Antiretroviral Treatment Access Study
Begins at Grady Memorial Hospital
A clinical study seeking to determine whether a case management intervention will improve attendance and usage of HIV health care services by individuals newly diagnosed with HIV infection will begin at Grady Memorial Hospital and local-area health departments and testing centers on January 1, 2001.
The Antiretroviral Treatment and Access Study (ARTAS) is funded with a multi-site, four-year grant by the Centers for Disease Control and will look specifically at strategies to increase access to care for low-income, HIV-infected persons. The study sites are Atlanta, Baltimore, Los Angeles and Miami, and will focus on "disadvantaged" populations, including minorities, uninsured, and drug users.
The primary objective of the study aims to measure the impact of a client-centered, case management intervention on the rate of access and use of HIV care by individuals newly diagnosed with HIV infection. Secondary objectives include determining client-identified barriers to accessing HIV care, and demographic and behavioral information.
Each site will enroll 150 persons who are newly diagnosed with HIV infection. Potential participants will be screened at sexually transmitted disease clinics, community clinics, university-based research clinics, drug treatment centers, inpatient services in hospitals, and counseling and testing sites. HIV counseling will be provided to all participants as part of the baseline enrollment information.
Dr. Carlos Del Rio, associate professor of medicine at Emory University and director of HIV Inpatient Services at Grady Hospital, says the CDC has big hopes for the study.
"The CDC hopes the study can lead to recommendations on policies about how to get patients into care nationwide," says Del Rio.
The criteria for participating in the study includes reported first diagnosis of HIV infection within the previous three months; HIV diagnosis will be confirmed from medical records or testing facility records; participants must be greater than or equal to 18 years of age; residence within the catchment area of local providers, including homeless persons; and ability to give informed consent.
Persons volunteering in the study will be randomized into two groups at the time of study enrollment. One arm will receive the standard-of-care post-test counseling currently offered by the various sites participating in the study. Standard-of-care participants will be referred to an HIV care provider and encouraged to seek and remain in care.
The second arm of the study is the case management intervention arm. These participants will receive the same care as those in the standard-of-care group. The case management is a highly structured intervention based on a strengths-based model. Components of the intervention include: accompanying the client to the initial HIV care visit; and reinforcing issues raised in the initial encounter with the care provider (i.e., benefits of ART, the rigors of pill-taking, the side effects of ART treatment; and the desirability of additional medical services).
Attention will also be given to completing a needs assessment to identify barriers and actively linking the client to other services, such as assisting with applications for housing, insurance or public assistance, transportation to childcare; and transferring the person to the case manager or social worker at the health care site, if needed.
All participants will complete a questionnaire at the time of enrollment, and at six-month and 12-month follow-up.
MORE ABOUT THE STUDY
A substantial proportion of newly diagnosed HIV-infected persons do not immediately seek an HIV care provider or clinic, and may stay "hidden" in more advanced stages of HIV infection. The ARTAS study aims to design and evaluate a case management intervention targeted at individuals recently diagnosed with HIV to determine if case management can "bridge the gap" between HIV diagnosis and entry into care.
According to protocol design, the outcome measure of "in care" will be a minimum of two or more visits by recently diagnosed HIV-infected persons over a 12-month period to an HIV care provider, with the further requirement that there be at least one of the two visits in each six-month period. A secondary objective is to determine if the rate of antiretroviral therapy (medication access) is higher for those associated with the case management arm than for those who received traditional counseling in the standard-of-care arm. Another secondary objective is to characterize in the interview barriers and facilitators of HIV care, and to determine if these perceived barriers correlate with the rate of use of HIV care.
Some of the outcome measures include participants who successfully start ART medications and successfully remain on the medications. Information will be gathered from chart abstractions on all participants.