How the NIC project builds on efforts to quantify unmet need
The NIC project builds on recent shifts in policy and HIV reporting regulations that enhance the feasibility of using standardized methods for characterizing people who have never received HIV care. The purpose of the NIC pilot project is to test and evaluate methods for a supplemental HIV surveillance system to describe a particular aspect of unmet need, specifically delayed entry into HIV care. The NIC pilot is focused on HIV-infected people who received an HIV diagnosis three to 15 months before the date of selection and have never received HIV care.
Eligibility was restricted to those more recently diagnosed, because formative work indicated that project staff would be more successful in contacting these people for interviews using the available contact information, which was collected at the time of diagnosis. Although those who have never received HIV care do not represent the entire population considered by HRSA to have unmet need for HIV services,22
this population was chosen as the focus of the NIC project because there is less information about it, the population can be clearly defined, and the definition can be applied consistently across jurisdictions. A focus on HIV-infected people who have not entered HIV care allows for rigorous testing of case identification and data collection methods and provides a foundation for broadening case definitions to include not only people who have never received HIV care, but also people who have received HIV care but who are not currently in care. The NIC pilot uses HIV/AIDS surveillance data to identify the population of interest, a strategy that has the advantage of being population-based and that has been proven to be one of the most promising strategies among those promoted by HRSA's framework for assessing unmet need.44
The design of the NIC pilot addresses recommendations from the Institute of Medicine (IOM) report “Measuring What Matters: Allocation, Planning and Quality Assessment for the Ryan White CARE Act,” which urges collaboration between HRSA and CDC and other agencies to estimate the number of people who have a diagnosis of HIV infection but who are not in care,45
at least for the subpopulation of people who have never received care. After methods have been validated for characterizing people who have never received care, adjustments in the methods might be made to include people who are not receiving care consistently or as often as recommended.
Description of the pilot project and findings from formative work
CDC is funding five state and local health department jurisdictions to implement the NIC pilot from September 2005 through September 2010 to test and evaluate methods to identify, locate, and interview people reported as HIV infected three to 15 months previously, who have never received HIV medical care. Through an objective review process, Indiana, New Jersey, Washington State, New York City, and Philadelphia were selected to participate in the pilot.
The NIC pilot adheres to the confidentiality and security protections required for all HIV surveillance data. Pilot areas adhere to local regulations pertaining to locating and contacting NIC-eligible participants. People eligible for NIC are located and contacted by using information from the HIV/AIDS Reporting System (HARS) database or through physicians, HIV testing centers, or case management service providers. State laws and regulations protect surveillance information, limit the uses of data for purposes not related to public health, and impose criminal penalties for the inappropriate disclosure of surveillance data.46
Each project area has been granted a Certificate of Confidentiality, which protects the NIC data held by the state or city health department from subpoena. At the federal level, surveillance data are held under the Federal Assurance of Confidentiality, which protects data held by CDC from subpoena.47
To determine eligibility for the NIC project, pilot project areas use local HIV/AIDS case and HIV laboratory databases and, if available, supplemental databases (e.g., Ryan White Title I, Ryan White Title II, and the AIDS Drug Assistance Program). The NIC pilot criteria for identifying people who have never entered care include people who have had a diagnosis of HIV infection reported in one of the five pilot areas, are at least 90 days post-diagnosis, and have had no CD4 or HIV viral load results reported to the relevant pilot area's HIV/AIDS surveillance system. Applying these criteria by using HIV/AIDS surveillance data potentially identifies the population of HIV-infected people whose diagnosis was made during a specified eligibility period and who met the criteria for “never in care.” This population serves as a sampling frame from which to select eligible people to be approached for interview.
Contact is initiated with people selected. During the formative phase of the project, the pilot project areas conducted a trial run of sampling frame construction by identifying people who met the NIC eligibility criteria among those diagnosed between November 2005 and December 2006. These estimates represent the best available data from HARS and associated laboratory databases, before verification of never-in-care status required by the NIC project protocol. Among the 10,090 people who were diagnosed during this 12-month period and reported to HIV/AIDS surveillance systems in these areas by February 28, 2007, 2,119 (21%) had not entered care as of December 31, 2007.
Across the pilot project areas, the percentage of people diagnosed in the 12-month period who met the NIC project definition ranged from 20% to 25%. shows that people who met the NIC project definition were more likely to be younger, African American, and Hispanic than those diagnosed in the same period for whom there was evidence of care entry.
