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

Sexually Transmitted Diseases

Volumn 40, Issue 12, 2013, Pages 939-943

  Keller, Marla J ^a   Buckley, Niall ^a   Katzen, Lauren L ^b   Walsh, Jennifer ^a   Friedland, Barbara ^b   Littlefield, Sarah ^b   Lin, Juan ^a   Xue, Xiaonan ^a,c   Cornelison, Terri ^d   Herold, Betsy C ^a   Einstein, Mark H ^a,c  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^b POPULATION COUNCIL   (United States)

^c ALBERT EINSTEIN CANCER CENTER   (United States)

^d NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEC PLACEBO GEL; HYDROXYETHYLCELLULOSE; ORAL CONTRACEPTIVE AGENT; PLACEBO; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; DYE STAIN ASSAY; FEMALE; GYNECOLOGICAL AND OBSTETRIC GENERAL EQUIPMENT; HUMAN; HUMAN EXPERIMENT; HYSTERECTOMY; IMMUNOAFFINITY CHROMATOGRAPHY; IMMUNOLOGY TEST KIT; INTRAUTERINE CONTRACEPTIVE DEVICE; MALE; NORMAL HUMAN; SENSITIVITY AND SPECIFICITY; SEXUAL INTERCOURSE; SMOKING; SPERM; STAINING; ULTRAVIOLET RADIATION; UTERINE TUBE LIGATION; VAGINAL APPLICATOR;

ADMINISTRATION, INTRAVAGINAL; ADULT; COITUS; COLORING AGENTS; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; MALE; PATIENT COMPLIANCE; PREDICTIVE VALUE OF TESTS; REPRODUCIBILITY OF RESULTS; SELF REPORT; SEMEN; SENSITIVITY AND SPECIFICITY; TIME FACTORS; ULTRAVIOLET RAYS;

EID: 84888212424     PISSN: 01485717     EISSN: 15374521     Source Type: Journal    
DOI: 10.1097/OLQ.0000000000000040     Document Type: Article

References (20)

1. van der Straten A, Montgomery ET, Hartmann M, et al. Methodological lessons from clinical trials and the future of microbicide research. Curr HIV/AIDS Rep 2013; 10:89-102
2. Wallace A, Thorn M, Maguire RA, et al. Assay for establishing whether microbicide applicators have been exposed to the vagina. Sex Transm Dis 2004; 31:465-468
3. Hogarty K, Kasowitz A, Herold BC, et al. Assessment of adherence to product dosing in a pilot microbicide study. Sex Transm Dis 2007; 34:1000-1003
4. Hemmerling A, Harrison WG, Brown JM, et al. Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations. Sex Transm Dis 2012; 39:710-712
5. Wallace AR, Teitelbaum A, Wan L, et al. Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials. Contraception 2007; 76:53-56
6. Skoler-Karpoff S, Ramjee G, Ahmed K, et al. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: A randomised, double-blind, placebo-controlled trial. Lancet 2008; 372:1977-1987
7. Austin MN, Rabe LK, Hillier SL. Limitations of the dye-based method for determining vaginal applicator use in microbicide trials. Sex Transm Dis 2009; 36:368-371
8. Katzen LL, Fernandez-Romero JA, Sarna A, et al. Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators. Sex Transm Dis 2011; 38:1050-1055
9. Mensch BS, Hewett PC, Abbott S, et al. Assessing the reporting of adherence and sexual activity in a simulated microbicide trial in South Africa: An interview mode experiment using a placebo gel. AIDS Behav 2011; 15:407-421
10. Keller MJ, Madan RP, Torres NM, et al. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel. PLoS One 2011; 6:e16475
11. Keller MJ, Carpenter CA, Lo Y, et al. Phase I randomized safety study of twice daily dosing of acidform vaginal gel: Candidate antimicrobial contraceptive. PLoS One 2012; 7:e46901
12. Abbott SA, Friedland BA, Sarna A, et al. An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India. AIDS Behav 2013;17:2222-2236
13. Moench TR, O'Hanlon DE, Cone RA. Evaluation of microbicide gel adherence monitoring methods. Sex Transm Dis 2012; 39:335-340
14. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010; 329:1168-1174
15. Lundwall A, Bjartell A, Olsson AY, et al. Semenogelin I and II, the predominant human seminal plasma proteins, are also expressed in non-genital tissues. Mol Hum Reprod 2002; 8:805-810
16. Old J, Schweers BA, Boonlayangoor PW, et al. Developmental validation of RSID-Semen: A lateral flow immunochromatographic strip test for the forensic detection of human semen. J Forensic Sci 2012; 57:489-499
17. Mauck CK. Biomarkers of semen exposure. Sex Transm Dis 2009; 36:S81YS83
18. Tien D, Schnaare RL, Kang F, et al. In vitro and in vivo characterization of a potential universal placebo designed for use in vaginal microbicide clinical trials. AIDS Res Hum Retroviruses 2005; 21:845-853
19. Zenilman JM, Yuenger J, Galai N, et al. Polymerase chain reaction detection of Y chromosome sequences in vaginal fluid: Preliminary studies of a potential biomarker for sexual behavior. Sex Transm Dis 2005; 32:90-94
20. Mauck CK, Schwartz JL. Dyeing to know: The use of vaginal applicator staining and other techniques to assess adherence to product use in microbicide trials. Sex Transm Dis 2012; 39:713-715