2002 National STD Conference
Poster Abstracts 51-75
Self-Reported HIV Status and Risk Factors Among Incarcerated Men Who Have Sex with Men (MSM)
C Higgins1, D Kodagoda2, D Carr2, M Bovee2, J Chen2, P Kerndt2
1University of California School of Public Health, Los Angeles, CA; 2Los Angeles County Department of Health Services, STD Program, Los Angeles, CA
Background: Since June 2000, confidential and voluntary HIV testing along with behavioral risk factor information was collected from men who have sex with men (MSM) housed in a segregated unit in a Los Angeles County Jail.
Objectives: To determine behavioral risk factors and the accuracy of self-reported HIV status.
Methods: Inmates provided blood for ELISA/Western Blot HIV testing. Self-reported behavioral data was collected through an interview. Data from June 2000-May 2001 was analyzed using logistic regression and the kappa statistic.
Results: Of the 521 individuals included in the sample, 24% of the participants were between 35 and 39, 61% were white, 34% were Black, and 20% reported a positive HIV status. Older-aged inmates, 35-39 years, were more likely to report a positive HIV status as compared to younger persons aged 20-24 (OR = 7.14, 95% CI 1.82, 25). African Americans were twice as likely as Caucasians to self-report a positive HIV status (OR = 2.04, 95% CI 1.15, 3.70). Ever attending a bathhouse to meet partners was positively associated with a reported positive HIV status (OR = 4.63, 95% CI 1.68, 12.76). Of the 339 individuals who agreed to test, 94% were found to have accurately reported their HIV status (Kappa = 0.68).
Conclusion: Older individuals and African Americans were more likely to report a positive HIV status as were individuals who ever attended a bathhouse. Although misclassification of HIV status may exist among those individuals who did not test for HIV, a high concordance between self-report and verified HIV serostatus is observed among the majority of inmates.
Implications for Programs: Incarcerated MSM are a sentinel population for monitoring HIV and behavioral surveillance, while needing STD case management and interventions.
Implications for Research: Further analysis of whether predictors of self-reported HIV status are the same for lab confirmed HIV status is needed.
Learning Objectives: By the end of this section, participants will be able to describe the HIV prevalence among incarcerated men in this setting.
Contact Information: Chandra Higgins / firstname.lastname@example.org
Prevalence and Indicators of Chlamydia trachomatis Infections Among Men in Massachusetts Correctional Facilities and STD clinics
M Nguyen1, S Ratelle1, M Whelan1, P Etkind1, B Dumas1, Y Tang1, P Rocheford2
1Division of STD Prevention, Massachusetts Department of Public Health, Boston, MA; 2Hampden County Jail, Springfield, MA
Background: Urine-based screening using nucleic acid amplification tests has made screening for Chlamydia trachomatis (Ct) in men more acceptable in a variety of settings.
Objectives: To determine the prevalence of Ct in men in Massachusetts sexually transmitted disease (STD) clinics and correctional facilities (CF) and examine and compare age and behavioral risk factors as predictors of chlamydial infection.
Methods: Between January 1 and December 31 2000, 3418 men entering a CF and 2548 men attending an STD clinic in Massachusetts were tested for Ct by the ligase chain reaction (LCR) assay.
Results: The prevalence of chlamydial infection among all males was 9.0%; 13.4% in STD clinics (6.4% in asymptomatic males) and 5.8% in CF. In both settings, the prevalence of Ct increases with decreasing age. Men in STD clinics were more likely to have two sex partners (OR = 8.25 [7.06–9.64]), a new sex partner (OR = 25.13 [20.74–30.45]), or a recent STD contact (OR = 33.89 [24.51–46.97]) in the past 60 days. For STD clinics, screening men under 25 and those over 25 with an STD contact in the past 60 days identifies 74.0% of cases while screening 47.4% of asymptomatic men. In correctional facilities, universal screening of all men under age 30 identifies 84.8% of cases by screening 51.5% of asymptomatic men.
Conclusions: Chlamydial infection is common in young men in both STD clinics and CF.
Implications for Policy: LCR testing is an acceptable Ct screening method for men in non-clinical settings. Asymptomatic young men presenting in CF have a prevalence of Ct similar to those presenting in STD clinics, making a compelling argument to consider screening.
Implications for Research: Outcome studies are needed to determine if screening of men will reduce the incidence of pelvic inflammatory disease in women. Additional studies are needed to determine the cost-effectiveness of screening men for CT.
Learning Objective: Participants will be able to describe differences between STD clinics and CF in Massachusetts in terms of prevalence of Ct in men and demographic and behavioral risk factors for men with Ct.
Description of Chlamydia and Gonorrhea Screening Among Juveniles in Essex County, NJ Juvenile Facility, January 2000–December 2000
New Jersey State Department of Health and Senior Services, Trenton, NJ
Background: Detained adolescents are at high risk for sexually transmitted diseases (STDs) and if not screened will go untreated to the community spreading infections. Therefore, correctional facilities provide an ideal environment for screening, treatment, prevention, and education efforts among incarcerated population.
Objectives: To describe epidemiological features of chlamydia and gonorrhea infections among juveniles in Essex County Juvenile Facility.
Methods: Serological tests were carried out from January 2000 through December 2000. Two thousand twenty six tests were analyzed using the ligase chain reaction (LCR) screening procedure, for a period of 12 months.
Results: Of the 2026 juveniles screened for chlamydia, 205 or 10.8% were diagnosed positive. Of these 2026 screened, 1761 were males and 265 were females. Of the 1761 males screened, 155 (or 9.4%) were positive. Of the 265 females screened, 50 (or 20.8%) were positive. Of the 2026 juveniles screened for gonorrhea, 77 (or 4.1%) were diagnosed positive. Of these 2026 screened, 1761 were males and 265 were females. Of the 1761 males screened 56 or (3.4%) were positive. Of the 265 females screened, 21 or (8.7%) were positive.
Conclusions: This study suggests that the existence of chlamydia and gonorrhea infections places individuals in this group at elevated risk for acquiring HIV infection.
Implications for Programs: Local health departments may want to consider screening for chlamydia and gonorrhea in juvenile facilities.
Implications for Research: Most juvenile systems have implemented some form of prevention program, including STD education, but there is still considerable work to be done to improve education and prevention in these facilities.
Learning Objective: Describe chlamydia and gonorrhea prevalence among youth entering the Essex County Juvenile Facility in New Jersey.
