care delivered by non-specialists and resistance from professional societies. Despite US investigators' involvement in most of the original research in LMIC, only a few cases directly involved LMIC researchers in US implementation. In order to achieve greater equity in global mental health and well-being, more efforts and targeted funding are needed to develop best practices for global health reciprocal innovation and iterative learning in HIC and LMIC., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Importance: Common mental disorders (CMD), which include depression and anxiety, are prevalent among people living with HIV and are associated with suboptimal antiretroviral therapy (ART) adherence., Objective: To assess the effect of a lay health worker-led psychological intervention on ART adherence, virologic suppression, and mental health symptoms., Design, Setting, and Participants: Open-label pragmatic cluster trial with 1:1 block randomization of 16 health facilities in rural Bikita, Zimbabwe. Recruitment occurred from October 2018 to December 2019, and participants were followed up for 12 months, ending in December 2020. Participants were adults aged 18 years and older, who spoke English or Shona, screened positive for CMD (Shona Symptoms Questionnaire [SSQ]-14 score ≥9), received first-line ART for 6 or more months, had no World Health Organization stage 4 disease, no psychosis, were not pregnant, and provided informed consent. Data were analyzed from March 2021 to February 2022., Intervention: The Friendship Bench, consisting of 6 lay health worker-led weekly problem-solving therapy sessions and optional peer-led group support., Main Outcomes and Measures: The primary outcome was mean adherence during 2 to 6 months of follow-up, and the secondary outcomes were mean adherence during 1 to 12 months of follow-up, change in SSQ-14 and Patient Health Questionnaire (PHQ-9) scores (3, 6, 9, and 12 months), and viral load suppression (6 and 12 months)., Results: A total of 516 participants were recruited (244 in Friendship Bench and 272 in enhanced standard care facilities); 438 (84.9%) were female and the mean (SD) age was 45.6 (10.9) years. Mean (SD) adherence between 2 to 6 months was 89.9% (18.4%) in the Friendship Bench group and 87.2% (20.1%) in the control group. The intervention had no statistically significant effect on adherence between 2 to 6 months (unadjusted mean difference, 1.93 percentage points; 95% CI, -1.20 to 5.06 percentage points; P = .23), between months 1 to 12 (mean difference 0.79 percentage points; 95% CI, -2.14 to 3.71 percentage points; P = .60), or viral suppression. Declines in SSQ-14 scores from baseline to 3 months (difference, -1.65; 95% CI, -3.07 to -0.24), 6 months (difference, -1.57; 95% CI, -2.98 to -0.15), and 9 months (difference, -1.63; 95% CI, -3.05 to -0.22) were greater in the Friendship Bench than the standard care group (P < .05). There were no differences in the decline in the SSQ-14 scores from baseline to 12 months and in declines in PHQ-9 scores from baseline to 3, 6, 9, and 12 months., Conclusions and Relevance: In this randomized trial of HIV-positive participants with CMD, the Friendship Bench intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and a ceiling effect., Trial Registration: ClinicalTrials.gov Identifier: NCT03704805.

Background: A critical step in research on the epidemiology of post-traumatic stress disorder (PTSD) in low-resource settings is the validation of brief self-reported psychometric tools available in the public domain, such as the Impact Event Scale - Revised (IES-R)., Aims: We aimed to investigate the validity of the IES-R in a primary healthcare setting in Harare, Zimbabwe., Method: We analysed data from a survey of 264 consecutively sampled adults (mean age 38 years; 78% female). We estimated the area under the receiver operating characteristic curve and sensitivity, specificity and likelihood ratios for different cut-off points of the IES-R, against a diagnosis of PTSD made using the Structured Clinical Interview for DSM-IV. We performed factor analysis to evaluate construct validity of the IES-R., Results: The prevalence of PTSD was 23.9% (95% CI 18.9-29.5). The area under the curve for the IES-R was 0.90. At a cut-off of ≥47, the sensitivity of the IES-R to detect PTSD was 84.1 (95% CI 72.7-92.1) and specificity was 81.1 (95% CI 75.0-86.3). Positive and negative likelihood ratios were 4.45 and 0.20, respectively. Factor analysis revealed a two-factor solution, with both factors showing good internal consistency (Cronbach's factor-1 α = 0.95, factor-2 α = 0.76). In a post hoc analysis, we found the brief six-item IES-6 also performed well, with an area under the curve of 0.87 and optimal cut-off of 15., Conclusions: The IES-R and IES-6 had good psychometric properties and performed well for indicating possible PTSD, but at higher cut-off points than those recommended in the Global North.

A working alliance (WA) is a multidimensional construct signifying a collaborative relationship between a client and a therapist. Systematic reviews of therapies to treat depression and anxiety, almost exclusively in adults, show WA is essential across psychotherapies. However, there are critical gaps in our understanding of the importance of WA in low-intensity therapies for young people with depression and anxiety. Here, we describe an initiative to explore the effect of WA on anxiety and depression outcomes in youth aged 14-24 years through a scoping review and stakeholders' consultations ( N  = 32). We analysed 27 studies; most were done in high-income countries and evaluated one-on-one in-person therapies (18/27). The review shows that optimal WA is associated with improvements in: relationships, self-esteem, positive coping strategies, optimism, treatment adherence, and emotional regulation. Young people with lived experience expressed that: a favourable therapy environment, regular meetings, collaborative goal setting and confidentiality were vital in forming and maintaining a functional WA. For a clinician, setting boundaries, maintaining confidentiality, excellent communication skills, being non-judgmental, and empathy were considered essential for facilitating a functional WA. Overall, a functional WA was recognised as an active ingredient in psychotherapies targeting anxiety and depression in young people aged 14-24. Although more research is needed to understand WA's influence in managing anxiety and depression in young people, we recommend routine evaluation of WA. Furthermore, there is an urgent need to identify strategies that promote WA in psychotherapies to optimise the treatment of anxiety and depression in young people., Competing Interests: Competing interestsThe authors declare no competing interests., (© The Author(s) 2023.)

To achieve universal health coverage, health system strengthening (HSS) is required to support the of delivery of high-quality care. The aim of the National Institute for Health Research Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme, with three healthcare platforms involving eight work-packages. Key to effective health system strengthening (HSS) is the pre-implementation phase of research where efforts focus on applying participatory methods to embed the research programme within the existing health system. To conceptualise the approach, we provide an overview of the key methods applied across work-package to address this important phase of research conducted between 2017 and 2021.Work-packages are being undertaken in publicly funded health systems in rural and urban areas in Ethiopia, Sierra Leone, South Africa, and Zimbabwe. Stakeholders including patients and their caregivers, community representatives, clinicians, managers, administrators, and policymakers are the main research participants.In each work-package, initial activities engage stakeholders and build relationships to ensure co-production and ownership of HSSIs. A mixed-methods approach is then applied to understand and address determinants of high-quality care delivery. Methods such as situation analysis, cross-sectional surveys, interviews and focus group discussions are adopted to each work-package aim and context. At the end of the pre-implementation phase, findings are disseminated using focus group discussions and participatory Theory of Change workshops where stakeholders from each work package use findings to select HSSIs and develop a programme theory.ASSET places a strong emphasis of the pre-implementation phase in order to provide an in-depth and systematic diagnosis of the existing heath system functioning, needs for strengthening and stakeholder engagement. This common approach will inform the design and evaluation of the HSSIs to increase effectiveness across work packages and contexts, to better understand what works, for whom, and how.

