Human Papillomavirus Vaccine Update.

Rates of cancers attributable to human papillomavirus (HPV) are rising. A safe and extremely effective vaccine is available to prevent many of these cancers. Studies have shown that health care providers' recommendation to immunize is the most important factor in parents' decision. Parents of all adolescent boys and girls should receive a strong and unequivocal recommendation to vaccinate their child against HPV at the 11- or 12-year-old well child visit. Ideally, adolescents complete their HPV vaccine series by their 13th birthday, leading to greater immune response and protection before most adolescents are exposed to sexually transmitted HPV.

Power of Knowledge: Effect of Two Educational Interventions on Readiness for Chlamydia Screening.

We compared (a) the effectiveness of print versus digital educational media for communicating information about Chlamydia trachomatis to adolescents and young adults and (b) the influence of media type on readiness for Chlamydia screening. Young men and women (n = 103), aged 15 to 24 years, were recruited from a youth center and university campus and randomized to receive the print or digital Chlamydia educational intervention. Participant mean knowledge score improved postintervention, but there was no association with type of intervention medium. Nearly two-thirds (61%) of sexually active participants endorsed an increased postintervention stage of readiness for screening; however, there was no association with type of intervention medium. Learning about Chlamydia infection may have positive effects on willingness to be screened. Further study is needed to evaluate the efficacy of educational interventions for increasing actual screening rates.

Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial.

HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15-17 years, from five community organizations were randomized to self-administered web-based assent (n=60) or investigator-administered paper assent with (n=29) or without (n=31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t118=-0.08, p=0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t58=1.96, p=0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation.

Could home sexually transmitted infection specimen collection with e-prescription be a cost-effective strategy for clinical trials and clinical care?

BACKGROUND: Results of a recent demonstration project evaluating feasibility, acceptability, and cost of a Web-based sexually transmitted infection (STI) testing and e-prescription treatment program (eSTI) suggest that this approach could be a feasible alternative to clinic-based testing and treatment, but the results need to be confirmed by a randomized comparative effectiveness trial. METHODS: We modeled a decision tree comparing (1) cost of eSTI screening using a home collection kit and an e-prescription for uncomplicated treatment versus (2) hypothetical costs derived from the literature for referral to standard clinic-based STI screening and treatment. Primary outcome was number of STIs detected. Analyses were conducted from the clinical trial perspective and the health care system perspective. RESULTS: The eSTI strategy detected 75 infections, and the clinic referral strategy detected 45 infections. Total cost of eSTI was $94,938 ($1266/STI detected) from the clinical trial perspective and $96,088 ($1281/STI detected) from the health care system perspective. Total cost of clinic referral was $87,367 ($1941/STI detected) from the clinical trial perspective and $71,668 ($1593/STI detected) from the health care system perspective. CONCLUSIONS: Results indicate that eSTI will likely be more cost-effective (lower cost/STI detected) than clinic-based STI screening, both in the context of clinical trials and in routine clinical care. Although our results are promising, they are based on a demonstration project and estimates from other small studies. A comparative effectiveness research trial is needed to determine actual cost and impact of the eSTI system on identification and treatment of new infections and prevention of their sequelae.

Fully integrated e-services for prevention, diagnosis, and treatment of sexually transmitted infections: results of a 4-county study in California.

OBJECTIVES: We examined the acceptability, feasibility, and cost of a fully integrated online system (eSTI) for sexually transmitted infection (STI) testing, treatment, and linkage to care with 4 Northern California health departments. METHODS: In April 2012, we implemented the eSTI system, which provided education; testing of self-collected vaginal swabs for chlamydia, gonorrhea, and trichomoniasis; e-prescriptions; e-partner notification; and data integration with clinic electronic health records. We analyzed feasibility, acceptability, and cost measures. RESULTS: During a 3-month period, 217 women aged 18 to 30 years enrolled; 67% returned the kit. Of these, 92% viewed their results online. STI prevalence was 5.6% (chlamydia and trichomoniasis). All participants with STIs received treatment either the same day at a pharmacy (62%) or within 7 days at a clinic (38%). Among participants completing follow-up surveys, 99% would recommend the online eSTI system to a friend, and 95% preferred it over clinic-based testing within a study. CONCLUSIONS: The fully integrated eSTI system has the potential to increase diagnosis and treatment of STIs with higher patient satisfaction at a potentially lower cost.

Adolescent and young adult understanding of the differences between chlamydia, HIV, and AIDS.