Contact Information: Dmitry Ivanov / Phone 609-588-7526 / Dmitry.Ivanov@doh.state.nj.us
Incentive Program to Increase Voluntary Syphilis Screening in a County Correctional Facility
G Nowels1, T Chrestoff1, H Scaife2
1Ohio Department of Health, Columbus, OH; 2Cuyahoga County Board of Health, Cleveland, OH
Background: Voluntary syphilis screening was begun under the Syphilis Elimination Program (SEP) at the Cuyahoga County Correctional Facility (CCCF) in May 2000. During the initial four-month period, there were approximately 300 people volunteering for screening.
Objective: Increase the number of inmates who would volunteer for syphilis screening using an incentive which would be applicable, inexpensive, and usable in correctional facility.
Methods: In consultation with personnel at CCCF, the single item which most prisoners did not like was the soap the facility used. An incentive program, which gave each person taking an RPR screening test a bar of Dove soap, was begun in October 2000. This program was expanded to include not only soap, but also a small jar of moisturizing lotion in December 2000.
Results: The number of inmates volunteering for syphilis screening during the initial four months of the project was approximately 300 per month. After offering the soap inducement in September of 2000, the number of inmates volunteering for testing increased to 495 per month. With the addition of the moisturizing cream the number of inmates volunteering for testing increased to 656 per month for December and January. For the next five months the number of inmates volunteering has remained high, but testing has not kept up with the volunteering number due to lack of jail staff.
Conclusions: During the last major outbreak of syphilis in the Cleveland area, the second highest reporting type of facility for infectious syphilis was found from the local prison system. Using this as baseline criteria, a good screening environment in the local prison may be used to catch an outbreak of syphilis in its earliest stages. Utilizing an incentive program to increase the number of individuals testing in this type of facility will increase the probability early syphilis may be detected.
Implications for Programs/Policy: With limited resources and an incentive program in a local correctional setting, many high-risk individuals can be tested for syphilis on a voluntary basis.
Implications for Research: Ascertain whether targeted approach using incentives in a voluntary setting can have an impact on reduction of syphilis, and whether this would be beneficial when used in a higher morbidity area.
Project Connect: Enhanced HIV and Syphilis Counseling and Testing Services in a Correctional Population
VP Jones1, G Olthoff1,4, S Brunson2, M Ward2, B Stanton3
1Prince George’s County Health Department, Forestville, MD; 2Maryland AIDS Administration, Baltimore, MD; 3Prince George’s County Correctional Center, Upper Marlboro, MD; 4Centers for Disease Control and Prevention, Atlanta, GA
Background: Project Connect was envisioned with the idea that an effective way to achieve HIV prevention was to empower HIV positive people to assist in the prevention of HIV in their close circle of friends as well as supporting safer sex behavior. The rational is to identify new cases through counseling and testing in the correctional center and subsequent prevention case management for the HIV positive persons who are found.
Objectives: The Prince George’s County Health Department is offering HIV and syphilis counseling and testing to every new arrestee in the Prince George’s County Detention Center. The population being reached is African American males and females between the ages of 18 and 40.
Methods: Every male and female arrested is offered HIV and syphilis counseling and testing as part of the local correctional center’s medical services. Health Department Staff – Disease Intervention Specialists (DIS) are in the correctional center up to four days a week in both the male and female intake units offering these services. The project will provide rapid turnaround time for HIV testing and the return of test results. All persons testing positive are provided post test counseling and partner counseling and referral services. All partners will be offered HIV testing in the field. Both positive and negative partners will be offered prevention case management services.
Results: Testing began January 2001 in the county correctional center. Three hundred eighty-eight (388) persons consented for testing. Seven positive cases have been identified, of those, 2 were new cases of HIV infection. Five of the inmates testing positive were post-test counseled while incarcerated. Each was also offered partner counseling and referral services. The other 2 positive inmates were released shortly after testing and their test results were sent to the appropriate jurisdiction for post test counseling and partner counseling services.
Implications for Programs: This project will provide rapid turn-around time for HIV testing and return of test results, ensure that post-test counseling is provided, and elicit the sex and needle sharing partners of those who test positive. Both HIV positive and negative sex and needle sharing partners will be offered the services of Prevention Case Management (PCM), which will include risk reduction counseling and referral for additional services using monetary incentives for participants, education and testing sessions will be hosted in the community for persons known or likely to have HIV-infected partners. This will be a continuous process in an attempt to access ever-widening and interlinked concentric circles of contacts who are at high risk of contracting HIV infection.
Demonstration Project Sponsoring Agency: Centers for Disease Control and Prevention, Atlanta, Georgia
Assessment of the Utility of Routine Screening for Chlamydia trachomatis and Neisseria gonorrhoeae in a Juvenile Detention Facility: San Bernardino County, California
RK Spencer1, ED Peace2, A Haro-Garcia1, HR Cockerill1, JG Nevarez1, AF Taylor1, RE Zane1, EK Frykman1, TJ Prendergast1, GR Greene3
1San Bernardino County Department of Public Health, San Bernardino, CA; 2San Bernardino County Probation Department, San Bernardino, CA; 3Arrowhead Regional Medical Center, Pediatrics Department, Colton, CA
Background: All wards of the court in San Bernardino County are provided a physical examination within 96 hours of admission to Juvenile Hall. Currently, only those complaining of symptoms are evaluated for sexually transmitted infections (STIs). It has been demonstrated that up to 75% of females and more than 50% of males with Chlamydia trachomatis (Ct) have been asymptomatic. Further, studies have shown that many youths with symptoms do not present for medical care.
Objectives: To determine the prevalence of Ct and Neisseria gonorrhoeae (GC) among wards of the court in San Bernardino County.
Methods: One thousand consecutive admissions to Juvenile Hall were screened for Ct and GC using ligase chain reaction. A standard questionnaire was used to record demographic data and other relevant variables.
Results: One hundred and one (10%) of those tested had Ct, GC, or both. Ninety-three (9%) were found to be infected with Ct (82 [88%] of whom were asymptomatic). Sixteen (2%) were found to be infected with GC. Eight were co-infected with both STIs. Positive cases were treated appropriately. Females and youths of color were over-represented among those found to be infected when compared with the general population of Juvenile Hall.
Conclusions: Routine screening for Ct/GC should be the standard of care for youths incarcerated within the juvenile justice system.
Implications for Programs/Policy: The findings presented herein can be used to approach state agencies and local boards of supervisors to request increased funding for Ct/GC screening programs in similar populations or to justify the internal reallocation of resources when increased funding is not available.
Implications for Research: Such findings could be used to support the implementation of cross-sectional studies which screen for syphilis, HIV, and hepatitis C.
Learning Objectives: Participants will be able to describe the prevalence of Ct/GC among incarcerated youth and provide justification for routine screening within the juvenile justice system.
