The 2nd International Conference on Adherence to Antiretroviral Therapy, dedicated to sharing and demonstrating experiences and mechanisms of improving adherence, was held in Richardson (just outside Dallas), Texas, December 4-7, 2003. Once again, this conference brought in attendees from around the world who have decided to take action against complacency in adherence initiatives by developing novel assessment techniques, make improvements to patterns of adherence to antiretrovirals in historically difficult populations, creatively institute programs in environments with limited resources and be confident enough to share that data over three days with others in related practice and outreach settings. Clinicians and others presented findings of their initiatives to enhance adherence, medication tolerability and outcomes in their respective institutions that dealt directly with patients. A small sample of those presentations is summarized here.
Dr. Lamberjack of the Children's Hospital of Columbus, Ohio provided attendees with approaches to enhancement of adherence in a family practice setting serving 42 counties in central and southern Ohio. Dr. Lamberjack's study's objective was to increase adherence in recognized non-compliance by providing pharmacist-based medication and adherence counseling. After interviewing patients and families regarding antiretrovirals, medication-taking patterns and reasons for missing doses, a compliance score was determined (scale 1-3: 3 = >90% compliant, 2 = 50% - 90% compliant, 1 = <50% compliant).
If patients fell into the categories of 1 or 2, they were scheduled for intervention by the pharmacist. Interventions were: 1) provision of medication-specific counseling and adherence importance, 2) written information on drug, dosing and adverse effect, 3) distribution of pill boxes and assorted reminders, and 4) follow-up phone calls and visits. Results were presented after 12 months of the program.
Twenty-six patients were targeted for interventions. The population was 85% female, 62% African-American, 8% Hispanic and ages ranged from 7-41 years. Where were they when they started? Eight percent were 3s, 27% were 2s and 65% were 1s (remember -- it's not good to be #1 here!). After the interventions? Sixty-one percent were 3s, 31% were 2s and only 8% were 1s. Accompanying the score changes were 62% of patients with reduced viral loads and improvements in CD4 counts.
Conclusions? Improvement in clinical markers and compliance can be realized by pharmacist counseling and interventions after those patients are identified. For more information on the scoring process and results, contact Dr. Lamberjack at firstname.lastname@example.org.
Non-adherence was the reason Dr. Lee and a team of providers of the McAuley Health Center at St. Mary's Mercy Medical Center in Grand Rapids, Michigan became involved in a multi-disciplinary approach to improving outcomes in the patients. This presentation described the initiatives just underway at this clinic.
A readiness assessment is performed by the team prior to any antiretroviral regimens being prescribed at this center. Potential barriers are addressed and the patient is encouraged to recruit friends and family members to assist in the treatment program. After this is completed, a one-on-one session with the clinical pharmacist is scheduled. This one-time educational session provides in-depth information, appropriate for the patient's understanding and education level, on the medications, side-effects, dosing and diet requirements.
Once completed, the patient receives: a one week follow-up phone call, a week two laboratory assessment and a visit with nurse-case management, a week 4 phone call from the clinical pharmacist, nurse-case management visits at weeks 6 and 12 and finally back to see the physician at week 14.
Multiple measures of adherence are done by self-report, pharmacy logs, pill counts and biological markers. Patients also receive a 24-hour prior to appointment reminder phone call and have access to clinical staff during non-clinic hours. Some limited results were presented that included prevention of ER visits due to on-call consultations with the pharmacists regarding adverse effects of medications and that adherence is improved. As mentioned in the most recent DHHS guidelines (U.S. Department of Health and Human Services), using multiple approaches, disciplines and levels of intervention are being shown to positively influence adherence.
Using readiness as a predictor of adherence is a sound approach to deciding if it is time to start antiretrovirals, according to a formal presentation by Dr. Enriquez of the University of North Carolina, Chapel Hill. This real-time observational study examined the level of readiness for health behavioral change and adherence in 36 HIV-positive persons who had previously failed therapy. An index of readiness was completed by patients prior to beginning new antiretroviral regimens. After six months of therapy, patients were divided into those who reached and sustained viral suppression and those who had not. A higher index of readiness was a significant predictor for virologic success (p<0.05). The researchers propose this follow-up study to a previously completed one reinforces the clinical utility of an index of readiness as a valid predictor for adherence. They also suggest that interventions enhancing readiness prior to prescribing antiretrovirals can improve adherence. These types of interventions were not provided however.
The Buddy System
"Project HAART" was a small study conducted by Plummer and Simoni at an outpatient HIV clinic in the Bronx that targeted improving adherence by enhancing social services for patients. This project established "buddies" for four domains of support: affirmational, emotional, spiritual and informational. Participants (study subjects) were patients recruited from the clinic and randomly assigned to the buddy program or to a control group.
The buddy group has six meetings (one every two weeks) with other buddies and others. Phone calls from a designated buddy were done two to three times per week. Participants completed questionnaires at the start, half-way through the program and at the end of the six-month study period. One-hundred thirty-six patients were enrolled. Forty-six percent were African-American, 44% Hispanic, 45% female, average age was 43, 85% were unemployed and 75% acknowledged heavy drug use. Results are based on the 86 participants completing the program. They reported an improved adherence at 6-month follow up based on patient self-reporting, although exact numbers were not provided nor were viral load and CD4 changes. This component of the conference was to provide proof-of-concept studies and not necessarily medical outcomes. This is, however, another reinforcement of how providing more than just direct medical-associated interventions can improve adherence.
Peer Support in the Clinic
Along similar lines, but seemingly a more formal program was presented by Micki McCaffery of the Kansas City Free Health Clinic based in Kansas City, Missouri. This clinic provides HIV and primary medical care to approximately 400 medically indigent HIV-positive adults. A peer-adherence program was put in place in late 2001. Eight clinic-based, peer, paraprofessional counselors (one Caucasian, five male) provide engagement support for medical care and adherence to patients on either an individual or group basis. These individuals, by maintaining contact with patients on a routine basis, provide the medical team critical information with respect to the patient's understanding and state of medical, social and economic status. Peer counselors, being on-site, are incorporated into each primary care visit and bring to the visit unique support, insight and skills to patients. Further information on this invaluable component and how to integrate it into a medical service model can be gained by contacting Ms. McCaffrey at email@example.com
More Peer Support
Another peer-counselor program is going on at the University of Maryland's Evelyn Jordan Center. At this other Ryan White-funded clinic, a social worker and three to four peer counselors provide interventions to patients identified by providers to be non-adherent (missing more than three medical appointments per year or difficulty with a prescribed regimen). Here an adherence intervention care plan is set-up after an interview with the patient. These interventions include the list of usual suspects: pill boxes, phone calls, case management, group education, and others. The findings of this project were based upon four years of follow-up and beyond the scope of this summary. Conclusions made by the researchers reinforce the need for continual assessments and ongoing interventions.
These and many other incredible success stories were presented over the three-day conference. The primary source of funding for the conference was pharmaceutical companies, but the vast majority of presenters were not easily recognized names on a national level. Instead, they are irreplaceable in their respective practice settings as was evident by the passion and level of excitement in learning mechanisms to improve adherence in resource-poor settings. The conference will be held once again this December, likely again in Dallas. More information on this conference can be found at: http://elements.netsos.com
Patrick G. Clay, Pharm.D., is an Assistant Professor at the University of Missouri, Kansas City and HIV Clinical Pharmacist at the Kansas City Free Clinic.