OBJECTIVE: To explore young people's understanding of the differences between Chlamydia, HIV, and AIDS. METHODS. Participants from a hospital-based adolescent clinic completed a self-administered written survey. Three questions assessed participants' understanding of the differences between Chlamydia, HIV, and AIDS. RESULTS: Nearly half of the 119 participants selected "No" or "Don't know" when asked if there are differences between Chlamydia and HIV and between HIV and AIDS. Increasing age was associated with correct response. CONCLUSIONS: A large proportion of youth in this sample did not know that there are differences between Chlamydia, HIV, and AIDS. Previous research suggests that some young people are afraid to be screened for Chlamydia because they fear that a Chlamydia diagnosis has the same ramifications as an AIDS diagnosis. Findings from this study indicate that more education about the differences between Chlamydia, HIV, and AIDS is needed.

Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting.

OBJECTIVES: To compare the effectiveness and cost-effectiveness of a promising new point-of-care (POC) chlamydia test with traditional nucleic acid amplification testing (NAAT), and to determine the characteristics that would make a POC test most cost-effective. METHODS: A decision tree was constructed to model chlamydia screening visits to a sexually transmitted disease clinic by a hypothetical cohort of 10,000 women. The model incorporated programmatic screening costs, treatment costs and medical costs averted through prevention of pelvic inflammatory disease (PID) and its sequelae. Parameter values and costs were estimated for each node in the decision tree based on primary data, published data and unpublished health data. RESULTS: For the base-case scenario (POC sensitivity 92.9%; 47.5% of women willing to wait 40 min for test results; test cost $33.48), POC was estimated to save US$5050 for each case of PID averted compared with NAAT. One-way sensitivity analyses indicated that POC would dominate NAAT if the POC test cost is

Cost-effectiveness analysis of Chlamydia trachomatis screening via internet-based self-collected swabs compared with clinic-based sample collection.

BACKGROUND: Although the Centers for Disease Control and Prevention have recommended population-wide Chlamydia trachomatis screening of sexually active women less than 26 years of age, more than half of sexually active young women are not routinely screened. A Website (IWTK, www.iwantthekit.org), was developed in 2004 to promote home-based sample collection. METHODS: A decision tree was designed to model a hypothetical cohort of 10,000 women per year who order an internet-based C. trachomatis screening kit. We compared the incremental cost-effectiveness of 2 screening strategies: self-sampling via the IWTK website, and traditional, clinic-based screening by the same cohort of women who used IWTK. Probabilities and costs were estimated for each node in the decision tree. Estimates were derived from primary data, published data, and unpublished health data. RESULTS: The internet-based screening strategy prevented 35.5 more cases of pelvic inflammatory disease and saved an additional $41,000 in direct medical costs as compared with the clinic-based screening strategy. CONCLUSION: Our model estimates demonstrated that an internet-based, self-swab screening strategy was cost-effective compared with the traditional, clinic-based screening strategy. Assuming that the popularity of the use of the internet as a resource for information about healthcare and sexually transmitted infections leads to an increased use of IWTK, the public health benefit of this cost-effective strategy will be even greater.

Vaccine counseling: a content analysis of patient-physician discussions regarding human papilloma virus vaccine.

OBJECTIVES: (1) Describe content and character of patient-physician human papilloma virus (HPV) vaccine discussions; (2) explore the relationship between selected characteristics and vaccine uptake. METHODS: Content analyses were conducted on 184 transcripts of audio-taped patient encounters with 11-26 year old female patients that occurred from August 2008 to March 2009 and contained mention of the HPV vaccine. Directed qualitative content analysis sought to identify key themes with a focus on elements related to communication. Quantitative content analysis included determination of associations between selected factors (e.g., physician specialty, communication variables, patient age) and vaccination rates. RESULTS: Communication themes identified though qualitative content analysis demonstrated potential opportunities for improvement in vaccine communication were identified. Quantitative content analysis showed twenty-eight percent of eligible patients received HPV vaccine and on average these patients were younger (17.0 vs. 19.6 years). The youngest and oldest patients were vaccinated less frequently. CONCLUSIONS: Targeting age groups with lower vaccination rates may increase overall vaccine uptake. Additional quantitative analyses of patient-physician discussions about vaccine may generate further recommendations regarding optimal communication strategies for HPV vaccine counseling.

Adolescents' understanding of research concepts: a focus group study.

