BACKGROUND: Few rigorously designed studies have documented the efficacy of interventions to improve medication adherence among patients prescribed highly active antiretroviral. Data are needed to justify the use of limited resources for these programs. METHODS: A 2-arm, randomized, controlled trial evaluated the efficacy of a community-based, home-visit intervention to improve medication adherence. Participants were 171 HIV-infected adults prescribed a minimum of 3 antiretroviral agents. The majority had a past or current history of substance abuse. Subjects were randomly assigned to receive home visits for 1 year or usual care. Medication adherence was assessed with Medication Event Monitoring stem caps at 3-month intervals from randomization through 3 months after the conclusion of the intervention. RESULTS: A larger proportion of subjects in the intervention group demonstrated adherence greater than 90% compared with the control group at each time point after baseline. The difference over time was statistically significant (Extended Mantel-Haenszel test: 5.80, P = 0.02). A statistically significant intervention effect on HIV-RNA level or CD4 cell count was not seen, but there was a statistically significant association between greater than 90% adherence and an undetectable HIV-RNA over time (P < 0.03). CONCLUSION: Home visits from a nurse and a community worker were associated with medication adherence greater than 90% among a cohort of socially vulnerable people living with HIV/AIDS in northeastern United States.

Collection of antiretroviral medication adherence data in the homes of HIV-infected people may have methodological advantages that can improve data quality. However, the feasibility of this approach has not been established. In addition, data on adherence, and its predictors, among HIV-infected women have been limited. Sixty-three HIV-positive women who were prescribed at least one antiretroviral drug in the last month were interviewed in their homes. A standard instrument was used to collect data on all antiretroviral medications prescribed and taken in the three days prior to the interview. Data were also collected on factors thought potentially to affect the ability to be adherent. The results of this study suggest that it is feasible to conduct home-based adherence research. Sixty-seven per cent reported taking all prescribed antiretroviral medication doses. One-third took a sub-optimal dose putting themselves at increased risk of treatment failure and the selection of resistant HIV strains. Unintentional reasons for missing doses were most commonly reported. An ability to describe the intended effect of antiretroviral therapy on HIV viral load was the best predictor of adherence. This finding is consistent with other research suggesting that adherence is associated with an understanding and belief in the effectiveness of antiretroviral therapy.