Sticking with ART – There May be an APP for That

Web-based computer programs and mobile “apps” help countless people track their health every day. Could a web-based program boost medication adherence in HIV-positive patients?

A randomized study of such a program, called “Life-Steps,” coupled with modules for stress reduction and mood management, suggests it may help HIV-infected people stay on their antiretrovirals (ARV). 

The study of 168 HIV-positive adults at a large urban-based health clinic finds that those patients who use the web-based program have significantly better ARV adherence rates than controls, researchers report in the journal AIDS and Behavior.

Although ARV adherence among the Life-Steps group did not really rise (it actually fell slightly), the rate remained steady above 72% throughout the 9-month test period -- compared with a drop from about 85% to 66% among controls.¹

“One reason for poor adherence is that people who are newly diagnosed with HIV often have no symptoms, and the drugs may produce unpleasant side effects. So the side effects are hard for them to overcome,” explains Rebekah K. Hersch PhD, senior vice president of ISA Associates, the Alexandria, Virginia-based behavioral science research firm testing the computer program. “If you feel healthy and have no symptoms you have no reason, no cues to take your medication.”

Other major barriers are stress and depression, says Steven A. Safren PhD, professor of psychology at Harvard Medical School and director of Behavioral Medicine at Massachusetts General Hospital, who developed the original Life Steps program, a cognitive-therapy (CBT) based HIV medication adherence intervention.

“One of the best studies estimates the rate of depression to be 36% among HIV-positive people, remarks Safren, whose research focuses on the issue. “If you think about having to adhere to a regimen of self-care and being depressed -- the sadness, the loss of interest, lack of appetite -- makes it harder to be motivated.”

“If people also feel stressed, having events in their lives that seem beyond their ability to cope, if they lack coping skills, it will also be hard to stay on a complicated drug regimen,” he adds. Self-medication with illegal drugs or alcohol may also interfere.

Overcoming Barriers

Unfortunately, the very nature of HIV medication regimens can make adherence especially difficult.

ARV medications may require different dosing schedules, different food intake patterns and different storage requirements, Dr. Hersch notes. Many medications cause side effects, which may necessitate taking other medication. All this is complicated by psychological factors and substance use.

Safren’s original Life Steps intervention, developed a decade ago, involved a single session of in-person CBT-based counseling designed to address these issues.  His team's 2009 randomized clinical trial of a CBT program that includes many Life Steps elements found greater improvements in both adherence and depression among the intervention group than among controls. 

“The program takes something that’s overwhelming for a person newly diagnosed with HIV and breaks it down into manageable components, including stress management and medication adherence,” he explains. “This way you can help people establish good habits early on when they may be more motivated.”

The newer web-based program is based on ISA’s “Stress and Mood Management” program and Safren’s in-person CBT program, which encompassed Life-Steps. The computer program features an onscreen “counselor” and interactive elements to guide participants through the Life Steps over a series of clinic visits.¹

“As much as possible, we wanted to reproduce what happens within a clinic. We didn’t want it to be video-based. So we created an on-screen narrator, an ‘adherence counselor,’ to walk people through the nine steps,” says Hersch. “We had to cover a lot of ground, including the importance of adherence, getting to appointments, coping with side effects, managing moods, and communicating with clinicians.”

The 168 study participants (mostly black males) had not been active in the clinic’s medication adherence program for at least 6 months or had a detectable viral load of  >48 (a proxy for non-adherence). Primary adherence data came from an electronic pill cap -- the MEMS6 Medication Event Monitoring System – that activates each time a medication bottle is opened, with self-reports on drug adherence, self-efficacy, stress and mood, substance use and viral loads as secondary measures.¹

The participants completed a baseline assessment and provided a 2-week MEMS cap baseline reading. Patients were then randomized to the web-based “Life-Steps for Managing Medication and Stress” program (n=89) or a control group (n=79), with follow up data collected at 3, 6 and 9 months. (Two patients in each group withdrew from the trial.) 

Twenty eight participants who did not have a computer were given access to the program at the clinic; no differences were seen in adherence at baseline between the two groups.

Patients using the Life-Steps program maintained higher ARV adherence rates than controls over the 9 months, as measured by the MEMS cap. In addition, the program resulted in a significant decrease in viral load. The MEMS data showed no significant differences in treatment effects across gender, race, or length of time taking HIV medications.

However, the researchers suggest it’s likely the use of an electronic pill cap had some effect on adherence because subjects knew their pill-taking was being electronically recorded, noting evidence that MEMS caps usually boost adherence rates for one or two months.

Real-World Effectiveness

Could such a program prove useful outside of a clinical trial, in a real-world clinic setting where HIV-positive patients tend to drift in and out of care, at home, or even as a mobile app -- without an electronic pill cap?

The Life Steps do lend themselves to similar programs and apps that help people manage chronic diseases and track diet and exercise, observes Safren. Features include schedules and cues for taking medications, handling slip-ups, and recognizing personal obstacles (such as forgetting to get refills, the stigma of taking HIV drugs, or simply getting to the pharmacy).¹

The program is currently available only as a password-protected website (www.lifestepsforhealth.com) and larger clinical trials in newly-diagnosed HIV patients are needed. But studies of chronic disease management programs such as those for diabetes and of other HIV adherence tools suggest it can be effective. For example, Safren has found that an on-line pager system helped to boost HIV drug adherence. 

A 2013 study of a computer-based HIV adherence program developed by Nova Southeastern University in Fort Lauderdale, Florida, concluded that (although effectiveness does depend on the people using the program) these innovations may be a cost-effective strategy for increasing adherence.

“It’s not better than in-person counseling. But we can reach people who don’t have access to a clinic or are less comfortable talking about their HIV,” says Hersch. “These programs can supplement clinicians and extend our reach. That’s the big plus of the Web.”

References:

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