OBJECTIVE: To identify ways to improve adolescents' understanding of informed assent by exploring adolescent comprehension of concepts common to all clinical trials as well as those specific to a human immunodeficiency virus vaccine trial. DESIGN: Qualitative descriptive study. SETTING: Community-based organizations. PARTICIPANTS: Healthy adolescents aged 15 to 17 years in 8 focus groups. INTERVENTION: Focus groups were conducted using a semistructured interview guide. Digital recordings of the groups were transcribed verbatim. OUTCOME MEASURE: Textual data were categorized by 2 investigators using directed qualitative content analysis techniques. Major themes and subthemes were identified, and representative quotes were selected. RESULTS: The general research concepts that were most difficult for teens to understand were placebo and randomization. The most difficult vaccine trial concepts were how a vaccine works and that a vaccine is used for prevention rather than treatment. The most difficult human immunodeficiency virus vaccine-specific trial concept was that standard human immunodeficiency virus antibody tests might provide a false-positive result for participants receiving the test vaccine. Focus group participants wanted to be informed about adverse effects, trial procedures, and whether previous research had been performed before making a decision about trial participation. CONCLUSIONS: Many clinical trial concepts were difficult for teens to understand. Attention needs to be directed toward developing effective ways to explain these concepts to adolescents participating in future human immunodeficiency virus vaccine and other clinical trials.

The cost-effectiveness of screening men for Chlamydia trachomatis: a review of the literature.

BACKGROUND: An important consideration in determining whether to implement or continue a program to screen men for chlamydia is its cost-effectiveness. A review of the literature on the cost-effectiveness of screening men for chlamydia could potentially provide guidance. METHODS: An Ovid Medline search was conducted for articles published between 1990 and July 2007 using terms for cost, chlamydia, and male. This search returned 175 articles; 25 were retained after eliminating those not relevant to cost-effectiveness studies of male chlamydia screening. We added 4 articles that were in-press or are published in this issue, for a total of 29. These articles were examined for common themes and their results summarized. RESULTS: The reviewed studies examined both proactive and opportunistic screening and included screening of risk groups and of the general population. Some older studies included enzyme immunoassays; more recent studies featured nucleic acid amplification assays. Six studies used dynamic transmission models. Fourteen studies analyzed male and female chlamydia screening interventions. Several contained sufficient data to examine the cost-effectiveness of male screening compared with female screening. Male screening was preferred to expanded female screening in 1 study. In other studies, combined male and female screening programs were cost-saving. CONCLUSIONS: Studies comparing chlamydia screening in men with chlamydia screening in women may be the most useful for guidance to programs. The studies which compare the 2 generally have found that screening men from the general population is not preferred to screening women from the general population, although 1 study found that screening of men from risk groups can be cost-effective compared with screening women from the general population.

Cost-effectiveness of screening strategies for Chlamydia trachomatis using cervical swabs, urine, and self-obtained vaginal swabs in a sexually transmitted disease clinic setting.

BACKGROUND: We evaluated the cost-effectiveness of Chlamydia screening strategies that use different methods of specimen collection: cervical swabs, urines, and self-obtained vaginal swabs. METHODS: A decision analysis was modeled for a hypothetical cohort of 10,000 per year of women attending sexually transmitted disease (STD) clinics. Incremental cost-effectiveness of 4 screening strategies were compared: 1) Endocervical DNA probe test (PACE2, Gen-Probe), 2) Endocervical AC2 (Aptima Combo 2, Gen-Probe), 3) Self-Obtained Vaginal AC2, and 4) Urine AC2. Sensitivities of the vaginal, urine, and cervical AC2 tests were derived from 324 women attending STD clinics. The primary outcome was cases of pelvic inflammatory disease prevented. The model incorporated programmatic screening and treatment costs and medical cost savings from sequelae prevented. RESULTS: Chlamydia prevalence in the sampled population was 11.1%. Sensitivities of vaginal, urine, and cervical AC2 were 97.2%, 91.7%, and 91.7%, respectively. The sensitivity of the DNA probe was derived from the literature and estimated at 68.8%. The self-obtained vaginal AC2 strategy was the least expensive and the most cost-effective, preventing 17 more cases of pelvic inflammatory disease than the next least expensive strategy. CONCLUSIONS: Use of a vaginal swab to detect Chlamydia in this STD clinic population was cost-saving and cost-effective.

Should asymptomatic men be included in chlamydia screening programs? Cost-effectiveness of chlamydia screening among male and female entrants to a national job training program.

