Use of the dye stain assay and ultraviolet light test for assessing vaginal insertion of placebo-filled applicators before and after sex

Marla J. Keller, Niall Buckley, Lauren L. Katzen, Jennifer Walsh, Barbara Friedland, Sarah Littlefield, Juan Lin, Xiaonan (Nan) Xue, Terri Cornelison, Betsy Herold, Mark H. Einstein

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

BACKGROUND: Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or presex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing. METHODS: Healthy monogamous couples received Microlax-type applicators (Tectubes, Åstorp, Sweden) filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert 1 dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen, followed by UV then DSA, and scored by 2 readers. Positive and negative controls were randomly included in applicator batches. RESULTS: Fifteen couples completed the study. Each woman returned at least 6 applicators over a 30-day period. The sensitivity for insertion of postsex applicators was higher for UV (97%) compared with DSA (90%), and the specificity was similar (≥96%). For presex applicators, the sensitivity and specificity were higher for DSA (100%) compared with UV testing (87% sensitivity, 96% specificity). Among returned postsex applicators, 95% tested positive by UV compared with 87% by DSA. Agreement between readers was significantly better on the presex applicators for DSA than for UV, and for postsex readings, agreement was less than half that for UV, although the results were not statistically significant. CONCLUSIONS: Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex.

Original languageEnglish (US)
Pages (from-to)939-943
Number of pages5
JournalSexually Transmitted Diseases
Volume40
Issue number12
DOIs
StatePublished - Dec 2013

Fingerprint

Ultraviolet Rays
Coloring Agents
Placebos
Gels
Semen
Sensitivity and Specificity
Sweden
Reading
Staining and Labeling

ASJC Scopus subject areas

  • Dermatology
  • Public Health, Environmental and Occupational Health
  • Microbiology (medical)
  • Infectious Diseases

Cite this

Use of the dye stain assay and ultraviolet light test for assessing vaginal insertion of placebo-filled applicators before and after sex. / Keller, Marla J.; Buckley, Niall; Katzen, Lauren L.; Walsh, Jennifer; Friedland, Barbara; Littlefield, Sarah; Lin, Juan; Xue, Xiaonan (Nan); Cornelison, Terri; Herold, Betsy; Einstein, Mark H.

In: Sexually Transmitted Diseases, Vol. 40, No. 12, 12.2013, p. 939-943.

Research output: Contribution to journalArticle

Keller, Marla J. ; Buckley, Niall ; Katzen, Lauren L. ; Walsh, Jennifer ; Friedland, Barbara ; Littlefield, Sarah ; Lin, Juan ; Xue, Xiaonan (Nan) ; Cornelison, Terri ; Herold, Betsy ; Einstein, Mark H. / Use of the dye stain assay and ultraviolet light test for assessing vaginal insertion of placebo-filled applicators before and after sex. In: Sexually Transmitted Diseases. 2013 ; Vol. 40, No. 12. pp. 939-943.
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abstract = "BACKGROUND: Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or presex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing. METHODS: Healthy monogamous couples received Microlax-type applicators (Tectubes, {\AA}storp, Sweden) filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert 1 dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen, followed by UV then DSA, and scored by 2 readers. Positive and negative controls were randomly included in applicator batches. RESULTS: Fifteen couples completed the study. Each woman returned at least 6 applicators over a 30-day period. The sensitivity for insertion of postsex applicators was higher for UV (97{\%}) compared with DSA (90{\%}), and the specificity was similar (≥96{\%}). For presex applicators, the sensitivity and specificity were higher for DSA (100{\%}) compared with UV testing (87{\%} sensitivity, 96{\%} specificity). Among returned postsex applicators, 95{\%} tested positive by UV compared with 87{\%} by DSA. Agreement between readers was significantly better on the presex applicators for DSA than for UV, and for postsex readings, agreement was less than half that for UV, although the results were not statistically significant. CONCLUSIONS: Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex.",
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AU - Keller, Marla J.

AU - Buckley, Niall

AU - Katzen, Lauren L.

AU - Walsh, Jennifer

AU - Friedland, Barbara

AU - Littlefield, Sarah

AU - Lin, Juan

AU - Xue, Xiaonan (Nan)

AU - Cornelison, Terri

AU - Herold, Betsy

AU - Einstein, Mark H.

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N2 - BACKGROUND: Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or presex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing. METHODS: Healthy monogamous couples received Microlax-type applicators (Tectubes, Åstorp, Sweden) filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert 1 dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen, followed by UV then DSA, and scored by 2 readers. Positive and negative controls were randomly included in applicator batches. RESULTS: Fifteen couples completed the study. Each woman returned at least 6 applicators over a 30-day period. The sensitivity for insertion of postsex applicators was higher for UV (97%) compared with DSA (90%), and the specificity was similar (≥96%). For presex applicators, the sensitivity and specificity were higher for DSA (100%) compared with UV testing (87% sensitivity, 96% specificity). Among returned postsex applicators, 95% tested positive by UV compared with 87% by DSA. Agreement between readers was significantly better on the presex applicators for DSA than for UV, and for postsex readings, agreement was less than half that for UV, although the results were not statistically significant. CONCLUSIONS: Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex.

AB - BACKGROUND: Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or presex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing. METHODS: Healthy monogamous couples received Microlax-type applicators (Tectubes, Åstorp, Sweden) filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert 1 dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen, followed by UV then DSA, and scored by 2 readers. Positive and negative controls were randomly included in applicator batches. RESULTS: Fifteen couples completed the study. Each woman returned at least 6 applicators over a 30-day period. The sensitivity for insertion of postsex applicators was higher for UV (97%) compared with DSA (90%), and the specificity was similar (≥96%). For presex applicators, the sensitivity and specificity were higher for DSA (100%) compared with UV testing (87% sensitivity, 96% specificity). Among returned postsex applicators, 95% tested positive by UV compared with 87% by DSA. Agreement between readers was significantly better on the presex applicators for DSA than for UV, and for postsex readings, agreement was less than half that for UV, although the results were not statistically significant. CONCLUSIONS: Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex.

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