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., (© 2022. The Author(s).)

Background: This study aimed to evaluate the real-world implementation of the Friendship Bench (FB) - an evidence-based brief psychological intervention delivered by community health workers (CHWs) - three years after its implementation in three city health departments in Zimbabwe. Implementation sites were evaluated according to their current performance using the RE-AIM framework making this one of the first evaluations of a scaled-up evidence-based psychological intervention in sub-Saharan Africa (SSA)., Methods: Using the RE-AIM guide ( www.re-aim.org ), the authors designed quantitative indicators based on existing FB implementation data. Thirty-six primary health care clinics (PHC) in Harare (n=28), Chitungwiza (n=4) and Gweru (n=4) were included. Among these clinics 20 were large comprehensive health care centers, 7 medium (mostly maternal and child healthcare) and 9 small clinics (basic medical care and acting as referral clinic). Existing data from these clinics, added to additionally collected data through interviews and field observations were used to investigate and compare the performance of the FB across clinics. The focus was on the RE-AIM domains of Reach, Adoption, and Implementation., Results: Small clinics achieved 34% reach, compared to large (15%) and medium clinics (9%). Adoption was high in all clinic types, ranging from 59% to 71%. Small clinics led the implementation domain with 53%, followed by medium sized clinics 43% and large clinics 40%. Small clinics performed better in all indicators and differences in performance between small and large clinics were significant. Program activity and data quality depends on ongoing support for delivering agents and buy-in from health authorities., Conclusion: The Friendship Bench program was implemented over three years transitioning from a research-based implementation program to one led locally. The Reach domain showed the largest gap across clinics where larger clinics performed poorly relative to smaller clinics and should be a target for future implementation improvements. Program data needs to be integrated into existing health information systems. Future studies should seek to optimize scale-up and sustainment strategies to maintain effective task-shared psychological interventions in SSA., (© 2022. The Author(s).)

Background: Common mental health disorders (CMDs) are leading causes of disability globally. The ongoing COVID-19 pandemic has further exacerbated the burden of CMDs. COVID-19 containment measures, including lockdowns, have disrupted access to in-person mental health care. It is therefore imperative to explore the utility of digital mental health interventions to bridge the treatment gap. Mobile health technologies are effective tools for increasing access to treatment at a lower cost. This study explores the utility of Inuka, a chat-based app hinged on the Friendship Bench problem-solving therapy intervention. The Inuka app offers double anonymity, and clients can book or cancel a session at their convenience. Inuka services can be accessed either through a mobile app or the web., Objective: We aimed to explore the feasibility of conducting a future clinical trial. Additionally, we evaluated the feasibility, acceptability, appropriateness, scalability, and preliminary effectiveness of Inuka., Methods: Data were collected using concurrent mixed methods. We used a pragmatic quasiexperimental design to compare the feasibility, acceptability, and preliminary clinical effectiveness of Inuka (experimental group) and WhatsApp chat-based counseling (control). Participants received 6 problem-solving therapy sessions delivered by lay counselors. A reduction in CMDs was the primary clinical outcome. The secondary outcomes were health-related quality of life (HRQoL), disability and functioning, and social support. Quantitative outcomes were analyzed using descriptive and bivariate statistics. Finally, we used administrative data and semistructured interviews to gather data on acceptability and feasibility; this was analyzed using thematic analysis., Results: Altogether, 258 participants were screened over 6 months, with 202 assessed for eligibility, and 176 participants were included in the study (recruitment ratio of 29 participants/month). The participants' mean age was 24.4 (SD 5.3) years, and most participants were female and had tertiary education. The mean daily smartphone usage was 8 (SD 3.5) hours. Eighty-three users signed up and completed at least one session. The average completion rate was 3 out of 4 sessions. Inuka was deemed feasible and acceptable in the local context, with connectivity challenges, app instability, expensive mobile data, and power outages cited as potential barriers to scale up. Generally, there was a decline in CMDs (F 2,73 =2.63; P=.08), depression (F 2,73 =7.67; P<.001), and anxiety (F 2,73 =2.95; P=.06) and a corresponding increase in HRQoL (F 2,73 =7.287; P<.001) in both groups., Conclusions: Study outcomes showed that it is feasible to run a future large-scale randomized clinical trial (RCT) and lend support to the feasibility and acceptability of Inuka, including evidence of preliminary effectiveness. The app's double anonymity and structured support were the most salient features. There is a great need for iterative app updates before scaling up. Finally, a large-scale hybrid RCT with a longer follow-up to evaluate the clinical implementation and cost-effectiveness of the app is needed., (©Jermaine Dambi, Clara Norman, Asmae Doukani, Stephan Potgieter, Jean Turner, Rosemary Musesengwa, Ruth Verhey, Dixon Chibanda. Originally published in JMIR Mental Health (https://mental.jmir.org), 07.10.2022.)

Background: The prevalence of common mental disorders (CMDs) among people living with HIV and people who inject drugs is high worldwide and in Vietnam. However, few evidence-informed CMD programs for people living with HIV who inject drugs have been adapted for use in Vietnam. We adapted the Friendship Bench (FB), a problem-solving therapy (PST)-based program that was successfully implemented among patients with CMDs in primary health settings in Zimbabwe and Malawi for use among people living with HIV on methadone maintenance treatment (MMT) with CMDs in Hanoi, Vietnam., Objective: This study aimed to describe the adaptation process with a detailed presentation of 4 phases from the third (adaptation) to the sixth (integration) of the Assessment-Decision-Adaptation-Production-Topical Experts-Integration-Training-Testing (ADAPT-ITT) framework., Methods: The adaptation phase followed a qualitative study design to explore symptoms of CMDs, facilitators, and barriers to conducting FB for people living with HIV on MMT in Vietnam, and patient, provider, and caretaker concerns about FB. In the production phase, we revised the original program manual and developed illustrated PST cases. In the topical expert and integration phases, 2 investigators (BNG and BWP) and 3 subject matter experts (RV, DC, and GML) reviewed the manual, with reviewer comments incorporated in the final, revised manual to be used in the training. The draft program will be used in the training and testing phases., Results: The study was methodologically aligned with the ADAPT-ITT goals as we chose a proven, effective program for adaptation. Insights from the adaptation phase addressed the who, where, when, and how of FB program implementation in the MMT clinics. The ADAPT-ITT framework guided the appropriate adaptation of the program manual while maintaining the core components of the PST of the original program throughout counseling techniques in all program sessions. The deliverable of this study was an adapted FB manual to be used for training and piloting to make a final program manual., Conclusions: This study successfully illustrated the process of operationalizing the ADAPT-ITT framework to adapt a mental health program in Vietnam. This study selected and culturally adapted an evidence-informed PST program to improve CMDs among people living with HIV on MMT in Vietnam. This adapted program has the potential to effectively address CMDs among people living with HIV on MMT in Vietnam., Trial Registration: ClinicalTrials.gov NCT04790201; https://clinicaltrials.gov/ct2/show/NCT04790201., (©Ha V Tran, Ha T T Nong, Thuy T T Tran, Teresa R Filipowicz, Kelsey R Landrum, Brian W Pence, Giang M Le, Minh X Nguyen, Dixon Chibanda, Ruth Verhey, Vivian F Go, Hien T Ho, Bradley N Gaynes. Originally published in JMIR Formative Research (https://formative.jmir.org), 08.07.2022.)

