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Jul 11, 2024, 6:14:20 AM7/11/24
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Biomedical HIV research is growing in West Africa, but biostatistical expertise is lagging. The Vanderbilt-Nigeria Biostatistics Training Program (VN-BioStat) seeks to establish a research and training platform for biostatisticians doing HIV-related research in Nigeria. The objectives of the program are: (i) Host two Nigerian data scientists per year (a total of 10 over 5 years) at Vanderbilt University Medical Center to gain hands-on biostatistics training and experience via one-year fellowships. Eligible trainees will be junior investigators with PhDs or nearing completion of their PhDs in statistics or related fields, including mathematics and computer science. (ii) Conduct annual workshops in Nigeria to provide biostatistics training. Trainees will undertake biostatistics coursework and hands-on training and participate in mentorship as biostatisticians involved in HIV research. Trainees will be at Vanderbilt for a full year and be part of an active biostatistics department. They will be immersed in a dry-lab HIV biostatistics project in collaboration with a Nigerian HIV research project and lead a methodologically focused research project. They will also participate in a one-month research training/grant writing program in Nashville. The VN-BioStat program will build on the existing momentum of ongoing initiatives to enhance research capacity in Nigeria by developing biostatistics leadership. VN-BioStat trainees will interact with investigators from Nigeria to provide collaborative biostatistical assistance with study design and data analysis, thus gaining real-world experience that will benefit the trainees and the broader research community in Nigeria.

Trainees will meet regularly (weekly or bi-weekly) with their research teams to complete the collaborative research project. In consultation with their mentors, the trainee will be expected to learn the necessary background material to understand the rationale for performing the study, write a statistical analysis plan, carry out the statistical analyses, produce a reproducible report, explain and interpret results to the research team both orally and in writing, draft the methods and results sections of a manuscript, and provide critical feedback to the larger manuscript. The trainee will typically be listed as the co-first or second author on the manuscript. The collaborative research project will give the trainees important, hands-on experience with a research project and opportunities to gain many skills through this process.

Students, faculty, and researchers have opportunities to study or do internships abroad, collaborate with foreign partners in a joint research group or a project through various exchange programs and scholarships.

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It is not clear what the most effective implementation strategies are for supporting the enactment and sustainment of depression care services in primary care settings. This type-II Hybrid Implementation-Effectiveness study will compare the effectiveness of three system-level strategies for implementing depression care programs at 36 community health stations (CHSs) across 2 provinces in Vietnam.

We hypothesize that the additional implementation supports will make mental health service implementation superior in the ES and CELC arms compared to the UI arm. The findings of this project could identify effective implementation models and assess the added value of specific QI strategies for implementing depression care in primary care settings in Vietnam, with implications and recommendations for other low- and middle-income settings. More importantly, this study will provide evidence for key stakeholders and policymakers to consider policies that disseminate, scale up, and advance quality mental health care in Vietnam.

Globally, there remains limited research on identifying the best training models for task-sharing evidence-based interventions (EBIs) in primary care settings in LMICs. For instance, our first MCCD study in Vietnam primarily focused on evaluating the effectiveness of the enhanced supervision model and failed to examine the effect of the training method on implementation outcomes or to document the intensity or fidelity of enhanced supervision [20]. Furthermore, EBIs using enhanced supervision components have not been compared to other implementation strategies in MH task-sharing, which has been cited as a major contributor to the research-to-practice gap [22, 23]. Establishing efficacious and feasible training models given local resource constraints is critical to effectively implement and sustain EBIs. More importantly, the scarcity of MH expertise and human resources is a reality in LMICs [24, 25], necessitating the need to rely on primary care and lay health workers to provide MH care [26]. However, little is known about what strategies would lead to successful implementation and sustainment of EBIs, particularly in the context of task-shifting in resource-limited settings [27] for both LMICs and high-income countries [28, 29]. Thus, an RCT comparing implementation strategies for task-shifting depression care both directly addresses the treatment gap in LMICs and further advances implementation science more broadly. With a weak MH system governance structure and associated policies, legislation, and effective action plan [30], Vietnam offers an excellent opportunity to empirically test implementation approaches and examine contextual and organizational factors associated with implementing and sustaining EBIs for LMICs.

This Type-II Hybrid Implementation-Effectiveness study [40] will primarily test implementation strategies on provider adoption and implementation quality. We will use a cluster RCT design to test the effectiveness of the implementation models on provider- and client-level outcomes with a mixed-methods approach. Specifically, this three-arm trial compares the three multi-component strategies for implementing depression care guidelines: (1) UI arm which includes basic depression care capacity workshops, limited technical assistance, and toolkits, 2) ES arm which includes all components of UI and additional structured clinical supervision from provincial and district supervisors, and 3) CELC arm which includes all components of ES, combined with the activation of a community-wide network of providers and stakeholders who are implementing continuous QI strategies (Fig. 1). The primary outcome is to compare the fidelity of MCCD on three implementation models using the RE-AIM framework [41], which will be assessed based on implementation outcomes (Reach, Adoption, Implementation quality, and Maintenance) and provider and client-related outcomes (Effectiveness) (Table 1). The secondary outcome is to assess factors associated with barriers and facilitators of quality implementation, which may serve as mechanisms for implementing additional supports for the ES and CELC arms. The tertiary outcome is to evaluate the incremental cost-effectiveness which quantifies the cost savings to policymakers when integrating various strategies for task-shifting depression care into primary care settings.

CHS providers will be given a collection of implementation tools, including an implementation guide that lists out step-by-step how to set up and implement depression care services, a detailed manual on how to provide BA therapy, the primary depression treatment intervention of the project. Clinical and research workflows are placed in visible locations inside the CHSs so that providers can always stay informed about the depression care steps and their new roles and responsibilities as MH professionals. Additionally, implementation forms will be printed out and given to CHS providers to assist them in documenting clinical activities and to collect implementation data for the research study.

Based on power considerations, we will recruit 10 providers from each CHS and 360 across the study, including five primary care providers (usually physician assistants or nurses) from the CHS and five (usually VHWs) working with the CHS, totaling 180 CHS providers and 180 non-CHS staff. Providers will be recruited post-enrollment but pre-CHS randomization at each CHS.

In addition to the PHQ-9, our client cohort study will collect additional information at baseline and 6-month surveys, including socio-demographic information (e.g., age, gender, education, marital status, household characteristics), house and general socio-economic status (e.g., house ownership, monthly expense, social standing), employment and business activities (e.g., employment status, regular source of income, personal and family monthly income), health functioning using the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) [54], quality of life (Q-LES-Q-SF) [55], self-efficacy using the adapted Adult AIDS Clinical Trials Group (AACTG) [56], depression stigma [53] and Behavioral Activation for Depression Scale (BADS-SF) [57], social support using the Medical Outcomes Study (MOS) [58], social capital, family environment using the McMaster Family Assessment Device (FAD) [59] and CHS Client Satisfaction Questionnaire (CSQ) [60].

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