Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial

Abstract Background Strict adherence to antiretroviral-based microbicide use is important for effective HIV prevention. We previously developed a composite measure of product adherence, protocol compliance, and semen exposure for determining vaginal use of tenofovir (TFV) 1% gel applicators through...

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Main Authors: Terry A. Jacot, Meredith R. Clark, Oluwatosin E. Adedipe, Susan Godbout, Tina Cunningham, Susan Ju, Jill L. Schwartz, Sinead Delany-Moretlwe, Andrea R. Thurman, Gustavo F. Doncel
Format: Article
Language:English
Published: BMC 2021-09-01
Series:Translational Medicine Communications
Subjects:
HIV
Online Access:https://doi.org/10.1186/s41231-021-00100-6
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spelling doaj-829fb4703ac84b359d27d1df33dac8052021-09-19T11:59:00ZengBMCTranslational Medicine Communications2396-832X2021-09-01611910.1186/s41231-021-00100-6Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trialTerry A. Jacot0Meredith R. Clark1Oluwatosin E. Adedipe2Susan Godbout3Tina Cunningham4Susan Ju5Jill L. Schwartz6Sinead Delany-Moretlwe7Andrea R. Thurman8Gustavo F. Doncel9CONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolCONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolCONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolCONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolSchool of Health Professions, Eastern Virginia Medical SchoolCONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolCONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolWITS RHI, University of WitwatersrandCONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolCONRAD/Department of Obstetrics & Gynecology, Eastern Virginia Medical SchoolAbstract Background Strict adherence to antiretroviral-based microbicide use is important for effective HIV prevention. We previously developed a composite measure of product adherence, protocol compliance, and semen exposure for determining vaginal use of tenofovir (TFV) 1% gel applicators through biomarkers and residual drug analyses. In this study, we tested the ability of the composite measure in vaginally used TFV gel applicators from a Phase III HIV prevention clinical trial. Methods Used vaginal gel applicators from the FACTS 001 study were swabbed for detection of vaginal bacterial markers (vaginal insertion), semen DNA markers (semen exposure), and residual TFV gel (product use). Results Of 1,098 evaluable TFV and placebo applicators, 80% had detectable vaginal insertion biomarkers and 52% had semen biomarkers. Ninety-nine percent of vaginally inserted applicators TFV applicators had detectable residual TFV as measured by liquid chromatography with tandem mass spectroscopy (LC–MS/MS). Residual TFV levels were also successfully detected using Fourier Transform Infrared (FTIR)-based spectroscopy. Conclusions Vaginal insertion and semen exposure biomarkers were detectable on used TFV 1% gel applicators. Residual TFV on these gel applicators was detectable by LC–MS/MS and FTIR-based spectroscopy, which has potential to be a more convenient and quicker method for detecting drug use. With continual improvements, this composite measure of product adherence, protocol compliance, and semen exposure has potential to assess use of not only TFV gel but also other topical microbicides or products.https://doi.org/10.1186/s41231-021-00100-6AdherenceBiomarkerHIVMicrobicidesPrEP
collection DOAJ
language English
format Article
sources DOAJ
author Terry A. Jacot
Meredith R. Clark
Oluwatosin E. Adedipe
Susan Godbout
Tina Cunningham
Susan Ju
Jill L. Schwartz
Sinead Delany-Moretlwe
Andrea R. Thurman
Gustavo F. Doncel
spellingShingle Terry A. Jacot
Meredith R. Clark
Oluwatosin E. Adedipe
Susan Godbout
Tina Cunningham
Susan Ju
Jill L. Schwartz
Sinead Delany-Moretlwe
Andrea R. Thurman
Gustavo F. Doncel
Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial
Translational Medicine Communications
Adherence
Biomarker
HIV
Microbicides
PrEP
author_facet Terry A. Jacot
Meredith R. Clark
Oluwatosin E. Adedipe
Susan Godbout
Tina Cunningham
Susan Ju
Jill L. Schwartz
Sinead Delany-Moretlwe
Andrea R. Thurman
Gustavo F. Doncel
author_sort Terry A. Jacot
title Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial
title_short Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial
title_full Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial
title_fullStr Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial
title_full_unstemmed Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial
title_sort application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase iii microbicide hiv prevention trial
publisher BMC
series Translational Medicine Communications
issn 2396-832X
publishDate 2021-09-01
description Abstract Background Strict adherence to antiretroviral-based microbicide use is important for effective HIV prevention. We previously developed a composite measure of product adherence, protocol compliance, and semen exposure for determining vaginal use of tenofovir (TFV) 1% gel applicators through biomarkers and residual drug analyses. In this study, we tested the ability of the composite measure in vaginally used TFV gel applicators from a Phase III HIV prevention clinical trial. Methods Used vaginal gel applicators from the FACTS 001 study were swabbed for detection of vaginal bacterial markers (vaginal insertion), semen DNA markers (semen exposure), and residual TFV gel (product use). Results Of 1,098 evaluable TFV and placebo applicators, 80% had detectable vaginal insertion biomarkers and 52% had semen biomarkers. Ninety-nine percent of vaginally inserted applicators TFV applicators had detectable residual TFV as measured by liquid chromatography with tandem mass spectroscopy (LC–MS/MS). Residual TFV levels were also successfully detected using Fourier Transform Infrared (FTIR)-based spectroscopy. Conclusions Vaginal insertion and semen exposure biomarkers were detectable on used TFV 1% gel applicators. Residual TFV on these gel applicators was detectable by LC–MS/MS and FTIR-based spectroscopy, which has potential to be a more convenient and quicker method for detecting drug use. With continual improvements, this composite measure of product adherence, protocol compliance, and semen exposure has potential to assess use of not only TFV gel but also other topical microbicides or products.
topic Adherence
Biomarker
HIV
Microbicides
PrEP
url https://doi.org/10.1186/s41231-021-00100-6
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