Background: Task-sharing treatment approaches offer a pragmatic approach to treating common mental disorders in low-income and middle-income countries (LMICs). The Friendship Bench (FB), developed in Zimbabwe with increasing adoption in other LMICs, is one example of this type of treatment model using lay health workers (LHWs) to deliver treatment., Objective: To consider the level of treatment coverage required for a recent scale-up of the FB in Zimbabwe to be considered cost-effective., Methods: A modelling-based deterministic threshold analysis conducted within a 'cost-utility' framework using a recommended cost-effectiveness threshold., Findings: The FB would need to treat an additional 3413 service users (10 per active LHW per year) for its scale-up to be considered cost-effective. This assumes a level of treatment effect observed under clinical trial conditions. The associated incremental cost-effectiveness ratio was $191 per year lived with disability avoided, assuming treatment coverage levels reported during 2020. The required treatment coverage for a cost-effective outcome is within the level of treatment coverage observed during 2020 and remained so even when assuming significantly compromised levels of treatment effect., Conclusions: The economic case for a scaled-up delivery of the FB appears convincing in principle and its adoption at scale in LMIC settings should be given serious consideration., Clinical Implications: Further evidence on the types of scale-up strategies that are likely to offer an effective and cost-effective means of sustaining required levels of treatment coverage will help focus efforts on approaches to scale-up that optimise resources invested in task-sharing programmes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Background: Non-communicable diseases (NCDs) contribute significantly to the global disease burden, with low-and middle-income (LMICs) countries disproportionately affected. A significant knowledge gap in NCDs exacerbates the high burden, worsened by perennial health system challenges, including human and financial resources constraints. Primary health care workers play a crucial role in offering health care to most people in LMICs, and their views on the barriers to the provision of quality care for NCDs are critical. This study explored perceived barriers to providing NCDs care in primary health care facilities in Zimbabwe., Methods: In-depth, individual semi-structured interviews were conducted with general nurses in primary care facilities until data saturation was reached. We focused on diabetes, hypertension, and depression, the three most common conditions in primary care in Zimbabwe. We used thematic content analysis based on an interview guide developed following a situational analysis of NCDs care in Zimbabwe and views from patients with lived experiences., Results: Saturation was reached after interviewing 10 participants from five busy urban clinics. For all three NCDs, we identified four cross-cutting barriers, a) poor access to medication and functional equipment such as blood pressure machines, urinalysis strips; b) high cost of private care; c)poor working conditions; and d) poor awareness from both patients and the community which often resulted in the use of alternative potentially harmful remedies. Participants indicated that empowering communities could be an effective and low-cost approach to positive lifestyle changes and health-seeking behaviours. Participants indicated that the Friendship bench, a task-shifting programme working with trained community grandmothers, could provide a platform to introduce NCDs care at the community level. Also, creating community awareness and initiating screening at a community level through community health workers (CHWs) could reduce the workload on the clinic nursing staff., Conclusion: Our findings reflect those from other LMICs, with poor work conditions and resources shortages being salient barriers to optimal NCDs care at the facility level. Zimbabwe's primary health care system faces several challenges that call for exploring ways to alleviate worker fatigue through strengthened community-led care for NCDs. Empowering communities could improve awareness and positive lifestyle changes, thus optimising NCD care. Further, there is a need to optimise NCD care in urban Zimbabwe through a holistic and multisectoral approach to improve working conditions, basic clinical supplies and essential drugs, which are the significant challenges facing the country's health care sector. The Friendship Bench could be an ideal entry point for providing an integrated NCD care package for diabetes, hypertension and depression., (© 2022. The Author(s).)

Background: Adolescents living with HIV have poor virological suppression and high prevalence of common mental disorders (CMDs). In Zimbabwe, the Zvandiri adolescent peer support programme is effective at improving virological suppression. We assessed the effect of training Zvandiri peer counsellors known as Community Adolescent Treatment Supporters (CATS) in problem-solving therapy (PST) on virological suppression and mental health outcomes., Methods and Findings: Sixty clinics were randomised 1:1 to either normal Zvandiri peer counselling or a peer counsellor trained in PST. In January to March 2019, 842 adolescents aged 10 to 19 years and living with HIV who screened positive for CMDs were enrolled (375 (44.5%) male and 418 (49.6%) orphaned of at least one parent). The primary outcome was virological nonsuppression (viral load ≥1,000 copies/mL). Secondary outcomes were symptoms of CMDs measured with the Shona Symptom Questionnaire (SSQ ≥8) and depression measured with the Patient Health Questionnaire (PHQ-9 ≥10) and health utility score using the EQ-5D. The adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were estimated using logistic regression adjusting for clinic-level clustering. Case reviews and focus group discussions were used to determine feasibility of intervention delivery. At baseline, 35.1% of participants had virological nonsuppression and 70.3% had SSQ≥8. After 48 weeks, follow-up was 89.5% for viral load data and 90.9% for other outcomes. Virological nonsuppression decreased in both arms, but there was no evidence of an intervention effect (prevalence of nonsuppression 14.7% in the Zvandiri-PST arm versus 11.9% in the Zvandiri arm; AOR = 1.29; 95% CI 0.68, 2.48; p = 0.44). There was strong evidence of an apparent effect on common mental health outcomes (SSQ ≥8: 2.4% versus 10.3% [AOR = 0.19; 95% CI 0.08, 0.46; p < 0.001]; PHQ-9 ≥10: 2.9% versus 8.8% [AOR = 0.32; 95% CI 0.14, 0.78; p = 0.01]). Prevalence of EQ-5D index score <1 was 27.6% versus 38.9% (AOR = 0.56; 95% CI 0.31, 1.03; p = 0.06). Qualitative analyses found that CATS-observed participants had limited autonomy or ability to solve problems. In response, the CATS adapted the intervention to focus on empathic problem discussion to fit adolescents' age, capacity, and circumstances, which was beneficial. Limitations include that cost data were not available and that the mental health tools were validated in adult populations, not adolescents., Conclusions: PST training for CATS did not add to the benefit of peer support in reducing virological nonsuppression but led to improved symptoms of CMD and depression compared to standard Zvandiri care among adolescents living with HIV in Zimbabwe. Active involvement of caregivers and strengthened referral structures could increase feasibility and effectiveness., Trial Registration: Pan African Clinical Trials Registry PACTR201810756862405., Competing Interests: The authors have declared that no competing interests exist.

