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RESEARCH, KNOWLEDGE MANAGEMENT AND PROGRAMS EVALUATIONS
RESEARCH OVERVIEW
Baylor-Uganda actively participates and fosters a culture of collaborative research in order to meet her vision of becoming a leading Clinical research entity in the region. The aim is to continually impact health policy and improve the lives of children, adolescents and families infected and affected by HIV. To achieve this, Baylor-Uganda conducts clinical and operational research and program evaluations as part of providing evidence-based solutions to global health challenges.
Dr. Thomas Quinn - Chief, International HIV/STD Section of the National Institute of Allergy and Infectious Diseases (NIAID) visits the Baylor - Uganda Research Team
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RESEARCH OUTPUT
On-Going Research
As of June 2020, there were 23 active studies; seven of which are randomized control trials (RCT) and 18 are observational studies. We also had 05 studies in preparatory stage (three RCT’s and 02 observational studies). For a synopsis of the studies, visit our research studies Page .
Baylor-Uganda Research Directorate Annual Report 1st July 2019 to 30th June 2020
Manuscripts Published from Baylor-Uganda research/data
Publications focused majorly on paediatric and adolescent HIV treatment and prevention, and paediatric haematology and oncology care. The full list of recent publications can be accessed at https://www.baylor-uganda.org/publications/.
Collaborative Research Partners
Baylor-Uganda collaborative research partners include; Johns Hopkins University School of Medicine, IMPAACT Network, HPTN, MRC-CTU at UCL, KAROLINSIKA Institute, H3Africa, THE UNION, CDC, DNDi, EGPAF, PENTA, Johns Hopkins Center for Health Equity (JHCHE), Infectious Diseases Research Collaboration (IDRC), University of California, Yale School of Public Health, EDCTP, MAKCHS, Rutgers University and University of Oxford.
Abstracts presented at national and international scientific meetings
The number of international conference presentations increased from 27 2018/19 to 36 in 2019/20. A scientific writing workshop was conducted by the research core team in Oct 2019, 26 participants were trained; out of which 19 (73%) staff successfully wrote and submitted abstracts, 17 (89.5%) abstracts were accepted and presented in various international scientific meetings. Baylor-Uganda staff successfully submitted 36 abstracts out of which 25 (69.4%) were accepted for presentation at international conferences.
Results Dissemination to Key Stakeholders
The Baylor-Uganda Community Advisory Board (CAB) was engaged in the dissemination of preliminary findings of IMPAACT 2009 (PK component) in May 2020, and IMPAACT 2010 in March 2020. The HOPe project preliminary findings were also disseminated at the launch of the CDC-funded Child and Adolescent Tuberculosis Center of Excellence (COE) for Sub-Saharan Africa held in Uganda in July 2019.
Baylor-Uganda Research Impacting Healthcare Policy
Research conducted at Baylor-Uganda continues to impact local and international health policies (table below). Details about studies that have impacted healthcare policies can be accessed at https://www.baylor-uganda.org/publications/.
