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Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017

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Abstract

MTN-017 compared the safety and acceptability of daily oral emtricitabine/tenofovir disoproxil fumarate, daily reduced-glycerin 1% tenofovir gel applied rectally, and the same gel applied before and after receptive anal intercourse. The Data Convergence Interview (DCI) and the Pharmacokinetic Data Convergence Interview (PK-DCI) were brief, collaborative interactions conducted with participants during adherence counseling sessions to improve accurate measurement of adherence to study product use. DCIs converged data from product return counts and participants’ responses to daily text messages. PK-DCIs, conducted 4 weeks later, converged results of the DCI with PK from the corresponding period. CIs were easily incorporated into adherence counseling sessions, increased the accuracy of adherence data, and provided valuable context to data on product use. Participants were readily engaged in the interviews but, if they felt confronted, provided more guarded responses. As such, how these CIs are conducted is critical to engage participants, even those with poor adherence, to openly discuss challenges with product use.

Resumen

En el estudio MTN-017 se comparó la seguridad y la aceptabilidad entre: una dosis oral diaria de emtricitabine/tenofovir disoproxil fumarate; un gel de 1% tenofovir aplicado diariamente por vía rectal; y el mismo gel aplicado antes y después del coito anal receptivo. La Entrevista de Coincidencia de Datos (ECD) y la Entrevista de Coincidencia de Datos Farmacokineticos (ECD-FK) eran breves interacciones colaborativas con los participantes, llevadas a cabo durante las sesiones de consejería de adherencia, para mejorar la medición de adherencia en el uso del producto durante el estudio. Las ECD combinaron datos de los conteos de productos devueltos y las respuestas de los participantes a mensajes de texto diarios. Las ECD-FK, que ocurrieron cuatro semanas después, combinaron los resultados de la ECD con el FK del período correspondiente. Las dos entrevistas de coincidencia fueron incorporadas fácilmente en las sesiones de consejería de adherencia, aumentaron la precisión de los datos de adherencia y agregaron un contexto para interpretar los datos sobre el uso del producto. Fue fácil involucrar a los participantes en las entrevistas; no obstante, si se sentían confrontados, sus respuestas eran más cautelosas Por lo tanto, cómo se llevan a cabo las entrevistas de coincidencia es clave para establecer cooperación con los participantes, aun los que tienen la más baja adherencia, para que compartan abiertamente los desafíos que enfrentan al usar el producto.

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Acknowledgements

The authors would like to specifically acknowledge the work of the 24 counselors across the study sites who conducted the DCI and PK-DCI with study participants.

Funding

The study was funded by the Microbicide Trials Network, which is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Drs. Balan, Carballo-Dieguez, Brown, and Ms. Giguere are also supported by The HIV Center for Clinical and Behavioral Studies, which is also supported by NIH Center grant P30 MH43520 (PI: Remien). The content is solely the responsibility of the authors and does not necessary represent the official views of the National Institute of Health.

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Authors and Affiliations

  1. HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, Unit 15, 1051 Riverside Drive, New York, NY, 10032, USA

    Iván C. Balán, Rebecca Giguere & Alex Carballo-Diéguez

  2. Department of Medicine, Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA

    William Brown III

  3. FHI 360, Durham, NC, USA

    Stephanie Horn

  4. Department of Medicine, Johns Hopkins University, Baltimore, MD, USA

    Craig W. Hendrix & Mark A. Marzinke

  5. Magee-Womens Research Institute, Pittsburgh, PA, USA

    Ratiya Pamela Kunjara Na Ayudhya

  6. Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Karen Patterson

  7. Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA

    Jeanna M. Piper

  8. School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

    Ian McGowan & Ross D. Cranston

  9. Asociación Civil Impacta Salud y Educación, Lima, Peru

    Javier R. Lama

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  1. Iván C. Balán
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  2. Rebecca Giguere
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  3. William Brown III
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  4. Alex Carballo-Diéguez
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  8. Ratiya Pamela Kunjara Na Ayudhya
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  9. Karen Patterson
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  11. Ian McGowan
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  12. Javier R. Lama
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  13. Ross D. Cranston
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on behalf of the MTN-017 Protocol Team

Corresponding author

Correspondence to Iván C. Balán.

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The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

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

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Balán, I.C., Giguere, R., Brown, W. et al. Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017. AIDS Behav 22, 986–995 (2018). https://doi.org/10.1007/s10461-017-1955-7

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  • DOI: https://doi.org/10.1007/s10461-017-1955-7

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