Implementation research is a multidisciplinary field that addresses the complex phenomenon of how context influences our ability to deliver evidence-informed healthcare. There is increasing realisation of the importance of applying robust implementation research to scale-up life-saving interventions that meet health-related sustainable development goals. However, the lack of high-quality implementation research is impeding our ability to meet these targets, globally. Within implementation research, theory refers to the proposed hypothesis and/or explanation of how an intervention is expected to interact with the local context and actors to bring about change. Although there is increasing interest in applying theory to understand how and why implementation programmes work in real-world settings, global health actors still tend to favour impact evaluations conducted in controlled environments. This may, in part, be due to the relative novelty as well as methodological complexity of implementation research and the need to draw on divergent disciplines, including epidemiology, implementation science and social sciences. Because of this, implementation research is faced with a particular set of challenges about how to reconcile different ways of thinking and constructing knowledge about healthcare interventions. To help translate some of the ambiguity surrounding how divergent theoretical approaches and methods contribute to implementation research, we draw on our multidisciplinary expertise in the field, particularly in global health. We offer an overview of the different theoretical approaches and describe how they are applied to continuously select, monitor and evaluate implementation strategies throughout the different phases of implementation research. In doing so, we offer a relatively brief, user-focused guide to help global health actors implement and report on evaluation of evidence-based and scalable interventions, programmes and practices., Competing Interests: Competing interests: NSew is the director of the London Safety and Training Solutions, which offers training in patient safety, implementation solutions and human factors to healthcare organisations and the pharmaceutical industry. The other authors have no conflicts of interest to declare., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

In Zimbabwe common mental disorders are prevalent among adolescents and the treatment gap is large. The recently introduced Youth Friendship Bench intervention (YouFB) addresses this gap by task-shifting youth lay health workers to offer a culturally contextualised, manual-based, six-session problem-solving therapy to adolescents, 16-19 years of age. The aim of this study was to explore participants´ experiences of YouFB to attain a first insight into this novel intervention. Interviews with nine adolescents were analysed using qualitative content analysis on a latent level. The experience of YouFB was positive, perceived to offer hope and relief from feelings of isolation and uncertainty, increase manageability of problems, and contribute to feelings of autonomy, resulting in a feeling of optimism about the future. The notion among participants that this brief intervention had such a positive influence on their lives, sparks interest because of its applicability in low-resource settings.

Introduction: Common mental disorders (CMDs) are a leading cause of disability globally. CMDs are highly prevalent in Zimbabwe and have been addressed by an evidence-based, task-shifting psychological intervention called the Friendship Bench (FB). The task-shifted FB programme guides clients through problem-solving therapy. It was scaled up across 36 implementation sites in Zimbabwe in 2016., Methods and Analysis: This study will employ a mixed-method framework. It aims to: (1) use quantitative survey methodologies organised around the Reach, Effectiveness, Adoption and Implementation and Maintenance evaluation framework to assess the current scaleup of the FB intervention and classify 36 clinics according to levels of performance; (2) use qualitative focus group discussions and semistructured interviews organised around the Consolidated Framework for Implementation Research to analyse determinants of implementation success, as well as elucidate heterogeneity in implementation strategies through comparing high-performing and low-performing clinics; and (3) use the results from aims 1 and 2 to develop strategies to optimise the Friendship Bench intervention and apply this model in a cluster randomised controlled trial to evaluate potential improvements among low-performing clinics. The trial will be registered with the Pan African Clinical Trial Registry (www.pactr.org). The planned randomised controlled trial for the third research aim will be registered after completing aims one and two because the intervention is dependent on knowledge generated during these phases., Ethics and Dissemination: The research protocol received full authorisation from the Medical Research Council of Zimbabwe (MRCZ A/242). It is anticipated that changes in data collection tools and consent forms will take place at all three phases of the study and approval from MRCZ will be sought. All interview partners will be asked for informed consent. The research team will prioritise open-access publications to disseminate research results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Non-communicable diseases (NCDs) are projected to become the leading cause of disability and mortality in sub-Saharan Africa by 2030; a vast treatment gap exists. There is a dearth of knowledge on developing evidence-based interventions that address comorbid NCDs using a task-shifting approach. The Friendship Bench, a brief psychological intervention for common mental disorders delivered by trained community grandmothers, is a promising intervention for comorbid NCDs. Although task-shifting appears to be a rational approach, evidence suggests that it may bring about tension between existing professionals from whom tasks are shifted. A Theory of Change approach is an effective way of managing the unintended tension by bringing together different stakeholders involved to build consensus on how to task shift appropriately to the parties involved. We aimed to use a theory of change approach to formulating a road map on how to successfully integrate diabetes and hypertension care into the existing Friendship Bench in order to come up with an integrated care package for depression, hypertension and diabetes aimed at strengthening NCD care in primary health care systems in Zimbabwe., Method: A theory of change workshop with 18 stakeholders from diverse backgrounds was carried out in February 2020. Participants included grandmothers working on the Friendship Bench project (n = 4), policymakers from the ministry of health (n = 2), people with lived experience for the three NCDs (n = 4), health care workers (n = 2), and traditional healers (n = 2). Findings from earlier work (situational analysis, desk review, FGDs and clinic-based surveys) on the three NCDs were shared before starting the ToC. A facilitator with previous experience running ToCs led the workshop and facilitated the co-production of the ToC map. Through an iterative process, consensus between the 18 stakeholders was reached, and a causal pathway leading to developing a framework for an intervention was formulated., Results: The ToC singled out the need to use expert clients (people with lived experience) to promote a patient-centred care approach that would leverage the existing Friendship Bench approach. In the face of COVID-19, the stakeholders further endorsed the use of existing digital platforms, notably WhatsApp, as an alternative way to reach out to clients and provide support. Leveraging existing community support groups as an entry point for people in need of NCD care was highlighted as a win-win by all stakeholders. A final framework for an NCD care package supported by Friendship Bench was presented to policymakers and accepted to be piloted in five geographical areas., Conclusions: The ToC can be used to build consensus on how best to use using an existing intervention for common mental disorders to integrate care for diabetes and hypertension. There is a need to evaluate this new intervention through an adequately powered study., (© 2021. The Author(s).)