People diagnosed with HIV from November 2005 to December 2006 and reported to HIV surveillance by February 2007 in Indiana, Philadelphia, New Jersey, New York City, and Washington State
Percentages of people never in care derived from HARS and associated laboratory data alone are likely overestimates, because of CD4 and viral load reporting delays and because some people without evidence of care entry should not be included. As mentioned, the NIC protocol requires verification of never-in-care status. Verification is accomplished through (1
) review of incoming CD4 and HIV viral load results; (2
) investigation into other events, such as death or change of residence (which are associated with not having a reported CD4 or HIV viral load result, but nonetheless render a person ineligible to be counted as never in care in the jurisdiction); and (3
) review of HIV counseling, testing, and partner services records containing information on whether linkage to care was successful. Those remaining eligible after this initial screening process are approached for participation and asked additional screening questions, including questions about entry to care. NIC pilot methods for identifying and interviewing eligible people have been described in more detail elsewhere.48
All five pilot areas administer a 30-minute structured interview to those determined to be eligible to describe the following: demographic characteristics, barriers to and facilitators of HIV medical care, met and unmet need for HIV-related ancillary services, social support, HIV testing history, and possible modes of exposure to HIV. Blood is collected by fingerstick and tested by a central laboratory to assess CD4 cell count and HIV viral load. In addition, four of the pilot areas (Indiana, New York City, Philadelphia, and Washington State) are conducting a 60-minute qualitative interview to allow participants to respond in their own words rather than selecting from investigator-defined responses to questions about health-care utilization, illness perception, stigma, and access to HIV information.
The five pilot areas funded to implement the NIC pilot are also participating in the Medical Monitoring Project (MMP), a supplemental HIV surveillance system that collects data on people receiving HIV medical care in the U.S.49
The MMP collects clinical and behavioral data from people receiving HIV medical care. If interview response rates are adequate, the five state and local health department jurisdictions participating in both the NIC project and the MMP should be able to assemble complementary descriptions of met and unmet need among people who are receiving HIV care and people who have never received care.
Potential contributions of national implementation of a never-in-care approach
If proven successful and implemented on a national scale, the NIC project could yield estimates of the number of HIV-infected people in the U.S. who have never accessed HIV care and could provide useful information for estimating the cost of addressing this unmet need. NIC project surveillance could be useful in developing and prioritizing strategies to increase the number of people who receive HIV care within three months of diagnosis. Such efforts are critical in addressing CDC's Advancing HIV Prevention goals of increasing access to HIV medical care and reducing HIV incidence.50
In an effort to increase the number of people who are aware of their HIV serostatus,50
CDC recommended expanding HIV testing and screening to all health-care settings.51
CDC's efforts to encourage HIV testing in nonclinical settings52
and make it routine in medical settings have increased the demand for HIV care services,17,53
but the impact of expanded testing on entry to care is unclear. Representative data on the number and characteristics of HIV-infected people who have never entered care are needed to evaluate this impact and monitor trends.
Information from the NIC project may help describe health-care access and utilization among people of minority races/ethnicities. Health-care access and utilization are often linked to socioeconomic status and race. In its 2003 report, “Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care,” the IOM described disparities in the quality of health care received by people of minority races/ethnicities.54
The NIC project is designed to uncover experiences with the health-care system that may have acted as barriers to HIV care. Such information may be useful in addressing one of the goals of CDC's HIV prevention strategic plan—to reduce the “disparities, stigma, and discrimination” that people of minority races/ethnicities may experience when accessing HIV care.20
Data on people who have never received HIV care may also provide further information for estimates of severity of need, on which HRSA bases decisions regarding allocation of Ryan White CARE Act funding for HIV-related care and support services.18
An expanded NIC project, used as a supplement to the national HIV/AIDS surveillance system, could serve as a critical tool for monitoring, evaluating, and improving initiatives so that all people with a diagnosis of HIV infection have the opportunity to initiate and continue care throughout all stages of disease.
The vision of a continuum of HIV prevention and treatment is incorporated throughout CDC's strategic plan for HIV prevention, recently extended through 2010.19,20
Achieving the benefits of prevention and treatment interventions requires optimizing each component of the continuum—from increasing the number of HIV-seronegative people who receive HIV-prevention services to increasing the numbers of people who are aware of their HIV serostatus, linking HIV-infected people to care, increasing the utilization of care and prevention services, and increasing adherence to prescribed therapies. The goals of CDC's strategic plan reflect the components of the continuum, and national HIV/AIDS surveillance activities are designed to monitor progress toward these goals: behavioral and incidence surveillance monitor progress in prevention,55
case surveillance monitors the expansion of HIV testing through reporting of new diagnoses,43
and the MMP monitors care.49
The strategic plan aims to increase the proportion of people who enter HIV medical care within three months after learning their diagnosis,20
but a mechanism to measure progress toward this goal is lacking. The NIC project, as a supplement to HIV/AIDS surveillance, could address these gaps and be a standardized system for monitoring delayed care entry.