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Initiation, Adherence, and Retention in a Randomized Controlled Trial of Directly Administered Antiretroviral Therapy

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Abstract

Directly administered antiretroviral therapy (DAART) can improve health outcomes among HIV-infected drug users. An understanding of the utilization of DAART—initiation, adherence, and retention—is critical to successful program design. Here, we use the Behavioral Model to assess the enabling, predisposing, and need factors impacting adherence in our randomized, controlled trial of DAART versus self-administered therapy (SAT) among 141 HIV-infected drug users. Of 88 participants randomized to DAART, 74 (84%) initiated treatment, and 51 (69%) of those who initiated were retained in the program throughout the entire six-month period. Mean adherence to directly observed visits was 73%, and the mean overall composite adherence score was 77%. These results were seen despite the finding that 75% of participants indicated that they would prefer to take their own medications. Major causes of DAART discontinuation included hospitalization, incarceration, and entry into drug-treatment programs. The presence of depression and the lack of willingness to travel greater than four blocks to receive DAART predicted time-to-discontinuation.

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Acknowledgments

The authors would like to acknowledge the National Institutes on Drug Abuse (R01 DA13805) for funding this study as well as providing career development awards for FLA (K24 DA 0170720), SAS (K23 DA 019381-02) and RDB (K23 DA 022143). DSR receives funding from the National Institutes of Health Medical Science Training Program (GM07205). The funding sources played no role in design of the study, data collection, analysis or interpretation of results or in the writing of the report. The authors would like to thank James Taylor, Rodolfo Lopez, Angel Ojeda and Natalie Laurenco for their contribution to the study implementation. Without their active participation and attention to detail, this study would not have been possible. We additionally would like to thank Paula Dellamura for administrative support. Most importantly, we would like to thank the participants in this study who dedicated time and energy to make this research possible.

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Authors and Affiliations

  1. Yale University AIDS Program, 135 College Street, Suite 323, New Haven, CT, 06510-2283, USA

    Duncan Smith-Rohrberg Maru, R. Douglas Bruce, Mary Walton, Jo Anne Mezger, Sandra A. Springer, David Shield & Frederick L. Altice

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  1. Duncan Smith-Rohrberg Maru
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  2. R. Douglas Bruce
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  3. Mary Walton
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  4. Jo Anne Mezger
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  5. Sandra A. Springer
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  6. David Shield
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  7. Frederick L. Altice
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Correspondence to Frederick L. Altice.

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Contributors

F.L. Altice was the principal investigator of the original clinical trial. D. Smith-Rohrberg conceived of this sub-study, wrote the first draft of the manuscript, and performed the statistical analyses. R.D. Bruce and M. Walton provided clinical oversight during the course of the study. F.L. Altice, M. Walton, J.A. Mezger, and R.D. Bruce were involved in the design and implementation of the original trial. All authors provided input into and approved the final written manuscript as submitted.

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Maru, D.SR., Bruce, R.D., Walton, M. et al. Initiation, Adherence, and Retention in a Randomized Controlled Trial of Directly Administered Antiretroviral Therapy. AIDS Behav 12, 284–293 (2008). https://doi.org/10.1007/s10461-007-9336-2

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