Introduction: Adolescents are at increased risk of HIV virological non-suppression compared to adults and younger children. Common mental disorders such as anxiety and depression are a barrier to adherence and virological suppression. The aim of this study was to identify factors associated with virological non-suppression among adolescents living with HIV (ALWH) in Zimbabwe who had symptoms of common mental disorders., Methods: We utilized baseline data from a cluster-randomized controlled trial of a problem-solving therapy intervention to improve mental health and HIV viral suppression of ALWH. Sixty clinics within 10 districts were randomized 1:1 to either the intervention or control arm, with the aim to recruit 14 adolescents aged 10 to 19 per clinic. Adolescents were eligible if they scored ≥7 on the Shona Symptom Questionnaire measuring symptoms of common mental disorders. Multivariable mixed-effects logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (95% CI) for factors associated with non-suppression, defined as viral load ≥1000 copies/mL., Results: Between 2 January and 21 March 2019 the trial enrolled 842 participants aged 10 to 19 years (55.5% female, 58.8% aged <16). Most participants (N = 613) were taking an NNRTI-based ART regimen (13 PI-based, 216 unknown) and median duration on ART was six years (IQR three to nine years, 240 unknown). Of the 833 with viral load data 292 (35.1%) were non-suppressed. Virological non-suppression was independently associated with male sex (adjusted OR (aOR) = 1.43, 95% CI 1.04 to 1.97), and with not knowing one's own HIV status (aOR = 1.77, 95% CI 1.08 to 2.88), or knowing one's status but not disclosing it to anyone (aOR = 1.99, 95% CI 1.36 to 2.93), compared to adolescents who knew their status and had disclosed it to someone., Conclusions: ALWH with symptoms of common mental disorders have high prevalence of virological non-suppression in Zimbabwe, especially if they do not know their status or have not disclosed it. In general adolescents should be informed of their HIV status, with encouragement on the beneficial health and social effects of viral suppression, to incentivise adherence. Efforts to strengthen the operationalization of disclosure guidelines for adolescents should now be prioritized., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Objectives: ASSET (Health System Strengthening in sub-Saharan Africa) is a health system strengthening (HSS) programme involving eight work-packages (ie, a research study that addresses a specific need for HSS) that aims to develop solutions that support high-quality care. Here we present the protocol for the implementation science (IS) theme within ASSET (ASSET-ImplmentER) that aims to understand what HSS interventions work, for whom and how, and how IS methodologies can be adapted to improve the HSS interventions within resource-poor contexts., Settings: Publicly funded health facilities in rural and urban areas in in Ethiopia, South Africa, Sierra Leone, and Zimbabwe., Participants: Research staff including principal investigators, coinvestigators, field staff, PhD students, and research assistants., Interventions: Work-packages use a mixed-methods effectiveness-effectiveness hybrid designs. At the end of the pre-implementation phase, a workshop is held whereby the IS theme, jointly with ASSET work-packages apply IS determinant frameworks to research findings to identify factors that influence the effectiveness of delivering evidence-informed care. Determinants are used to select a set of HSS interventions for further evaluation, where work-packages also theorise selective mechanisms. In the piloting and rolling implementation phase , work-packages pilot the HSS interventions. An iterative process then begins involving evaluation, reflection and adaptation. Throughout this phase, IS determinant frameworks are applied to monitor and identify barriers/enablers to implementation. Selective mechanisms of action are also investigated. Implementation outcomes are evaluated using qualitative and quantitative methods. The psychometric properties of outcome measures including acceptability, appropriateness and feasibility are also evaluated. In a final workshop, work-packages come together, to reflect and explore the utility of the selected IS methods and provide suggestions for future use.Structured templates are used to organise and analyse common and heterogeneous patterns across work-packages. Qualitative data are analysed using thematic analysis and quantitative data are analysed using means and proportions., Conclusions: We use a novel combination of IS methods at a programmatic level to facilitate comparisons of determinants and mechanisms that influence the effectiveness of HSS interventions in achieving implementation outcomes across different contexts. The study also contributes conceptual development and clarification at the underdeveloped interface of IS, HSS and global health.The ASSET-ImplementER theme is considered minimal risk as we only interview researchers involved in the different work-packages. To this effect we have received approval from King's College London Ethics Committee for research that is considered minimal risk (Reference number: MRA-20/21-21772)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To examine the proportion of people living with HIV who screen positive for common mental disorders (CMD) and the associations between CMD and self-reported adherence to antiretroviral therapy (ART)., Setting: Sixteen government-funded health facilities in the rural Bikita district of Zimbabwe., Design: Cross-sectional study., Participants: HIV-positive non-pregnant adults, aged 18 years or older, who lived in Bikita district and had received ART for at least 6 months., Outcome Measures: The primary outcome was the proportion of participants screening positive for CMD defined as a Shona Symptoms Questionnaire score of 9 or greater. Secondary outcomes were the proportion of participants reporting suicidal ideation, perceptual symptoms and suboptimal ART adherence and adjusted prevalence ratios (aPR) for factors associated with CMD, suicidal ideation, perceptual symptoms and suboptimal ART adherence., Results: Out of 3480 adults, 18.8% (95% CI 14.8% to 23.7%) screened positive for CMD, 2.7% (95% CI 1.5% to 4.7%) reported suicidal ideations, and 1.5% (95% CI 0.9% to 2.6%) reported perceptual symptoms. Positive CMD screens were more common in women (aPR 1.67, 95% CI 1.19 to 2.35) than in men and were more common in adults aged 40-49 years (aPR 1.47, 95% CI 1.16 to 1.85) or aged 50-59 years (aPR 1.51, 95% CI 1.05 to 2.17) than in those 60 years or older. Positive CMD screen was associated with suboptimal adherence (aPR 1.53; 95% CI 1.37 to 1.70)., Conclusions: A substantial proportion of people living with HIV in rural Zimbabwe are affected by CMD. There is a need to integrate mental health services and HIV programmes in rural Zimbabwe., Trial Registration Number: NCT03704805., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Adolescents living with HIV have poor treatment outcomes, including lower rates of viral suppression, than other age groups. Emerging evidence suggests a connection between improved mental health and increased adherence. Strengthening the focus on mental health could support increased rates of viral suppression. In sub-Saharan Africa clinical services for mental health care are extremely limited. Additional mechanisms are required to address the unmet mental health needs of this group. We consider the role that community-based peer supporters, a cadre operating at scale with adolescents, could play in the provision of lay-support for mental health., Methods: We conducted qualitative research to explore the experiences of peer supporters involved in delivering a peer-led mental health intervention in Zimbabwe as part of a randomized control trial (Zvandiri-Friendship Bench trial). We conducted 2 focus group discussions towards the end of the trial with 20 peer supporters (aged 18-24) from across 10 intervention districts and audio recorded 200 of the peer supporters' monthly case reviews. These data were thematically analysed to explore how peer supporters reflect on what was required of them given the problems that clients raised and what they themselves needed in delivering mental health support., Results: A primary strength of the peer support model, reflected across the datasets, is that it enables adolescents to openly discuss their problems with peer supporters, confident that there is reciprocal trust and understanding derived from the similarity in their lived experiences with HIV. There are potential risks for peer supporters, including being overwhelmed by engaging with and feeling responsible for resolving relationally and structurally complex problems, which warrant considerable supervision. To support this cadre critical elements are needed: a clearly defined scope for the manageable provision of mental health support; a strong triage and referral system for complex cases; mechanisms to support the inclusion of caregivers; and sustained investment in training and ongoing supervision., Conclusion: Extending peer support to explicitly include a focus on mental health has enormous potential. From this empirical study we have developed a framework of core considerations and principles (the TRUST Framework) to guide the implementation of adequate supportive infrastructure in place to enhance the opportunities and mitigate risks., Competing Interests: The authors have declared that no competing interests exist.

Purpose: The Friendship Bench is a successful task-shifting intervention for addressing common mental disorders in Zimbabwe. The intervention takes a cognitive behavioural therapy and problem-solving approach provided by lay health workers (LHWs). The LHWs live in the same environment as their clients and are thus exposed to the same traumas and stressors as are their clients. Little is known about the long-term psychological effects on LHWs involved in this type of work., Methods: A random sample of LHWs (n=182) was assessed using the Posttraumatic Stress Disorder Checklist (PCL-5) and the Shona Symptom Questionnaire (SSQ-14), both locally validated., Results: The prevalence of PTSD and CMD was low among all surveyed LHWs. Eleven (6%) and 17 (11%) presented with probable PTSD and CMD, respectively., Conclusion: Despite living and working in the same settings as their clients, the Friendship Bench LHWs show good mental health outcomes.