Contact Information: Rhonda Spencer / Phone 909-383-3060 / email@example.com
One-Time Money: It Can Make a Difference
D Coleman, M Krempasky, K Dorian, M Headlee
Columbus Health Department, Columbus, OH
Background: In 1997, after intense local health department (LHD) lobbying, $2 million was allocated by the Ohio Department of Health for STD diagnosis and treatment. Ten LHDs received funding. Reaching youth at high risk for STDs was a major concern. Working through the Ohio Sexual Health Coalition, 7 LHDs initiated expanded STD services at juvenile detention centers (JDC) throughout the state.
Objectives: To provide STD education, diagnosis, and treatment to adolescents in JDCs in Ohio, and to determine the need for continuing these services based upon youth acceptance, STD prevalence, the ability to treat, and success of partner notification.
Methods: After the project was piloted by the Columbus Health Department at the Franklin County JDC, six additional LHDs (Akron, Canton, Cincinnati, Combined District-Montgomery County, Mansfield-Richland County, and Zanesville-Muskingham County) joined the initiative. Client-specific sexual health education and non-invasive LCR testing was provided in a non-threatening, one-to-one manner with the youth. LHD staff returned in a week to provide additional education, results, and treatment.
Results: Combined gonorrhea and/or chlamydia prevalence was found to exceed 16%. Nearly 75% of those infected were asymptomatic. After initial funds were exhausted, four of the seven LHDs were able to continue JDC services.
Conclusions: STD prevalence is high in JDC youth, and they are receptive to noninvasive testing. Due to lack of adequate funding, many of these high-risk youth do not have access to STD services.
Implications for Program/Policy: Strong consideration needs to be given to providing funding for JDC STD testing, even if it may mean diverting money from other established, but lower prevalence, programs.
Implications for Research: Future studies should look at the cost effectiveness of delivering STD testing and treatment to youth in JDCs.
Learning Objectives: Participants will be able to identify key benefits of noninvasive screening for gonorrhea and chlamydia in a JDC population. Participants will receive information regarding benefits realized and obstacles encountered when working on state-wide initiatives with one-time money.
Prevalence of Chlamydia and Gonorrhea Among Females in a Juvenile Detention Facility, Honolulu, Hawaii
A Katz1,2, M Lee2, R Ohye2, J Oshiro3, J Tomas2, N Chun2, R Atienza2
1University of Hawaii John A. Burns School of Medicine, Honolulu, HI; 2Diamond Head STD Clinic, STD/AIDS Prevention Branch, Hawaii State Department of Health, Honolulu, HI; 3Hale Ho’omalu, Detention Services Branch, Family Courts, Hawaii State Judiciary, Honolulu, HI
Background: Sexually transmitted disease (STD) rates are thought to be highest among sexually active adolescents. Many gonorrheal (GC) or chlamydial infections in adolescent females go undetected due to a combination of subclinical symptoms, denial, and avoidance of testing. Female adolescents in juvenile detention centers have demonstrated higher rates of STDs than comparably aged non-incarcerated females.
Objective: To ascertain the feasibility of screening females for STDs at a juvenile detention facility and to determine the prevalence of chlamydial and GC infections in this population.
Methods: Free and confidential GC and chlamydia screening was offered to all female detainees, on selected dates. Consenting females underwent a pelvic examination. GC cultures were taken from the rectum, urethra, endocervix, and urethra. Chlamydia screening was performed using a DNA probe (Genprobe®) on a swab from the endocervix.
Results: Sixty-three of 142 female juvenile detainees consented to be screened for chlamydia and GC. Ten of 63 females were screened positive for chlamydia (15.9%), while two of 63 were culture positive for gonorrhea (3%): one with a rectal positive site; one with urethral and endocervical positive sites. The overall chlamydia positivity rate for the State of Hawaii was 3.8% for females of all ages, and 5.9% among 15–19 year old females. The overall GC culture positivity rate for the State of Hawaii was 0.4% for females of all ages, and 0.6% for females 15 –19 years old.
Conclusions: Although this pilot project had a limited number of subjects, the high STD rates justify the institution of an ongoing screening program for this high-risk and previously ignored group.
Implication for Programs/Policy: Resources must be allocated to support routine STD screening and treatment within both the female and male juvenile detention population. Noninvasive, urine-based screening may increase participation rates.
Implications for Research: Future research and evaluation should monitor success in locating case partners, and in measuring STD rates in these partners.
By the end of this session, participants will be able to identify a previously overlooked population at risk for gonorrhea and chlamydia.
By the end of this session, participants will be able to explain different approaches to screen juveniles for STDs in detention facilities.
Contact Information: Alan R. Katz / Phone 808-956-5741 / firstname.lastname@example.org
Azithromycin as a Cost-Saving Alternative to Penicillin G Benzathine for Treatment of Incubating Syphilis in Exposed Contacts
J Blandford, T Gift
Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA
Background: Treatment of incubating syphilis with intramuscular benzathine penicillin is not always practical in the field, and exposed contacts may not comply with referrals for treatment. The availability of a single-dose, oral therapy could increase the number of partners treated prophylactically and reduce future infections. In one study, a 1-gram dose of oral azithromycin was shown to be 100% effective in treating incubating syphilis.
Objective(s): To evaluate the cost-effectiveness of directly observed oral administration of azithromycin as an alternative to referral for benzathine penicillin for treatment of incubating syphilis.
Methods: We used a decision-analysis model to compare the direct costs and effectiveness of field treatment with azithromycin versus referral for benzathine penicillin therapy. Costs were evaluated from both program and societal perspectives. We assigned initial efficacy values of 90% for azithromycin and 100% for benzathine penicillin. Our outcome was cases of early syphilis averted. We included costs associated with long-term complications of untreated syphilis, excepting the increased risk for HIV infection and congenital syphilis. Sensitivity analyses were performed on all variables.
Results: From both program and societal perspectives, directly observed treatment with azithromycin in the field is cost-saving at the current wholesale price of $17.32 (sachet formulation) when efficacy exceeds 90%. At public-sector pricing ($11.50), azithromycin is cost-saving from the program perspective at efficacy levels as low as 75%. Azithromycin therapy will result in fewer cases of primary or more advanced stages of syphilis, provided that the drug’s efficacy is at least 87%.
Conclusions: Azithromycin is a cost-effective alternative treatment for incubating syphilis in settings where standard intramuscular therapy is not practical.
Implications for Programs/Policy: Azithromycin may become the treatment of choice for exposed partners when standard benzathine penicillin therapy cannot be administered in the field.
Implications for Research: Further evaluation of azithromycin’s efficacy in treating incubating syphilis is needed to confirm the findings of a cost and treatment advantage.
Learning Objectives: Participants will be able to evaluate the costs and effectiveness of alternative strategies for the prophylactic treatment of incubating syphilis.
