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Effect of Directly Observed Antiretroviral Therapy Compared to Self-Administered Antiretroviral Therapy on Adherence and Virological Outcomes among HIV-Infected Prisoners: A Randomized Controlled Pilot Study

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Abstract

The effect of directly observed therapy (DOT) versus self-administered therapy (SAT) on antiretroviral (ART) adherence and virological outcomes in prison has never been assessed in a randomized, controlled trial. Prisoners were randomized to receive ART by DOT or SAT. The primary outcome was medication adherence [percent of ART doses measured by the medication event monitoring system (MEMS) and pill counts] at the end of 24 weeks. The changes in the plasma viral loads from baseline and proportion of participants virological suppressed (<400 copies/mL) at the end of 24 weeks were assessed. Sixty-six percent (90/136) of eligible prisoners declined participation. Participants in the DOT arm (n = 20) had higher viral loads than participants in the SAT (n = 23) arm (p = 0.23). Participants, with complete data at 24 weeks, were analyzed as randomized. There were no significant differences in median ART adherence between the DOT (n = 16, 99% MEMS [IQR 93.9, 100], 97.1 % pill count [IQR 95.1, 99.3]) and SAT (n = 21, 98.3 % MEMS [IQR 96.0, 100], 98.5 % pill count [95.8, 100]) arms (p = 0.82 MEMS, p = 0.40 Pill Count) at 24 weeks. Participants in the DOT arm had a greater reduction in viral load of approximately −1 log 10 copies/mL [IQR −1.75, −0.05] compared to −0.05 [IQR −0.45, 0.51] in the SAT arm (p value = 0.02) at 24 weeks. The proportion of participants achieving virological suppression in the DOT vs SAT arms was not statistically different at 24 weeks (53 % vs 32 %, p = 0.21). These findings suggest that DOT ART programs in prison settings may not offer any additional benefit on adherence than SAT programs.

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Acknowledgments

The authors wish to thank the correctional medical staff of the North Carolina Department of Public Safety specifically Loreese O’ Kane Johnston (pharmacy) and Mr. Donnie Pope (Laboratory supervisor) who were vital to the implementation of this study. We appreciate the assistance with recruitment of participants from Ms. Carol Anne Harrell, PA. We thank Dr. Douglas Longshore for his help with development of the adherence counseling portion of the intervention. We thank Ms. Chelu Mfalila for biostatical analysis. We would like to acknowledge Robert Michael, Meheret Mamo, Tasseli McKay, Jessica Keys, Jessica Hopkins, Anna Perry, Sonia Napravnik and Divya Ravi for assistance with data cleaning and data management. Lastly, we appreciate the contribution and efforts of the prison study participants. This paper is dedicated to the enduring memory of our late colleague and mentor, Andrew H. Kaplan MD who was the principal investigator for this study. This work was supported by the National Institute of Drug Abuse (R01 DA013826 to AK), University of North Carolina Center for AIDS Research (CFAR) (P30-AI50410) and National Institute of Mental Health (5K23MH094250-02 to BLW).

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Authors and Affiliations

  1. Department of Medicine, School of Medicine, University of North Carolina School of Medicine, 130 Mason Farm Road, Chapel Hill, NC, 27284, USA

    Becky L. White, Carol E. Golin, David A. Wohl & Andrew H. Kaplan

  2. Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA

    Carol E. Golin

  3. Center for AIDS Research, University of North Carolina, Chapel Hill, NC, USA

    Carol E. Golin, Catherine A. Grodensky, Michael G. Hudgens & David A. Wohl

  4. Gilead Sciences, Cary, NC, USA

    C. Nichole Kiziah

  5. Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA

    Amy Richardson & Michael G. Hudgens

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  1. Becky L. White
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  2. Carol E. Golin
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  3. Catherine A. Grodensky
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  4. C. Nichole Kiziah
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  7. David A. Wohl
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  8. Andrew H. Kaplan
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Corresponding authors

Correspondence to Becky L. White or Carol E. Golin.

Additional information

Andrew H. Kaplan—deceased.

This paper was presented in part at the 4th International Conference on HIV Treatment Adherence—April 5–7, 2009.

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White, B.L., Golin, C.E., Grodensky, C.A. et al. Effect of Directly Observed Antiretroviral Therapy Compared to Self-Administered Antiretroviral Therapy on Adherence and Virological Outcomes among HIV-Infected Prisoners: A Randomized Controlled Pilot Study. AIDS Behav 19, 128–136 (2015). https://doi.org/10.1007/s10461-014-0850-8

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  • DOI: https://doi.org/10.1007/s10461-014-0850-8

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