Strengthening research capacity through an intensive training program for biomedical investigators from low- and middle-income countries: the Vanderbilt Institute for Research Development and Ethics (VIRDE).

BACKGROUND: Capacity strengthening initiatives aimed at increasing research knowledge and skills of investigators in low- and middle-income countries (LMICs) have been implemented over the last several decades. With increased capacity, local investigators will have greater leadership in defining research priorities and impact policy change to help improve health outcomes. Evaluations of models of capacity strengthening programs are often limited to short-term impact. Noting the limitations of traditional output-based evaluations, we utilized a broader framework to evaluate the long-term impact of the Vanderbilt Institute in Research Development and Ethics (VIRDE), a decade-old intensive grant development practicum specifically tailored for investigators from LMICs. METHODS: To assess the impact of VIRDE on the research careers of alumni over the past 10 years, we surveyed alumni on research engagement, grant productivity, career trajectory, and knowledge gained in grant writing. Descriptive statistics, including means and total counts, and paired sample t-tests were used to analyze the data. RESULTS: Forty-six of 58 alumni completed the survey. All respondents returned to their home countries and are currently engaged in research. Post-VIRDE grant writing knowledge ratings were significantly greater than pre-VIRDE. The number of respondents submitting grants post-VIRDE was 2.6 times higher than before the program. Eighty-three percent of respondents submitted a total of 147 grants post-VIRDE, of which 45.6% were awarded. Respondents acknowledged VIRDE's positive impact on career growth and leadership, with 88% advancing in career stage. CONCLUSIONS: Gains in grant writing knowledge and grant productivity suggest that VIRDE scholars built skills and confidence in grant writing during the program. A substantial proportion of respondents have advanced in their careers and continue to work in academia in their country of origin. Results show a sustained impact on the research careers of VIRDE alumni. The broader framework for research capacity strengthening resulted in an expansive assessment of the VIRDE program and alumni, illuminating successful program elements and implications that can inform similar capacity strengthening programs.

Training the next generation of Biostatisticians in West Africa: The Vanderbilt Nigeria Biostatistics Training Program (VN-BioStat).

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: 1) 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. 2) 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.

The V-RAMP Program: Building Research Administration and Management Capacity in Nigeria.

The increasing volume and complexity of research activities in Nigeria necessitates urgent measures to improve research infrastructure in grants administration and management. The Vanderbilt-Nigeria Research Administration and Management Training Program (V-RAMP) seeks to build infrastructure capacity in research administration and management and research ethics at a major teaching hospital in Nigeria. We will perform a mixed methods needs assessment of the administrative and management environment and develop an action plan to address infrastructure needs, prioritize processes, and guide program implementation. We will capacitate a newly established Office of Research Administration and improve the knowledge and skills of research administrators and grant managers via short term in-person trainings in Nashville, Tennessee and in Kano, Nigeria and through remote learning opportunities. We will enhance local administrative efficiency and performance of research ethics operations through training and mentoring of members and staff of the ethics review committee. Systematic processes to streamline protocols, including a REDCap protocol tracking database and standard operating procedures in the responsible conduct of research and rigor and reproducibility will also be developed. V-RAMP will enable the creation of a high-quality research administration environment that is knowledgeable, efficient, and compliant regarding the fiscal, management and ethical standards of sponsored research.

HIV Research Training Partnership of the University of Zambia and Vanderbilt University: Features and Early Outcomes.

Background: Despite the burden of HIV being highest in sub-Saharan Africa (SSA), research expertise and capacity to address scientific questions regarding complications of HIV and ART, especially chronic non-communicable conditions, is limited in the region. The comorbidities prevalent in persons with HIV are mediated through diverse mechanisms, many of which can be context or region-specific and are yet to be elucidated. The phenotype, risk factors, and effective interventions for these conditions may differ between populations and settings, and therefore there is an urgent need for research to help understand these processes and how to best address them in SSA. Here, we report the research capacity building activities in SSA conducted by the University of Zambia (UNZA)-Vanderbilt Training Partnership for HIV-Nutrition-Metabolic Research (UVP), drawing lessons and challenges for a wide global health audience. Methods: We reviewed program data and conducted interviews with program leaders and participants to understand and document the progress and outcomes of the partnership. We report the program's early achievements, highlighting drivers and challenges. Results: Between 2015 and 2019, UVP made substantial progress on its goals of training new UNZA PhD scientists to investigate complex nutritional and metabolic factors related to long-term HIV complications and comorbidities. The program has supported 11 UNZA PhD students with dual UNZA-Vanderbilt mentorship; three have graduated, and other candidates are progressing in their PhD studies. The project also supported institutional capacity through UNZA faculty participation in Vanderbilt grant writing workshops, with strong success in obtaining grants among those who participated. UVP also supported development of greater structure to UNZA's PhD program and a mentorship curriculum, both now adopted by UNZA. The major drivers for success included UVP's alignment of goals between UNZA and Vanderbilt, and local institutional ownership. The longstanding history of collaborations between the two institutions contributed substantially to alignment and mutual support of UVP's goals. Several challenges were noted, including limits on direct research funding for students and a relatively small pool of funded investigators at UNZA. Conclusions: Despite some challenges, UVP has achieved positive outcomes over its first four years. Longstanding partnerships and local institutional ownership were the main drivers. We expect the challenges to mitigated as the project continues and produces more UNZA researchers and teams and more funded projects, collectively building the local research community. With continued resources and clear focus, we expect that UNZA's investigators and partners will attract research funding and generate high-impact research outputs across a broad range of studies in HIV as well as newer threats from non-communicable conditions experienced by long-term survivors of HIV and by the general population.

Impact of methadone on drug use and risky sex in China.

This study examined the impact of methadone on drug-using and risky sexual behaviors among 557 heroin injection drug users in one of the first methadone programs in China. Structured questionnaires were administered to collect data on methadone utilization, drug use, and risky sexual behaviors. Blood samples were tested for blood-borne infections. Multivariate logistic analyses revealed that, among opioid-addicted individuals, methadone participants were less likely to use or inject drugs and share needles than nonparticipants. They also were less likely to have multiple sexual partners or have unprotected sex. Those currently enrolled in methadone maintenance had lower risk of using and injecting drugs than those who were no longer receiving methadone. Data suggest positive, short-term impact on these important behaviors, but further studies are needed to examine the long-term impact of methadone treatment on disease rates.

Translation of biomedical prevention strategies for HIV: prospects and pitfalls.

Early achievements in biomedical approaches for HIV prevention included physical barriers (condoms), clean injection equipment (both for medical use and for injection drug users), blood and blood product safety, and prevention of mother-to-child transmission. In recent years, antiretroviral drugs to reduce the risk of transmission (when the infected person takes the medicines; treatment as prevention) or reduce the risk of acquisition (when the seronegative person takes them; preexposure prophylaxis) have proven to be efficacious. Circumcision of men has also been a major tool relevant for higher prevalence regions such as sub-Saharan Africa. Well-established prevention strategies in the control of sexually transmitted diseases and tuberculosis are highly relevant for HIV (ie, screening, linkage to care, early treatment, and contact tracing). Unfortunately, only slow progress is being made in some available HIV-prevention strategies such as family planning for HIV-infected women who do not want more children and prevention of mother-to-child HIV transmission. Current studies seek to integrate strategies into approaches that combine biomedical, behavioral, and structural methods to achieve prevention synergies. This review identifies the major biomedical approaches demonstrated to be efficacious that are now available. We also highlight the need for behavioral risk reduction and adherence as essential components of any biomedical approach.