Staying healthy: Taking Antiretrovirals Regularly (STAR)

Adherence with prescribed medication regimens is critically important for patients with HIV infection, due to recent advances in HIV therapeutics. Due to the unique nature of the drugs they take (e.g., rapid development of viral resistance when only minimal doses are missed) as well as complexity of the medication regimens, there is an urgent need to develop interventions to assist patients in medication compliance. Poor adherence to antiretroviral drugs not only can result in the development of resistance by HIV to multiple drugs, but to whole classes of drugs; resistant HIV strains pose a public health danger.

In this proposal the best strategies from prior adherence and behavior change research are utilized in an intervention trial that expands previous work in that it is: (1) interdisciplinary; (2) provides sufficient “dosage” or amount of intervention; and (3) includes booster maintenance sessions.

A sample of 144 HIV-infected men and women having difficulty adhering to their antiretroviral regimen will be randomly assigned to one of two conditions: a tailored behavioral group (TBG) intervention facilitated by a behavioral psychologist and a nurse practitioner, which includes social support and patient education; or a standard care condition (SC). Extended intervention and relapse prevention are needed for long-term adherence: this intervention consists of an initial 5 sessions and 4 booster sessions. All participants will be assessed at pre- and post-intervention, and at 3, 9, 15, and 21 month follow-ups.

The aims of the study are:
1. to determine whether a tailored, behavioral intervention that includes social support and patient education components and maintenance booster sessions promotes medication adherence and effective problem-solving related to medication compliance among HIV-positive individuals over long-term follow-up;
2. to determine the level of adherence that is maintained over time in the intervention group;
3. to determine if improvement in medication adherence is associated with less evidence of emotional and behavioral distress, and better quality of life;
4. to explore how medication adherence is associated with sexual transmission risk behaviors; and
5. to explore relationships between medication adherence and potential moderating and mediating variables (including self-efficacy and outcome expectancies related to adherence, behavioral intentions, coping methods, and health care satisfaction).
The results of this study will provide empirical data urgently needed by medical providers, public health agencies, community clinics, and other organizations as they attempt to develop medication adherence interventions for HIV-infected populations.