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Background:  Adherence clinics have the potential to improve response to highly active antiretroviral therapy (HAART), but controlled trials are limited and do not account for regimen-related characteristics.  A randomized, controlled pilot study was conducted to examine the effect of an adherence clinic on adherence and virologic outcomes over a 28-week period.

Methods:  Consecutive eligible patients beginning new HAART in an indigent care clinic were randomized to an adherence clinic or to their primary care provider for education and monitoring.  Group assignment was stratified prior to randomization according to antiretroviral regimen complexity (twice daily vs > 3 times daily) and potential tolerability (ritonavir vs non-ritonavir regimen).  Patients in the adherence clinic group received active intervention in the adherence clinic for up to 12 weeks, consisting of education about appropriate HAART administration, food restrictions, side effect management strategies, and monitoring patient progress after therapy initiation.  Adherence (electronic monitoring, patient self-report) and viral load (RT-PCR) end point assessments were performed at weeks 4, 16, and 28.  All analyses were performed as intent-to-treat (ITT).

Results:  33 randomized patients (adherence clinic, n = 16; primary care, n = 17) comprised the ITT population.  The majority of patients had received prior HAART (78%) and had an AIDS diagnosis (79%).  Antiretroviral therapy included protease inhibitor (PI)-based HAART (49%), non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART (39%), and NNRTI/PI combinations (12%).  The 2 groups were well-matched with respect to demographics and antiretroviral regimens.  Mean adherence in the adherence clinic group at weeks 16 and 28 was 77% and 74% vs 56% and 51% in the primary care group (difference:  21.4% [90% CI: 1.1 to 41.7], 22.8% [90% CI: 1.2 to 44.4], respectively).  The adherence clinic group had a greater proportion of patients who took their medication on schedule (69% vs 42%; p = 0.025) and was more likely to exhibit >90% adherence at week 4 (81% vs 47%; p = 0.07).  The proportion of patients with HIV-1 RNA <400 copies/mL at week 16 was greater in the adherence clinic group (100% vs 71% in the primary care group; p = 0.044) and approached significance at weeks 4 and 28 (62% vs 29% and 94% vs 65%, respectively; p  = 0.08).

Conclusions:  Adherence and virologic response were consistently higher in patients followed in an adherence clinic over 28 weeks.  This preliminary study suggests that an adherence clinic care model can improve adherence behavior and viral suppression with HAART.

Keywords: Adherence; HAART; Randomized Controlled Trials