Contact Information: John Blandford / Phone 404-639-6498 / email@example.com
A Cost-Effective, Targeted, Capacity Expansion of HIV/AIDS Services in Substance Abuse Treatment Agencies
P Tambe, R Lewis-Hardy, V Hartwell, J Creighton, L Allen, A Troutman, D Daniels
Fulton County Department of Health and Wellness, Atlanta, Georgia
Background: Fulton County ranks the highest in Georgia for sexually transmitted infections including HIV. Because of limited resources, a significant gap exists in the availability of HIV and STD/TB screening and related services for the racial/ethnic minority communities that access care for substance abuse treatment.
Objective: The objective for the Health Department was to provide individualized assistance to substance abuse treatment providers to expand their on-site services and to educate, screen and link clients to STD/HIV/TB treatment.
Methods: The Health Department surveyed thirteen substance abuse treatment sites for barriers to screening for STD/HIV/TB. Individualized support such as venipuncture classes, certification courses for HIV testing counseling, HIV education, blood specimen transportation and technical training to set procedures and reporting of HIV data was provided by the Health Department.
Results: Two thousand substance abusing clients received STD/TB or HIV screening at the substance abuse treatment agencies of which 67 clients were reported to be HIV positive. Approximately 350 clients with STD/HIV/TB infections were linked with appropriate clinics to provide treatment and partner notification.
Conclusion: Strong collaboration between public health STD/HIV/TB clinics and substance abuse providers is a cost effective method to increase capacity of substance abuse providers to screen the clients at high risk for STD/HIV/TB.
Implication for Program: A team effort by the Health Department and substance abuse providers assures early detection and treatment of infections and follow up for clients with STD/HIV/TB infections who do not routinely seek medical care.
Implication for Research: Future research is needed to assess cost-benefit ratios and to increase adherence to therapy by offering education and STD/HIV/TB screening in the substance abuse treatment facilities.
Learning Objectives: Participants will be able to increase cost-effective STD/HIV/TB screenings and treatment to high risk groups through improved collaborations.
Cost-Effectiveness of Universal Screening for Gonorrhea and Chlamydia Among Inmates in United States Jails
J Kraut1, A Haddix2, R Greifinger3, K Irwin4
1Northern Illinois University, DeKalb, IL; 2Rollins School of Public Health, Atlanta, GA; 3Bromeen Group, New Rochelle, NY; 4Centers for Disease Control and Prevention, Atlanta, GA
Background: Although the value of STD screening in jails is now widely recognized, the most effective and cost-effective implementation strategies must be
2002 National STD Prevention Conference
identified. Universal screening shortly after intake has been proposed as one effective strategy to decrease morbidity and transmission of gonorrhea and chlamydia.
Objective: Examine the cost-effectiveness of universal gonorrhea and chlamydia screening of inmates on intake as compared with the common strategy of presumptive treatment (without laboratory testing) of symptomatic inmates.
Methods: Decision analysis models were developed to estimate the cost-effectiveness of pathogen-specific screening strategies for men and women. Analyses were based on hypothetical cohorts of 10,000 inmates. Parameter estimates were drawn from literature and expert opinion. We evaluated the costs and benefits to the health system (including jails), specifically, cases of pelvic inflammatory disease (PID) prevented by screening women and cases of potentially infectious acute infections detected by screening men.
Results: At chlamydia prevalence rates of 8% or more, universally screening female inmates was cost saving in terms of cases of pelvic inflammatory disease (PID) averted. At gonorrhea prevalence rates of 6% or more, universally screening women was considered cost-effective because it cost the health system ~$1,700 to prevent a case of PID. At chlamydia prevalence rates of 4% or more, universally screening men was considered cost-effective because it cost ~$1,950 to detect an acute, potentially infectious case. Universally screening men for gonorrhea was not cost-effective.
Conclusions: At prevalence levels typical of many jails, universal screening at intake for these STDs is cost-effective, and for chlamydia in women, would save money. Jail screening programs may provide STD services to high-risk persons with limited access to care elsewhere.
Implications for Programs/Policy: Universal screening for chlamydia and gonorrhea at intake is a cost-effective strategy that should be considered in jails with high prevalence of these STDs.
Implications for Research: Additional cost-effectiveness analyses of other jail STD-screening strategies should be evaluated.
Learning Objectives: Participants will be able to identify relevant costs and benefits of jail-screening programs and allow them to evaluate jail screening in their community.
Contact Information: Julie R. Kraut / Phone 815-753-2436 / firstname.lastname@example.org
CLIA Waived vs Moderately Complex Rapid HIV Testing: How Much Will it Cost?
DL Sykes1, BM Branson2, SR Truax1
1Office of AIDS, California Dept. of Health Services, Sacramento, CA; 2Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA
Background: Rapid HIV tests are useful in both clinic and outreach settings because more persons learn their results. Some newer rapid tests are simple, accurate, do not require special laboratory equipment, and can be performed in £15 minutes. The Clinical Laboratory Improvement Act (CLIA) could categorize these diagnostic tests as moderately complex or as waived. The two categories require different personnel.
Objective: Estimate the costs for California’s HIV testing program if simple, rapid HIV tests are categorized as waived versus moderately complex.
Methods: We calculated personnel costs for rapid HIV testing under the two CLIA categories. Based on specific qualifications required and the state’s personnel classification system, hourly wages to perform rapid tests would be $9 if waived and $17 if moderately complex. Counseling times were derived from the counseling and testing database. We estimated that rapid tests would require 15 minutes to perform.
Results: Of approximately 200,000 annual HIV tests, 1% is positive. Risk assessment (pretest counseling) requires 20 minutes. Disclosure sessions (posttest counseling) average 15 minutes for HIV-negative persons and 45 minutes for HIV-positive. Annually, a total of 117,667 hours are required for counseling, and approximately 51,000 hours for rapid testing. If the counselor also performs the test, waived HIV testing would cost California $1,518,000 per year, and moderately complex, $2,867,339 ($1.35 million more.) If a person other than the counselor performs the test, additional personnel costs would exceed $408,000 annually if rapid tests were categorized as moderately complex, assuming these persons actually spent all work hours performing tests.
Conclusion: Rapid HIV testing will cost substantially more with moderately complex than waived categorization under CLIA.
Implications for Programs/Policy: Waived rapid HIV tests will be most cost-effective, but subject to less formal oversight. Therefore, programs need to develop systems to guarantee quality and proficiency.
HIV Testing with Oral Fluids and Rapid Tests is More Effective and Less Costly
F Spielberg1, S Jackson1, B Varghese2, B Branson2, SD Reed1, G Goldbaum1,3, SD Sullivan1
1University of Washington, Seattle, WA; 2Center for Disease Control and Prevention (CDC), Atlanta, GA; 3Public Health –Seattle & King County, WA
Background: The HIV Alternative Testing study showed that needle exchange (NE) and bathhouse (BH) clients prefer rapid and oral fluid HIV testing, and are more likely to receive their results under these testing methods as compared .