Background: The global shortage of mental health workers is a significant barrier to the implementation and scale-up of mental health services. Partially as a result of this shortage, approximately 85% of people with mental, neurological and substance-use disorders in low- and middle-income countries do not receive care. Consequently, developing and implementing scalable solutions for mental health capacity-building has been identified as a priority in global mental health. There remains limited evidence to inform best practices for capacity building in global mental health. As one in a series of four papers on factors affecting the implementation of mental health projects in low- and middle-income countries, this paper reflects on the experiences of global mental health grantees funded by Grand Challenges Canada, focusing on the barriers to and drivers of capacity-building., Methods: Between June 2014 and May 2017, current or former Grand Challenges Canada Global Mental Health grantees were recruited using purposive sampling. N = 29 grantees participated in semi-structured qualitative interviews, representing projects in Central America and the Caribbean (n = 4), South America (n = 1), West Africa (n = 4), East Africa (n = 6), South Asia (n = 11) and Southeast Asia (n = 3). Based on the results of a quantitative analysis of project outcomes using a portfolio-level Theory of Change framework, six key themes were identified as important to implementation success. As part of a larger multi-method study, this paper utilized a framework analysis to explore the themes related to capacity-building., Results: Study participants described barriers and facilitators to capacity building within three broad themes: (1) training, (2) supervision, and (3) quality assurance. Running throughout these thematic areas were the crosscutting themes of contextual understanding, human resources, and sustainability. Additionally, participants described approaches and mechanisms for successful capacity building., Conclusions: This study demonstrates the importance of capacity building to global mental health research and implementation, its relationship to stakeholder engagement and service delivery, and the implications for funders, implementers, and researchers alike. Investment in formative research, contextual understanding, stakeholder engagement, policy influence, and integration into existing systems of education and service delivery is crucial for the success of capacity building efforts.

Background: Adolescents living with HIV (ALHIV) experience a high burden of mental health disorder which is a barrier to antiretroviral therapy adherence. In Zimbabwe, trained, mentored peer supporters living with HIV (Community Adolescent Treatment Supporters - CATS) have been found to improve adherence, viral suppression and psychosocial well-being among ALHIV. The Friendship Bench is the largest integrated mental health programme in Africa. We hypothesise that combining the CATS programme and Friendship Bench will improve mental health and virological suppression among ALHIV compared with the CATS programme alone., Methods: We will conduct a cluster-randomised controlled trial in 60 clinics randomised 1:1 in five provinces. ALHIV attending the control arm clinics will receive standard CATS support and clinic support following the Ministry of Health guidelines. Those attending the intervention arm clinics will receive Friendship Bench problem-solving therapy, delivered by trained CATS. Participants with the signs of psychological distress will be referred to the clinic for further assessment and management. The primary outcome is HIV virological failure (≥1000 copies/ml) or death at 48 weeks. Secondary outcomes include the proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life., Conclusions: This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV. If effective this intervention has the potential to be scaled-up to improve these outcomes.Trial registration: PACTR201810756862405. 08 October 2018., Competing Interests: The authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: There is a lack of data from low- and middle-income countries on whether anxiety independently predicts a more chronic course for depression., Methods: We undertook secondary data analysis of a cluster randomised controlled trial in Zimbabwe which had tested the effectiveness of the Friendship Bench intervention for common mental disorders compared to enhanced usual care. Inclusion for the current study was participants from the trial who had probable major depression at baseline, defined as scoring => 11 on the locally validated Patient Health Questionnaire (PHQ9). This emerged to be 354 of the original 573 (61.78%) of the original trial sample. Anxiety was measured using the locally validated cut-point on the Generalised Anxiety Disorder scale (GAD-7). Persistent depression was defined as scoring => 11 on the PHQ-9 at six-months follow-up. Analysis in Stata 15 used random-effects logistic regression to adjust for clustering by clinic., Outcomes: Of the 354 participants who were eligible for treatment, 329 (92·9%) completed 6-month follow-up assessment. 37% of the trial sample had persistent depression at 6-months follow-up; 59% in the control arm and 17% in the intervention arm. Co-morbid anxiety present at trial baseline was independently associated with persistent depression after adjusting for age, gender and baseline depression severity (adjusted OR = 2·83, 95% CI 1·32-6·07). There was no evidence of effect modification by trial arm. Baseline depression severity also predicted persistent depression. Interpretation Treatment for depression in low and middle-income countries (LMIC) should be directed towards those with greatest need. This includes people with co-morbid anxiety and greater depression severity at initial assessment who are less likely to remit at six months. Advice on coping with anxiety, psychological treatments which target common anxiety symptoms such as fear, avoidance, excessive worry and intrusive thoughts, and Selective Serotonin Reuptake Inhibitors (SSRIs) should be made more widely available in LMIC and offered to those with persistent mixed depression and anxiety., Competing Interests: We declare no conflicts of interests., (© 2020 Published by Elsevier Ltd.)

Background: Depression is highly prevalent among patients newly starting antiretroviral treatment (ART) in Malawi and many other countries. Untreated depression at ART initiation can disrupt the HIV care continuum. Effective approaches for depression screening and treatment exist for low-resource settings, but they are rarely applied. Identifying effective implementation strategies are critical., Methods: A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a screening-only "control" phase and an active "intervention" phase. During the intervention phase, providers prescribed antidepressants or referred patients for Friendship Bench problem-solving therapy. We evaluated the program's impact on retention in HIV care, viral suppression, and depression remission at 6 months using tabular comparisons and log-binomial models to estimate adjusted risk ratios and mean differences among the intervention group relative to the control group., Results: Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms. During the intervention phase, 86% of participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants with moderate to severe depressive symptoms started antidepressants. Few participants in the intervention group received consistent depression treatment over their first 6 months in care. In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4-0.9)]., Conclusions: While it is feasible to integrate depression screening and treatment initiation into ART initiation, providing ongoing depression treatment over time is challenging. Similar implementation science studies focused on maintaining depression management will be increasingly important as we strive to understand and test the best ways to implement evidence-based depression treatment within HIV care., Competing Interests: The authors have declared that no competing interests exist.

This study investigated the experience of lay health workers (LHWs) delivering problem-solving therapy (PST) for common mental disorders (CMD) as well as clients' views of the PST program referred to as the Friendship Bench (FB). Semi-structured interviews were conducted with LHWs (n = 5) and clients living with HIV (PLWH) (n = 10). Data were analyzed using thematic content analysis. LHWs described a severe form of CMD amongst PLWH with a history of trauma, naming it kufungisisa kwe njodzi (excessive thinking due to trauma), a local cultural equivalent of PTSD. The term kufungisisa (thinking too much) has been used as the local equivalent for CMD. Trauma or njodzi was seen both as a circumscribed event and as linked to ongoing pervasive experiences such as living with HIV, stigma, and poverty. Although LHWs recognized symptoms of PTSD such as intrusion, avoidance, and hyper-arousal, they did not know how to address these specifically and chose to address them as a severe form of kufungisisa . There is a need to integrate aspects of PTSD management within care packages for CMD delivered by LHWs.

Background: Depression is a common psychiatric disorder that is highly prevalent among people living with HIV (PLWH). Depression is linked to poor adherence to anti-retroviral medication while in the peri-natal period may affect birth outcomes. Intimate partner violence (IPV) has been linked to depression. Little is known about the factors associated with depression in HIV positive pregnant women in Zimbabwe., Methods: We carried out a cross-sectional study in 4 busy primary care clinics offering antenatal services during the months of June through to September in 2016. Simple random sampling was used to screen HIV positive pregnant women while they waited to be attended to at each clinic. Eligible women who gave written informed consent were screened using a locally validated screening tool-the Edinburgh Postnatal Depression Scale (EPDS)., Results: A total of 198(85%) participants were recruited out of 234 that were approached. The mean age of participants was 26.6(SD 4.5), of these, 176 (88.9%) had secondary education or more. A total of 78 (39.4%) (95% CI 32.5-46.3) met criteria for antenatal depression according to the local version of the EPDS. Factors associated with antenatal depression after multivariate analysis were intimate partner violence (IPV) [OR 3.2 (95% CI 1.5-6.7)] and previous history of depression OR 4.1 (95% CI 2.0-8.0)]., Conclusion: The prevalence of antenatal depression among HIV positive pregnant women in primary care clinics is high. Factors associated with antenatal depression in pregnant HIV positive women are IPV and previous history of depression. There is need for routine screening for depression during the antenatal period and interventions targeting depression in this population should include components to address IPV.

