Structured counselling programmes may help people with HIV adhere to their antiretroviral regimens, say researchers in a report published in the December 15th issue of the Journal of Acquired Immune Deficiency Syndromes. However, they add that the effect may last only a few months after the end of the programme, suggesting that ongoing support might be needed to keep adherence high over the long term.
Adherence is crucial to the success of anti-HIV therapy, and many trials have identified factors that predict whether or not a person will adhere to their regimen. However, there is little data on the efficacy of strategies designed to improve adherence.
To help fill this gap, researchers with the US-based Healthy Living Project investigated medication adherence issues among HIV-positive subjects participating in trial of a cognitive behavioural intervention program designed to address sexual risk-taking behaviour.
The programme comprised 15 structured, individual counselling sessions, each of which explored environmental, emotional and behavioural aspects of risk-taking behaviour. Module One (Stress, Coping and Adjustment) addressed issues surrounding quality of life, coping and building supportive social networks and was delivered during the first five months of the study.
Module Two (Safer Behaviors) addressed avoiding sexual and drug-related risk of transmission of HIV and other infections and disclosure of HIV status. Module Two was delivered during months five and ten. Module Three (Health Behaviors) addressed access to medical care, adherence to anti-HIV treatments and participation in health care decisions. The final module was presented from months ten to 15. Participants were then followed up to month 25.
Over 3800 HIV-positive participants were randomly assigned to receive the counselling programme or to receive no counselling. Researchers assessed adherence among participants on antiretroviral therapy using a three-day recall survey.
In the current report, investigators focused on changes in adherence patterns among “low adherers,” that is, the 204 participants who reported at baseline taking fewer than 85% of their doses. The mean adherence of this group was between 60 to 65% and did not differ between the counselled and uncounselled group.
At month five, immediately after the Stress, Coping and Adjustment module, mean adherence increased in both groups, up to almost 85% in the counselled group and to just over 70% in the uncounselled group. This led to a statistically significant almost 13% greater increase in the counselled group.
At month ten, after the Safe Behaviors module, there was no difference between the two groups, with each group reporting a mean adherence between 80 and 85%.
At month 15, after the Health Behaviors module, mean adherence among the uncounselled participants fell to under 80%, while it rose in the counselled group to just under 90%, leading to a significant difference of 10% between the two arms.
To put these results in context, the researchers point to research that has shown that a 10% increase in mean adherence has been associated with an up to 50% decrease in viral load and a 20 to 30% decrease in progression to AIDS.
At months 20 and 25, the difference between groups disappeared, with both counselled and uncounselled arms reporting a mean adherence of approximately 80 to 85%.
In interpreting their results, the authors conclude that “cognitive behavioral interventions may effectively improve ART [antiretroviral therapy] adherence, but the effects of the intervention may be short lived.”
They state that the increase in both arms of the trial is not surprising given the study design. They point out that since the group selected for inclusion in the trial was the low adherence portion of the entire population, their adherence might naturally increase towards the population mean over time. Also, they propose that the repeated assessment of adherence may have increased adherence in both groups through simply raising participants’ awareness of adherence.
Nonetheless, the researchers assert that the data support the conclusion that the intervention had an effect above and beyond the effect of regression towards the mean or non-specific assessment effects.