The goal for our research group is to conduct patient-oriented research that may help reduce morbidity and mortality for tuberculosis (TB), HIV, malaria, and other infectious diseases of importance in resource-limited settings.
Our clinical research program has centered on the evaluation of novel rapid diagnostic tests, clinical trials to evaluate point-of-care testing interventions, and applying implementation science frameworks for methods to accelerate treatment and improve patient-centered outcomes. We have been conducting translational, clinical and implementation science research, including randomized controlled trials, in sub-Saharan Africa since 2003, and in south-east Asia since 2015. Our research group consists of Research Scientists, doctoral and masters graduate students, medical students, and undergraduates. We have developed and maintained strong research collaborations in South Africa, Kenya, Thailand, Uganda, Brazil, Bangladesh, and Vietnam.
Our research program has been funded through several institute of the National Institutes of Health, including NIAID, NICHD, NIBIB, NIMH, and Fogarty International Center, the US Centers for Disease Control (CDC), the Bill and Melinda Gates Foundation, and several industry partners. In addition, Dr. Drain serves as the Director of Clinical Research for the International Clinical Research Center (ICRC), the Director of the Clinical and Translational Science Core for the Seattle Tuberculosis Research Advancement Center (Sea-TRAC), and has been a standing member of the Guideline Committee on HIV Treatment and Monitoring at the World Health Organization.
Research Focus Areas
HIV
STREAM HIV Study
Title: Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa
Major Goals: In this study, we will evaluate a combined implementation of clinic-based point-of-care HIV viral load testing and task shifting among healthcare workers as a novel and effective strategy for managing chronic HIV care in low and middle-income countries.
Source of Support: NIH/NIAID; R01 AI 147752
DREAM Resistance Study
Title: Drug Resistance Genotypic and Phenotypic Correlates of Efavirenz and Dolutegravir based Treatment Outcomes across Non-B HIV-1 Subtypes Major Goals: This proposal seeks to expand our understanding of HIV drug resistance and its correlates and consequences in low and middle income counties where HIV-1 non-B subtypes circulate. Source of Support: NIH/NIAID, R01 AI 147309
RESTRICT Study
Title: A novel REverSe Transcriptase Chain Termination (RESTRICT) assay for near-patient, objective monitoring of long-term PrEP adherence
Major Goals: In this proposal, we will optimize the REverSe TRanscrIptase Chain Termination (RESTRICT) assay to measure TFVDP concentrations in PrEP clients, validate the assay to meet CLIA requirements, and conduct a feasibility and acceptability study among PrEP clients and providers.
Source of Support: NIH/NIAID; R01 AI 157756
V-OLA HIV Study
Title: V-OLA: point of care HIV viral load monitoring and drug resistance testing
Major Goals: The goal of this study is to develop the first test for detection of viral load and HIV drug resistance that is appropriate for use in low-resource settings.
Source of Support: NIH/NIAID; R01 AI 145486
PUMA Study
Title: Point-of-care Urine Monitoring of Adherence (PUMA): Testing a Real-Time Urine Assay of Tenofovir in PrEP
Major Goals: The goal of this project is to examine a novel urine-based immunoassay to tenofovir as a real-time metric of adherence to PrEP. We will use data from a directly-observed therapy study of tenofovir to package the antibody-based assay into a point-of-care assay; look at the correlation between urine levels via this immunoassay with plasma levels in Partners PrEP; and perform a pilot study among women in Kenya on PrEP of the impact of real-time monitoring and feedback using this assay on adherence.
Source of Support: NIH/NIAID; R01 AI 143340
Standing Tall
Title: Standing Tall – A Pilot Randomized Controlled Trial of a Community-Based Intervention to Improve Health Outcomes for Newly Diagnosed HIV-Positive Young Adults in South Africa
Major Goals: The work proposed in this administrative supplement will provide critical insight into the acceptability and feasibility of rapid ART scale-up among HIV-positive adolescents and young adults, as well as the potential role for POC testing.
Source of Support: NIH/NIMH; R34MH114897
Head Start Study
Title: Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV
Major Goals: The overall objective of this study is to conduct a cluster randomized controlled trial to discern the effectiveness of “Head StART,” community ART delivery for those newly
diagnosed with HIV, compared to standard care (facility-based ART delivery) to achieve HIV viral.
Source of Support: NIH/NIMH; R01MH130216-01A1
TB
Prove TB Study
Title: Prospective Evaluation of Novel Diagnostics for Tuberculosis in KwaZulu-Natal, South Africa: The PROVE TB Study
Major Goals: The goal of this study is to conduct prospective clinical evaluations of emerging TB diagnostics, with an emphasis on novel urine LAM assays, among adults and children in a high TB-burden setting of KwaZulu-Natal, South Africa. This grant will be used to maintain a biorepository of well-characterized clinical specimens that can be used for either for retrospective validation of TB diagnostic or to share with partners developing novel TB diagnostics, including new LAM antibodies.
