When highly active antiretroviral therapy (HAART) became the treatment of choice for HIV/AIDS in the mid-1990s, many viewed it as the next best thing to a cure. These standard HIV treatments of two to four medications taken in combination can virtually stop the virus in its tracks, transforming the disease from death sentence into chronic illness. But there's a catch--HAART is demanding.
According to recent studies, adherence rates of 95 percent or higher are needed for it to work. Furthermore, patients' failure to adhere to medication regimens can cause the virus to multiply rapidly and become drug resistant.
Many patients, however, find it hard to maintain such high adherence rates because of side effects, complex and rigorous dosing requirements, and psychosocial factors, according to Perry N. Halkitis, PhD, a health research psychologist. Recent studies identify HAART adherence rates ranging from 56 percent to 77 percent, depending on how it is measured, he says.
"Which human being [adheres to a recommended behavior] 100 percent of the time? Who doesn't miss the gym now and again, or forget to take his or her vitamin supplements?" asks Halkitis, one of an emerging group of research psychologists studying ways to improve patient adherence to HAART. "People are not perfect, and yet we want HIV-positive individuals on meds to be."
Many patients may require interventions to help them meet such high adherence requirements, psychologists say. Such interventions are urgently needed, says psychologist Jeffrey T. Parsons, PhD, in the fall 2002 issue of Psychology & AIDS, the APA Office on AIDS newsletter, because "few published studies exist that document efficacy of behavioral interventions designed to improve medication adherence among persons with HIV."
Why HAART is so hard
To better understand what promotes adherence, psychologists have first been studying what hampers it. Using her theoretical research on stress and coping, for example, health psychologist Margaret A. Chesney, PhD, has studied patient characteristics associated with poor adherence to HAART. Chesney is among several researchers who've found a correlation between poor adherence and alcohol and cocaine use. She and a few colleagues have also found a link between depression and poor adherence.
"Few studies have compared the effectiveness of interventions to improve adherence among substance users or depressed patients," says Chesney, deputy director of the National Center for Complementary and Alternative Medicine. "But data indicate that certain strategies may have some success," says the former co-director of the Center for AIDS Prevention at the University of California, San Francisco.
For example, she says that recent guidelines from the U.S. Department of Health and Human Services:
Recommend temporary postponement of HAART initiation in patients who may benefit more immediately from psychological treatment or treatment for chemical dependency.
Suggest that greater adherence may be possible among substance abusers who have consistent support and contact with staff.
Another obstacle to adherence, according to Chesney, is patients' lack of understanding of their HAART regimens. Chesney and colleagues found that a large number of patients did not fully understand their prescribed regimens during an Adult AIDS Clinical Trial Group study--published in AIDS Care (Vol. 12, No. 3) in 2002. Trial participants were asked to complete a questionnaire about their medication compliance. "It quickly became apparent that many participants who reported high levels of adherence were adhering to a regimen that was not the one prescribed," Chesney says.
The problem, according to Chesney, was that clinic staff weren't counseling patients enough. "In some clinics, patients were basically given a grocery bag with their medications," Chesney says. "Staff didn't sit down and help them generate a strategy for integrating the medication into their daily lives."
These regimens involved varying numbers of capsules or tablets of numerous medications that needed to be taken at varying frequencies throughout the day, Chesney continues. Complicating matters further, clinical-trial drugs often look alike; manufacturers seldom vary their appearance at the experimental stage.
Chesney and colleagues subsequently developed patient-counseling strategies using behavioral and educational components to improve HAART adherence. They include:
Making certain that the patient understands the regimen.
Developing a plan for setting out the regimen on a daily basis, including using weekly or daily pill boxes.
Identifying daily activities that can serve as cues or reminders to take medication, integrating medication into daily life.
Discussing recently missed doses to identify adherence barriers.
A recent study by Halkitis and colleagues reveals another compliance insight. The study found significant drops in HIV medication adherence in a cohort of New York City gay and bisexual men after Sept. 11, 2001. This and other findings point to the difficulty of grappling with challenging life events while also coping with HIV-related problems, says Halkitis of his study, published in the May Journal of Urban Health: Bulletin of the New York Academy of Medicine (Vol. 80, No. 1).
Anything that disrupts people's routines can affect adherence, adds Halkitis, the co-director of New York University's Center for HIV/AIDS Educational Studies and Training who received the 2002 APA Committee on Psychology and AIDS Emerging Leader Award. Says Halkitis: "Our goal is to help people develop adherence strategies for dealing with these changes or breaks in routine...and to develop systems that will allow patients' adherence routines to be applied to different contexts, times and places."
Beepers and buddies
Jane M. Simoni, PhD, a clinical psychologist at the University of Washington, Seattle, is preparing to test two such systems in a controlled, randomized intervention with inner-city outpatients at a public hospital clinic in Seattle.
The study--funded by the National Institute of Mental Health--will compare the relative effectiveness of a "buddy" system and a pager intervention against standard care, which requires each patient to meet with a pharmacist, nutritionist and social worker before starting medications. The buddy intervention involves training adherent HAART patients from the clinic to provide emotional, affirmational and informational support to study participants. Buddies call participants three times a week. Buddies and study participants also attend peer support meetings every other week for three months. The pager intervention uses two-way, alpha-numeric beepers programmed to automatically alert patients to take their HAART doses according to their prearranged schedules.
About 240 patients will be matched with a buddy, a pager, both or standard care. Participants' adherence will be assessed using self-report questionnaires, pharmacy-refill records and the Medication Event Monitoring System, an automated pill counter.
Based on findings from two preliminary studies and her review of HAART adherence interventions, Simoni expects the more comprehensive buddy and pager interventions to be more helpful to patients. She says the study may also yield data that will assist practitioners in matching clients to intervention strategies.
NYU's Halkitis, for one, supports Simoni's efforts to tailor interventions. "One-size-fits all will not work here," he says.APA's Office on AIDS offers an online curriculum for its HOPE program, which teaches psychologists to become HIV/AIDS prevention trainers. For more information, contact Director John Anderson, PhD, at the APA address; (202) 336-6042.