Objectives: Calculate the costs of alternatives for HIV testing at a NE and two BHs for gay men in Seattle.
Methods: Four testing strategies were offered to a total of 18,089 people. One testing strategy was randomly assigned to the sites each day. The strategies were as follows: 1) Standard blood HIV testing, with counseling and a return visit for results; 2) Rapid testing with SUDS; 3) Standard oral fluid HIV testing; and 4) Standard HIV testing with the option of written materials for counseling. Time flow studies assessed the resources necessary for each strategy. Measures of effectiveness were acceptance of testing and receipt of results. We analyzed (from the provider perspective) the cost per test result received.
Results: At the BHs, rapid testing was more effective for receipt of results (157 per 1000 offered) and less costly ($75 per result received) than oral fluid testing (124, $112), or standard testing, with (82, $130) or without (92, $118) the counseling option. At the NE, oral fluid testing (71, $155) was most effective, but rapid testing (65, $136) was least costly. Both were more effective and less costly than standard testing, with (51, $175) or without (27, $318) the counseling option. In sensitivity analysis, if oral fluid testing cost less than $12, it would be more cost-effective than rapid testing at the NE.
Conclusions: Fewer clients learned their HIV status with standard HIV testing than with rapid or oral fluid testing at both the NE and BHs. Standard HIV testing was also the most costly.
Implications for Programs/Policy: With rapid or oral fluid testing, considerably more persons at high-risk learn their HIV status, at a lower cost than with the current standard HIV testing process.
Acceptance of Alternate HIV Counseling and Testing Strategies (Rapid, Oral Fluid, and Optional versus Standard Counseling)
F Spielberg1, BM Branson2, GM Goldbaum1,3, A Rossini1, D Lockhart1, A Kurth1, RW Wood1,3
1University of Washington, Seattle, WA; 2Centers for Disease Control and Prevention (CDC), Atlanta, GA; 3Public Health –Seattle & King County, WA
Background: Many people at risk for HIV prefer alternatives to standard HIV counseling and testing, which require venipuncture and two clinic visits.
Objectives: We compared test acceptance, and receipt of results with alternative counseling and testing strategies among clients at a needle exchange, two bathhouses for gay men, and an STD clinic.
Methods: Four testing strategies were offered, with one strategy, randomly chosen, offered per day. The four strategies were as follows: 1) Standard two-visit HIV blood testing, with counseling; 2) Rapid testing with SUDS; 3) Standard oral fluid testing; and 4) Standard testing with optional written materials for counseling. At the STD clinic, only rapid and standard testing were offered. All four strategies were offered at the other two sites, where clients also chose whether to receive their results by telephone or in person.
Results: Over 270 days, 18,089 clients were offered testing. Among the 7915 (44%) eligible, 1405 (18%) were tested. Acceptance varied by strategy and site, ranging from 9% (standard) to 20% (oral) at the needle exchange, 14% (optional counseling) to 23% (oral) at the bathhouses, and 68% (standard) to 70% (rapid) at the STD clinic. At the needle exchange and bathhouses, 79% preferred written pretest materials. Receipt of test results ranged from 56% (standard) to 83% (rapid) at the needle exchange; 74% (standard) to 99% (rapid) at the bathhouses; and 68% (standard) to 98% (rapid) at the STD clinic. At the bathhouses, 93% of clients chose telephone results, compared with 31% at the needle exchange.
Conclusions: At each site acceptance of HIV testing was highest with oral fluid testing, and receipt of results was highest with rapid testing. Both acceptance and receipt of results were significantly less with standard HIV testing.
Implications for Programs/Policy: Offering oral fluid and rapid HIV testing increases the number of persons who agree to testing and receive their results.
Development and Application of a Rapid Sensitive/Less-Sensitive Testing Strategy to Ascertain HIV Incident Cases
N Constantine1, A Sill2, N Jack3, F Cleghorn2, K Kreisel1,2, J Edwards3, T Cafarella2, H Smith3, C Bartholomew3, W Blattner2
1Department of Pathology, University of Maryland School of Medicine, Baltimore, MD; 2Institute of Human Virology, Baltimore, MD; 3Medical Research Foundation of Trinidad and Tobago, Port of Spain, Trinidad, West Indies
Background: The ascertainment of early HIV-1 infection is important for studies involving early therapeutic interventions and for estimating HIV incidence, but is logistically complex to implement.
Objective: Our objective was to develop and validate a sensitive/less sensitive (S/LS) rapid serologic testing strategy and confirmatory algorithm that would be effective in identifying persons with recent HIV infection and that could increase the timely enrollment of cases.
Methods: The Unigold HIV rapid assay (UG) was procedurally modified, calibrated and validated for its ability to differentiate recent (<133 days after the first detection of viremia) from established HIV infections. A total of 187 samples, collected in Trinidad and Tobago were used to modify the UG to a less sensitive format (UG LS) and results were verified using an EIA S/LS method.
Results: A sample dilution of 1:115 and a total assay time of 11 minutes for the UG LS test were used for identifying recently infected individuals. The UG LS method correctly classified 88.4% of recent infections and most were confirmed when tested with the EIA S/LS. Use of the algorithm increased enrollment of subjects nearly 20-fold over p24 antigen screening and 116% over the use of an EIA S/LS method.
Conclusions: A rapid HIV assay and an appropriate testing algorithm have been developed and validated that can reliably identify persons with recent HIV infection. This rapid S/LS strategy can significantly minimize loss to follow-up, thereby increasing enrollment of cases into intervention programs. The rapid method is equivalent in performance to other S/LS methods.
Implications for Programs: This testing strategy can assist programs in identifying persons recently infected with HIV for follow-up interventions.
Implications for Research: Identification of recent HIV infection can assist in incidence estimates and natural history studies.
Contact Information: Niel Constantine / email@example.com
HIV Assays Move to the Next Generation: Rapid Confirmation of Infection
N Constantine, F Ketema, K Kreisel
Department of Pathology, University of Maryland School of Medicine, Baltimore, MD
Background: Current HIV confirmatory assays are cumbersome to perform, have long turn-around times, and require instrumentation.
Objective: To investigate the ability of two prototype rapid confirmatory HIV assays to accurately classify confirmed HIV positive samples.