OBJECTIVE: To compare the cost-effectiveness of various chlamydia screening strategies within a population of male and female youth entering a national job training program. STUDY DESIGN: Cost-effectiveness analysis of various chlamydia screening strategies among a cohort of 4000 female and male New England job training students. Strategies for women include (a) no screening, (b) universal endocervical DNA probe screening, (c) universal urine based NAAT screening, and (d) universal endocervical NAAT screening. Strategies for men include (a) no screening, (b) selective urine NAAT screening of leukocyte esterase (LE)-positive urines, and (c) universal urine-based NAAT screening. RESULTS: Universal endocervical NAAT screening of women and universal urine NAAT screening of men were the most effective and cost-effective strategies individually and in combination. Endocervical NAAT screening of women prevented 23 more cases of PID and saved $27,000 more than endocervical DNA probe screening. Likewise, universal urine NAAT screening of men prevented 21 more cases of PID in their female partners and saved $16,000 more than selective urine NAAT screening of LE positive men. CONCLUSIONS: Use of a sensitive NAAT to screen both men and women for chlamydia upon entry to a National Job Training Program is cost-effective, cost-saving, and provides a public health opportunity to substantially reduce chlamydia infections among youth at risk for sexually transmitted diseases.

Correlates of readiness to receive Chlamydia screening among 2 populations of youths.

OBJECTIVES: To assess young people's preferences for Chlamydia testing venues and methods, attitudes about testing, sex differences among these variables, and their predictive associations with young people's readiness for screening. DESIGN: Survey. SETTING: National Job Training site and Department of Youth Services site. PARTICIPANTS: One hundred fifty male and 150 female youths from the National Job Training site and 150 male youths from the Department of Youth Services site. MAIN OUTCOME MEASURE: Modifiable predictors of stage of readiness for Chlamydia screening. RESULTS: Modifiable variables associated with increasing readiness for Chlamydia screening included the following: (1) among males in the Department of Youth Services group, perceived likelihood of ever having a Chlamydia infection; (2) among males from the National Job Training site, lack of condom use as a risk factor for Chlamydia infection and perception of untreated Chlamydia infection as dangerous; and (3) among females from the National Job Training site, belief that a partner could have a Chlamydia infection and fewer perceived social consequences of Chlamydia testing. CONCLUSION: Interventions targeted at sex-specific modifiable variables may help reduce undiagnosed Chlamydia infection among sexually active youth.

Patterns and knowledge of nonmedical use of stimulants among college students.

OBJECTIVE: To determine patterns and knowledge of nonmedical use of stimulants among a sample of college students. DESIGN: Completion of an anonymous survey consisting of 23 questions designed to explore college student use of medications intended to treat attention-deficit/hyperactivity disorder. SETTING: A private liberal arts college in New England. PARTICIPANTS: Three hundred forty-seven undergraduate students. MAIN OUTCOME MEASURE: Nonmedical use of stimulants. RESULTS: Thirty-one students (9.2%) reported nonmedical stimulant use. Two hundred forty students (71.4%) had peers who used nonprescribed stimulants, 149 (44.3%) knew of peers who made stimulant medication-seeking visits to a physician although they did not believe that they had attention-deficit/hyperactivity disorder, and 178 (53.0%) knew of people who sold stimulants to students. Nonprescription users were significantly more knowledgeable about the effects of stimulants than nonusers, and nonusers whose peers used nonprescribed stimulants were more knowledgeable about the effects of stimulants than nonusers whose peers did not use nonprescribed stimulants. After controlling for age, race, and sex, the variables that predicted nonmedical use of stimulants were beliefs that stimulants help individuals study better, stay awake, and lose weight. CONCLUSIONS: A substantial proportion of college students in this sample were using nonprescribed stimulants. Among nonusers, those whose peers use nonprescribed stimulants were much more knowledgeable about the effects of stimulant use than those whose peers do not use stimulants. This knowledge may confer an increased risk of future nonmedical stimulant use if students become tempted to seek the beneficial effects experienced by their peers.

Effect of perineal cleansing on contamination rate of mid-stream urine culture.

