Table 1.

Representative Implementation Research Approach in Africa to Investigate the Efavirenz-Dolutegravir Pharmacokinetic Interaction in Second-line Treatment Regimens

Gap for Second-line Dolutegravir Implementation Research	Organization	Contribution
Dolutegravir rollout sponsor	PEPFAR	Multiple country organization for implementing dolutegravir access
Clinical care site	Hospital-based clinic, Ministry of Health Clinic	Recruitment of participants into protocol
Clinical research unit	NIAID/DAIDS Clinical Trials Units	Study design, regulatory compliance, staff mentoring
Research and training	Fogarty International Center	Funding for HIV research and training programs, support for pilot research projects for scholars
Pharmacogenomics	H3Africa	Laboratory technology for genotyping, sample collection, and transport guidelines
Pharmacovigilance	Pharmacovigilance System in Sub-Saharan Africa	Umbrella organization for organizing the implementation research project
Pharmacokinetics	Clinical Pharmacology Laboratories (eg, South Africa, Zimbabwe, Uganda)	Bioanalysis research with required mass spectrometry instrumentation, validated drug assays
Data collection and harmonization	IeDEA Cohort Consortium	Data collection to facilitate multiple clinical research sites, data analysis

Abbreviations: HIV, human immunodeficiency virus; IeDEA, International Epidemiology Databases to Evaluate AIDS; NIAID/DAIDS, National Institute of Allergy and Infectious Diseases, Division of AIDS; PEPFAR, US President’s Emergency Plan For AIDS Relief.