MEDICAL ADHERENCE AND COPING WITH THE CONSEQUENCES OF HIV INFECTION

Grant Title: Serodiscordant Couples, Medical Adherence, and HIV Risk

Project Name: SMART Couples Study

Funding Source and Project Period: NIMH, R01; 1999-2004

Collaborating Institutions and Key Personnel:

HIV Center:
Principal Investigator: Robert H. Remien, Ph.D.
Co-Principal Investigator: Nabila El-Bassel, D.S.W.
(Columbia University School of Social Work)
Co-Investigators: Alex Carballo-Diéguez, Ph.D.; Curtis Dolezal, Ph.D.;
Robert Kertzner, M.D.
Postdoctoral Fellow: Michael J. Stirratt, Ph.D.
Consultant: Glenn Wagner, Ph.D.

St. Luke's Roosevelt Hospital Center:
Co-Investigator: Joanna S. Dognin, Psy.D.

Project Overview: Adherence to HIV/AIDS medical care and medication regimens is critical for the health and survival of people living with HIV, but adherence can also be very challenging. Patients must visit their medical provider regularly to monitor their health, manage medication side effects, and to check viral load and other blood markers for disease progression. Drug regimens must be followed closely to optimize the clinical benefits of combination antiretroviral therapy. Poor medication adherence can lead to the development of drug-resistant strains of HIV, which poses a serious problem for both the individual and the community. The individual may lose the benefit of particular classes of drugs, which can contribute to clinical and immunological decline. That individual is also in a position to transmit the drug-resistant HIV to his or her sex partners, who would then be infected with a strain that is already resistant to combination therapies.

Spouses or relationship partners of people with chronic illnesses can make a valuable contribution to their health care maintenance, and a substantial research literature has pointed to the importance of social support in helping to establish and maintain health-care behaviors. Unfortunately, standard medical care for HIV/AIDS does not typically include the patient's "significant others" in medical appointments and health education programs. Further, most currently funded studies aimed at improving the medical adherence of HIV+ men and women target the individual (alone) for intervention. We believe that involving a supportive partner in health education visits with health-care professionals could help improve healthy behaviors (i.e., adherence to medical care) for HIV+ persons. This couple-centered approach also presents an opportunity to address potential sexual risk-taking with the dyad, rather than with either individual in isolation.

The SMART Couples Study, therefore, aimed to determine whether a brief, clinic-based, theory-driven counseling intervention with HIV serodiscordant couples was effective in improving medication adherence among the HIV+ partners in these relationships over that which is observed in "usual" clinic care; the study also examined whether these effects lasted up to 6 months following the intervention. The secondary aims were to determine whether medication adherence is associated with clinical outcomes in HIV+ patients, to identify "personal" and "partner" psychosocial determinants of medical adherence, to examine differences and similarities in "supportive" behaviors according to the gender and sexual orientation of the relationship partners, to assess relationships between beliefs about medical treatments for HIV, perceived HIV transmission risk, and actual risk behavior, and finally, to examine the relationship between medical adherence and adherence to "safer sex" guidelines among HIV+ men and women on highly active antiretroviral therapy.

This was a clinic-based study conducted in collaboration with St. Luke's Roosevelt Hospital Center (SLRHC). The study design sought to randomize 240 eligible HIV serodiscordant couples to receive either the brief intervention or standard clinic care. The study was designed in this manner because there was no evidence that the brief intervention is effective, and all participants had access to individual adherence counseling as part of their clinic's or provider's "standard of care." Participating couples completed a three-tiered screening procedure to determine their study eligibility. Assessments were administered at four time-points (baseline, post-intervention and 3- and 6-month follow-ups) over a period of approximately nine months. Assessments included a CAPI/ACASI interview and two-weeks of medication adherence monitoring through Medication Event Monitoring System (MEMS) technology.

The study enrolled HIV serodiscordant couples in which 1) the HIV+ partner was receiving primary medical care, had a current prescription for combination antiretroviral therapy, and demonstrated problems with medication adherence (defined as taking less than 80% of prescribed doses at regular intervals), 2) the relationship length was at least six months, and 3) both partners were English-speaking adults (over age 18). The study enrolled heterosexual, gay male, and lesbian couples. Couples were excluded if one or both partners demonstrated severe cognitive dysfunction or psychotic disorders. The final sample was composed of 215 HIV serodiscordant couples (78 heterosexual couples with a male HIV+ partner, 81 heterosexual couples with a female HIV+ partner, 38 gay male couples, and 18 lesbian couples).

The results of the trial indicated that the brief, couple-focused behavioral intervention was effective in improving medication adherence. All participants had sub-optimal adherence levels at baseline due to the study eligibility criteria. Intervention participants showed higher mean medication adherence at post-intervention when compared to controls whether adherence was defined as proportion of prescribed doses taken (76% vs 60%), or doses taken within specified time parameters (58% vs 35%). Also, intervention arm participants were significantly more likely to achieve high levels of adherence (greater than 80%, 90%, or 95%) when compared to controls. However, in most cases, effects diminished with time as seen at three and six-month follow-ups.

This is the first study of a couple-focused intervention for ART adherence, and it is one of very few randomized controlled studies to demonstrate effectiveness in improving ART adherence, especially with use of electronic monitoring and intention-to-treat analyses. Outcomes of this trial suggest that patients should be encouraged to bring relationship partners with them to medical appointments and that clinicians should try to include patients' partners in discussions of treatment decisions and adherence. This approach does not incur significant cost and is therefore feasible in resource poor settings. Involving a significant other in the enhancement of support for adherence to ART can benefit the individual and the public health.

Publications and Presentation Abstracts:
Remien, R.H., Stirratt, M.J., Dolezal, C., Dognin, J.S., Wagner, G.J., Carballo-Dieguez, A., El-Bassel, N., & Jung, T.M. (2005). Couple-focused support to improve HIV medication adherence: A randomized controlled trial. AIDS, 19, 807-814.

Remien, R.H., Stirratt, M.J., Dolezal, C., Lobozzo, J. S., Wagner, G.J., Carballo-Dieguez, A., El-Bassel, N., & Jung, T.M. (2004, December). A couple-based intervention improves adherence among inner-city patients with poor adherence. Poster presented at the 3rd Annual International Adherence to Therapy in HIV Conference: Elements of Success, Dallas, TX.

Stirratt, M. J., Remien, R. H., & Dolezal, C. (2004, October). The role of HIV serostatus disclosure in antiretroviral medication adherence. Presentation to the National Institute of Health AIDS Training Meeting, Washington, DC.

Update: 7/8/05