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Discussion
ART that suppresses HIV-1 replication reduces transmission of HIV-1 to a sexual partner; however, this benefit requires strict adherence to treatment. Treatment for prevention approaches generally requires initiating ART when patients are healthier and therefore at higher CD4 counts. One study compared 60 individuals in Uganda with CD4 <250 cells with those with ≥250 cells and found greater number of treatment interruptions and more uncontrolled virus in those in the higher baseline CD4 category. No studies have examined adherence to ART when the stated purpose of the ART was specifically to test whether it would reduce transmission of HIV-1 to a sexual partner.
In this analysis, we noted higher levels of adherence to ART than typically observed in the context of ART for treatment. In addition, such adherence in the infected person is greater than reported in an observational study of couples in Zambia. The high level of adherence in this report may have reflected the intense management in the conduct of the HPTN 052 study, the benefit of couples' counseling, feedback about viral load suppression, or altruism related to prevention of transmission of HIV (a potential benefit communicated during the informed consent process). Additionally, counselors used an evidence-based cognitive-behavioral counseling intervention (LifeSteps) as the basis of their adherence counseling training and used checklists and visit documentation to maximize the actual delivery of this counseling approach in these settings.
We found that the only psychosocial variable that predicted adherence in the multivariable models was the mental health score on the quality of life assessment. Although the association of mental health to adherence is consistent with meta-analytic work in individuals with HIV-1 showing an association of depression to nonadherence, the lack of association of variables such as substance use and social support differs from what has been reported in studies of adherence in patients prescribed ART for treatment.
Our HIV-1 serodiscordant couples were in relatively stable relationships, located in resource-limited countries where initiation of ART was recommended at lower CD4 cell counts than what was dictated by the study, and who were volunteering for an HIV prevention trial where provision of care might be greater than what would otherwise be received in the local setting. Accordingly, participants electing to take medications for prevention purposes, and/or for purposes of being in a prevention trial, may have higher motivation for health behaviors in general. Hence, as seen in this study, the strength of the association of some of the typical psychosocial variables to health behavior may be attenuated when the need for treatment is also not as strong.
Nevertheless, higher mental health scores remained independently associated with better adherence. A treatment study that complemented HPTN 052 and was conducted at the same sites, ACTG5175, found that illicit drug use and general health perceptions but not mental health scores were variables associated with adherence in longitudinal multivariable models. These results suggest that there may be different psychosocial variables predicting adherence when attempting to maximize ART for prevention rather than ART for treatment.
There are several limitations to this analysis. First, self-report and pill count adherence are not as objective as other indicators, such as medication event monitoring systems, other electronically monitored adherence devices, unannounced pill counts, or blood ART levels. However, the association of viral load to both pill count and self-report PCA adherence scores shows that these can be useful indicators of adherence. Second, this analysis mainly examined main effects and not interactions because of the wide number of potential variables possible for interactions, such as study site, HIV risk group, gender, and country. Third, although participants enrolled in the study as a prevention trial, it is possible that some participants' motivation to join was as a vehicle to gaining ART as the treatment for themselves. Hence, although the time the study began initiating ART was not considered necessarily beneficial to the patient, this could have affected the motivations to take ART and be adherent to ART.
The results of this analysis demonstrate a very high degree of adherence to ART, which correlates well with the durable suppression of viremia observed. It seems likely that high adherence can be expected in many groups of couples given the fact that ART dramatically suppressed HIV transmission in 10 of 12 observational studies. Adherence to treatment is likely optimized when evidence-based counseling is an ongoing part of provision of ART, when couples are counseled together, when the prevention benefit to the sexual partner is made clear, and when feedback about viral suppression is provided. These data suggest the potential utility of implementing these approaches in clinical settings.
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