Background: There is a dearth of validated tools measuring posttraumatic stress disorder (PTSD) in low and middle-income countries in sub-Saharan Africa. We validated the Shona version of the PTSD Checklist for DSM-5 (PCL-5) in a primary health care clinic in Harare, Zimbabwe., Method: Adults aged 18 and above attending the clinic were enrolled over a two-week period in June 2016. After obtaining written consent, trained research assistants administered the tool to eligible participants. Study participants were then interviewed independently using the Clinician Administered PTSD Scale (CAPS-5) as the gold standard by one of five doctors with training in mental health., Result: A total of 204 participants were assessed. Of these, 91 (44.6%) were HIV positive, 100 (49%) were HIV negative, while 13 (6.4%) did not know their HIV status. PTSD was diagnosed in 40 (19.6%) participants using the gold standard procedure. Using the PCL-5 cut-off of ≥33, sensitivity and specificity were 74.5% (95%CI: 60.4-85.7); 70.6% (95%CI: 62.7-77.7), respectively. The area under the ROC curve was 0.78 (95%CI: 0.72-0.83). The Shona version of the PCL-5 demonstrated good internal consistency (Cronbach's alpha = 0.92)., Conclusion: The PCL-5 performed well in this population with a high prevalence of HIV. There is need to explore ways of integrating screening tools for PTSD in interventions delivered by lay health workers in low and middle-income countries (LMIC).

Background: Suicidal ideation may lead to deliberate self-harm which increases the risk of death by suicide. Globally, the main cause of deliberate self-harm is depression. The aim of this study was to explore prevalence of, and risk factors for, suicidal ideation among men and women with common mental disorder (CMD) symptoms attending public clinics in Zimbabwe, and to determine whether problem solving therapy delivered by lay health workers can reduce common mental disorder symptoms among people with suicidal ideation, using secondary analysis of a randomised controlled trial., Methods: At trial enrolment, the Shona Symptom Questionnaire (SSQ) was used to screen for CMD symptoms. In the intervention arm, participants received six problem-solving therapy sessions conducted by trained and supervised lay health workers, while those in the control arm received enhanced usual care. We used multivariate logistic regression to identify risk factors for suicidal ideation at enrolment, and cluster-level logistic regression to compare SSQ scores at endline (6 months follow-up) between trial arms, stratified by suicidal ideation at enrolment., Results: There were 573 participants who screened positive for CMD symptoms and 75 (13.1%) reported suicidal ideation at baseline. At baseline, after adjusting for confounders, suicidal ideation was independently associated with being aged over 24, lack of household income (household income yes/no; adjusted odds ratio 0.52 (95% CI 0.29, 0.95); p = 0.03) and with having recently skipped a meal due to lack of food (adjusted odds ratio 3.06 (95% CI 1.81, 5.18); p < 0.001). Participants who reported suicidal ideation at enrolment experienced similar benefit to CMD symptoms from the Friendship Bench intervention (adjusted mean difference - 5.38, 95% CI -7.85, - 2.90; p < 0.001) compared to those who had common mental disorder symptoms but no suicidal ideation (adjusted mean difference - 4.86, 95% CI -5.68, - 4.04; p < 0.001)., Conclusions: Problem-solving therapy delivered by trained and supervised lay health workers reduced common mental disorder symptoms among participants with suicidal thoughts who attended primary care facilities in Zimbabwe., Trial Registration: pactr.org ldentifier: PACTR201410000876178.

There is growing evidence supporting the use of lay health workers (LHWs) to address the treatment gap for common mental disorders (CMD) through task-shifting. This study looks at the experience of LHWs delivering a problem solving therapy (PST) intervention for CMD for people living with HIV (PLWH) in a primary health care setting. Semi-structured interviews of LHWs (n = 7) and PLWH (10) who received PST were carried out using thematic content analysis. Over a 4 year period LHWs developed indigenous concepts of PST which were: Opening the mind (Kuvhura pfungwa), uplifting (kusimudzira), strengthening and strengthening further (kusimbisa and kusimbisisa) respectively. Using terms locally conceived through knowledge sharing amongst LHWs made it acceptable to deliver PST as part of their daily work. Indigenous terms conceived and developed by LWHs to describe components and processes of PST contribute to the therapy's acceptability and continued use in primary care facilities.

Importance: Depression and anxiety are common mental disorders globally but are rarely recognized or treated in low-income settings. Task-shifting of mental health care to lay health workers (LHWs) might decrease the treatment gap., Objective: To evaluate the effectiveness of a culturally adapted psychological intervention for common mental disorders delivered by LHWs in primary care., Design, Setting, and Participants: Cluster randomized clinical trial with 6 months' follow-up conducted from September 1, 2014, to May 25, 2015, in Harare, Zimbabwe. Twenty-four clinics were randomized 1:1 to the intervention or enhanced usual care (control). Participants were clinic attenders 18 years or older who screened positive for common mental disorders on the locally validated Shona Symptom Questionnaire (SSQ-14)., Interventions: The Friendship Bench intervention comprised 6 sessions of individual problem-solving therapy delivered by trained, supervised LHWs plus an optional 6-session peer support program. The control group received standard care plus information, education, and support on common mental disorders., Main Outcomes and Measures: Primary outcome was common mental disorder measured at 6 months as a continuous variable via the SSQ-14 score, with a range of 0 (best) to 14 and a cutpoint of 9. The secondary outcome was depression symptoms measured as a binary variable via the 9-item Patient Health Questionnaire, with a range of 0 (best) to 27 and a cutpoint of 11. Outcomes were analyzed by modified intention-to-treat., Results: Among 573 randomized patients (286 in the intervention group and 287 in the control group), 495 (86.4%) were women, median age was 33 years (interquartile range, 27-41 years), 238 (41.7%) were human immunodeficiency virus positive, and 521 (90.9%) completed follow-up at 6 months. Intervention group participants had fewer symptoms than control group participants on the SSQ-14 (3.81; 95% CI, 3.28 to 4.34 vs 8.90; 95% CI, 8.33 to 9.47; adjusted mean difference, -4.86; 95% CI, -5.63 to -4.10; P < .001; adjusted risk ratio [ARR], 0.21; 95% CI, 0.15 to 0.29; P < .001). Intervention group participants also had lower risk of symptoms of depression (13.7% vs 49.9%; ARR, 0.28; 95% CI, 0.22 to 0.34; P < .001)., Conclusions and Relevance: Among individuals screening positive for common mental disorders in Zimbabwe, LHW-administered, primary care-based problem-solving therapy with education and support compared with standard care plus education and support resulted in improved symptoms at 6 months. Scaled-up primary care integration of this intervention should be evaluated., Trial Registration: pactr.org Identifier: PACTR201410000876178.

