Limitations of the dye-based method for determining vaginal applicator use in microbicide trials

Sexually Transmitted Diseases

Volumn 36, Issue 6, 2009, Pages 368-371

  Austin, Michele N ^a   Rabe, Lorna K ^a   Hillier, Sharon L ^a,b  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BRILLIANT BLUE FCF; DYE; MICROBICIDE; N [4 CHLORO 3 (3 METHYL 2 BUTENYLOXY)PHENYL] 2 METHYL 3 FURANCARBOTHIOAMIDE; PROPYLENE; UNCLASSIFIED DRUG; VIVAGEL;

ADULT; ARTICLE; CONTROLLED STUDY; DEVICE; DRUG USE; FEMALE; GRAM STAINING; HUMAN; LACTOBACILLUS; MAJOR CLINICAL STUDY; PATIENT COMPLIANCE; SENSITIVITY AND SPECIFICITY; SEXUALLY TRANSMITTED DISEASE; SINGLE DRUG DOSE; STAINING; VAGINA EPITHELIUM; VAGINA SMEAR; VAGINAL APPLICATOR;

ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS; CLINICAL TRIALS AS TOPIC; COLORING AGENTS; DRUG DELIVERY SYSTEMS; FEMALE; FLORIDA; HUMANS; MIDDLE AGED; PATIENT COMPLIANCE; PENNSYLVANIA; POLYPROPYLENES; PUERTO RICO; SENSITIVITY AND SPECIFICITY;

EID: 67049108638     PISSN: 01485717     EISSN: None     Source Type: Journal    
DOI: 10.1097/OLQ.0b013e3181972397     Document Type: Article

References (16)

1. Quinn TC, Overbaugh J. HIV/AIDS in women: An expanding epidemic. Science 2005; 308:1582-1583.
2. Obrien RF. Vaginal microbicides. Adolesc Med Clin 2006; 17:673-685.
3. Barnhart KT, Rosenberg MJ, MacKay HT, et al. Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm. Obstet Gynecol 2007; 110:577-586.
4. Gallo MF, Steiner MJ, Warner L, et al. Self-reported condom use is associated with reduced risk of Chlamydia, gonorrhea, and trichomoniasis. Sex Transm Dis 2007; 34:829-833.
5. van der Straten A, Moore J, Napierala S, et al. Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe. Contraception 2008; 77:435-443.
6. Padian NS, van der Straten A, Ramjee G, et al. Diaphragm and lubricant gel for prevention of HIV acquisition in Southern African women: A randomized controlled trial. Lancet 2007; 370: 251-261.
7. Roddy RE, Zekeng L, Ryan KA, et al. A controlled trial of nonoxynol 9 film to reduce male-to-male transmission of sexually transmitted diseases. N Engl J Med 1998; 339:504-510.
8. 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.
9. Wallace A, 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.
10. Hogarty K, Kasowitz A, Herald B, et al. Assessment of adherence to product dosing in a pilot microbicide study. Sex Transm Dis 2007; 34:1000-1003.
11. Metzger DS, Koblin B, Turner C, et al. Randomized controlled trial of audio-computer assisted self-interviewing: Utility and acceptability in longitudinal studies. Am J Epidemiol 2000; 152: 99-106.
12. Rogers SM, Willis G, Al-Tayyib A, et al. Audio computer assisted interviewing to measure HIV risk behaviors in a clinic population. Sex Transm Infect 2005; 81:501-507.
13. Newman JC, Des Jarlais DC, Turner CF, et al. The differential effects of face-to face and computer interview modes. Am J Pub Health 2002; 92:294-297.
14. Gallo MF, Behets FM, Steiner MJ, et al. Prostate-specific antigen to ascertain reliability of self-reported coital exposure to semen. Sex Transm Dis 2006; 33:476-479.
15. Gallo MF, Behets FM, Steiner MJ, et al. Validity of self-reported safe sex among female sex workers in Mombasa, Kenya-PSA analysis. Int J STD AIDS 2007; 18:33-38.
16. Mensch B, Hewitt P, Rankin J, et al. Assessing the reporting of adherence and sexual activity in a simulated microbicide trial: preliminary results from an interview mode experiment in the phase 3 carraguard® sites, South Africa. Microbicides 2008, New Delhi, Poster Presentation.