Methods: Two rapid HIV assays, the Quix Rapid HIV Confirmatory assay (Quix), which uses recombinant and synthetic peptide antigens in a flow-through format, and the BIONOR HIV Confirmatory Test (BIONOR), which uses synthetic peptide antigens on magnetic particles, were evaluated against 849 and 631 samples, respectively; all had been well-characterized using Western blot (WB) assays. Greater than 85% of the samples were HIV WB-confirmed positive, while the remaining had negative or indeterminate results. The analytical sensitivity of the rapid confirmatory assays was assessed using HIV-1 seroconversion panels.
Results: Both the Quix and BIONOR assays exhibited 100% sensitivity using confirmed positive samples, and were 87–90% concordant with samples having WB inconclusive or negative results. The sensitivity for confirming recent seroconversion was as good, or better than the FDA-licensed HIV-1 WB assay in 10/13 panels for Quix, and in 1/1 panel for BIONOR. Both rapid tests exhibited excellent precision and reproducibility.
Conclusion: We conclude that these rapid HIV confirmatory assays have demonstrated proof of principle for the accurate confirmation of HIV-1 infection, can offer specific results in a short turn-around time, and have important applications in a variety of testing situations.
Implications for Programs/Policy: Both assays have applications for providing definitive test results in a clinically relevant time frame (e.g., occupational exposure, women in labor, etc.), and are especially useful in developing nations where resources are less than optimal.
Implications for Research: Being the first of their kind, these two rapid tests can serve as models for other rapid confirmatory assays, eliminating the tedious and relatively sophisticated procedures associated with current HIV confirmatory assays.
Contact Information: Niel Constantine / firstname.lastname@example.org
How Well Do Rapid HIV Tests Detect Seroconverters?
B Branson, N Meredith, J Mei, H Hannon
Centers for Disease Control and Prevention, Atlanta, GA
Background: Several newer rapid HIV tests have become available that are easy to perform, require little technical expertise, and provide results in 20 minutes or less.
Objective: Evaluate how well newer rapid HIV tests detect seroconverters compared with the EIA and Western blot.
Methods: Three commercial seroconversion panels (Boston Biomedica, Inc.) were tested with three different EIAs (Abbott, Organon Teknika (OT), and Genetic Systems), three Western blot (WB) kits (BioRad, Epitope, and Cambridge), and eight rapid HIV tests (Determine, Hemastrip, MedMira, MultiSpot, OraQuick, Quix, SUDS, and Unigold.)
Results: On the first seroconversion panel, all rapid tests except Quix were reactive at the same bleed as the EIAs (84 days since first bleed.) On this specimen, the BioRad WB was positive but the other two WBs were indeterminate. The second seroconversion panel was unusual, in that the Abbott EIA remained positive, but the other two EIAs reverted to negative and only the Cambridge WB was ever positive. Determine and MultiSpot were reactive with all specimens that were reactive with the Abbott EIA. MedMira, OraQuick, and Unigold were positive on some (but not all) Abbott-positive specimens, and Hemastrip, Quix, and SUDS were negative on all. With the third seroconversion panel, five rapid tests (Determine, Hemastrip, OraQuick, MultiSpot, and Unigold) were positive one bleed sooner than were the Abbott and OT EIAs, when the Western blot was still negative (28 days since first bleed); MedMira, Quix, and the Abbott and OT EIAs were positive at the next bleed (33 days since first bleed), and SUDs and the Genetic Systems EIA, one bleed later (35 days after first bleed.)
Conclusions: Except for Quix and SUDS, the rapid HIV tests detected HIV seroconversion as soon as or sooner than the EIAs.
Implications for Programs/Policy: Rapid HIV tests are as reliable as EIAs for screening.
Accuracy of Newer Rapid Tests for HIV Antibody
B Branson1, A Uniyal2, C Fridlund1, T Granade1, P Kerndt2
1Centers for Disease Control and Prevention, Atlanta, GA; 2Los Angeles STD Control Program, LA, CA
Background: Several newer rapid HIV tests have become available that are easy to perform, require little technical expertise, and provide results in 20 minutes or less.
Objective: Evaluate the sensitivity and specificity of three one-step rapid HIV tests (Determine, Oraquick, and Unigold) and three multiple-step rapid tests (MedMira, Multispot, and SUDS) in clinic settings where they are likely to be used.
Methods: Persons seeking HIV testing were recruited for the study from an STD clinic and an HIV testing site in Los Angeles. Determine, OraQuick, MedMira, and Unigold were performed on whole blood. OraQuick was also performed on oral fluids, and MultiSpot and SUDS were used with plasma. Test results were compared with EIA/Western blot.
Results: Of the 816 participants, 35 (4.2%) tested positive by EIA/Western blot. All 35 HIV-positive persons were correctly identified by Determine, OraQuick (both whole blood and oral fluid) and Multispot (sensitivity = 100 %.) The FDA-approved SUDS was false-negative with one specimen (sensitivity 97.1%), MedMira with two (sensitivity 94.1%), and Unigold, four (sensitivity 87.9%). No false-positive results occurred with Determine or MultiSpot (specificity 100 %.) The specificity of OraQuick (blood) was 99.9%; OraQuick (oral fluid), 99.6%; Unigold, 99.7%; and MedMira, 98%.
Conclusions: Three of the six rapid tests demonstrated excellent sensitivity and specificity, better than that of the FDA-approved SUDS test. Two of these (Determine and OraQuick) are one-step rapid tests that are easy to perform with whole blood or oral fluids.
Implications for Programs/Policy: Point-of-care testing appears to be feasible with several different rapid tests that are accurate and suitable for clinics with minimal laboratory facilities.
Implications for Research: Evaluations in low prevalence settings need to be conducted to determine which combination of these rapid tests has the best positive predictive value.
Quality Control for HIV Rapid Tests
J Mei1, N Meredith1, D Kothe1, B Branson2, WH Hannon1
1Division of Laboratory Sciences, and 2Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA
Background: There are numerous rapid HIV test devices available on the world market. The function of many devices is validated by internal controls, where a visible line or spot indicates that the device is working and the test has been performed correctly. The use of external quality control materials is good laboratory practice because it further minimizes erroneous results due to improper use or device failure. Though some tests provide external HIV controls, many do not. CDC conducted experiments to investigate the optimal characteristics for external HIV quality control materials to be used with rapid HIV test devices.
Objective: To characterize serum-based, external quality control materials for use with rapid HIV test devices.
Methods: HIV rapid test devices were acquired by CDC for investigation. Manufacturers’ directions for the testing of human serum were followed for each device. Commercial HIV-1 serum controls and pooled sera from HIV-positive donors were tested neat, and at specific dilutions prepared with either human serum or an HIV-negative, commercially available base matrix to obtain the greatest dilution that still gave a positive response. Both undiluted HIV controls and the dilutions were also tested with two commercially available enzyme immunoassay (EIA) and Western blot kits. The performance of individual rapid tests with HIV-positive controls were compared to EIA results and Western blot patterns.
