Mutual capacity building model for adaptation (MCB-MA): a seven-step procedure bidirectional learning and support during intervention adaptation.

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.

Integrating a mental health intervention into PrEP services for South African young women: a human-centred implementation research approach to intervention development.

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.

Global health reciprocal innovation to address mental health and well-being: strategies used and lessons learnt.

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.

The impact of working alliance in managing youth anxiety and depression: a scoping review.

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.

Effect of the Friendship Bench Intervention on Antiretroviral Therapy Outcomes and Mental Health Symptoms in Rural Zimbabwe: A Cluster Randomized Trial.

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.

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

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

Prevalence of post-traumatic stress disorder and validity of the Impact of Events Scale - Revised in primary care in Zimbabwe, a non-war-affected African country.

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.

Effect of the Friendship Bench intervention on antiretroviral therapy outcomes and mental health symptoms in rural Zimbabwe: A cluster randomized trial.

Importance: Common mental disorders (CMD) are prevalent in people living with HIV and associated with suboptimal antiretroviral therapy (ART) adherence. Objective: To assess the effect of a lay health worker-led psychological intervention on adherence to ART, virologic suppression and mental health symptoms. Design: Pragmatic cluster trial with block randomization of health facilities. Treatment assignment was known to participants, providers, evaluators, and data analysts. Recruitment started in October 2018 and the last follow-up visit was done in December 2020. Participants were followed up for 12 months. Setting: Sixteen public health care facilities in Bikita, a rural district in Masvingo Province, about 300 km south of Harare. Participants: Men and non-pregnant women aged 18 years or older who spoke English or Shona, screened positive for CMD (Shona Symptoms Questionnaire [SSQ]-14 score ≥9), had received first-line ART for at least six months, had no WHO clinical stage 4 disease, no psychotic symptoms, and gave informed consent. Intervention: The Friendship Bench, a lay health worker-led intervention consisting of six weekly individual counselling sessions of problem-solving therapy and optional peer-led group support. Main Outcomes and Measures: The primary outcome was Medication Event Monitoring System (MEMS) mean adherence between 2-6 months of follow-up. Secondary outcomes included mean adherence between 1-12 months, change from baseline SSQ-14 and Patient Health Questionnaire (PHQ-9) score at 3, 6, 9, and 12 months and change in viral load suppression (viral load <1000 copies per mL) at months 6 and 12. Results: We recruited 516 participants, 244 in Friendship bench and 272 in standard care facilities. The mean age was 45.6 years (SD 10.9), and most participants were women (84.9%). In the Friendship Bench group, 88.1% of participants attended all six individual counselling sessions. Rates of adherence (>85%) and virologic suppression (>90%) were high in both groups. The intervention had no statistically significant effect on adherence or viral suppression. Declines in SSQ-14 scores from baseline to 3 months (-1.65, 95% CI -3.07 to -0.24), 6 months (-1.57, 95% CI -2.98 to -0.15), and 9 months (-1.63, 95% CI -3.05 to -0.22) were greater in the Friendship Bench than the standard care group (p<0.05). 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: The Friendship Bench intervention is a feasible and acceptable approach to closing the treatment gap in mental health care in rural Zimbabwe. The intervention improved CMD symptoms but the intervention effect was smaller than previously shown in an urban setting. The intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and ceiling effect. Trial registration: ClinicalTrials.gov Identifier: NCT03704805. Key points: Question: Does the Friendship Bench intervention improve antiretroviral therapy (ART) adherence, viral suppression and mental health symptoms in people living with HIV in rural Zimbabwe?Findings: In this cluster-randomized trial, participants in the intervention group had a significantly greater decrease in symptoms of common mental disorders than those in the control group, but the intervention showed no significant effect on antiretroviral therapy (ART) adherence or viral suppression.Meaning: The intervention did not affect adherence and viral suppression and the effect of the intervention on mental health symptoms was smaller than previously shown.

Stigma experienced by people living with HIV who are on methadone maintenance treatment and have symptoms of common mental disorders in Hanoi, Vietnam: a qualitative study.

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.

Using the RE-AIM framework to evaluate the implementation of scaling-up the Friendship Bench in Zimbabwe - a quantitative observational study.

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.

A Digital Mental Health Intervention (Inuka) for Common Mental Health Disorders in Zimbabwean Adults in Response to the COVID-19 Pandemic: Feasibility and Acceptability Pilot Study.

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 (F2,73=2.63; P=.08), depression (F2,73=7.67; P<.001), and anxiety (F2,73=2.95; P=.06) and a corresponding increase in HRQoL (F2,73=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.

Adaptation of a Problem-solving Program (Friendship Bench) to Treat Common Mental Disorders Among People Living With HIV and AIDS and on Methadone Maintenance Treatment in Vietnam: Formative Study.

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.

Barriers to the provision of non-communicable disease care in Zimbabwe: a qualitative study of primary health care nurses.

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.

HeAlth System StrEngThening in four sub-Saharan African countries (ASSET) to achieve high-quality, evidence-informed surgical, maternal and newborn, and primary care: protocol for pre-implementation phase studies.

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.

Peer-led counselling with problem discussion therapy for adolescents living with HIV in Zimbabwe: A cluster-randomised trial.

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.

Economic threshold analysis of delivering a task-sharing treatment for common mental disorders at scale: the Friendship Bench, Zimbabwe.

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.

A guide to systems-level, participatory, theory-informed implementation research in global health.

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.

Using a theory of change to develop an integrated intervention for depression, diabetes and hypertension in Zimbabwe: lessons from the Friendship Bench project.

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.

Optimising implementation strategies of the first scaleup of a primary care psychological intervention for common mental disorders in Sub-Saharan Africa: a mixed methods study protocol for the optimised Friendship Bench (OptFB).

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.

Potential Resilience to Post-traumatic Stress Disorder and Common Mental Disorders among Lay Health Workers Working on the Friendship Bench Programme in Zimbabwe.

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.