| Study | Objective | Policy impact |
ODYSSEY Trial
Funding source:
Viiv Health care and PENTA Foundation | To compare efficacy and safety of dolutegravir-based ART vs standard of care for HIV-infected children <18years of age starting ART or switching to second line HIV ART. | The FDA, WHO and Uganda MoH adopted use of dolutegravir (DTG) among HIV-infected children less than 20kg. Baylor-Uganda research site, under Dr. Adeodata Kekitiinwa’s leadership as site PI and Dr Pauline Amuge as trial manager; contributed pharmacokinetic, safety and efficacy data that led to the FDA approval of dispersible dolutegravir tablets (5mg, 10mg, 25mg) for use in children living with HIV for first-line and second line. Link to the video: https://vimeo.com/432489467 ODYSSEY news: ODYSSEY trial plays an important role in FDA approval of Dolutegravir for children |
IMPAACT 2010 (VESTED study) Funding Source: NIAID and IMPAACT
| To compare DTG, EFV, TAF and TDF containing regimens with regard to safety and virologic efficacy during pregnancy and through 50 weeks of maternal and infant follow-up postpartum | The MoH adopted use of dolutegravir (DTG) and TAF-containing treatment regimens for pregnant and lactating women in the HIV treatment guidelines 2020. The Baylor-Uganda site PI, Dr Violet Korutaro, was among the investigators who participated in this study The IMPAACT 2010 study proved that DTG is started at 14-28 weeks of pregnancy is safe and more effective for viral suppression during pregnancy than an EFV-containing regimen. The results of this study were discussed at CROI as a late breaker abstract. |
HOPe project
Funder: PEPFAR/CDC | Increasing TB and HIV case finding among household TB contacts through household-based outreach and patient engagement (HOPe). | The national TB and leprosy control program (NTLP) at the ministry of health has developed and tested an electronic TB and leprosy case-based surveillance system (eCBSS) benchmarking on the electronic contact tracing register that was piloted by Baylor-Uganda in Kyenjojo district under Dr. Pauline Amuge’s leadership. This will be a nation-wide TB and leprosy electronic case-based surveillance system to facilitate centralised active surveillance and data-driven training and mentorship in TB care from the national TB and leprosy program. |
LOLIPOP study, a Phase I/II Sponsor: DNDi
| To estimate the population average exposure to LPV, ABC and 3TC in the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands. | The 4-in-1 (ABC/3TC/LPV/RTV) capsule ART formulation had been adopted by WHO for HIV treatment among younger children >3kg to <25kg. Baylor Uganda was among the sites for this study, with Dr Grace Kisitu leading the study at the site. The paediatric formulation, 4-in-1 has been included in HIV-infected children, weighing 3 to 25 kg following findings from this study. https://www.aidsdatahub.org/sites/default/files/resource/who-considerations-introducing-new-antiretroviral-drug-formulations-children-2020.pdf |
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CAPACITY BUILDING FOR RESEARCH
Baylor-Uganda, working closely with her partners, has implemented a successful capacity building model for researchers; with the goal of developing research that addresses community problems and informs healthcare policies. The capacity building activities span both individuals and institutional capacity. These include but not limited to;
- Standardized trainings —incorporating competence-based training principles, in-house online training and follow-up support for Good Clinical Practices (GCP) and Human Subject Protections (HSP) for staff, GCLP.
- Customized trainings —developing tailored trainings focused on specific needs and challenges, such as Grants Management; Research Data Analysis; Study Coordination; Quality Management; Safety reporting; Good documentation practices; and manuscript writing. Five (5) quality assurance quality control staff were trained by a technical advisor; CMEs were held for staff at COE and CMEs were held for the staff in the regions
- Coaching and Mentoring —collaborating with technical specialists who mentor and coach young investigators, for example 03 new study Investigator of Records/ Principal Investigators were coached; medical students were coached; new researcher from various graduate programs were mentored
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SYSTEMS AND INFRASTRUCTURE FOR RESEARCH
Baylor Uganda CAP-accredited Laboratory
Research Pharmacy
The DAIDS –approved research pharmacy installed a chemosphere that now facilitates conduct of research on injectable ART. On-site training was done for pharmacists on use of a chemosphere in the research pharmacy for preparation of investigational products. The Baylor-Uganda research pharmacy was also selected by NDA as one of the reference pharmacies for. The Baylor-Uganda CRS pharmacist of record, Dr Rogers Sekabira and the clinic Manager Dr Jacqueline Kanywa leading a US delegation visiting the Baylor-Uganda research pharmacy.
Regulatory Affairs Office
The regulatory affairs office ensures that all studies at Baylor Uganda are conducted in compliance with the applicable research regulations i.e. local, international and sponsor regulations. The regulatory affairs office has established an electronic (e-regulatory) filing and monitoring system for all its functions related to research at Baylor.