Results: Eight different rapid tests were used for the evaluation. No one HIV-positive serum control material performed in the same way with all rapid test devices. All devices gave a positive response with undiluted controls. Most tests were reactive with dilutions >1:40. One device was quite sensitive, and was still reactive at dilutions >1:1280 and beyond with some of the control materials. Almost all of the rapid devices were more sensitive than the two EIAs, i.e., still reactive with dilutions of HIV-positive controls that were hundreds of times more dilute than those at which the EIAs were no longer reactive.
Conclusions: External HIV quality control materials can be designed for use with HIV rapid tests. To ensure a device is accurate, the concentration of an optimal control material should be close to the limit of the sensitivity of the device. Because the different rapid tests exhibit different sensitivities, one control material may not work equally well with multiple devices.
Effect of Testing Site on Client Satisfaction with Rapid HIV Tests
A Uniyal1, LV Smith1, B Branson2, B Bolan3, T Horton3, JL Chen1, T Woerhrle4, P Kerndt1
1Los Angeles County Sexually Transmitted Disease Program, Los Angeles, CA; 2Centers for Disease Control and Prevention, Atlanta, GA; 3Los Angeles Gay and Lesbian Center, Los Angeles, CA; 4University of Southern California, Los Angeles, CA
Background: Rapid HIV testing allows same-day results, increasing the number of persons who learn their HIV status. Understanding how clients perceive rapid testing can increase acceptance of HIV screening.
Objective: Evaluate client perceptions of rapid testing differ at testing sites.
Methods: Two hundred thirty-six clients at a public STD clinic and 1,106 at a community-based testing site (the Los Angeles Gay and Lesbian Center [LAGLC]) who agreed to a rapid HIV test completed post-test client satisfaction questionnaires.
Results: Participants were 81% male, 54% white, 10% black, and 25% Latino; 87% had been tested previously. HIV prevalence was 3% at the STD clinic and 5% at LAGLC. Demographic and behavioral characteristics differed at the two sites; STD clinic patients were more likely to be black or Latino, heterosexual women, first-time testers, and to perceive their HIV risk as low. More persons at LAGLC were MSM or WSW. In logistic regression, STD clinic participants were more likely to find testing stressful (OR 1.7, 95% CI: 1.22, 2.38). STD clinic patients (OR 2.15, 95% CI: 1.45, 3.19), blacks (OR 2.26, 95% CI: 1.32, 3.86), Latinos (OR 5.32, 95% CI: 3.69, 7.67), and persons testing for the first time (OR 1.64, 95% CI: 1.05, 2.56) felt they received results too quickly, but only Latinos thought it would be better to wait a week for results (OR 2.54, 95% CI: 1.54, 4.07).
Conclusion: Some patients at STD clinics and minorities perceived HIV testing to be stressful. It is unclear whether rapid testing increases this stress, given that few persons would prefer waiting a week for results.
Implications for Programs: Screening programs need customized approaches for counseling at different testing sites to minimize stressful consequences of rapid testing.
Implications for Research: Further research in different populations is required to design optimal counseling strategies.
1. Participants will be able to identify how testing site may affect client satisfaction with rapid HIV testing. 2. Participants will be able to describe other potential barriers to client satisfaction with rapid HIV testing.
Contact information: Lisa V. Smith / Phone 213-744-3093 / email@example.com
New York State’s Experience with Assessment of Waived Testing and PPMP Practices: Are We Ready for Waived HIV Antibody Tests?
LM Clarke, R Jenny, S Shulman, A Reilly, C Olsen
New York State Department of Health, Wadsworth Center, Albany, New York
Background: New York State (NYS), a CLIA-exempt state, conducted a study as part of CDC’s Laboratory Sentinel Monitoring Network to assess testing practices among sites designated as Limited Service Laboratories (LSLs). These are point of care testing sites, other than physician offices, that are limited to waived assays or provider performed microscopy procedures (PPMP). Although NYS has provided regulatory oversight to comprehensive clinical laboratories since 1965, it is only since 1996 that the program has begun registration and assessment of LSLs.
Objectives: To determine the type and extent of oversight necessary, practical and feasible for waived and PPMP sites.
Methods: Selection criteria included geographical location, facility type, test volume and affiliation or lack of affiliation with a NYS-permitted laboratory. Data were collected using questionnaires developed to obtain information describing testing and quality assurance (QA) practices.
Results: Between September 2000 and September 2001 on-site surveys were conducted in 495 of the nearly 3,000 LSLs. Greater than half of the sites consisted of nursing facilities and clinics; nurses performed more than 80% of the testing. The five waived assays most frequently performed were blood glucose (83%), urinalysis (60%), occult blood (47%), urine hCG (38%) and strep antigen (20%). A large proportion of sites lacked adequate procedural and QA practices. Among non-affiliated LSLs, 40% and 68% did not perform manufacturer’s recommended quality control for glucometer and urinalysis testing, respectively.
Implications for Programs/Policy: Findings raise concern for the quality of waived testing performed in settings not typically staffed by professional laboratorians and also underscore the need to provide adequate oversight and training opportunities. The desire to increase access by promoting waiver of additional tests, including HIV antibody tests, heightens the need to reassess current regulatory requirements for waived tests.
Implications for Research: The findings support the need to identify and implement training and oversight strategies that will effectively raise the level of QA practices in these settings.
Contact Information: Lorraine M. Clarke / 518-485-5357 / firstname.lastname@example.org
Trends in STD Diagnostic Technologies in California, 1996-2000
G Gould, M Kang, T Bobo, H Bauer, J Montes, R Tulloch, G Bolan, M Samuel
California Department of Health Services, Sexually Transmitted Disease Control Branch, Berkeley, CA
Background: Monitoring laboratory practices and diagnostic testing allows sexually transmitted disease (STD) control programs to verify disease trends, note changes in types and volume of testing, address laboratory and reporting procedures, and evaluate control programs.
Objectives: To describe changes in diagnostic testing and technology among California laboratories performing STD tests.
Methods: In 1996, 1997, 1999, and 2000, a state-wide, self-administered survey of STD diagnostic test utilization was distributed to all California laboratories that reported performing STD tests. The volume of tests performed with different technologies for each reportable STD and several non-reportable STDs were summed and compared between surveys, by type of laboratory.
Results: Yearly surveys were sent to all laboratories performing STD diagnostic tests, of which over 97% responded. Thirty to forty percent of STD tests were performed in freestanding private facilities and only 9 to 11 percent in public health facilities. The overall volume of chlamydia and gonorrhea testing has increased from 1996 to 2000. In addition, the proportion of testing done with nucleic acid amplification methods for both chlamydia and gonorrhea increased, from 4.9% to 37.6% and from 0.6% to 32.9% respectively.
