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Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials

Oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has been evaluated as pre-exposure prophylaxis (PrEP). We describe the accuracy of self-reported adherence to FTC/TDF and pill counts when compared to drug concentrations in the FEM-PrEP trial. Using drug concentrations of plasma tenofovir (...

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Autores principales: Agot, Kawango, Taylor, Douglas, Corneli, Amy L., Wang, Meng, Ambia, Julie, Kashuba, Angela D. M., Parker, Caleb, Lemons, Ansley, Malahleha, Mookho, Lombaard, Johan, Van Damme, Lut
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415940/
https://www.ncbi.nlm.nih.gov/pubmed/25100053
http://dx.doi.org/10.1007/s10461-014-0859-z
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author Agot, Kawango
Taylor, Douglas
Corneli, Amy L.
Wang, Meng
Ambia, Julie
Kashuba, Angela D. M.
Parker, Caleb
Lemons, Ansley
Malahleha, Mookho
Lombaard, Johan
Van Damme, Lut
author_facet Agot, Kawango
Taylor, Douglas
Corneli, Amy L.
Wang, Meng
Ambia, Julie
Kashuba, Angela D. M.
Parker, Caleb
Lemons, Ansley
Malahleha, Mookho
Lombaard, Johan
Van Damme, Lut
author_sort Agot, Kawango
collection PubMed
description Oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has been evaluated as pre-exposure prophylaxis (PrEP). We describe the accuracy of self-reported adherence to FTC/TDF and pill counts when compared to drug concentrations in the FEM-PrEP trial. Using drug concentrations of plasma tenofovir (TFV) and intracellular tenofovir diphosphate (TFVdp) among a random sub-sample of 150 participants assigned to FTC/TDF, we estimated the positive predictive value (PPV) of four adherence measures. We also assessed factors associated with misreporting of adherence using multiple drug-concentration thresholds and explored pill use and misreporting using semi-structured interviews (SSIs). Reporting use of ≥1 pill in the previous 7 days had the highest PPV, while pill-count data consistent with missing ≤1 day had the lowest PPV. However, all four measures demonstrated poor PPV. Reported use of oral contraceptives (OR 2.26; p = 0.014) and weeks of time in the study (OR 1.02; p < 0.001) were significantly associated with misreporting adherence. Although most SSI participants said they did not misreport adherence, participant-dependent adherence measures were clearly unreliable in the FEM-PrEP trial. Pharmacokinetic monitoring remains the measure of choice until more reliable participant-dependent measures are developed.
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spelling pubmed-44159402015-05-07 Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials Agot, Kawango Taylor, Douglas Corneli, Amy L. Wang, Meng Ambia, Julie Kashuba, Angela D. M. Parker, Caleb Lemons, Ansley Malahleha, Mookho Lombaard, Johan Van Damme, Lut AIDS Behav Original Paper Oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has been evaluated as pre-exposure prophylaxis (PrEP). We describe the accuracy of self-reported adherence to FTC/TDF and pill counts when compared to drug concentrations in the FEM-PrEP trial. Using drug concentrations of plasma tenofovir (TFV) and intracellular tenofovir diphosphate (TFVdp) among a random sub-sample of 150 participants assigned to FTC/TDF, we estimated the positive predictive value (PPV) of four adherence measures. We also assessed factors associated with misreporting of adherence using multiple drug-concentration thresholds and explored pill use and misreporting using semi-structured interviews (SSIs). Reporting use of ≥1 pill in the previous 7 days had the highest PPV, while pill-count data consistent with missing ≤1 day had the lowest PPV. However, all four measures demonstrated poor PPV. Reported use of oral contraceptives (OR 2.26; p = 0.014) and weeks of time in the study (OR 1.02; p < 0.001) were significantly associated with misreporting adherence. Although most SSI participants said they did not misreport adherence, participant-dependent adherence measures were clearly unreliable in the FEM-PrEP trial. Pharmacokinetic monitoring remains the measure of choice until more reliable participant-dependent measures are developed. Springer US 2014-08-07 2015 /pmc/articles/PMC4415940/ /pubmed/25100053 http://dx.doi.org/10.1007/s10461-014-0859-z Text en © The Author(s) 2014 https://creativecommons.org/licenses/by/4.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Paper
Agot, Kawango
Taylor, Douglas
Corneli, Amy L.
Wang, Meng
Ambia, Julie
Kashuba, Angela D. M.
Parker, Caleb
Lemons, Ansley
Malahleha, Mookho
Lombaard, Johan
Van Damme, Lut
Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials
title Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials
title_full Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials
title_fullStr Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials
title_full_unstemmed Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials
title_short Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials
title_sort accuracy of self-report and pill-count measures of adherence in the fem-prep clinical trial: implications for future hiv-prevention trials
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415940/
https://www.ncbi.nlm.nih.gov/pubmed/25100053
http://dx.doi.org/10.1007/s10461-014-0859-z
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