STUDY OBJECTIVE: Urinary tract infection (UTI) and chlamydial or gonococcal urethritis are the most common causes of female dysuria. While chlamydia and gonorrhea can be detected with a nucleic acid amplification test performed on an uncleansed first part voided urine sample, urine cultures to test for UTI require a mid-stream clean caught sample. In order to determine whether collecting two sequential non-clean caught urine samples during the same void to test for chlamydia, gonorrhea, and UTI is a reasonable approach, we assessed the degree to which perineal cleansing reduces bacterial contamination of mid-stream urine cultures. DESIGN: Experimental study comparing mid-stream urine samples collected with (n = 25) and without (n = 25) perineal cleansing. SETTING: A university-based adolescent clinic PARTICIPANTS: We recruited fifty 14-23-year-old (mean 18.5 yrs, SD 2.3) asymptomatic females. MAIN OUTCOME MEASURE: Perineal flora contamination rate of mid-stream urine cultures collected with and without perineal cleansing. RESULTS: No culture grew >10(4) colonies of a pathogenic bacterium. Eleven (44%) of the experimental group samples and 9 (36%) of the control samples grew >10(4) colonies of perineal bacterial flora (chi(2) = .33, P = 0.56). Participants' previous experience collecting mid-stream urine was not associated with less bacterial contamination. CONCLUSIONS: Among this small sample of asymptomatic young women, perineal cleansing did not significantly reduce perineal flora contamination of mid-stream urine cultures. If larger studies of symptomatic young women replicate these findings, young women could collect two sequential urine samples from the same void to test for chlamydia, gonorrhea, and UTI.

Performance of urine leukocyte esterase in asymptomatic male youth: another look with nucleic acid amplification testing as the gold standard for Chlamydia detection.

PURPOSE: To re-evaluate the sensitivity and specificity of leukocyte esterase (LE) for screening adolescent and young adult males for Chlamydia trachomatis using a nucleic acid amplification test (NAAT) as the gold standard. METHODS: This study was conducted at two Massachusetts Department of Youth Services sites and one Job Corps site. Recently admitted asymptomatic sexually active male youth aged 14 to 25 years (mean 16.6 years) were recruited between January 2001 and July 2003 (N = 1008). Participants provided first part voided urine specimens for testing with LE and Chlamydia NAAT. The sensitivity, specificity, and positive and negative predictive value of urine LE for identification of Chlamydia infection were determined using NAAT as the gold standard. RESULTS: Fifty-seven (5.7%) participants were infected with Chlamydia as defined by a positive NAAT. Defining trace + as the LE cut point resulted in sensitivity and specificity of 57.9% and 78.3%, respectively. Defining 1+ as the cut point resulted in sensitivity and specificity of 47.4% and 96.1%, respectively. CONCLUSIONS: Urine leukocyte esterase is a moderately sensitive method to screen for Chlamydia. Nevertheless, a substantial proportion of infections are not detected with LE screening. When feasible, urine NAAT provides a much more sensitive and equally noninvasive method of detecting Chlamydia. However, if LE is used as an initial screen followed by NAAT confirmation of LE positive samples, we recommend using trace LE as the cut point for positive results.

Adolescent and young adult women's misunderstanding of the term Pap smear.

OBJECTIVE: To learn more about young women's understanding of the term Pap smear. DESIGN: Self-administered survey. SETTING: UMass Memorial Adolescent Clinic. PARTICIPANTS: Female patients 14 years or older (and their mothers when available) who visited the clinic between June 10 and August 9, 2002. MAIN OUTCOME MEASURES: Accuracy of participants' written definition for the term Pap smear and knowledge that a "Pap smear" is a test for cervical cancer and not synonymous with a pelvic examination, sexually transmitted disease test, pregnancy test, or checkup. RESULTS: Three (2.7%) of the 111 adolescent participants provided an accurate definition of the term Pap smear. Sixty-eight percent mistakenly believed that a Pap smear was the same as a pelvic examination. Age, history of sexual intercourse, and having had a Pap smear correlated with a better Pap smear definition rating. CONCLUSIONS: Remarkably few patients who participated in this study understood the meaning of the term Pap smear. Confusion about gynecologic terms may hinder efforts to enhance compliance with sexually transmitted disease and cervical cancer screening. Educational initiatives are needed to improve young people's comprehension and to prevent misunderstandings about gynecologic care and miscommunication between patients and their health care providers.

Can the diagnosis of pelvic inflammatory disease be excluded without a bimanual examination?

Now that urine-based tests are available for detection of Chlamydia and gonorrhea, we sought to determine whether history alone could be used to exclude pelvic inflammatory disease (PID) and thus preclude a bimanual examination. The study design was a retrospective chart review. The study population included females aged 15-24 years diagnosed with PID. Outcome measures were documentation of screening symptoms (abdominal pain, dyspareunia, or abnormal vaginal bleeding) in the medical record. Our primary analysis was sensitivity of screening symptoms for identifying patients with PID. At least 1 of the 3 screening symptoms was reported by 93% of the PID group. If absence of all 3 screening symptoms were used as a screening instrument to exclude a bimanual examination, many women with lower genital tract symptoms could be evaluated noninvasively. However, this approach could result in delayed diagnosis of PID in a small number of patients. Before this strategy is adopted, a large prospective study is needed.