Conclusions: Yearly laboratory surveys afford the opportunity to measure changes in test technologies being used, to identify high volume laboratories, and to identify laboratories using procedures no longer recommended. Furthermore, increases in the volume of chlamydia testing and the use of more sensitive tests provide evidence for the success of programs that promote screening and amplified testing. These findings can also aid in the interpretation of concurrent increases in chlamydia and gonorrhea disease reporting.
Implications for Programs/Policy: Communicating survey findings provides opportunities to give specific feedback to laboratories. Changes in test technology and the rate at which individual laboratories adopt them may affect reported morbidity. Laboratory surveys can be a useful way for programs to monitor these changes.
Implications for Research: Research is needed on the impact of changing test technology on disease incidence trends. Laboratory surveys can help to determine if morbidity changes are related to true increases in disease or due to the use of more sensitive test technologies used by laboratories.
Learning Objectives: Participants will be able to describe changes in California STD laboratory methods. Participants will also be able to discuss the importance of monitoring laboratory practices.
Contact Information: Gail Gould / 916-327-0944 / email@example.com
Performance of the Gen-Probe® APTIMA® Combo 2 Semi-Automated Assay for Chlamydia trachomatis and Neisseria gonorrhoeae on the DTS 1600 (Direct Tube Sampling) System
DH Green1, DA Reed2
1Philadelphia Department of Public Health, Philadelphia, PA; 2Gen-Probe Incorporated, San Diego, CA
Background: The Gen-Probe APTIMA Combo 2 (AC2) assay was recently cleared by the FDA for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in swabs and urine specimens from both symptomatic and asymptomatic males and females. The AC2 assay is a multiplex, nucleic acid amplification test that detects both organisms simultaneously with no need for reflex testing.
Objective: To improve laboratory ease-of-use and increase assay throughput, we have adapted the assay to be used on the DTS 1600 automated liquid handling instrument, which performs sample preparation steps including specimen transfer and reagent transfers.
Methods: The DTS 1600 system was compared with the manual assay using 500 swab and urine specimens at two different sites. Some specimens were spiked with GC and CT RNA.
Results: Comparison of the DTS 1600 with the manual assay showed equivalent assay performance. There were no false-positive results, indicating that the instrument does not cause cross-contamination. Throughput using the DTS 1600 system is 792 specimens in less than eight hours, yielding 792 CT results and 792 GC results.
Conclusions: Performance of the AC2 assay on the semi-automated DTS 1600 system is equivalent to the manual assay.
Implications for Programs: The semi-automated AC2 assay can efficiently be used by clinical laboratories for highly sensitive detection of CT and GC in urine and urogenital swab samples.
Implications for Research: Future research should concentrate on achieving full automation of this assay and expanding the types of samples that can be tested by this assay.
The Lack of Sensitivity of the Leukocyte Esterase Test (LET) in Detecting Chlamydial Infections in Men Entering Jails in Massachusetts
S Ratelle1, M Nguyen1, M Whelan1, P Etkind1, B Dumas1, Y Tang1, P Rocheford2
1Division of STD Prevention, Massachusetts Department of Public Health, Boston, MA; 2Hampden County Jail, Springfield, MA
Background: The LET is a simple, inexpensive tool for screening urine samples in men to identify urethritis, which may be due to Chlamydia trachomatis (Ct). Although nucleic acid amplification tests (NAATS) are extremely sensitive and specific for Ct, the LET has been investigated as an initial screening step to reduce the need for NAATs and thereby reduce the overall cost of testing.
Objectives: To assess the usefulness of the LET in the development of a screening strategy for Ct in men in correctional facilities (CF).
Methods: Between January 1, 2000, and December 31, 2000, 2,191 men entering a jail in Springfield, Massachusetts were tested simultaneously on first-void urine for Ct by the LCR and for urethral inflammation by the LET.
Results: The prevalence of Ct among all males was 5.2% (115/2191). The sensitivity, specificity, positive predictive value, and negative predictive value for the LET in identifying Ct were 7% (8/115), 98.3% (2040/2076), 18.2% (8/44), and 95% (2040/2147), respectively. Among Ct cases, the LET identified 0% (0/13), 7% (6/84), and 0% (0/36), of men aged >30, aged 21–25, and aged <20, respectively.
Conclusions: In this CF, the LET is not helpful as a preliminary screening tool for Ct due to the high rate of false negatives. Even as an initial screening test in older (age >30) populations in which universal screening for Ct may not be cost-effective, the sensitivity of the LET is so low that using behavioral predictors may be more informative.
Implications for Policy: This study suggests that, in the correctional setting, the LET is not a useful screening tool to detect chlamydial infections.
Implications for Research: More studies are needed to assess the performance of the LET in other correctional facilities. Factors contributing to the poor performance of the LET need to be investigated.
Learning Objectives: Participants will be able to describe the test performance characteristics of the LET for detecting chlamydial infections among men entering a jail in Massachusetts.
Evaluation of Vaginal Swab
Specimens in the APTIMA® Combo 2 Assay for Detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC)
M Mauricio, M Bott, M Castillo, S Turner, J Shaw
Gen-Probe, San Diego, CA
Background: The APTIMA Combo 2 Assay (AC2) has been shown to have excellent performance with endocervical, male urethral, and urine specimens, and is newly FDA-cleared. Extending the AC2 assay to include vaginal swab specimens will provide an option for less invasive and costly specimen collection. Self-collection of vaginal swabs is reported to be easy to perform and is well accepted by women.
Objectives: To determine the analytical performance of vaginal swab specimens in the AC2.
Methods: Interfering substances (blood, white blood cells, gynecological products, and non-target organisms) were tested in CT- and GC-spiked, self-collected vaginal specimens. CT and GC target detection was demonstrated by spiking rRNA into vaginal swab specimens. A target stability study at 2°C to 30°C was conducted.
Results: The non-target organisms tested did not interfere with target signal recovery. None of the 11 known and potentially interfering gynecological products, blood, or white blood cells interfered with AC2 performance at any of the normal and excessive levels tested. Target detection was demonstrated at 5 fg CT and 250 fg GC. Target stability of 60 days at 2°C to 30°C was achieved.
Conclusions: Based on these data, APTIMA Combo 2 analytical performance with vaginal swab specimens mirrors that demonstrated with traditional urogenital specimens.
Implications for Programs/Policy: Easier, less invasive specimen collection yields opportunities to reach more patients and populations than do current methods.
Implications for Research: Clinical performance comparisons and patient acceptance/preference studies on the various female specimens are likely next steps.