Source of Support: Bill & Melinda Gates Foundation; OPP1213504
Prove TB-Vietnam Study
Title: Development of a reference assay and standards to harmonize measurement of TB LAM in urine
Major Goals: Prospective Evaluation of Novel Diagnostics for Tuberculosis in Ha Noi, Viet Nam” (PROVE-TB-VN).
Source of Support: Bill & Melinda Gates Foundation; OPP1208704
Oral Swab for TB Diagnosis
Title: Development of methods for use of oral swab in TB diagnosis
Major Goals: This project will further the development of methods for detecting Mycobacterium tuberculosis (MTB) DNA in non-invasive oral swab samples in relevant clinical settings. It will also evaluate user attitudes toward oral sample analysis (OSA), and evaluate OSA as means to find the “missing millions” of undiagnosed TB cases.
Source of Support: Bill & Melinda Gates Foundation; INV-004527
Urine cell-free DNA for TB
Title: Transrenal DNA for point-of-care diagnosis of TB
Major Goals: We aim to develop a test for TB using an easily-collected urine sample.
Source of Support: NIH/NIAID; R21 AI163613-01
Pediatric TB-FLOW Study
Title: Enhancing Pediatric Diagnosis of Tuberculosis with FLOW Technology
Major Goals: To optimize and adapt Salus’ urine-based FLOW technology for the diagnosis of tuberculosis in pediatric patients
Source of Support: NIH/NICHD; R43/R44 HD101201A
TBESC 3
Title: Tuberculosis Epidemiologic Studies Consortium III Support Services
Major Goals: The purpose of this grant is to establish a multicenter epidemiologic research study using the principles of implementation science to identify the characteristics of LTBI targeted testing and treatment programs that are associated with the greatest effectiveness.
Source of Support: US Centers for Disease Control; 75D30121C12880
Abbott hsLAM
Title: Clinical Validation of a High-Sensitivity Urine LAM Assay
Major Goals: The work proposed aims to validated a new urine hsLAM assay and defined the optimal diagnostic algorithms among the target populations of adults and children in several high-priority TB-endemic countries.
Source of Support: Abbott Laboratories; 15662006
Sea-TRAC
Title: Seattle Tuberculosis Research Advancement Center – Clinical and Translational Science Core (“CTSC”)
Major Goals: The CTSC will strengthen clinical and translational TB research through training and consultation in clinical science methodology and support of local collaborations; strengthen TB clinical research by developing and expanding partnerships with national and international collaborators conducting clinical and translational research in TB; and foster and catalyze collaborations with investigators with established cohorts, robust clinical databases, and biospecimens for advancing basic, translation, and clinical TB research.
Source of Support: NIH/NIAID; 1P30AI168034-01
TRTC
Title: UW TB Research & Training Center (TRTC)
Major Goals: The goal of this grant is to support the UW TB Research & Training Center which fosters innovation and collaboration among investigators, trainees, and local institutions in Seattle.
Source of Support: Bill & Melinda Gates Foundation; OPP1187752
COVID
InBios Covid Study
Title: Development of an FDA-cleared Rapid Diagnostic Tests to Detect Biomarkers of SARS-COV-2 Infection
Major Goals: The primary objective of the study is to evaluate the positive percent agreement (PPA) and negative percent agreement (NPA) of the SCoV-2 Ag Detect™ Rapid Self-Test used in a non-laboratory setting by lay users compared to a reference test, a SARS-CoV-2 RT-PCR test that has received emergency use authorization (EUA) from the FDA. Paired anterior nasal swab specimens will be prospectively collected from enrolled subjects with symptoms of respiratory infection consistent with SARS-CoV-2 infection within 5 days of the subject’s first onset of symptoms. The study endpoint will be achieved when at least 30 unique PCR positive subjects and at least 150 subjects total are enrolled and tested from multiple sites.
Source of Support: US Department of Defense; W81XWH-16-D-0009
ROSSEY Study
Title: Using COVID-19 Testing and Risk Communication Strategies to Accelerate Children’s Return to School
Major Goals: This project proposes to develop, test, and evaluate risk communication strategies on COVID-19 preventive behaviors, COVID-19 testing, and vaccination using a cluster randomized controlled trial. The study partners with a large school district and will recruit 900 Hispanic families.
Source of Support: NIH/NICHD; 1OT2HD107544-02
Rapid Diagnostic Testing
DASH Study
Title: Rapid Diagnostic-Facilitated Access to Self-Care & Health Services
Major Goals: To develop and evaluate an integrated self-care rapid diagnostic testing package(s) that will facilitate home- or community-based screening, testing, and treatment initiation for both infectious and chronic non-communicable diseases (NCDs) in LMICs.
Source of Support: Bill and Melinda Gates Foundation; INV-050665