Community Advisory Board (CAB)
The CAB educates communities of interest about new and on-going studies at Baylor Uganda. Conversely, CAB also receives the communities’ views or perceptions of the studies, their fears, likely barriers and enablers for recruitment in the community. The CAB has been active in meeting stakeholders in Key population/ Priority populations to inform them about the new research in PrEP; and participated in dissemination of the IMPAACT 2009 and IMPAACT 2010 results to HIV treatment and prevention stakeholders in Uganda.
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CONDUCTING ETHICAL RESEARCH DURING SPECIAL CIRCUMSTANCES
Continuity of health care and research during the COVID-19 pandemics: Best Practices
Baylor Uganda research teams continued study participants’ follow up during the COVID-19 pandemic.
- COVID-19 risk management plans: Research continuity plans were developed in line with guidance from the study sponsors, prevailing government directives, and the Baylor-Uganda COVID-19 task force. Best practices included; developing institutional SOPS on transporting participants and staff; delivery of drugs to participants using courier services and community linkage officers; adherence to all COVID-19 Infection Prevention Control (IPC) safety measures, use of personal protective gear by participants and staff.
Photo. Research Fleet and distribution assistant, Mr Kasinge Joe; screening HPTN 084 study participant for COVID-19 before transportation to the study clinic.
- IPC training: The required IPC training during this COVID-19 era was done using majorly virtual platforms such as Zoom, emails, and staff whatsapp groups. The latter was particularly useful in the event of internet challenges and especially for quick national updates on COVID-19 disease.
- Drug delivery to participants
Innovations using the approved courier systems to deliver study products for Odyssey and IMPAACT P1115 study participants whose movement from district to district was restricted as part of government safety measures were used to ensure study product compliance.
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PAEDIATRIC ONCOLOGY AND HAEMATOLOGY TRAINING PROGRAM
On-going research
The PHO program is currently implementing the CAPP-Study (clinical and pathological phenotypes of paediatric cancers in sub-Sahara African setting). The main purpose of the CAPP Study is to accurately characterize the clinical and pathological phenotypes of childhood cancers, and their determinants that are critical to adapt treatment modalities and protocols that have been successfully used in Europe/USA so that children in SSA achieve survival outcomes that are at par with their counterparts in high income countries.
There are also two quality improvement (QI) projects conducted by Joan Nakabiri (Mucositis assessment of paediatrics patients receiving chemotherapy at MNRH) and Cosiate Abenawe (Paediatric advanced warning signs assessment in children with cancer at MNRH)
Partners and Collaborations
There’s a psychosocial support initiative that is run by volunteers to help support patients with their psychosocial needs like transport back home, food, clothing and counselling.
Systems and Infrastructure for PHO program research
The PHO is constituted by a team of; 06 fellows, 11 Nurses, 05 Medical Officers, 02 research staff, 06 faculty members, 02 pharmacists, 04 Data team members, 01 training coordinator and 01 program manager. All these personnel facilitate the smooth running of the program and research.
Capacity Building
- The PHO fellowship program had 04 paediatric haematology-oncology specialists graduate in October 2019. These include; Doctors Victoria Mwebe, Deogratias Munube, Lulu Chirande and Robert Kimutai and they had all done/started QI projects as part of their fellowship program, that is in Neuroblastoma, Ketamine sedation, LCH and Retinoblastoma respectively. Currently there are 06 PHO fellows in year 2 under training and 06 fellows who have recently finished their final examinations awaiting graduation.
- The PHO program also runs a specialist nursing training program. Out of the 11 enrolled in 2019, seven completed this training and graduated in Mar 2019.
- Weekly continuous medical education sessions (CMEs) are run by the faculty and fellows. These include; solid tumor boards, leukemia/lymphoma tumor boards
- Weekly Journal clubs, mortality and morbidity, global oncology conference, reflective practice and leadership seminars, research seminars, are also held with the felloes and faculty.