Objective: Post-traumatic stress disorder is pervasive in low- and middle-income countries. There is evidence to suggest that post-traumatic stress disorder is more common among people living with HIV than non-infected matched controls. We carried out a systematic review of interventions for adult post-traumatic stress disorder from resource poor settings with a focus on people living with HIV., Methods: We included all studies that investigated interventions for adult post-traumatic stress disorder from resource poor settings with a focus on interventions that were either randomised controlled trials or observational cohort studies carried out from 1980 to May 2015., Results: Of the 25 articles that were identified for full review, two independent reviewers identified seven studies that met our study inclusion criteria. All randomised controlled trials (RCT) (n = 6) used cognitive behavioural therapy-based interventions and focused on people living with HIV in resource poor settings. There was only one study focusing on the use of lay counsellors to address post-traumatic stress disorder but core competencies were not described. There were no intervention studies from Africa, only an observational cohort study from Rwanda., Conclusion: Rigorously evaluated interventions for adult post-traumatic stress disorder in people living with HIV are rare. Most were undertaken in resource poor settings located in high-income countries. There is a need for research on the development and implementation of appropriate interventions for post-traumatic stress disorder in people living with HIV in low- and middle-income countries., (© 2016 John Wiley & Sons Ltd.)

Background: In low income countries in Sub-Saharan Africa there are few validated tools to screen for common disabling mental disorders such as depression and general anxiety disorder (GAD)., Objectives: We validated three screening tools: the Shona Symptom Questionnaire for common mental disorders (SSQ-14), the Patient Health Questionnaire for depression (PHQ-9), and the Generalized Anxiety Disorder questionnaire (GAD-7). The study participants were attendees at a primary health care clinic in Harare, Zimbabwe., Methods: Consecutive adults aged 18 and above attending the clinic were enrolled over a two-week period in September 2013. Trained research assistants administered the screening tools to eligible participants after obtaining written consent. Participants were then interviewed by one of four psychiatrists using the Structured Clinical Interview of the DSM-IV (SCID). Performance characteristics were calculated for each tool, against the SCID as the gold standard., Results: A total of 264 participants were enrolled, of whom 52 (20%) met the SCID criteria for depression alone, 97 (37%) for mixed depression and anxiety and 9 (3%) for anxiety alone. Of the 237 where HIV status was known, 165 (70%) were HIV positive. With the optimal cutoff of ≥9, the sensitivity and specificity for the SSQ-14 against a diagnosis of either depression and/or general anxiety were 84% (95%CI:78-89%) and 73% (95%CI:63-81%) respectively. Internal reliability was high (Cronbach α=0.74). The optimal cutoff for PHQ-9 was ≥11, which provided a sensitivity of 85% (95%CI:78-90%) and specificity of 69% (95%CI:59-77%) against a SCID diagnosis of depression (Cronbach α=0.86). The GAD-7 (optimal cutoff ≥10) had sensitivity and specificity of 89% (95%CI:81-94%) and 73% (95%CI:65-80%) respectively against a SCID diagnosis of GAD (Cronbach α=0.87)., Conclusion: Screening tools for depression and GAD had good performance characteristics in a primary health care population in Zimbabwe with a high prevalence of HIV. These can be used for research and also in clinical care to screen patients who may benefit from treatment., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Background: There are few accounts of evidence-based interventions for depression and other common mental disorders (CMDs) in primary care in low-income countries. The Friendship Bench Project is a collaborative care mental health intervention in primary care in Harare for CMDs which began as a pilot in 2006., Case Presentation: We employed a mixture of quantitative and qualitative approaches to investigate the project's acceptability and implementation, 4-8 years after the initial pilot study. We carried out basic descriptive analyses of routine data on attendance collected between 2010 and 2014. We also conducted five focus group discussions (FGDs) with LHWs in 2013 and 12 in-depth interviews, six with staff and six with patients, to explore experiences of the intervention, which we analysed using grounded theory. Results show that the intervention appears highly acceptable as evidenced by a consistent number of visits between 2010 and 2014 (mean 505 per year, SD 132); by the finding that the same team of female community LHWs employed as government health promoters continue to deliver assessment and problem-solving therapy, and the perceived positive benefits expressed by those interviewed. Clients described feeling 'relieved and relaxed' after therapy, and having their 'mind opened', and LHWs describing satisfaction from being agents of change. Characteristics of the LHWs (status in the community, maturity, trustworthiness), and of the intervention (use of locally validated symptom screen, perceived relevance of problem-solving therapy) and continuity of the LHW team appeared crucial. Challenges to implementation included the LHWs ongoing need for weekly supervision despite years of experience; the supervisors need for supervision for herself; training needs in managing suicidal and hostile clients; poor documentation; lack of follow-up of depressed clients; and poor access to antidepressants., Conclusions: This case study shows that a collaborative care intervention for CMDs is positively received by patients, rewarding for LHWs to deliver, and can be sustained over time at low cost. Next steps include evaluation of the impact of the intervention through a randomised trial, and testing of a technological platform for supporting supervision and monitoring clients' attendance.

Background: There is a paucity of data on how to deliver complex interventions that seek to reduce the treatment gap for mental disorders, particularly in sub-Saharan Africa. The need for well-documented protocols which clearly describe the development and the scale-up of programs and interventions is necessary if such interventions are to be replicated elsewhere. This article describes the use of a theory of change (ToC) model to develop a brief psychological intervention for common mental disorders and its' evaluation through a cluster randomized controlled trial in Zimbabwe., Methods: A total of eight ToC workshops were held with a range of stakeholders over a 6-month period with a focus on four key components of the program: formative work, piloting, evaluation and scale-up. A ToC map was developed as part of the process with defined causal pathways leading to the desired impact. Interventions, indicators, assumptions and rationale for each point along the causal pathway were considered., Results: Political buy-in from stakeholders together with key resources, which included human, facility/infrastructure, communication and supervision were identified as critical needs using the ToC approach. Ten (10) key interventions with specific indicators, assumptions and rationale formed part of the final ToC map, which graphically illustrated the causal pathway leading to the development of a psychological intervention and the successful implementation of a cluster randomized controlled trial., Conclusion: ToC workshops can enhance stakeholder engagement through an iterative process leading to a shared vision that can improve outcomes of complex mental health interventions particularly where scaling up of the intervention is desired.

Background: Common mental disorders (CMD) are a leading cause of disability globally. Emerging evidence indicates that in low and middle income countries the treatment gap for CMD can be addressed through the use of trained and supervised lay health workers (LHWs). Few clinical trials have evaluated the use of such task-shifting approaches in sub-Saharan Africa. In Zimbabwe, we have successfully piloted a task-shifting intervention delivered by LHWs. This protocol describes a cluster randomised controlled trial to assess the effectiveness of this intervention., Methods: Each of 24 randomly selected clinics from a pool of 42 in Harare will recruit 24 participants (N = 576). The clinics are randomised in a 1:1 ratio to receive either the intervention package [a problem solving therapy package delivered over a 4-6 week period by LHWs (N = 24) followed by a 6-week group support programme which focuses mainly on teaching a craft skill] or enhanced usual care, which includes usual care and psycho-education. Primary care attenders aged 18 years and above who score positive on a locally validated CMD screening questionnaire (Shona Symptom Questionnaire, SSQ-14) will be eligible for recruitment and asked for informed consent to participate in the trial. The primary measure is the SSQ score at 6 months., Conclusion: This effectiveness trial using LHWs to address the treatment gap for CMD will contribute to the body of knowledge on the feasibility and ability for scale-up of interventions for CMD., Trial Registration: PACTR201410000876178.