Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial

Megan M. McLaughlin; Molly F. Franke; Maribel Muñoz; Adrianne K. Nelson; Olga Saldaña; Janeth Santa Cruz; Milagros Wong; Zibiao Zhang; Leonid Lecca; Eduardo Ticona; Jorge Arevalo; Eduardo Sanchez; Jose Luis Sebastián; Sonya Shin

doi:10.1007/s10461-017-1680-2

Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial

Megan M. McLaughlin, Molly F. Franke, Maribel Muñoz, Adrianne K. Nelson, Olga Saldaña, Janeth Santa Cruz, Milagros Wong, Zibiao Zhang, Leonid Lecca, Eduardo Ticona, Jorge Arevalo, Eduardo Sanchez, Jose Luis Sebastián, Sonya Shin

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5 Scopus citations

Abstract

We conducted a cluster-randomized trial to estimate effects of directly observed combination antiretroviral therapy (DOT-cART) on retention with viral suppression among HIV-positive adults in Peru. We randomly allocated facilities to receive the 12-month intervention plus the standard of care, including adherence support provided through accompaniment. In the intervention arm, health workers supervised doses, twice daily, and accompanied patients to appointments. Among 356 patients, intention-to-treat analyses showed no statistically significant benefit of DOT, relative to no-DOT, at 12 or 24 months (adjusted probability of primary outcome: 0.81 vs. 0.73 and 0.76 vs. 0.68, respectively). A statistically significant benefit of DOT was found in per-protocol and as-treated analyses at 12 months (0.83 for DOT vs. 0.73 for no DOT, p value: 0.02 per-protocol, 0.01 as-treated), but not 24 months. Rates of retention with viral suppression were high in both arms. Among adults receiving robust adherence support, the added effect of time-limited DOT, if any, is small-to-moderate.

Original language	English
Pages (from-to)	287-296
Number of pages	10
Journal	AIDS and Behavior
Volume	22
Issue number	1
DOIs	https://doi.org/10.1007/s10461-017-1680-2
State	Published - 1 Jan 2018

Bibliographical note

Funding Information:
Funding This study was funded by the National Institute of Mental Health (R01MH083550-01A2). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Publisher Copyright:
© 2017, Springer Science+Business Media New York.

Keywords

Antiretroviral
Directly observed treatment
HIV
Treatment support

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10.1007/s10461-017-1680-2

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McLaughlin, M. M., Franke, M. F., Muñoz, M., Nelson, A. K., Saldaña, O., Cruz, J. S., Wong, M., Zhang, Z., Lecca, L., Ticona, E., Arevalo, J., Sanchez, E., Sebastián, J. L., & Shin, S. (2018). Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial. AIDS and Behavior, 22(1), 287-296. https://doi.org/10.1007/s10461-017-1680-2

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abstract = "We conducted a cluster-randomized trial to estimate effects of directly observed combination antiretroviral therapy (DOT-cART) on retention with viral suppression among HIV-positive adults in Peru. We randomly allocated facilities to receive the 12-month intervention plus the standard of care, including adherence support provided through accompaniment. In the intervention arm, health workers supervised doses, twice daily, and accompanied patients to appointments. Among 356 patients, intention-to-treat analyses showed no statistically significant benefit of DOT, relative to no-DOT, at 12 or 24 months (adjusted probability of primary outcome: 0.81 vs. 0.73 and 0.76 vs. 0.68, respectively). A statistically significant benefit of DOT was found in per-protocol and as-treated analyses at 12 months (0.83 for DOT vs. 0.73 for no DOT, p value: 0.02 per-protocol, 0.01 as-treated), but not 24 months. Rates of retention with viral suppression were high in both arms. Among adults receiving robust adherence support, the added effect of time-limited DOT, if any, is small-to-moderate.",

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McLaughlin, MM, Franke, MF, Muñoz, M, Nelson, AK, Saldaña, O, Cruz, JS, Wong, M, Zhang, Z, Lecca, L, Ticona, E, Arevalo, J, Sanchez, E, Sebastián, JL & Shin, S 2018, 'Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial', AIDS and Behavior, vol. 22, no. 1, pp. 287-296. https://doi.org/10.1007/s10461-017-1680-2

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AU - Franke, Molly F.

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AU - Nelson, Adrianne K.

AU - Saldaña, Olga

AU - Cruz, Janeth Santa

AU - Wong, Milagros

AU - Zhang, Zibiao

AU - Lecca, Leonid

AU - Ticona, Eduardo

AU - Arevalo, Jorge

AU - Sanchez, Eduardo

AU - Sebastián, Jose Luis

AU - Shin, Sonya

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N2 - We conducted a cluster-randomized trial to estimate effects of directly observed combination antiretroviral therapy (DOT-cART) on retention with viral suppression among HIV-positive adults in Peru. We randomly allocated facilities to receive the 12-month intervention plus the standard of care, including adherence support provided through accompaniment. In the intervention arm, health workers supervised doses, twice daily, and accompanied patients to appointments. Among 356 patients, intention-to-treat analyses showed no statistically significant benefit of DOT, relative to no-DOT, at 12 or 24 months (adjusted probability of primary outcome: 0.81 vs. 0.73 and 0.76 vs. 0.68, respectively). A statistically significant benefit of DOT was found in per-protocol and as-treated analyses at 12 months (0.83 for DOT vs. 0.73 for no DOT, p value: 0.02 per-protocol, 0.01 as-treated), but not 24 months. Rates of retention with viral suppression were high in both arms. Among adults receiving robust adherence support, the added effect of time-limited DOT, if any, is small-to-moderate.

AB - We conducted a cluster-randomized trial to estimate effects of directly observed combination antiretroviral therapy (DOT-cART) on retention with viral suppression among HIV-positive adults in Peru. We randomly allocated facilities to receive the 12-month intervention plus the standard of care, including adherence support provided through accompaniment. In the intervention arm, health workers supervised doses, twice daily, and accompanied patients to appointments. Among 356 patients, intention-to-treat analyses showed no statistically significant benefit of DOT, relative to no-DOT, at 12 or 24 months (adjusted probability of primary outcome: 0.81 vs. 0.73 and 0.76 vs. 0.68, respectively). A statistically significant benefit of DOT was found in per-protocol and as-treated analyses at 12 months (0.83 for DOT vs. 0.73 for no DOT, p value: 0.02 per-protocol, 0.01 as-treated), but not 24 months. Rates of retention with viral suppression were high in both arms. Among adults receiving robust adherence support, the added effect of time-limited DOT, if any, is small-to-moderate.

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JF - AIDS and Behavior

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ER -

Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial

Abstract

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Keywords

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