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Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials.
Contraception. 2008 Feb; 77(2):122-9.C

Abstract

BACKGROUND

Candidate vaginal microbicides could cause genital irritation, which in turn could facilitate HIV transmission instead of preventing it. While genital epithelial findings are documented in a standardized manner in most microbicide trials, little is known about background rates and predictors for many types of genital findings.

STUDY DESIGN

A secondary analysis was conducted using data from a Phase II expanded safety study of the candidate microbicide Carraguard gel (Population Council, NY, USA) in Thailand. Genital findings were identified by visual inspection of the cervix, vaginal walls and external genitalia during pelvic exams prior to gel use (screening and enrollment) and during gel use (at 2 weeks and Months 1-12). Women were interviewed about potential risk factors for genital findings at every visit and tested routinely for sexually transmitted and vaginal infections.

RESULTS

A total of 258 genital findings were identified in 152 woman-years of follow-up. Genital findings were positively associated with older age, increased parity, self-report of genital symptoms, positive HSV-2 serology, bacterial vaginosis by Nugent scoring and the presence of a genital finding at baseline. Furthermore, vaginal findings were positively associated with vaginal practices and yeast infections. Genital findings were negatively associated with use of hormonal contraception, inconsistently associated with frequency of sex and applicator use, and not associated with condom use.

CONCLUSIONS

Several factors that are common in women of reproductive age account for the background rate of genital epithelial findings in this population.

Authors+Show Affiliations

Academic Medical Center, Center for Poverty-related Communicable Diseases, Amsterdam, The Netherlands. j.h.vandewijgert@amc.uva.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

18226677

Citation

van de Wijgert, Janneke H H M., et al. "Differentiating Normal From Abnormal Rates of Genital Epithelial Findings in Vaginal Microbicide Trials." Contraception, vol. 77, no. 2, 2008, pp. 122-9.
van de Wijgert JH, Kilmarx PH, Jones HE, et al. Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials. Contraception. 2008;77(2):122-9.
van de Wijgert, J. H., Kilmarx, P. H., Jones, H. E., Karon, J. M., & Chaikummao, S. (2008). Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials. Contraception, 77(2), 122-9. https://doi.org/10.1016/j.contraception.2007.10.006
van de Wijgert JH, et al. Differentiating Normal From Abnormal Rates of Genital Epithelial Findings in Vaginal Microbicide Trials. Contraception. 2008;77(2):122-9. PubMed PMID: 18226677.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials. AU - van de Wijgert,Janneke H H M, AU - Kilmarx,Peter H, AU - Jones,Heidi E, AU - Karon,John M, AU - Chaikummao,Supaporn, Y1 - 2007/12/27/ PY - 2007/08/23/received PY - 2007/10/15/accepted PY - 2008/1/30/pubmed PY - 2008/5/13/medline PY - 2008/1/30/entrez SP - 122 EP - 9 JF - Contraception JO - Contraception VL - 77 IS - 2 N2 - BACKGROUND: Candidate vaginal microbicides could cause genital irritation, which in turn could facilitate HIV transmission instead of preventing it. While genital epithelial findings are documented in a standardized manner in most microbicide trials, little is known about background rates and predictors for many types of genital findings. STUDY DESIGN: A secondary analysis was conducted using data from a Phase II expanded safety study of the candidate microbicide Carraguard gel (Population Council, NY, USA) in Thailand. Genital findings were identified by visual inspection of the cervix, vaginal walls and external genitalia during pelvic exams prior to gel use (screening and enrollment) and during gel use (at 2 weeks and Months 1-12). Women were interviewed about potential risk factors for genital findings at every visit and tested routinely for sexually transmitted and vaginal infections. RESULTS: A total of 258 genital findings were identified in 152 woman-years of follow-up. Genital findings were positively associated with older age, increased parity, self-report of genital symptoms, positive HSV-2 serology, bacterial vaginosis by Nugent scoring and the presence of a genital finding at baseline. Furthermore, vaginal findings were positively associated with vaginal practices and yeast infections. Genital findings were negatively associated with use of hormonal contraception, inconsistently associated with frequency of sex and applicator use, and not associated with condom use. CONCLUSIONS: Several factors that are common in women of reproductive age account for the background rate of genital epithelial findings in this population. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/18226677/Differentiating_normal_from_abnormal_rates_of_genital_epithelial_findings_in_vaginal_microbicide_trials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(07)00460-X DB - PRIME DP - Unbound Medicine ER -