I frequently am asked why programs like the HRSA/HAB/SPNS Projects are evaluated. Why, people wonder, do we have to ask if these programs produce positive medical outcomes? And, if we do, shouldn't we use randomized research designs?

It is well established from clinical trials of new pharmaceuticals that current HIV/AIDS medication regimens, especially in combination, work to reduce viral load and generally improve health. Other drugs can act as prophylaxes for opportunistic infections and these effects have been well established in clinical trials. Do we have to evaluate  programs to establish that these therapies work? To this question, I would answer, "Not really... much more rigorous and controlled studies have already established efficacy."

Clinical trials, however, enroll "eligible" patients and then make sure that they have adhered to the recommended dosing and its timing for the drug being tested (or the placebo). Patients are screened for eligibility. Patients who do not adhere to the protocol may be removed from the pool for whom effects are established at the time that efficacy is statistically assessed.

Given the complexity of current HIV/AIDS medication dosing regimens and their reliance on timing and diet, one could argue, as I would, that perhaps not all individuals with HIV/AIDS will be able to as rigidly adhere to the treatment regimen as might be required by a standardized treatment (research) protocol. This might especially be the case for someone who is unemployed and homeless, abuses drugs, has children that need care, has mental illness, deals with an abusive partner, or has just gotten out of the criminal justice system and is distrustful of all institutions.

As is seen throughout the Online Knowledge Base on HIV/AIDS Services which documents the relative success of the HRSA/HAB/SPNS models, the patients served by these real-world projects are those who might not be represented in clinical trials of HIV/AIDS drugs. The clients of these SPNS Projects may still use crack (or have stopped very recently), may be engaging in sex work, may have recently come out of prison, may have several young children that must be watched while the patient is in care, may have sex partners or other family members who cannot be told the patient is HIV seropositive, or may still abuse alcohol repeatedly. The clients of these SPNS Projects may know little English and be unable to access services in their native language, they may be much younger or older than other patients at a program, and they may feel stigmatized because of their race-ethnicity, sexual orientation, or other behaviors. The clients of these SPNS Projects may be homeless or precariously housed, often without access to a refrigerator in which to store medications and a telephone with which to contact their healthcare provider, and are dependent upon the public healthcare system. The patients of these SPNS Projects may want to work (and be medically able to do so) but not have skills that allow them to keep jobs, or they may be unable to hold a job and obtain medical services on a regular schedule. The clients of these SPNS Projects are as likely to be women as men.

The clients of these programs often are the patients who will be under-represented in clinical trials. The patients served by these SPNS programs, by the very nature of their needs, behaviors, demographics, geographic distribution, and other factors may not access clinical trials as well as other individuals with HIV/AIDS, or they may tend to be ruled ineligible to participate in these programs.

The SPNS Programs are Special Projects of National Significance selected by peer review for their ability to provide state-of-the-art services to members of populations with significant unmet needs and to produce optimal outcomes. 

When we study the outcomes achieved by these programs, we are establishing the successes that can be expected for very high-need patients who may not have accessed services in the past, and whose behaviors, constraints, and vulnerabilities may make it difficult for them to meet all of the expectations of their healthcare providers unless supportive services are also provided. Such patients may not feel comfortable in healthcare centers. They may not understand what they are being asked to do. And, the requirements of treatment (or their everyday lives) may unleash a torrent of emotional and social problems.

The SPNS Projects establish a "gold standard" for the "best" average outcomes that can be expected for groups of high-need and vulnerable individuals accessing HIV/AIDS services. The SPNS Projects have demonstrated how to eliminate disparities in medical and psychosocial outcomes between groups of high-need and vulnerable individuals and those with fewer vulnerabilities. The results obtained from these projects go beyond those of the randomized, clinical trials that established the efficacy of the medical treatments for HIV/AIDS. The results from these SPNS Projects show the level of outcomes that can be achieved using state-of-the-art medical treatments with patients who may use illegal drugs, may have mental illness, have to miss appointments because their children require care, need transportation to the provider, and who may be assaulted by a partner because their HIV status becomes known. The results from these SPNS Projects show how to minimize disparities in medical outcomes, and indeed maximize those outcomes for all individuals.

The SPNS Projects show us how good treatment is provided in the real-world of the Ryan White CARE Act Treatment System which provides services for those individuals who cannot get HIV/AIDS services elsewhere. The SPNS Projects show us that considerable success can be obtained in the "treatment system of last resort" if caring, well-trained healthcare providers and their medical state-of-the-art treatments are supplemented with psychosocial supports in the language of the patient, with childcare for young children, with support groups of peers with HIV/AIDS, with case management, and with substance abuse, mental health, and counseling services.

The point of evaluating these programs is to evaluate how well current therapies and systems of care work in the real world of patients who must use the "treatment system of last resort" if indeed we can convince them to do so. These therapies work for high need and vulnerable patients, and programs can be implemented that minimize disparities in outcomes.