Hiv — Program Refinements to Optimize Model Impact and Scalability Based on Evidence
Citation(s)
Irvine MK, Chamberlin SA, Robbins RS, Kulkarni SG, Robertson MM, Nash D Come as You Are: Improving Care Engagement and Viral Load Suppression Among HIV Care Coordination Clients with Lower Mental Health Functioning, Unstable Housing, and Hard Drug Use. AIDS Behav. 2017 Jun;21(6):1572-1579. doi: 10.1007/s10461-016-1460-4.
Penrose K, Robertson M, Nash D, Harriman G, Irvine M Social Vulnerabilities and Reported Discrimination in Health Care Among HIV-Positive Medical Case Management Clients in New York City. Stigma Health. 2020 May;5(2):179-187. doi: 10.1037/sah0000187. Epub 2019 Aug 12.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
