Self-Collected Vaginal Specimens for the Detection of Multiple STIs in

Adolescent Detainees

Cynthia M. Holland, M.D., M.P.H.,

Harold C. Wiesenfeld, M.D., C.M.,

Pamela J. Murray, M.D., M.H.P.

Children’s Hospital of Pittsburgh,

Magee-Women’s Hospital, Pittsburgh, PA

STIs in Teens

• Estimated 25% of sexually experienced teens develop an STI prior to graduating high school

• Highest prevalence of bacterial infection is in 15-24 year old females

• Most infected individuals are asymptomatic

• Screening recommended every six months

Advances in STI Screening: Nucleic Acid Amplification

• Polymerase chain reaction (PCR)

• Increased sensitivity

• Allows for new sites of specimen collection– Urine testing for C. trachomatis and N.

gonorrhoeae– Vaginal introital swab testing for C.

trachomatis, N. gonorrhoeae, and T. vaginalis

Adolescents in Juvenile Detention

• Many detainees lack regular medical care

• Prevalence of STIs is 9-48%

• Screening all females may not be feasible

Research Question

Can female adolescent detainees be effectively screened for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis using self-collected vaginal specimens (SCVS)?

Hypotheses

• More infections would be diagnosed and treated when self-testing was available than would be identified by standard care practices

• Self-testing for STIs would be highly acceptable and preferable to this population

Outcomes

• Prevalence of STIs in female detainees

• Detection rates for STIs using SCVS as compared to detection rates obtained using clinically-indicated pelvic exams

• Acceptability of testing procedure

Setting

• Allegheny County juvenile detention facility

• Teens ages 12-17 years

• Nurse-administered health screen at admission

• Exam by a physician within 48 hours

• Pelvic exams when indicated

Subjects

• Females, age 12-17 years

• Recent admission to detention center

• All girls able to give informed assent were eligible

• Non-monetary incentives provided

• Need for parental consent waived by Institutional Review Board

Methods: Recruitment

• Twice-weekly recruitment

• Small groups of recently-admitted girls

• Purpose of study and SCVS collection explained

• SCVS collected in private

Methods: Laboratory Evaluation

• Dacron swab placed directly into PCR Medium

• Commercially available PCR test used for C. trachomatis and N. gonorrhoeae

• Non-commercially available PCR test used for T. vaginalis

Methods: Data Collection

• Self-administered questionnaire completed– Demographic information – Sexual history– Acceptability of self-testing

• Pretested in detention setting for comprehension and appropriateness of response choices

Results: Subjects Enrolled

• 137/161 (85%) girls approached agreed to participate (final N=133)

• Mean age 15.3 yrs + 1.2 yrs

• 56% African American, 28% Caucasian

Results: Sexual Experience

• 85% were sexually experienced (n=113)

• 60% (67/113) of sexually experienced girls had a pelvic exam within the last six months

• 47% used a condom at last intercourse

Results: STI Prevalence

• 21% of all enrollees had at least one STI

• C. trachomatis prevalence 16%

• T. vaginalis prevalence 11%

• N.gonorrhoeae prevalence 8.5%

• Treatment arranged in but one case

How much would we have missed?

• Only 28% of girls with infections received a pelvic exam as part of routine care while detained.

• No difference in the prevalence of STIs among those who had pelvic exams and those who underwent self-testing only.

Results: Acceptability

• 95% stated that specimen collection was easy

• 95% willing to do self-testing between annual pelvic exams

• 81% preferred self-testing to standard testing– Privacy (62%)– Faster than pelvic exam (46%)– Not painful (43%)

Results: Preferences for Testing

• Preferred methods for STD testing:

Self-collected vaginal swab (39%)

Urine test (37%)

Either self-obtained swab or urine test (11%)

Full pelvic exam (8%)

Limitations

• Enrollment non-sequential, based on availability of investigator

• Results may not be generalizable to all teens

• Group dynamics may influence participation

Limitations

• Expense of PCR testing

• T.vaginalis PCR not comercially available

• FDA has not approved SCVS as an appropriate site for testing

Implications

• More frequent screening of high risk individuals

• Use in settings where pelvic exams are not feasible

• Use in patients who refuse pelvic exams

• Aids in selection of individuals who require comprehensive testing

Need for Further Study

• Cost-effectiveness analysis

• Comparison of self-collected vaginal swabs and urine testing

• Impact of less invasive testing on obtaining annual pelvic exams and PAP smears

• Acceptability to providers

Conclusions

• 21% of female detainees had at least one STI diagnosed using self-collected vaginal specimens.

• 72% of these infections would have been missed using standard STI testing procedures.

• Acceptability for the screening procedure was high.

Indications for a Pelvic Exam in a Sexually Active Adolescent

• Symptoms of a possible STD

• Unexplained pelvic or abdominal pain

• Partner with a known or suspected STD

• More than six months since last pelvic exam

• Never had a pelvic exam

• Sex with multiple partners/high-risk partners since last exam

• Frequent unprotected sex since last exam

• Pelvic exam is mandated for future placement

• Patient requests exam for routine screening