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

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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.

Resumen

Realizamos un estudio clínico aleatorizado por grupos para estimar los efectos que tiene la terapia antirretroviral combinada directamente observada (DOT-cART) sobre la retención con supresión viral entre adultos VIH-positivos en el Perú. Cada establecimiento fue aleatorizado para recibir la intervención de 12 meses, adicional a la atención estándar, incluyendo acompañamiento como soporte para la adherencia. En el brazo de intervención, los trabajadores de salud supervisaron la toma de dosis, dos veces diariamente, acompañando a los pacientes a sus citas médicas. Entre 356 pacientes, el análisis por intención-de-tratar no mostro un beneficio estadísticamente significativo del DOT respecto al no-DOT tanto a los 12 como a los 24 meses (probabilidad ajustada del indicador primario: 0.81 vs. 0.73 y 0.76 vs. 0.68, respectivamente). Un beneficio estadísticamente significativo del DOT se encontró en el análisis por-protocolo y en el análisis ‘tratado en el estudio’ a los 12 meses (0.83 para DOT vs. 0.73 para no-DOT; valor-p: 0.02 por-protocolo, 0.01 tratado en el estudio), pero no a los 24 meses. Las tasas de retención con supresión viral fueron altas en los dos brazos del estudio. Entre adultos que recibieron un robusto soporte para asegurar la adherencia, el efecto adicional de DOT-cART de tiempo-limitado, si lo hay, es menor a moderado.

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Acknowledgements

We acknowledge and thank the patients, treatment supporters, providers, and health promotors who participated in this study. We thank Kevin Savage and Carly Rodriguez for assistance with manuscript preparation.

Author Contributions

Design of the work: S.S., MMunoz, E.T., J.A., E.S., J.L.S. Acquisition of data for the work: A.K.N., O.S., M.W. Data analysis: MMcLaughlin, M.F., Z.Z. Interpretation: S.S., MMunoz, O.S., J.S.C., L.L. Drafting and revising the work: MMcLaughlin, M.F., S.S. Critical for important intellectual content: S.S., MMunoz, A.K.N., O.S., J.S.C., M.W., Z.Z., L.L., E.T., J.A., E.D., J.L.S. All authors approved the final version to be published.

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.

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    Authors and Affiliations

    1. Harvard Medical School, Boston, MA, USA

      Megan M. McLaughlin

    2. Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, USA

      Molly F. Franke, Adrianne K. Nelson & Sonya Shin

    3. Socios En Salud, Lima, Peru

      Maribel Muñoz, Olga Saldaña, Janeth Santa Cruz, Milagros Wong, Leonid Lecca & Sonya Shin

    4. Division of Global Health Equity, Brigham and Women’s Hospital, Boston, MA, USA

      Zibiao Zhang & Sonya Shin

    5. Peru Ministry of Health, Lima, Peru

      Eduardo Ticona, Jorge Arevalo, Eduardo Sanchez & Jose Luis Sebastián

    6. Universidad Nacional Mayor de San Marcos, Lima, Peru

      Eduardo Ticona

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    1. Megan M. McLaughlin
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    Correspondence to Molly F. Franke.

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    The authors report no conflicts of interest.

    Ethical Approval

    All procedures performed in studies involving human participants were in accordance with the ethical standards of the Partners HealthCare Human Research Committee, and the Research Ethics Committee of the Peru National Institutes of Health.

    Informed Consent

    Informed consent was obtained from all individual participants included in the study.

    Additional information

    Megan M. McLaughlin and Molly F. Franke have contributed equally to this work.

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    McLaughlin, M.M., Franke, M.F., Muñoz, M. et al. Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial. AIDS Behav 22, 287–296 (2018). https://doi.org/10.1007/s10461-017-1680-2

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